Centratex

vitamins and minerals

Dosage Form: capsule
Centratex

Capsules

Capsules

Iron 106 mg, Sodium Ascorbate 200 mg, Thiamine 10 mg, Riboflavin 6 mg, Pyridoxine 5mg, Folic Acid 1 mg, Cyanocobalamin 15 mcg, Niacinamide 30 mg, Pantothenic Acid 10 mg, Zinc 18.2 mg, Magnesium 6.9 mg

Copper (Copper sulfate)	0.8 mg
Manganese (Manganese Sulfate)	1.3 mg

A medical food, for use only under the direction and supervision of a licensed physician.

RX only

Centratex Description

Active Ingredients (Each capsule)

Ferrous Fumerate	106 mg(Iron)
Vitamin C (Sodium Ascorbate)	200 mg
Vitamin B1 (Thiamine Mononitrate)	10 mg
Vitamin B2 (Riboflavin)	6 mg
Vitamin B6 (Pyridoxine HCL)	5 mg
Folic Acid	1 mg
Vitamin B12	15 mcg
Niacinamide	30 mg
Pantothenic Acid	10 mg
Zinc (Zinc Sulfate)	18.2 mg
Magnesium (Magnesium Sulfate)	6.9 mg
Copper (Copper Sulfate)	0.8 mg
Manganese (Manganese Sulfate)	1.3 mg

Inactive Ingredients

Microcrystalline Cellulose, Silica, Magnesium Stearate, Gelatin Capsule

INDICATIONS

For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.

Contraindications

Centratex is contraindicated in patients with a known hypersensitivity to any of its ingredients. Iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, and hemolytic anemias. Folic acid may obscure signs and symptoms of pernicious anemia and is therefore a contraindication as well.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Iron is toxic and has been shown to cause severe reactions in children including death.

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

Precautions

General

Folic acid in doses above 0.1 mg – 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

PEDIATRIC USE

Safety and effectiveness in pediatric patients has not been established.

GERIATRIC USE

No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly persons may have decreased hepatic, renal, or cardiac function.

ADVERSE REACTION

Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving Centratex shortly after meals.

Centratex Dosage and Administration

Adults only: 1 capsule daily between meals, orally. Not recommended in children.

How is Centratex Supplied

Centratex is supplied as a natural gelatin capsule with tan speckled powder. Centratex is available in bottles of 100 (NDC 23359-100-10) and bottles of 30 (NDC 23359-100-30) Dispense in a tight, light resistant container as defined in the USP/NF with a child resistant closure. Store at room temperature between 15-30 degrees C (59-86 degrees F) Keep in a cool, dry place.

RX ONLY

Centurion Labs, LLC

Birmingham, AL 35243

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 23359-100-10

Centratex

Iron (Ferrous Fumarate, anhydrous)	106 mg
Vitamin C (Sodium Ascorbate)	200 mg
Vitamin B1 (Thiamine Mononitrate)	10 mg
Vitamin B2 (Riboflavin)	6 mg
Vitamin B6 (Pyridoxine HCl)	5 mg
Vitamin B12 (Cyanocobalamin Concentrate)	15 mcg
Folic Acid	1 mg
Niacinamide (Nicotinamide)	30 mg
Pantothenic Acid (Calcium Pantothenate)	10 mg
Zinc (Zinc Sulfate)	18.2 mg
Magnesium (Magnesium Sulfate)	6.9 mg
Manganese (Manganese Sulfate)	1.3 mg
Copper (Copper Sulfate)	0.8 mg

CENTURION LABS

Rx Only

Net Contents: 100 capsules

Centratex  iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, niacinamide, calcium pantothenate, zinc sulfate, magnesium sulfate, manganese sulfate, and cupric sulfate anhydrous  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23359-100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iron (Iron) Iron 106 mg Sodium Ascorbate (Sodium Cation) Sodium Ascorbate 200 mg Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 10 mg Riboflavin (Riboflavin) Riboflavin 6 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 5 mg Folic Acid (Folic Acid) Folic Acid 1 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 15 ug Niacinamide (Niacinamide) Niacinamide 30 mg Calcium Pantothenate (Pantothenic Acid) Calcium Pantothenate 10 mg Zinc Sulfate (zinc) Zinc Sulfate 18.2 mg Magnesium Sulfate (Magnesium) Magnesium Sulfate 6.9 mg Manganese Sulfate (Manganese) Manganese Sulfate 1.3 mg Cupric Sulfate Anhydrous (Copper) Cupric Sulfate Anhydrous 0.8 mg

Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline   Silicon Dioxide   Magnesium Stearate   Gelatin

Product Characteristics Color BROWN (clear with tan speckled powder) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23359-100-10 100 TABLET In 1 BOTTLE None 2 23359-100-30 30 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/14/2009

Labeler - Centurion Labs (806756461)

Revised: 01/2010Centurion Labs

More Centratex resources

• Centratex Side Effects (in more detail)
• Centratex Dosage
• Centratex Use in Pregnancy & Breastfeeding
• Centratex Drug Interactions
• Centratex Support Group
• 0 Reviews for Centratex - Add your own review/rating

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Compare Centratex with other medications

• Vitamin/Mineral Supplementation and Deficiency

Savlon First Aid Wash 0.5% w / v Cutaneous Spray

1. Name Of The Medicinal Product

Savlon® First Aid Wash 0.5% w/v Cutaneous Spray, Solution.

2. Qualitative And Quantitative Composition

Cetrimide 0.5 % w/v

3. Pharmaceutical Form

Cutaneous spray, solution (Cutaneous spray)

4. Clinical Particulars

4.1 Therapeutic Indications

For cuts, grazes, insect bites, minor wounds, spots, minor burns and scalds.

4.2 Posology And Method Of Administration

For topical application.

Adults, children and the elderly

Hold upright and spray from a distance of 2 to 4 inches on the affected area.

Spray the affected area two or three times a day.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Prolonged and repeated administration may lead to hypersensitivity.

Do not use if the skin is weeping or badly inflamed.

Avoid contact with the eyes.

For external use only.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no clinically significant interactions.

4.6 Pregnancy And Lactation

The safety of First Aid Antiseptic Spray during pregnancy and lactation has not been established but it is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Skin irritation may occasionally occur and hypersensitivity reactions may develop in certain individuals.

4.9 Overdose

It is unlikely that systemic toxicity will result from the ingestion of First aid Antiseptic Spray, although it may give rise to gastrointestinal irritation.

Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cetrimide is a quaternary ammonium disinfectant having bactericidal activity against both gram-positive and gram-negative organisms.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium citrate

Anhydrous citric acid

Di-Sodium edetate

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None stated

6.5 Nature And Contents Of Container

Polythene bottle 100 ml with plastic spray pump of 50 microlitre dosage.

6.6 Special Precautions For Disposal And Other Handling

Hold upright and spray from a distance of 2 to 4 inches on the affected area.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/0507

9. Date Of First Authorisation/Renewal Of The Authorisation

11 April 1997

10. Date Of Revision Of The Text

February 2011

LEGAL CATEGORY

GSL

calcitriol

Generic Name: calcitriol (vitamin D3) (kal si TRYE ol)

Brand names: Rocaltrol, Calcijex

What is calcitriol?

Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

Calcitriol is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.

Calcitriol is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.

Calcitriol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about calcitriol?

You should not use this medication if you have high levels of calcium or vitamin D in your blood, or if you have ever had an allergic reaction to calcitriol or other forms of vitamin D. Drink plenty of fluids unless your doctor has told you to restrict your fluid intake. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance. Do not take other vitamin or mineral supplements unless your doctor has told you to. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb calcitriol.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Calcitriol is only part of a complete program of treatment that may also include a special diet. Follow your diet and medication routines very closely. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

What should I discuss with my healthcare provider before taking calcitriol?

You should not use this medication if you have high levels of calcium or vitamin D in your blood, or if you have ever had an allergic reaction to calcitriol or other forms of vitamin D.

To make sure you can safely take calcitriol, tell your doctor about all of your medical conditions.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Calcitriol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take calcitriol?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink plenty of fluids unless your doctor has told you to restrict your fluid intake. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Calcitriol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

If you need to be on bed-rest or have any type of surgery, your dose or testing needs may change. Follow your doctor's instructions. Store at room temperature away from moisture, light, and heat.

