Each tablet  of Fomax-D® contains :

• Alendronic acid 70 mg (as  Alendronate sodium ).       
• Vitamin D3    2800IU.

• Fomax-D® treats your osteoporosis and If you are at risk of vitamin D3 insufficiency. It reduces the risk of spine and hip fractures in women after menopause.
• Fomax-D® is indicated for increasing bone mass in men with osteoporosis.

¤ Do not take Fomax-D® if :

• you are allergic to alendronic acid, colecalciferol or any of the other ingredients of  this medicine.
• you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing.
• you cannot stand or sit upright for at least 30 minutes.
• your doctor has told you that you have low blood calcium.

¤ If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Fomax- D® if taken at the same time. Therefore, it is important that you wait at least 30 minutes before taking any other oral medicines or supplements.
• Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Fomax-D®.
• It is likely that certain medicines or food additives may prevent the vitamin D3 in Fomax- D® from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
• Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D3.
• Additional vitamin D3 supplements may be considered on an individual basis.

• Fomax-D® is only intended for use in postmenopausal women.
• Dont take Fomax-D® if you are or think you may be pregnant, or if you are breast-feeding.

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat,possibly causing difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms.
• unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone,

Other side effects include:

Very common (may affect more than 1 in 10 people):

• bone, muscle and/or joint pain which is sometimes severe.

Common (may affect up to 1 in 10 people):

• joint swelling, abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence, hairloss;itching,headache;dizziness,tiredness;
• swelling in the hands or legs.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach,black or tar-like stools,blurred vision; pain or redness in the eye,rash; redness of the skin
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,taste disturbance.

Rare (may affect up to 1 in 1,000 people):

• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach or peptic ulcers(sometimes severe or with bleeding),narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach).
• rash made worse by sunlight;mouth ulcers.

Very rare (may affect up to 1 in 10,000 people):

• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Overdosage:

• If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

¤ Always take Fomax-D® exactly as your doctor or pharmacist has told you. 
¤ Take one Fomax-D® tablet once a week.
Follow these instructions carefully:
1) Choose the day of the week that best fits your schedule. Every week, take one   
  Fomax- D® tablet on your chosen day.
2) After getting up for the day and before taking any food, drink, or othe medicine, 
   swallow your Fomax- D® tablet whole with a full glass of water only (not mineral 
   water) (not less than 200 ml).
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.
•Do not crush or chew the tablet or allow it to dissolve in your mouth because of the 
possibility of mouth ulceration.
3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 
minutes after swallowing the tablet. Do not lie down until after your first food of the 
day.
4) Do not take Fomax- D® at bedtime or before getting up for the day.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or
    worsening heartburn, stop taking Fomax- D® and contact your doctor.
6) After swallowing your Fomax- D® tablet, wait at least 30 minutes before taking 
   your first food, drink, or other medicine of the day, including antacids, calcium 
   supplements and vitamins.

¤ Fomax- D® is effective only if taken when your stomach 
  is empty.
¤ Fomax- D® should not be given to children and adolescents less than 18 years of age.

Talk to your doctor or pharmacist before taking Fomax-D® if:

• you suffer from kidney problems,
• you have, or have recently had, any swallowing or digestive problems.
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
• you have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome).
• you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,
• you have cancer.
• you are undergoing chemotherapy or radiotherapy.
• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies.
• you are or have been a smoker (as this may increase the risk of dental problems). It is important to maintain good oral hygiene when being treated with Fomax-D® . You should have routine dental check-ups throughout your treatment and you should contact  your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

¤ Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects \ your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Fomax-D®. These 

¤ side effects may worsen if patients continue to take Fomax- D® after developing these symptoms.

• Blister of 4 tablets, pack of one blister.

• Store in a dry place, in temperature below 25º C.