FOSAMAX Once Weekly Tablets (2018)
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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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