FOSAVANCE Tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

FOSAVANCE 70 mg/2,800 IU tablets. FOSAVANCE 70 mg/5,600 IU tablets.

2. Qualitative and quantitative composition

FOSAVANCE 70 mg/2,800 IU tablets Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3). Excipients with known effect: ...

3. Pharmaceutical form

Tablet. FOSAVANCE 70 mg/2,800 IU tablets: Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and 710 on the other. FOSAVANCE 70 mg/5,600 ...

4.1. Therapeutic indications

FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures.

4.2. Posology and method of administration

Posology The recommended dose is one tablet once weekly. Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember. They should ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. ...

4.4. Special warnings and precautions for use

Alendronate Upper gastrointestinal adverse reactions Alendronate can cause local irritation of the upper gastrointestinal mucosa. Because there is a potential for worsening of the underlying disease, caution ...

4.5. Interaction with other medicinal products and other forms of interaction

Alendronate If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of ...

4.6. Fertility, pregnancy and lactation

FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women. Pregnancy There are no or limited amount of data from the use ...

4.7. Effects on ability to drive and use machines

FOSAVANCE has no or negligible direct influence on the ability to drive and use machines. Patients may experience certain adverse reactions (for example, blurred vision, dizziness and severe bone muscle ...

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension ...

4.9. Overdose

Alendronate Symptoms Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bisphosphonates, combinations ATC code: M05BB03 Mechanism of action Alendronate Alendronate sodium is a bisphosphonate that ...

5.2. Pharmacokinetic properties

Alendronate Absorption Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight ...

5.3. Preclinical safety data

Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted. Alendronate Non-clinical data reveal no special hazard for humans based on conventional studies of safety ...

6.1. List of excipients

Microcrystalline cellulose (E460) Lactose anhydrous Medium chain triglycerides Gelatin Croscarmellose sodium Sucrose Colloidal silicon dioxide Magnesium stearate (E572) Butylhydroxytoluene (E321) Modified ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

18 months.

6.4. Special precautions for storage

Store in the original blister in order to protect from moisture and light.

6.5. Nature and contents of container

FOSAVANCE 70 mg/2,800 IU tablets: Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets. FOSAVANCE 70 mg/5,600 IU tablets: Aluminium/aluminium blisters, in cartons containing ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

8. Marketing authorization number(s)

FOSAVANCE 70 mg/2,800 IU tablets: EU/1/05/310/001 – 2 tablets EU/1/05/310/002 – 4 tablets EU/1/05/310/003 – 6 tablets EU/1/05/310/004 – 12 tablets FOSAVANCE 70 mg/5,600 IU tablets: EU/1/05/310/006 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015

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