Gensof 10 Mg/70 Mg Tablets

GENSOF is indicated

• for the treatment of postmenopausal osteoporosis to reduce the risk of fractures, including those of the hip and spine (vertebral compression fractures).
• to treat and reduce the risk of glucocorticoid induced osteoporosis in postmenopausal women not receiving oestrogen.
• for the treatment of primary/hypogonadal osteoporosis in men and to reduce the risk of vertebral fractures.

Treatment of postmenopausal osteoporosis: The recommended dosage is 10 mg once a day.

Treatment and reduction of the risk of glucocorticoid-induced osteoporosis in postmenopausal women not receiving oestrogen: The recommended dosage is 10 mg once a day.

Treatment of primary/hypogonadal osteoporosis in men: The recommended dosage is 10 mg once a day.

Treatment of postmenopausal osteoporosis: The recommended dosage is one 70 mg tablet once weekly.

Treatment of primary/idiopathic osteoporosis in men: The recommended dosage is one 70 mg tablet once weekly.

Hypersensitivity to alendronate or any other components of the formulation.

Severe renal function impairment when creatinine clearance is less than 35 ml/minute.

Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia.

The inability to stand or sit upright for 30 minutes after taking the medicine.

Paediatric age group: Safety and efficacy have not been established.

Pregnancy and lactation.

Hypocalcaemia (see Warnings and Special Precautions)

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates, including GENSOF, in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on GENSOF therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of GENSOF treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating doctor should guide the management plan of each patient based on individual benefit/risk assessment.

Hypocalcaemia and vitamin D deficiency should be corrected before starting GENSOF therapy, as GENSOF may exacerbate these conditions.

The risk benefit should be considered in patients suffering from upper gastrointestinal diseases, such as dysphagia, duodenitis, gastritis, ulcers or symptomatic oesophageal conditions, because of possible irritant effects of GENSOF on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease.

Oesophageal adverse experiences, such as oesophagitis, oesophageal ulcers and oesophageal erosions, infrequently followed by oesophageal stricture, have been reported in patients receiving treatment with GENSOF; in some cases these have been severe and require hospitalisation. Doctors should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue GENSOF and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe oesophageal adverse experiences appears to be greater in patients who lie down after taking GENSOF and/or who fail to swallow it with a full glass of water, and/or who continue to take GENSOF after developing symptoms suggestive of oesophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see u201cDOSAGE AND DIRECTIONS FOR USEu201d).

An increased incidence of upper gastrointestinal adverse events may occur in patients taking GENSOF concomitantly with NSAIDs. There may be additive hypocalcaemic effects with aminoglycosides. Substances, such as calcium supplements, osmotic laxatives, antacids, food and beverages will interfere with the absorption of GENSOF. Patients are advised to wait at least 30 minutes after taking GENSOF before taking any other medication, or food. No adverse experiences attributable to the concomitant use of alendronate and oestrogen (intravaginal, transdermal, or oral) in postmenopausal women have been identified.

The safety of GENSOF has not been established in pregnancy or lactation.

There are no data to suggest that GENSOF affects the ability to drive or use machines.

Side-effects: The following adverse reactions have been reported with GENSOF:

Hepato-biliary disorders: Less frequent: Raised liver enzymes, hepatitis, hepatocellular damage

Blood and lymphatic system disorders: Less frequent: Anaemia, leucopenia, thrombocytopenia

Renal and urinary disorders: Less frequent: Renal Failure

Cardiac disorders: Less frequent: Atrial fibrillation

Neoplasms benign malignant (including cysts and polyps): Less frequent: Oesophageal cancer

Metabolism and nutrition disorders: Less frequent: Symptomatic hypocalcaemia, generally in association with predisposing conditions (see u201cSpecial Precautionsu201d) hypophosphataemia.

Nervous system disorders: Frequent: Headache

Eye disorders: Less frequent: Uveitis, scleritis

Gastrointestinal disorders: Frequent: Abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distention, oesophagitis, oesophageal erosions, nausea, vomiting, constipation, diarrhoea, flatulence, acid regurgitation and melaena. Less frequent: Oesophageal stricture, oropharyngeal ulceration, gastritis, gastric and duodenal ulcers, some severe and with complications, oesophageal perforations. (See u201cSpecial Precautionsu201d and u201cDOSAGE AND DIRECTIONS FOR USEu201d).

Skin and subcutaneous tissue disorders: Less frequent: Rash (occasionally with photosensitivity), erythema and pruritus, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal, connective tissue and bone disorders: Frequent: Musculoskeletal (bone, muscle or joint) pain, myalgia. Less frequent: Osteonecrosis of the jaw (see u201cWARNINGSu201d), synovitis.

Immune system disorders: Less frequent: Hypersensitivity reactions, including urticaria and angioedema

General disorders and administrative site conditions: Less frequent: Malaise, fever

Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage. The administration of milk and antacids may be of benefit. Because of the risk of oesophageal irritation, vomiting should not be induced. Keep the patient in an upright position.