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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

Fosamax (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Sharp & Dohme Limited
Διεύθυνση :
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Name of the medicinal product

FOSAMAX 10 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 13.05 mg of alendronate sodium, which is the molar equivalent to 10 mg of alendronic acid. Excipients: Each tablet contains 103.95 mg lactose anhydrous. For a full list of excipients ...

Pharmaceutical form

Tablets. Oval white tablets marked with 936 on one side, and plain on the other.

Therapeutic indications

Fosamax is indicated for the treatment of osteoporosis in post-menopausal women to prevent fractures. Fosamax is indicated for the treatment of osteoporosis in men to prevent fractures. Fosamax is indicated ...

Posology and method of administration

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks ...

Contraindications

Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to any component ...

Special warnings and precautions for use

Fosamax can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when Fosamax is given to patients ...

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 Fosamax. Therefore, ...

Pregnancy and lactation

Use during pregnancy Alendronate should not be used during pregnancy. There are no adequate data from the use of alendronate in pregnant women. Animal studies do not indicate direct harmful effects with ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines has been performed. However, certain adverse reactions that have been reported with Fosamax may affect some patients' ability to drive ...

Undesirable effects

Fosamax has been studied in nine major clinical studies (n=5,886). In the longest running trials in post-menopausal women up to five years experience has been collected. Two years safety data are available ...

Overdose

No specific information is available on the treatment of overdosage with Fosamax. Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, ...

Pharmacodynamic properties

Fosamax is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with 'Fosamax' is of normal quality. Treatment of post-menopausal ...

Pharmacokinetic properties

Absorption Relative to an intravenous (IV) reference dose, the oral bioavailability of alendronate in women was 0.7% for doses ranging from 5 to 40 mg when administered after an overnight fast and two ...

Preclinical safety data

In test animal species the main target organs for toxicity were kidneys and gastro-intestinal tract. Renal toxicity was seen only at doses >2 mg/kg/day orally (ten times the recommended dose) and was evident ...

List of excipients

10 mg tablets: Microcrystalline cellulose Anhydrous lactose Croscarmellose sodium Magnesium stearate Carnauba wax

Incompatibilities

None known.

Shelf life

3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Blisters of opaque white PVC lidded with aluminium foil. Pack size: 28 tablets.

Special precautions for disposal and other handling

None.

Marketing authorization holder

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

Marketing authorization number(s)

10 mg tablets: PL 0025/0326

Date of first authorization / renewal of the authorization

10 mg tablets: 28 July 1995/ 3 June 2008

Date of revision of the text

December 2011