ALENDRONIC ACID 70MG TABLETS
Active substance: SODIUM ALENDRONATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 70 mg TABLETS
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 eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Alendronic Acid 70 mg Tablets are and what they are used for 2. Before you take Alendronic Acid 70 mg Tablets. 3. How to take Alendronic Acid 70 mg Tablets. 4. Possible side eects. 5. How to store Alendronic Acid 70 mg Tablets. 6. Further information. 1. WHAT ALENDRONIC ACID 70 MG TABLETS ARE AND WHAT THEY ARE USED FOR Your medicine is in the form of a tablet. Alendronic Acid belongs to a group of medicines called bisphosphonates. Bisphosphonates can be used to help bone disease such as osteoporosis. Alendronic Acid can treat and prevent osteoporosis in post-menopausal women, by stopping bones becoming thin and weak. 2. BEFORE YOU TAKE ALENDRONIC ACID 70 MG TABLETS Do not take Alendronic Acid 70mg Tablets if: you are allergic to Alendronic Acid or any of the tablet ingredients you have problems with your food pipe (oesophagus) causing difficulty swallowing you know you have very low blood calcium (hypocalcaemia) you are unable to stand or sit upright for at least 30 minutes. Take special care with Alendronic Acid 70 mg Tablets It is important to tell your doctor before taking Alendronic Acid 70 mg Tablets if: you suer from kidney problems you have any swallowing or digestive or gut problems you have pain on swallowing you have been told you have low blood calcium or you suer from vitamin D deficiency. This needs to be treated before you start taking sodium alendronate trihydrate you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care you have parathyroid gland problems (small paired glands located near the thyroid gland at the base of the neck) 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 cancer you are undergoing chemotherapy or radiotherapy you are taking corticosteroids (such as prednisone or dexamethasone) you are or have been a smoker (as this may increase the risk of dental problems). Blood calcium and phosphate levels may be aected by these tablets. It is
important that you tell your doctor that you are taking alendronic acid if you have a blood test. You may be advised to have a dental check- up before starting treatment with Alendronic Acid 70 mg Tablets. It is important to maintain good oral hygiene when being treated with Alendronic Acid 70 mg Tablets. 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. Patients should avoid dental treatment whilst taking Alendronic Acid. If you have to have dental treatment discuss this with your doctor first. 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. This includes in particular, calcium supplements or antacids for indigestion. Wait at least 30 minutes after taking Alendronic Acid 70 mg Tablets before taking any other medicines. Taking Alendronic Acid 70mg Tablets with food and drink If taken at the same time it is likely that food and drink (including mineral water) will interfere with the absorption of Alendronic Acid. Therefore you should take Alendronic Acid 70 mg Tablets with plain water at least 30 minutes before any food or drink. Pregnancy and breast-feeding Do not take Alendronic Acid 70 mg Tablets if you are pregnant, planning to become pregnant or you are breast-feeding. Children and adolescents Alendronate should not be given to children and adolescents. Driving and using machines There have been side eects (including blurred vision, dizziness and severe bone muscle or joint pain) reported with Alendronic Acid that may aect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary (see 'Possible side eects'). Important information about some of the ingredients in Alendronic Acid 70 mg Tablets This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE ALENDRONIC ACID 70 MG TABLETS Always take Alendronic Acid 70 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once weekly. Your doctor will tell you which day of the week to take your tablet. Swallow the tablet whole while standing upright. Take with a full glass (not less than 200 mls or 7 fl. oz.) of plain water (not mineral water). * Do not take with mineral water (still or sparkling) * Do not take with coee 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 a bedtime and do not lie down for at least 30 minutes after taking Alendronic Acid 70 mg Tablets.