See also: Calcitriol dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking calcitriol?

Do not take other vitamin or mineral supplements unless your doctor has told you to. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb calcitriol.

Calcitriol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using calcitriol and call your doctor at once if you have a serious side effect such as:

• 
  

  weakness, headache, drowsiness;

  
  


• 
  

  nausea, vomiting, stomach pain, constipation;

  
  


• 
  

  loss of appetite;

  
  


• 
  

  dry mouth, increased thirst;

  
  


• 
  

  metallic taste in your mouth;

  
  


• 
  

  urinating more than usual;

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  changes in behavior;

  
  


• 
  

  muscle pain, bone pain, muscle weakness, loss of height;

  
  


• 
  

  slow growth (in a child taking calcitriol); or

  
  


• 
  

  severe pain in your upper stomach spreading to your back.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Calcitriol Dosing Information

Usual Adult Dose for Hypocalcemia:

Oral
Initial dose: 0.25 mcg orally once a day.
Maintenance dose: May increase by 0.25 mcg/dose at 4 to 8 week intervals.

Parenteral
Initial dose: 0.5 mcg IV 3 times a week.
Maintenance dose: May increase by 0.25 to 0.5 mcg/dose at 2 to 4 week intervals.

Usual Adult Dose for Renal Osteodystrophy:

Oral
Initial dose: 0.25 mcg orally once a day.
Maintenance dose: May increase by 0.25 mcg/dose at 4 to 8 week intervals.

Parenteral
Initial dose: 0.5 mcg IV 3 times a week.
Maintenance dose: May increase by 0.25 to 0.5 mcg/dose at 2 to 4 week intervals.

Usual Adult Dose for Hypoparathyroidism:

Initial dose: 0.25 mcg orally once a day in the morning.
Maintenance dose: May increase by 0.25 mcg/dose at 2 to 4 week intervals. Most patients respond to 0.25 to 2 mcg once a day.

Usual Adult Dose for Rickets:

1 mcg orally once a day

Usual Adult Dose for Secondary Hyperparathyroidism:

Predialysis patients: 0.25 mcg orally once a day in the morning.

Dialysis patients: 0.25 mcg orally once a day in the morning. Increase dose, if needed, by 0.25 mcg/dose at 2 to 4 week intervals. For some patients 0.25 mcg orally every other day may be enough. Most patients respond to doses of 0.25 to 1 mcg once a day. Alternatively, 0.5 to 4 mcg IV may be administered three times per week at the end of each dialysis.

Pulse oral therapy:
Study (n=5), patients on Continuous Ambulatory Peritoneal Dialysis:
5 mcg orally given twice per week.
Study (n=19), patients on hemodialysis:
4 mcg orally given twice per week.

Usual Pediatric Dose for Hypoparathyroidism:

Less than 1 year: 0.04 to 0.08 mcg/kg orally once a day.

1 to 5 years: 0.25 to 0.75 mcg orally once daily. May increase by 0.25 mcg/dose at 2 to 4 week intervals.

Greater than or equal to 6 years: 0.5 to 2 mcg. May increase by 0.25 mcg/dose at 2 to 4 week intervals.

Usual Pediatric Dose for Rickets:

Vitamin D dependent rickets: 1 mcg orally once a day.

Vitamin D resistant rickets (familial hypophosphatemia): Initial: 0.015 to 0.02 mcg/kg orally once daily; maintenance: 0.03 to 0.06 mcg/kg orally once daily; maximum dose: 2 mcg once daily.

Usual Pediatric Dose for Hypocalcemia:

Hypocalcemia secondary to hypoparathyroidism:
Neonates: 1 mcg orally once daily for the first 5 days of life, or 0.02 to 0.06 mcg/kg/day.

Hypocalcemic tetany:
Neonates: 0.05 mcg/kg IV once daily for 5 to 12 days or 0.25 mcg orally once daily followed by 0.01 to 0.10 mcg/kg/day divided in 2 doses daily
(maximum daily dose: 2 mcg).

