PACKAGE LEAFLET: INFORMATION FOR THE USER. Alendroninezuur Mylan 70 mg, tabletten. (sodium alendronate trihydrate)

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Alendroninezuur Mylan 70 mg, tabletten (sodium alendronate trihydrate) Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Alendroninezuur Mylan is and what it is used for 2. Before you take Alendroninezuur Mylan 3. How to take Alendroninezuur Mylan 4. Possible side effects 5. How to store Alendroninezuur Mylan 6. Further information. 1. WHAT ALENDRONINEZUUR MYLAN IS AND WHAT IT IS USED FOR Alendroninezuur Mylan belongs to a group of medicines called bisphosphonates. Bisphosphonates can be used to help bone disease such as osteoporosis. Osteoporosis is a thinning or weakening of the bones. Alendroninezuur Mylan can treat osteoporosis in post-menopausal women. Alendroninezuur Mylan can reduce the chance of fracturing your hip or your spine. Alendroninezuur Mylan is a once weekly treatment. What is osteoporosis? Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture ( dowager s hump ) and loss of mobility. How can osteoporosis be treated? Osteoporosis can be treated and it is never too late to begin treatment. Alendroninezuur Mylan not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip. As well as your treatment with Alendroninezuur Mylan, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

2 Stopping smoking Exercise Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones. Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme. Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D). 2. BEFORE YOU TAKE ALENDRONINEZUUR MYLAN Do not take Alendroninezuur Mylan and tell your doctor if: you are allergic to sodium alendronate trihydrate or any of the other ingredients of this medicine you have problems with your food pipe (oesophagus) causing difficulty swallowing you are not able to stand or sit upright for at least 30 minutes you know you have very low calcium levels in your blood (hypocalcaemia). Take special care with Alendroninezuur Mylan. You should tell your doctor before taking this medicine if: you have difficulty swallowing or have digestive or gut problems you have pain on swallowing you know your blood calcium is to low or you suffer from vitamin D deficiency. This needs to be treated before you start taking sodium alendronate trihydrate you have severe kidney problems you have gum disease you have a planned dental extraction you have any allergies. Visit your dentist for a dental check-up before you take Alendroninezuur Mylan if you: have cancer are receiving chemotherapy or radiotherapy are taking corticosteroids do not receive regular dental care you have gum disease smoke. Patients should avoid dental treatment whilst taking Alendroninezuur Mylan. If you have to have dental treatment discuss this with your doctor first. Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment. Stop taking this medicine and tell your doctor if you notice: soreness, pain and difficulty swallowing pain in the centre of the chest heartburn, either new or worse than usual ulcers in your mouth and throat. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, or any of the following: calcium supplements antacids for indigestion

3 corticosteroid medicine, such as prednisolone or dexamethasone, used to reduce inflammation; as it is important that you have a good dietary intake of calcium and vitamin D. Wait at least 30 minutes after taking Alendroninezuur Mylan before taking any other medicines. Taking Alendroninezuur Mylan with food and drink: Food and drinks may reduce the absorption of Alendroninezuur Mylan into the blood. Therefore, wait at least 30 minutes before taking any food or drinks. Pregnancy and breast-feeding: Do not take Alendroninezuur Mylan if you are pregnant, planning to become pregnant or you are breast-feeding. Ask your doctor for advice before taking any medicine. Driving and using machines: There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendroninezuur Mylan that may affect your ability to drive or operate machinery. Individual responses to Alendroninezuur Mylan may vary. (See POSSIBLE SIDE EFFECTS.) Important information about some of the ingredients in Alendroninezuur Mylan: This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose monohydrate, contact your doctor before taking this medicinal product. 3. HOW TO TAKE ALENDRONINEZUUR MYLAN Always take Alendroninezuur Mylan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take one Alendroninezuur Mylan tablet once a week. Follow these instructions carefully to make sure you will benefit from Alendroninezuur Mylan. Choose the day of the week that best fits your schedule. Every week, take one Alendroninezuur Mylan tablet on your chosen day. Swallow the tablet whole while standing upright. Take with a full glass plain water (not mineral water) (not less than 200 ml or 7 fl. oz). 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 or let the tablet dissolve in your mouth. Take on an empty stomach, as soon as you get out of bed in the morning, before you eat or drink anything. Do not take at bedtime and do not lie down for at least 30 minutes after taking Alendroninezuur Mylan. Wait at least 30 minutes after swallowing the tablet before you eat, drink or take any other medicines. Children: Alendroninezuur Mylan should not be given to children. Alendroninezuur Mylan is not recommended for patients with severe kidney problems. If you take more Alendroninezuur Mylan than you should: Drink a full glass of milk and contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Do not make yourself vomit, and do not lie down.

