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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

FOSAMAX Once Weekly Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

FOSAMAX Once Weekly 70 mg tablets.

Qualitative and quantitative composition

Each tablet contains 70 mg alendronic acid (as sodium trihydrate). Excipients with known effect: Each tablet contains 113.4 mg lactose (as lactose anhydrous). For the full list of excipients, see section ...

Pharmaceutical form

Tablet. Oval white tablets, marked with an outline of a bone image on one side, and 31 on the other.

Therapeutic indications

FOSAMAX is indicated in adults for the treatment of postmenopausal osteoporosis. It reduces the risk of vertebral and hip fractures.

Posology and method of administration

Posology The recommended dosage is one 70 mg tablet once weekly. Patients should be instructed that if they miss a dose of FOSAMAX Once Weekly, they should take one tablet on the morning after they remember. ...

Contraindications

Hypersensitivity to the active substance 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. ...

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

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 alendronate. ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of alendronate in pregnant women. Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia ...

Effects on ability to drive and use machines

FOSAMAX 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 or ...

Undesirable effects

Summary of the safety profile In a one-year study in postmenopausal women with osteoporosis the overall safety profiles of FOSAMAX Once Weekly 70 mg (n=519) and alendronate 10 mg/day (n=370) were similar. ...

Overdose

Symptoms Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose. Management ...

Pharmacodynamic properties

Pharmacotherapeutic group: Bisphosphonate, for the treatment of bone diseases ATC Code: M05B A04 Mechanism of action The active ingredient of FOSAMAX, alendronate sodium trihydrate, is a bisphosphonate ...

Pharmacokinetic properties

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 fast and two ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Studies in rats have shown that ...

List of excipients

Microcrystalline cellulose Lactose anhydrous Croscarmellose sodium Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aluminum/aluminum blisters in cartons containing 2, 4, 8, 12 or 40 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Marketing authorization number(s)

PL 00025/0399

Date of first authorization / renewal of the authorization

10 November 2000/9 November 2005

Date of revision of the text

19 June 2018

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