Management of hypocalcemia in patients with chronic kidney disease (CKD): Indicated for therapy when serum levels of 25(OH)D are greater than 30 ng/mL (75 nmol/L) and serum levels of intact parathyroid hormone (iPTH) are above the target range for the stage of CKD; serum levels of corrected total calcium are less than 9.5 to 10 mg/dL and serum levels of phosphorus are less than age appropriate upper limits of normal (ULN).

Children and Adolescents: CKD Stages 2 to 4:

Less than 10 kg: 0.05 mcg orally every other day.
10 to 20 kg: 0.1 to 0.15 mcg orally daily.
Greater than 20 kg: 0.25 mcg orally daily.

If iPTH decrease is less than 30% after 3 months of therapy and serum levels of calcium and phosphorus are within the target ranges based upon the CKD Stage, increase dosage by 50%.

If iPTH decrease is less than the target range for CKD stage, hold calcitriol therapy until iPTH increases to above target range; resume therapy at half the previous dosage (if dosage is less than 0.25 mcg capsule or 0.05 mcg liquid, use every other day therapy).

If serum levels of total corrected calcium exceed 10.2 mg/dL, hold calcitriol therapy until serum calcium decreases to less than 9.8 mg/dL; resume therapy at half the previous dosage (if dosage is less than 0.25 mcg capsule or 0.05 mcg liquid, use every other day therapy).

If serum levels of phosphorus increase to greater than the age appropriate upper limits, hold calcitriol therapy (initiate or increase phosphate binders until the levels of serum phosphorus decrease to age appropriate limits); resume therapy at half the previous dosage.

Children and Adolescents with CKD Stage 5: Serum calcium times phosphorus product (Ca x P) should not exceed 65 mg(2)/dL(2) for infants and children less than 12 years of age and 55 mg(2)/dL(2) for adolescents, serum phosphorus should be within target, serum calcium less than 10 mg/dL.

iPTH 300 to 500 pg/mL: 0.0075 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 0.25 mcg daily.

iPTH greater than 500 to 1000 pg/mL: 0.015 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 0.5 mcg daily.

iPTH greater than 1000 pg/mL: 0.025 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 1 mcg daily.

Dosage adjustment: If iPTH decrease is less than 30% after 3 months of therapy and serum levels of calcium and phosphorus are within the target ranges based upon the CKD Stage 5, increase dosage by 50%.

What other drugs will affect calcitriol?

Tell your doctor about all other medicines you use, especially:

• 
  

  digoxin (digitalis, Lanoxin, Lanoxicaps);

  
  


• 
  

  cholestyramine (Questran, Prevalite);

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  lanthanum (Fosrenol);

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);

  
  


• 
  

  steroids such as prednisone, fluticasone (Advair, Flovent), mometasone (Asmanex, Nasonex), dexamethasone (Cortastat, DexPak, Decadron) and others; or

  
  


• 
  

  a (water pill) diuretic such as hydrochlorothiazide (HCTZ, Esidrix, Hydrodiuril, Microzide,Oretic), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

  
  

This list is not complete and other drugs may interact with calcitriol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More calcitriol resources

• Calcitriol Dosage
• Calcitriol Use in Pregnancy & Breastfeeding
• Drug Images
• Calcitriol Drug Interactions
• Calcitriol Support Group
• 4 Reviews for Calcitriol - Add your own review/rating

• Calcitriol Prescribing Information (FDA)


• Calcitriol Professional Patient Advice (Wolters Kluwer)


• Calcitriol Monograph (AHFS DI)


• Calcitriol MedFacts Consumer Leaflet (Wolters Kluwer)


• Calcijex Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Calcijex Prescribing Information (FDA)


• Rocaltrol Prescribing Information (FDA)


• Rocaltrol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare calcitriol with other medications

• Hypocalcemia
• Hypoparathyroidism
• Renal Osteodystrophy
• Rickets
• Secondary Hyperparathyroidism

Where can I get more information?

• Your pharmacist can provide more information about calcitriol.