4 If you forget to take Alendroninezuur Mylan: Take the tablet on the morning after you remember. Do not take two tablets in the same week but return to taking one tablet once a week. If you stop taking Alendroninezuur Mylan: Always talk to your doctor or pharmacist before stopping taking Alendroninezuur Mylan. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Alendroninezuur Mylan can cause side effects although not everybody gets them. If any of the following happen, stop taking Alendroninezuur Mylan and tell your doctor immediately or go to the nearest hospital emergency department. You may be experiencing an allergic reaction to the tablets: Swelling of the face, lips, tongue and/or throat Difficulty swallowing or breathing Itchy red skin or a nettle rash. These are rare but serious reactions. You may need medical attention. Common side effects (affecting fewer than 1 in 10 people): Abdominal pain, indigestion, constipation or diarrhoea, wind or feeling bloated Difficulty swallowing An unpleasant sour taste in the mouth caused by the stomach acid coming back up into the mouth Gullet ulcer (oesophagus the tube that connects your mouth with your stomach) Pain in bones, muscles or joints Headache. Uncommon side effects (affecting fewer than 1 in 100 people): Rash, itching, redness of the skin (erythema), hair loss Feeling or being sick, an inflamed gullet (oesophagus the tube that connects your mouth with your stomach) or stomach (gastritis), black or bloody stools. Rare side effects (affecting fewer than 1 in 1000 people): Rash, worsened by sun light, flu-like symptoms (muscle pain, not feeling well, fever) at the start of the treatment Gastrointestinal ulcers, sometimes severe, or bleeding, although it is not certain whether alendronate is the cause. Mouth ulcers when the tablets have been chewed or sucked Narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach) Pain in the eyes, worse or blurred vision (uveitis), inflammation of the white of the eye ball (scleritis) Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth Jaw problems associated with delayed healing and infection, often following tooth extraction, Severe bone, muscle and/or joint pain Transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment Very rare side effects (affecting fewer than 1 in people) severe skin reactions

5 During post-marketing experience the following side effects have been reported (frequency unknown): Nervous system disorders: dizziness Taste changes Joint swelling Tiredness Swelling in the hands or legs Fracture of the thigh bone in patients on long-term treatment with Alendroninezuur Mylan. Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone. Tell your doctor or pharmacist promptly about these or any other unusual symptoms. It will help if you make a note of what you experienced, when it started and how long it lasted. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ALENDRONINEZUUR MYLAN Keep Alendroninezuur Mylan out of the reach and sight of children. Do not take Alendroninezuur Mylan after the expiry date, which is stated on the label and blister after Exp. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Alendroninezuur Mylan contains: The active substance is sodium alendronate trihydrate equivalent to 70 mg of alendronic acid. The other ingredients are lactose monohydrate, Microcrystalline cellulose E460, Povidone E1201, Croscarmellose sodium E468, Magnesium stearate E470b and purified water. What Alendroninezuur Mylan looks like and contents of the pack: Alendroninezuur Mylan are white, bi-convex tablets, embossed AD70 on one side and G on the reverse. Alendroninezuur Mylan is available in blister packs or bottles of 4, 8 or 12 tablets. Not all pack sizes and types may be marketed. Marketing Authorisation Holder: <To be completed nationally> Manufacturer:

6 <To be completed nationally> This medicinal product is authorised in the Member States of the EEA under the following names: France: Acide Alendronique Qualihealth 70 mg, comprimé Italy: Dralenos Netherlands: Alendroninezuur Mylan 70 mg, tabletten The leaflet was last approved in MM/YYYY