Etanordes 35 mg Tablets

The active substance is risedronate sodium. Each film-coated tablet contains risedronate sodium hemipentahydrate 35 mg equivalent to 32.5 mg risedronic acid. Contains lactose. The other ingredients of ETANORDES 35 mg TABLETS are cellulose microcrystalline, crospovidone, hydroxy propyl cellulose and magnesium stearate. The coating material of ETANORDES 35 mg TABLETS contains colloidal anhydrous silica, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, macrogol / PEG 400, macrogol / PEG 8000 and titanium dioxide.

ETANORDES 35 mg TABLETS are used to treat osteoporosis in postmenopausal women, in combination with calcium. Patients with a vitamin D deficiency, should also receive supplemental vitamin D.

• Do not take ETANORDES 35 mg TABLETS:
- If you are allergic to risedronate sodium, or any of the other ingredients of ETANORDES 35 mg TABLETS.
- If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level).
- If you have severe kidney problems.
• Take special care with ETANORDES 35 mg TABLETS:
- ETANORDES 35 mg TABLETS can cause stomach or intestinal problems such as difficulty in swallowing, inflammation of the oesophagus, an oesophageal ulcer or a stomach ulcer.
- This may occur especially if you do not take ETANORDES 35 mg TABLETS while you are sitting up or standing, if you do not drink a full glass of plain water with ETANORDES 35 mg TABLETS, or if you lie down in less than 30 minutes after taking ETANORDES 35 mg TABLETS.
- Tell your doctor if:
o You have had stomach or intestinal problems in the past or problems with your oesophagus (the tube that connects your mouth with your stomach).
o You have pain or discomfort in your stomach or oesophagus.
o You had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
o You have anaemia, clotting/bleeding disorders, an infection, cancer, are undergoing chemotherapy, are taking corticosteroids, are having dental procedures, or have poor oral hygiene or ill-fitting dentures. If you have any of these conditions and are taking ETANORDES 35 mg TABLETS, you are at a higher risk of developing bone loss in the jaw (called osteonecrosis of the jaw) and bone breakage (such as atypical fracture of the femur).
o You have any kidney problems.
o You have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level). If you have one (or more) of these problems, it should be corrected before taking.

Always take ETANORDES 35 mg TABLETS 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 ETANORDES 35 mg TABLETS is too strong or too weak, talk to your doctor or pharmacist.
• Dosage:
Usual adult dose:
- Take one ETANORDES 35 mg TABLETS once a week.
- Choose one day of the week that best fits your schedule. Every week, take the ETANORDES 35 mg TABLETS on your chosen day.
- Take the tablet whilst you are in an upright position (you may sit or stand).
- Do not lie down for 30 minutes after taking your tablet.
- Swallow it with at least one glass (120 ml) of plain water.
- Swallow it whole. Do not suck or chew it.
- The safe and effective use of ETANORDES 35 mg TABLETS in children and growing adolescents has not been established.
• If you take more ETANORDES 35 mg TABLETS than you should:
If you have accidentally taken more ETANORDES 35 mg TABLETS than prescribed, milk or antacids containing magnesium, calcium or aluminium can be taken, and medical attention must be sought. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
• If you forget to take ETANORDES 35 mg TABLETS:
If you have forgotten to take your tablet on your chosen day, take it on the day you remember. Return to taking one tablet once a week on the day the tablet is normally taken. Do not take two tablets in one day to make up for the tablet you missed.

ETANORDES 35 mg TABLETS 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:
- symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsening heartburn
- black or tar-like stools, vomiting blood
- severe joint, bone or muscle pain
- jaw pain, numbness or swelling
- severe skin reactions that can include blistering of the skin
- eye inflammation, usually with pain, redness and light sensitivity.
• Tell your doctor if any of the side-effects below are severe, bothersome, do not go away or about any concerns you have while taking ETANORDES 35 mg TABLETS.
- Urinary tract infection
- lack of energy, headaches, dry eyes, red painful eyes with a possible change in vision, ringing in the ears
- persistent cough, inflammation or narrowing of the throat, inflammation of the sinuses, lung infection
- heartburn, indigestion, nausea, vomiting, belching, stomach pain, constipation, diarrhoea, inflammation of the large intestine, inflammation or ulcer of the oesophagus, inflammation of the stomach
- feeling anxious
- pain in your bones, muscles or joints, muscle weakness, leg cramps
- skin rash, itching.
Not all side-effects reported for ETANORDES 35 mg TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ETANORDES 35 mg TABLETS, please consult your doctor, pharmacist or other health care professional for advice.