Vicks Formula 44M

Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Children's Tylenol Flu, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M

What is Vicks Formula 44M (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medication?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking this medication?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  cough with mucus, or cough caused by emphysema or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Vicks Formula 44M (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed thoroughly before you swallow it.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking this medication?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medication side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats, severe restless feeling or nervousness;

  
  


• 
  

  mood changes, confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  feeling short of breath;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  constipation or diarrhea;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  feeling nervous or restless.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Vicks Formula 44M (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medicines you use, especially:

• 
  

  leflunomide (Arava);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  bladder or urinary medications;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a bronchodilator;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Vicks Formula 44M resources

• Vicks Formula 44M Side Effects (in more detail)
• Vicks Formula 44M Use in Pregnancy & Breastfeeding
• Vicks Formula 44M Drug Interactions
• Vicks Formula 44M Support Group
• 1 Review for Vicks Formula 44M - Add your own review/rating

• Vicks Formula 44M Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vicks Formula 44M with other medications

• Cold Symptoms
• Influenza

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Vicks Formula 44M side effects (in more detail)

Vagifem 10 micrograms vaginal tablets

1. Name Of The Medicinal Product

Vagifem 10 micrograms vaginal tablets.

2. Qualitative And Quantitative Composition

Each vaginal tablet contains:

Estradiol hemihydrate equivalent to estradiol 10 micrograms.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal tablet.

White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1).

The experience treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Vagifem is administered intravaginally using the applicator.

Initial dose: One vaginal tablet daily for two weeks.

Maintenance dose: One vaginal tablet twice a week.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

A switch to the higher dose product Vagifem 25 micrograms should be considered if the response after three months is insufficient for satisfactory symptom relief.

Vagifem may be used in women with or without an intact uterus.

During treatment, especially during the first two weeks of daily administration, minimal systemic absorption may occur but as plasma estradiol levels usually do not exceed normal postmenopausal levels the addition of a progestagen is not recommended.

Vaginal infections should be treated before start of the Vagifem therapy.

Administration:

1. Open the blister pack at the plunger end.

2. Insert the applicator in the vagina until resistance is met (8-10 cm).

3. Release the tablet by pressing the plunger.

4. Withdraw the applicator and discard.

4.3 Contraindications

• Known, past or suspected breast cancer

• Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal

• Known hypersensitivity to the active substances or to any of the excipients

• Porphyria.

4.4 Special Warnings And Precautions For Use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Medical examination/follow-up

Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during systemic oestrogen treatment, in particular:

• Leiomyoma (uterine fibroids) or endometriosis

• A history of, or risk factors for, thromboembolic disorders (see below)

• Risk factors for oestrogen dependent tumours, e.g. 1^st degree heredity for breast cancer

• Hypertension

• Liver disorders (e.g. liver adenoma)

• Diabetes mellitus with or without vascular involvement

• Cholelithiasis

• Migraine or (severe) headache

• Systemic lupus erythematosus

• A history of endometrial hyperplasia (see below)

• Epilepsy

• Asthma

• Otosclerosis.

Due to the local administration of low dose estradiol in Vagifem, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment.

Reasons for immediate withdrawal of therapy

Therapy should be discontinued in case a contra-indication is discovered and in the following situations:

• Jaundice or deterioration in liver function

• Significant increase in blood pressure

• New onset of migraine-type headache

• Pregnancy

Endometrial hyperplasia

Women with intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with Vagifem.

The risk of endometrial cancer after treatment with oral unopposed oestrogens is dependent on both duration of treatment and on oestrogen dose. The dose of estradiol in Vagifem is very low and treatment is local. A minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once daily administration (see section 5.2). No systemic effect is expected during the local oestrogen treatment with Vagifem, and the addition of a progestagen is not recommended.

As a general rule, oestrogen replacement therapy should not be prescribed for longer than one year without another physical, including gynaecological examination being performed.

If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with Vagifem.

Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

Vagifem is a locally acting low dose estradiol preparation and therefore the occurrence of the below mentioned conditions is less likely than with systemic oestrogen treatment.

Breast cancer

Systemic oestrogen or oestrogen-progestagen treatment may increase the risk of breast cancer. Relative risk of breast cancer with conjugated equine oestrogens or estradiol was greater when a progestagen was added, either sequentially or continuously, and regardless of type of progestagen. A large randomised clinical trial (WHI trial) showed no increase in breast cancer incidence in hysterectomised postmenopausal women treated with conjugated equine oestrogen alone.

Venous thromboembolism

Systemic HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.

