COMPOSITION
One tablet of FOSAMAX contains: Active substance: alendronic acid sodium salt 13.05 mg
(equivalent to alendronic acid 10 mg); Excipients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate, carnauba wax.

PHARMACEUTICAL FORM
Tablets. Blister pack of 14 tablets.

PHARMACOTHERAPEUTIC CATEGORY
FOSAMAX is a biphosonate belonging to the category of drugs that act on the bone structure and mineralization.

THERAPEUTIC INDICATIONS
FOSAMAX is indicated in the treatment of osteoporosis in women of post-menopausal age and in men.

CONTRAINDICATIONS
Diseases of the oesophagus which delay oesophageal emptying, such as stenosis (narrowing) and achalasia (impairment of oesophageal function). Inability to stand upright for at least 30 minutes. Hypersensitivity to the active substance or to any of the excipients. Hypocalcaemia (low levels of calcium in the blood) (see "PRECAUTIONS FOR USE"). Pregnancy and lactation (see "SPECIAL WARNINGS").Children (see "DOSE, METHODS AND TIME OF ADMINISTRATION").

PRECAUTIONS FOR USE
FOSAMAX can cause local irritation of the mucosa of the upper gastrointestinal tract. The risk of serious undesirable events of the oesophagus is greater in patients who do not take FOSAMAX in the appropriate manner and/or who continue to take FOSAMAX after the development of symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to and understood by the patient (see "DOSE, METHODS AND TIME OF ADMINISTRATION"). Patients should be informed that failure to follow these precautions may increase the risk of oesophageal problems. It is important to warn the doctor if you have any active upper gastrointestinal problems such as dysphagia (difficulty swallowing), oesophageal diseases, gastritis, duodenitis or ulcers since FOSAMAX can cause irritation to upper gastrointestinal mucosa and has the potential to exacerbate the underlying gastrointestinal disease. FOSAMAX is not recommended in patients with severely impaired renal function (creatinine clearance <35 ml/min) (see "DOSE, METHODS AND TIME OF ADMINISTRATION"). Before starting FOSAMAX therapy, and periodically thereafter, the doctor is likely to require a check of your calcaemia (blood calcium levels). Hypocalcaemia should be corrected before initiating therapy with FOSAMAX (see "CONTRAINDICATIONS"). Other mineral metabolism disorders (such as vitamin D deficiency) should be treated adequately.

INTERACTIONS
Before initiating therapy with FOSAMAX, tell your doctor if you are taking any other medication, including over the counter products. If taken at the same time, it is likely that calcium supplements, antacids and other drugs for oral administration will interfere with the absorption of FOSAMAX. Therefore, patients must wait at least half and hour before taking any other oral medication.

SPECIAL WARNINGS

Alendronate therapy should only be initiated once your doctor has ruled out other causes of osteoporosis, other than oestrogen deficiency and age.
FOSAMAX can cause local irritation of the upper gastrointestinal mucosa. Oesophageal undesirable effects such as oesophagitis (oesophageal irritation), oesophageal ulcers and oesophageal erosions, rarely followed by stricture or oesophageal perforation, have been reported in patients receiving FOSAMAX. Some of these cases were serious and hospitalisation was required. Discontinue FOSAMAX treatment and contact your doctor immediately in case of dysphagia (difficulty in swallowing), odynophagia (painful swallowing), retrosternal pain or onset or worsening of heartburn (retrosternal burning sensation).

Pregnancy and lactation
Alendronate is not intended for use in women of child-bearing potential.

DOSE, METHOD AND TIME OF ADMINISTRATION
The recommended dosage is 1 tablet of 10 mg once daily.
FOSAMAX should be taken in the morning upon rising for the day, at least half an hour before taking any food, drink or drug for the day, with a glass of ordinary tap water. Other drinks (including mineral water) food and some drugs may reduce the absorption of FOSAMAX (see "INTERACTIONS"). To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/undesirable events (see "PRECAUTIONS FOR USE"). FOSAMAX should only be taken on rising for the day with a full glass of water; Do not chew or allow the tablet to dissolve in the mouth because of the potential for oropharyngeal ulceration; Do not lie down until after first food which should be at least 30 minutes after taking the tablet; FOSAMAX should not be taken at bedtime or before rising for the day; In case of difficulty or pain on swallowing, chest pain or onset or worsening stomach pyrosis, discontinue FOSAMAX and contact your doctor. All patients should receive an adequate quantity of calcium in their diet (see "PRECAUTIONS FOR USE". No dosage adjustment is necessary in elderly patients or patients with mild-moderate renal impairment (creatinine clearance 35-60 ml/min). The use of FOSAMAX is not recommended in patients with a more severe degree of renal impairment (creatinine clearance < 35 ml/min), as there is no information on this matter.

Children
Since the medicine has not been studied in children, its use is contraindicated in this age-group.

OVERDOSE
No specific information is available on the treatment of overdose with FOSAMAX. Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer, may result from oral overdose. Milk or antacids should be given to bind alendronate. Owing to the risk of oral irritation, vomiting should not be induced and the patient should remain fully upright. In case of accidental ingestion/intake of an excessive dose of FOSAMAX, tell your doctor immediately or go to the nearest hospital.

UNDESIRABLE EFFECTS
The undesirable effects reported during clinical studies and/or with marketed use of the product, are as follows:
General disorders: hypersensitivity reactions which include urticaria, angioedema, (swelling of the face, lips, tongue and/or throat which can cause respiratory or swallowing difficulties).
Gastrointestinal tract: abdominal pain, dyspepsia, dysphagia, tympanites, constipation, diarrhoea, flatulence, nausea, vomiting, oesophagitis, oesophageal erosions and rarely oesophageal stricture or perforation and oropharyngeal ulceration: rare cases of gastric or duodenal ulcer have been reported, some serious and associated with complications; although a causal relationship with the drug has not been demonstrated, it cannot be ruled out.
Musculoskeletal system: musculoskeletal pain (bone, muscle or joint).
Nervous system: headache.
Skin and related tissues: rash (skin eruption), occasionally with photosensitivity and rarely erythema.
Ophthalmic disorders: rarely uveitis and scleritis.
Laboratory findings: Mild and transient decreases in serum calcium and phosphate have been reported (see "PRECAUTIONS FOR USE").
The patient is invited to inform his doctor on the event of onset of any undesirable effect not described in the leaflet.

EXPIRY AND STORAGE
Check the expiry date printed on the pack. The expiry date refers to the product in an unopened and correctly stored pack. Important: do not use the medicine after this date.

Keep the medicine out of the reach of children.