Wait at least 30 minutes after swallowing the tablet before you eat, drink or take any other medicines. Stop taking this medicine and tell your doctor if you notice: soreness, pain and diculty swallowing pain in the centre of the chest heartburn, either new or worse than usual ulcers in your mouth and throat. If you take more Alendronic Acid 70 mg Tablets than you should: Drink a full glass of milk and contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the container with you. Do not make yourself vomit, and do not lie down. If you forget to take Alendronic Acid 70 mg Tablets Take the tablet on the morning after you remember. Do not take two tablets on the same day but return to taking one tablet once a week, on the day instructed by your doctor. If you stop taking Alendronic Acid 70 mg Tablets Always talk to your doctor or pharmacist before stopping taking Alendronic Acid 70 mg Tablets. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Alendronic Acid 70 mg Tablets can cause side eects although not everybody gets them. The following terms are used to describe how often side eects have been reported. Very common (occurring in at least 1 of 10 patients treated) Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1 of 1,000 and less than 1 of 100 patients treated) Rare (occurring in at least 1 of 10,000 and less than 1 of 1,000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Very common bone, muscle and/or joint pain which is sometimes severe. Common heartburn; diculty 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 joint swelling abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence hair loss; itching headache; dizziness tiredness; swelling in the hands or legs. Uncommon 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 allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing
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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; 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. mouth ulcers when the tablets have been chewed or sucked. 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. 5. HOW TO STORE ALENDRONIC ACID 70 MG TABLETS Keep Alendronic Acid 70 mg Tablets out of the reach and sight of children. Do not take Alendronic Acid 70 mg Tablets 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 Alendronic Acid 70 mg Tablets contains Each tablet contains 70 mg of the active ingredient alendronic acid as sodium alendronate. It also contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate. What Alendronic Acid 70 mg Tablets looks like and contents of the pack Alendronic Acid 70 mg Tablets are white, bi-convex tablets, embossed 'AD70' on one side and 'G' on the reverse. Alendronic Acid 70 mg Tablets are available in cartons of 4 tablets. The pharmacist will dispense the number of tablets prescribed by your doctor. Marketing Authorisation holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturers Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last revised in: 01/2012
21111212
LT1517AD 10003454
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 70 mg TABLETS
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 eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Alendronic Acid 70 mg Tablets are and what they are used for 2. Before you take Alendronic Acid 70 mg Tablets. 3. How to take Alendronic Acid 70 mg Tablets. 4. Possible side eects. 5. How to store Alendronic Acid 70 mg Tablets. 6. Further information. 1. WHAT ALENDRONIC ACID 70 MG TABLETS ARE AND WHAT THEY ARE USED FOR Your medicine is in the form of a tablet. Alendronic Acid belongs to a group of medicines called bisphosphonates. Bisphosphonates can be used to help bone disease such as osteoporosis. Alendronic Acid can treat and prevent osteoporosis in post-menopausal women, by stopping bones becoming thin and weak. 2. BEFORE YOU TAKE ALENDRONIC ACID 70 MG TABLETS Do not take Alendronic Acid 70mg Tablets if: you are allergic to Alendronic Acid or any of the tablet ingredients you have problems with your food pipe (oesophagus) causing difficulty swallowing you know you have very low blood calcium (hypocalcaemia) you are unable to stand or sit upright for at least 30 minutes. Take special care with Alendronic Acid 70 mg Tablets It is important to tell your doctor before taking Alendronic Acid 70 mg Tablets if: you suer from kidney problems you have any swallowing or digestive or gut problems you have pain on swallowing you have been told you have low blood calcium or you suer from vitamin D deficiency. This needs to be treated before you start taking sodium alendronate trihydrate you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care you have parathyroid gland problems (small paired glands located near the thyroid gland at the base of the neck) 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 cancer you are undergoing chemotherapy or radiotherapy you are taking corticosteroids (such as prednisone or dexamethasone) you are or have been a smoker (as this may increase the risk of dental problems). Blood calcium and phosphate levels may be aected by these tablets. It is