In the oestrogen alone sub-study of WHI, the risk of VTE (DVT and pulmonary embolism (PE)) was reported to be increased for women receiving daily conjugated equine oestrogens (CEE) compared to placebo (30 versus 22 per 10,000 women-years). The occurrence of such an event is more likely in the first year of treatment than later.

Generally recognised risk factors for VTE include a personal history or family history, severe obesity (BMI>30 kg/m²) and systemic lupus erythematosus (SLE). The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4 to 6 weeks prior to surgery, if possible. Treatment should not be restarted until the woman is completely mobilised.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g., painful swelling of a leg, sudden pain in the chest, dyspnea). Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials that oestrogens or combined oestrogen-progestagen protect against coronary artery disease.

Stroke

In the WHI estrogen alone sub-study, a statistically significant increased risk of stroke was reported in women receiving daily conjugated oestrogens (CE 0.625 mg) compared to placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated after the first year of treatment and persisted.

Ovarian cancer

Use of systemic oestrogen alone and oestrogen plus progestagen therapies for at least 5-10 years has been associated with a slightly increased risk of ovarian cancer in some epidemiological studies.

Other conditions

Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed during the first weeks of treatment.

There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.

Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to a local administration of the very low dose of estradiol in Vagifem, systemic interactions of clinical relevance are not expected.

4.6 Pregnancy And Lactation

Vagifem is not indicated during pregnancy. If pregnancy occurs during medication with Vagifem, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.

Lactation

Vagifem is not indicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

No effects known.

4.8 Undesirable Effects

Adverse events from clinical trials:

More than 673 patients have been treated with Vagifem 10 micrograms in clinical trials, including over 497 patients treated up to 52 weeks.

Oestrogen–related adverse events such as breast pain, peripheral oedema and postmenopausal bleedings have been reported at very low rates, similar to placebo, with Vagifem 10 micrograms, but if they occur, they are most likely present only at the beginning of the treatment. The adverse events observed with a higher frequency in patients treated with Vagifem 10 micrograms as compared to placebo and which are possibly related to treatment are presented below.

System organ class	Common	Uncommon	Rare
Infections and infestations		Vulvovaginal mycotic infection
Nervous system disorders	Headache
Gastrointestinal disorders	Abdominal pain	Nausea
Reproductive system and breast disorders	Vaginal haemorrhage, vaginal discharge or vaginal discomfort
Skin and subcutaneous tissue disorders		Rash
Investigations		Weight increased
Vascular disorders		Hot flush Hypertension

Post-marketing experience:

In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported for patients being treated with Vagifem 25 micrograms, and are considered possibly related to treatment. The reporting rate of these spontaneous adverse reactions is very rare (<1/10,000 patient years).

• Neoplasms benign and malignant (incl. cysts and polyps): breast cancer, endometrial cancer

• Immune system disorders: generalized hypersensitivity reactions (e.g. anaphylactic reaction/shock)

• Metabolism and nutrition disorders: fluid retention

• Psychiatric disorders: insomnia

• Nervous system disorders: migraine aggravated

• Vascular disorders: deep venous thrombosis

• Gastrointestinal disorders: diarrhoea

• Skin and subcutaneous tissue disorders: urticaria, rash erythematous, rash pruritic, genital pruritus

• Reproductive system and breast disorders: endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

• General disorders and administration site conditions: drug ineffective

• Investigations: weight increased, blood oestrogen increased.

Other adverse reactions have been reported in association with systemic oestrogen treatment:

• Myocardial infarction, congestive heart disease

• Stroke

• Gall bladder disease

• Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura

• Increase in size of fibroids

• Epilepsy

• Libido disorder

• Deterioration of asthma

• Probable dementia (see section 4.4).

4.9 Overdose

Vagifem is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural and semisynthetic oestrogens, plain

ATC code: G03CA03

The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.

Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics. The biological effect of 17β-estradiol is carried out through a number of specific oestrogen receptors. The steroid receptor complex is bound to the cells DNA and induces synthesis of specific proteins.

Maturation of the vaginal epithelium is dependant upon oestrogens. Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.

Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.

A 12-month double-blind, randomized, parallel group, placebo-controlled multicenter study was conducted to evaluate the efficacy and safety of Vagifem 10 micrograms in the treatment of postmenopausal vaginal atrophy symptoms.

