Gensof 10 mg/70 mg

GENSOF belongs to a class of medicines called bisphosphonates. GENSOF works by preventing bone breakdown and increasing bone density.

• The treatment of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break).

• The treatment of osteoporosis in men. It reduces the chance of having a spinal fracture (break).

Do not take GENSOF:

• If you are hypersensitive (allergic) to alendronate, or any of the other ingredients of GENSOF.
• If you have severe kidney problems.
• If you have disorders of the oesophagus e.g. narrowing or achalasia (a condition causing difficulty in swallowing, regurgitation and sometimes chest pain).
• If you have low blood calcium levels.
• If you have a vitamin D deficiency.
• If you cannot stand or sit upright for 30 minutes after taking GENSOF.
• If you are pregnant.
• If you are breast-feeding.
• In children. The safety of GENSOF in children has not been determined.
• If you have stomach or intestine problems such as inflammation of the small intestine, difficulty in swallowing, inflammation of the stomach, ulcers or a disease of the oesophagus.

Take special care with GENSOF:

• A dental examination should be considered before you start treatment with GENSOF if you have cancer, are undergoing chemotherapy, are taking corticosteroids or have poor oral hygiene. If you have any of these conditions and are taking GENSOF, certain dental procedures should be avoided if possible. If you develop bone destruction in the jaw (called osteonecrosis of the jaw) while taking GENSOF, having dental surgery may make this condition worse. Consult your dentist for more details.
• Before starting therapy with GENSOF, low blood calcium levels and vitamin D deficiency should be corrected.
• Tell your doctor if you have stomach or intestine problems such as inflammation of the small intestine, difficulty in swallowing, inflammation of the stomach, ulcers or a disease of the oesophagus.
• GENSOF may cause problems in your oesophagus (the tube that connects the mouth and stomach). These problems include inflammation, or ulcers of the oesophagus, which may sometimes bleed and cause narrowing of the oesophagus. This may occur especially if you do not drink a full glass of water with GENSOF or if you lie down in less than 30 minutes after taking GENSOF, or before your first food of the day. Stop taking GENSOF and call your doctor right away if you get any of these signs of possible serious problems of the oesophagus: Chest pain, new or worsening heartburn, trouble or pain when swallowing.
• Mouth sores (ulcers) may occur if the GENSOF tablet is chewed or sucked.
• Do not take GENSOF at bedtime or before getting up for the day.
• Small decreases in blood levels of calcium and phosphate may occur, especially in patients taking glucocorticoid medicines.
• Make sure that you are taking in adequate calcium and vitamin D, especially if you are receiving glucocorticoid medicines.

Taking GENSOF with food and drink:

• Take GENSOF you get up for the day and at least 30 minutes before taking your first food, drink, or other medicine.
• Swallow your GENSOF tablet with a full glass of plain water only.
• Do not take GENSOF with mineral water or other beverages.

Always take GENSOF exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of GENSOF is too strong or too weak, talk to your doctor or pharmacist.

• It is important to take GENSOF only as directed by your doctor.

• It is very important that you follow the following steps to help GENSOF reach your stomach quickly and help reduce possible irritation of your oesophagus (the tube that connects your mouth with your stomach):

1. Take GENSOF after you get up for the day and at least 30 minutes before taking your first food, drink, or other medicine.
2. Swallow your GENSOF tablet with a full glass of plain water only.
3. Do not take GENSOF with mineral water or other beverages.
4. Do not crush, chew or suck the tablet. Swallow the tablet whole.
5. Do not lie down, stay fully upright (sitting, standing or walking) for at least 30 minutes after swallowing GENSOF. Do not lie down until after your first food of the day.
6. Do not take GENSOF at bedtime or before getting up for the day.
7. After swallowing GENSOF, wait at least 30 minutes before taking calcium and vitamin D supplements. Calcium and vitamin D supplements should be taken if your diet is inadequate.

• Dosage:

• For the treatment of osteoporosis (thinning of bone) in women after menopause, the usual dose is one 10 mg tablet once daily.
• For the treatment of osteoporosis in men, the usual dose is one 10 mg tablet once daily.
• For the treatment of osteoporosis (thinning of bone) in women after menopause, the usual dose is one 70 mg tablet once weekly.
• For the treatment of osteoporosis in men, the usual dose is one 70 mg tablet once weekly.

GENSOF can have side-effects. Get emergency medical help if you have any of these signs of an allergic reaction:

• hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side-effects:

• chest pain
• new or worsening heartburn
• trouble or pain when swallowing.
• black or tar-like stools, vomiting blood
• severe joint, bone or muscle pain
• jaw pain, numbness or swelling
• severe skin reactions

Other side-effects include: symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth; headache; blurred vision, pain or redness in the eye; abdominal (stomach area) pain; heartburn; abdominal swelling; ulcers of the oesophagus; irritation or inflammation of the oesophagus; narrowing of the oesophagus; mouth sores (ulcers); stomach ulcers; ulcers in the duodenum (first part of the small intestine); inflammation of the stomach; excess amount of air/gas in the stomach; nausea; vomiting; constipation; diarrhoea; rash; redness of the skin; itching; transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment; decreases in blood levels of calcium and phosphate.

Tell your doctor if any of the above side-effects are severe, bothersome, do not go away or about any concerns you have while taking GENSOF. Not all side-effects reported for GENSOF are included in this leaflet. Should your general health worsen while taking GENSOF, please consult your doctor, pharmacist or other health care professional for advice.

Store in a dry place at or below 25 °C (room temperature). Do not remove blisters from carton until required for use. Keep original containers well closed. Keep all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).