Preovidlen 70 mg/600 Iu Tablets

PREOVIDLEN contains the active substances alendronic acid (alendronate) and cholecalciferol (vitamin D 3 ). PREOVIDLEN belongs to a group of medicines called non-hormonal bisphosphonates. PREOVIDLEN is used in women to treat post-menopausal osteoporosis (a disease that weakens the bones) and to help make sure they get enough vitamin D. This will reduce the risk of developing fractures.

Do not take PREOVIDLEN : • if you are hypersensitive (allergic) to alendronic acid, cholecalciferol or any of the other ingredients of PREOVIDLEN (listed in section 6). • if you have certain problems with your oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing. • if you cannot stand or sit upright for at least 30 minutes. • if your doctor has told you that you have low blood calcium. • if you have kidney problems. • if you are pregnant or breastfeeding. • if the patient is a child.

Warnings and precautions

Take special care with PREOVIDLEN: • if you have, or have recently had, any swallowing or digestive problems including disease of the oesophagus ( the tube that connects your mouth with your stomach) , inflammation of the lining of the stomach (gastritis) and part of your small intestine (duodenitis), a sore in the lining of your stomach (ulcer) and active bleeding from your stomach.

Do not share medicines prescribed for you with any other person. Always take PREOVIDLEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of PREOVIDLEN is: One PREOVIDLEN tablet once a week. Follow these instructions carefully. 1) Choose the day of the week that best fits your schedule. Every week, take one PREOVIDLEN tablet on your chosen day. It is very important to follow instructions 2), 3), 4) and 5) to help the PREOVIDLEN tablet reach your stomach quickly and help reduce the chance of irritating your oesophagus - the tube that connects your mouth with your stomach. 2) After getting up for the day and before taking any food, drink, or other medicine, swallow your PREOVIDLEN tablet whole with a full glass of water only (not mineral water) (not less than 200 ml), so that PREOVIDLEN is adequately absorbed. • 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 developing sores in your mouth.

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 PREOVIDLEN 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 PREOVIDLEN and contact your doctor. 6) After swallowing your PREOVIDLEN tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. PREOVIDLEN is effective only if taken when your stomach is empty. Your doctor will tell you how long your treatment with PREOVIDLEN will last. If you have the impression that the effect of PREOVIDLEN is too strong or too weak, tell your doctor or pharmacist. If you take more PREOVIDLEN than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Low blood calcium (hypocalcaemia), low levels of phosphate in the blood (hypophosphataemia) and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose. If you forget to take PREOVIDLEN Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of PREOVIDLEN, take the dose that you have missed on the morning after you remember. Return to taking one tablet once a week, as originally scheduled on your chosen day. If you have forgotten to take several doses, contact your doctor without delay.

PREOVIDLEN can have side effects. Not all side effects reported for PREOVIDLEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PREOVIDLEN, please consult your healthcare provider for advice. If any of the following happens, stop taking PREOVIDLEN and tell your doctor immediately or go to the casualty department at your nearest hospital: • Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing, • rash or itching, • fainting, • blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). These are all very serious side effects. If you have them, you may have had a serious reaction to PREOVIDLEN. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: • Ear pain, discharge from the ear, and/or an ear infection as these could be signs of bone damage in the ear ( osteonecrosis of the external auditory canal), • black or tar-like stool (melena), • 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 (osteonecrosis of the jaw),

• development of a hole or sore (ulcer) or bleeding in the upper gastrointestinal tract (upper gastrointestinal PUB’s) with symptoms such as stomach cramps, bloody or black stools, feeling tired and weak and blood in vomit, • increased heart rate, rapid breathing, low blood pressure, fever, chills, vomiting which may include blood; these may be signs that you have holes in your oesophagus (oesophageal perforations). These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent side effects : • Headache, dizziness, • a sensation of whirling and loss of balance (vertigo), • abdominal pain, pain or an uncomfortable feeling in the upper middle part of your stomach area (dyspepsia), constipation, diarrhoea, a build-up of gas in the stomach (flatulence), an open sore in the lining of your oesophagus (oesophageal ulcer), d ifficulty swallowing foods or liquids (dysphagia), bloating and swelling in the belly area (abdominal distension), contents from your stomach moving back up into your oesophagus (acid regurgitation), • loss of hair (alopecia), • bone, muscle or joint pain which is sometimes severe, joint swelling, • abnormal physical weakness or lack of energy (asthenia), swelling of lower legs or hands (peripheral oedema).

Less frequent side effects: • Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth (hypocalcaemia), • changes or impaired sense of taste (dysgeusia) , • inflammation of the eye (uveitis, scleritis, or episcleritis), • nausea, vomiting, inflammation of the lining of the stomach (gastritis), inflammation of the oesophagus (oesophagitis), valve between the lower end of the oesophagus and the stomach does not close tightly (oesophageal erosions), • broken hip bone and the long bone in the upper part of the leg (atypical subtrochanteric and diaphyseal femoral fractures), • pain in the muscles (myalgia), feeling of being ill or having no energy (malaise) and high temperature (fever), (typically in association with start of treatment). Side effects with an unknown frequency: • Decreased calcium and phosphate levels in the blood. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of PREOVIDLEN.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Keep blister in carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).