important that you tell your doctor that you are taking alendronic acid if you have a blood test. You may be advised to have a dental check- up before starting treatment with Alendronic Acid 70 mg Tablets. It is important to maintain good oral hygiene when being treated with Alendronic Acid 70 mg Tablets. 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. Patients should avoid dental treatment whilst taking Alendronic Acid. If you have to have dental treatment discuss this with your doctor first. 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. This includes in particular, calcium supplements or antacids for indigestion. Wait at least 30 minutes after taking Alendronic Acid 70 mg Tablets before taking any other medicines. Taking Alendronic Acid 70mg Tablets with food and drink If taken at the same time it is likely that food and drink (including mineral water) will interfere with the absorption of Alendronic Acid. Therefore you should take Alendronic Acid 70 mg Tablets with plain water at least 30 minutes before any food or drink. Pregnancy and breast-feeding Do not take Alendronic Acid 70 mg Tablets if you are pregnant, planning to become pregnant or you are breast-feeding. Children and adolescents Alendronate should not be given to children and adolescents. Driving and using machines There have been side eects (including blurred vision, dizziness and severe bone muscle or joint pain) reported with Alendronic Acid that may aect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary (see 'Possible side eects'). Important information about some of the ingredients in Alendronic Acid 70 mg Tablets This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE ALENDRONIC ACID 70 MG TABLETS Always take Alendronic Acid 70 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once weekly. Your doctor will tell you which day of the week to take your tablet. Swallow the tablet whole while standing upright. Take with a full glass (not less than 200 mls or 7 fl. oz.) of plain water (not mineral water). * Do not take with mineral water (still or sparkling) * Do not take with coee 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 a bedtime and do not lie down for at least 30 minutes after taking Alendronic Acid 70 mg Tablets.
Wait at least 30 minutes after swallowing the tablet before you eat, drink or take any other medicines. Stop taking this medicine and tell your doctor if you notice: soreness, pain and diculty swallowing pain in the centre of the chest heartburn, either new or worse than usual ulcers in your mouth and throat. If you take more Alendronic Acid 70 mg Tablets than you should: Drink a full glass of milk and contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the container with you. Do not make yourself vomit, and do not lie down. If you forget to take Alendronic Acid 70 mg Tablets Take the tablet on the morning after you remember. Do not take two tablets on the same day but return to taking one tablet once a week, on the day instructed by your doctor. If you stop taking Alendronic Acid 70 mg Tablets Always talk to your doctor or pharmacist before stopping taking Alendronic Acid 70 mg Tablets. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Alendronic Acid 70 mg Tablets can cause side eects although not everybody gets them. The following terms are used to describe how often side eects have been reported. Very common (occurring in at least 1 of 10 patients treated) Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1 of 1,000 and less than 1 of 100 patients treated) Rare (occurring in at least 1 of 10,000 and less than 1 of 1,000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Very common bone, muscle and/or joint pain which is sometimes severe. Common heartburn; diculty 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 joint swelling abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence hair loss; itching headache; dizziness tiredness; swelling in the hands or legs. Uncommon 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 allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing
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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; 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. mouth ulcers when the tablets have been chewed or sucked. 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. 5. HOW TO STORE ALENDRONIC ACID 70 MG TABLETS Keep Alendronic Acid 70 mg Tablets out of the reach and sight of children. Do not take Alendronic Acid 70 mg Tablets 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 Alendronic Acid 70 mg Tablets contains Each tablet contains 70 mg of the active ingredient alendronic acid as sodium alendronate. It also contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate. What Alendronic Acid 70 mg Tablets looks like and contents of the pack Alendronic Acid 70 mg Tablets are white, bi-convex tablets, embossed 'AD70' on one side and 'G' on the reverse. Alendronic Acid 70 mg Tablets are available in cartons of 4 tablets. The pharmacist will dispense the number of tablets prescribed by your doctor. Marketing Authorisation holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturers Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last revised in: 01/2012
21111212
LT1517AD 10003454
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