After 12 weeks of treatment with Vagifem 10 micrograms the change from baseline, in comparison with placebo treatment, demonstrated significant improvements in the three primary endpoints: Vaginal Maturation Index and Value, normalization of Vaginal pH and relief of the moderate/severe urogenital symptoms considered most bothersome by the subjects.

Endometrial safety of Vagifem 10 micrograms was evaluated in the above mentioned trial and a second, open-label, multicenter trial. In total, 386 women underwent endometrial biopsy at the beginning and at the end of 52 weeks treatment. Incidence rate of hyperplasia and/or carcinoma was 0.52% (95% CI 0.06%, 1.86%), indicating no increased risk.

5.2 Pharmacokinetic Properties

Absorption

Oestrogens are well absorbed through the skin, mucous membranes, and the gastrointestinal tract. After vaginal administration, estradiol is absorbed circumventing first-pass metabolism.

A 12 weeks single-centre randomised, open label, multiple dose, parallel-group trial was conducted to evaluate the extent of systemic absorption of estradiol from the Vagifem 10 micrograms tablet. Subjects were randomized 1:1 to receive either 10 micrograms or 25 micrograms Vagifem. Plasma levels of estradiol (E2), oestrone (E1) and oestrone sulphate (E1S) were determined. AUC_(0-24) for plasma E2 levels increased almost proportionally after the administration of 10 micrograms and 25 micrograms Vagifem. The AUC_(0-24) indicated higher systemic estradiol levels for the 10 micrograms E2 tablet as compared to baseline on treatment days 1, 14 and 83, being statistically significant at days 1 and 14 (Table 1). However, average plasma E2 concentrations (C_{ave (0-24)}) at all evaluated days remained within the normal postmenopausal range in all subjects. The data from days 82 and 83 as compared to baseline indicate that there is no cumulative effect during twice weekly maintenance therapy.

Table 1 Values of PK parameters from plasma Estradiol (E2) concentrations:

	Vagifem 10 micrograms
	AUC(0-24) pg.h/mL (geom. mean)	Cave(0-24) pg/mL (geom. mean)
Day -1	75.65	3.15
Day 1	225.35	9.39
Day 14	157.47	6.56
Day 82	44.95	1.87
Day 83	111.41	4.64

The levels of oestrone and oestrone sulphate after 12 weeks of Vagifem 10 micrograms administration did not exceed baseline levels, i.e., no accumulation of oestrone or oestrone sulphate was observed.

Distribution

The distribution of exogenous oestrogens is similar to that of endogenous oestrogens. Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Oestrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin.

Biotransformation

Exogenous oestrogens are metabolized in the same manner as endogenous oestrogens. The metabolic transformations take place mainly in the liver. Estradiol is converted reversibly to oestrone, and both can be converted to oestriol, which is the major urinary metabolite. In postmenopausal women, a significant portion of the circulating oestrogens exist as sulphate conjugates, especially oestrone sulphate, which serves as a circulating reservoir for the formation of more active oestrogens.

Elimination

Estradiol, oestrone and oestriol are excreted in the urine along with glucuronide and sulfate conjugates.

Special patient groups

The extent of systemic absorption of estradiol during treatment with Vagifem 10 micrograms has been evaluated in postmenopausal women, aged 60-70 (mean age 65.4) only.

5.3 Preclinical Safety Data

17β-Estradiol is a well-known substance. Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Hypromellose

Lactose monohydrate

Maize starch

Magnesium stearate

Film-coating:

Hypromellose

Macrogol 6000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Each tablet is contained in a disposable single-use polyethylene/polypropylene applicator. The applicators are packed separately in PVC/aluminium foil blisters.

18 packs contain 3 blister cards of 6 applicators with inset tablets

24 packs contain 4 blister cards of 6 applicators with inset tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

The registered office in the UK is:-

Novo Nordisk Ltd

Broadfield Park

Brighton Road

Crawley

West Sussex

RH11 9AT

Tel: 01293 613555

8. Marketing Authorisation Number(S)

PL 04668/0237

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 17^th February 2010

10. Date Of Revision Of The Text