Artwork No. - Colours Used Customer Accord Pantone Black Description Alendronic Acid 70 mg Market UK / IE Language English Size 170 x 550 mm (PIL) Min. Font Size 9 Version No. 8 (Page 1 of 2) (IB020) Date 23_03_17 (Alendronic Acid 70 mg (ACC-UK)IB020-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

supplements and vitamins. Alendronic Acid is effective only if taken when your stomach 5. How to store Alendronic Package leaflet: Information for the user is empty. Acid Tablets If you take more Alendronic Acid Tablets Alendronic Acid Once weekly 70 mg Tablets than you should • Keep this medicine out of the sight and (Alendronic Acid) reach of children. If you take too many tablets by mistake, • This medicinal product does not require drink a full glass of milk and contact your Read all of this leaflet carefully before you start • you have poor dental health, gum disease, a any special storage conditions doctor immediately. Do not make yourself vomit, and taking this medicine because it contains important planned dental extraction or you don’t receive routine • Do not take this medicine after the expiry date which do not lie down. information for you. dental care is stated on the carton and the blister after EXP. The • Keep this leaflet. You may need to read it again. • You have expiry date refers to the last day of that month. • If you have any further questions, ask your doctor or • You are undergoing chemotherapy or radiotherapy If you forget to take Alendronic Acid Tablets pharmacist. • You are taking angiogenesis inhibitors (such as • Do not throw away any medicines via wastewater or • This medicine has been prescribed for you only. Do bevacizumab, or thalidomide) If you miss a dose, just take one Alendronic Acid household waste. Ask your pharmacist how to throw not pass it on to others. It may harm them, even if • You are taking corticosteroids (such as prednisone or Tablets 70 mg on the morning after you remember. Do away medicines you no longer use. These measures their symptoms are the same as yours. dexamethasone) not take a double dose to make up for a forgotten will help protect the environment. • If you get any side effects, talk to your doctor or • You are or have been a smoker (as this may dose. Return taking one tablet once a week, as pharmacist. This includes any possible side effects increase the risk of dental problems) originally scheduled on your chosen day. 6. Contents of the pack and other not listed in this leaflet. See section 4. information • It is particularly important to understand the You may be advised to have a dental check-up before If you stop taking Alendronic Acid Tablets It is important that you continue taking Alendronic Acid information in section 3. How to take Alendronic Acid, starting treatment with Alendronic acid Tablets. What Alendronic Acid Tablets contain before taking this medicine. Tablets for as long as your doctor prescribes the It is important to maintain good oral hygiene when medicine. Since it is known how long you should take Alendronic Acid Tablets, you should discuss the need The active substance is alendronic acid (as sodium What is in this leaflet being treated with Alendronic Acid Tablets. You should alendronate). 1. What Alendronic Acid Tablets are and what they are have routine dental check-ups throughout your to stay on this medicine with your doctor periodically to used for treatment and you should contact your doctor or determine if Alendronic acid tablets are still right for you. Each tablet contains 70mg alendronic acid (as 2. What you need to know before you take Alendronic dentist if you experience any problems with your alendronate sodium ) Acid Tablets mouth or teeth such as loose teeth, pain or swelling. 3. How to take Alendronic Acid Tablets If you have any further questions on the use of this medicine, ask your doctor or pharmacist. The other ingredients are lactose anhydrous, cellulose 4. Possible side effects Irritation, inflammation or ulceration of the gullet microcrystalline (E460), croscarmellose sodium and 5. How to store Alendronic Acid Tablets (oesophagus – the tube that connects your mouth with magnesium stearate. 6. Contents of the pack and other information your stomach) often with symptoms of , 4. Possible side effects heartburn, or difficulty or pain upon swallowing may What Alendronic Acid Tablets look like and content Like all medicines, this medicine can cause side 1. What Alendronic Acid Tablets occur, especially if patients do not drink a full glass of of the pack: water and/or if they lie down less than 30 minutes after effects, although not everybody gets them. are and what they are used for taking Alendronic Acid Tablets. These side effects may Alendronic Acid 70 mg Tablets are available as white See your doctor immediately if you notice any of the worsen if patients continue to take Alendronic Acid to off-white, oval, biconvex tablet debossed with ‘AHI’ What is Alendronic acid? following side effects, which may be serious, and for Tablets after developing these symptoms. on one side and plain on other side. Alendronic acid tablet is a tablets containing the active which you may need urgent medicinal treatment: substance alendronic acid (commonly called Children and adolescents Common (may affect up to 1 in 10 people): alendronate) and belongs to a group of non-hormonal Alendronic Acid 70 mg Tablets are available in OPA-Al-PVC/Al blister packs containing 4 tablets or medicines called . Alendronic acid • heartburn; difficulty swallowing; pain upon Alendronic acid Tablets should not be given to children 12* tablets. prevents the loss of bone that occurs in women after swallowing; ulceration of the gullet (oesophagus – and adolescents. Not all pack sizes may be marketed they have been through the menopause, and helps to the tube that connects your mouth with your rebuild bone. It reduces the risk of spine and hip * Not for UK market Other medicines and Alendronic acid Tablets stomach) which can cause chest pain, heartburn or fractures. difficulty or pain upon swallowing. Marketing Authorisation Holder Tell your doctor or pharmacist if you are taking, have United Kingdom What are Alendronic Acid Tablets used for? Rare (may affect up to 1 in 1,000 people): recently taken or might take any other medicines. Accord Healthcare Limited Your doctor has prescribed alendronic acid tablets to Sage House, 319 Pinner Road It is likely that supplements, antacids, and • allergic reactions such as hives; swelling of the face, treat your . Alendronic acid reduces the North Harrow, Middlesex, HA1 4HF some oral medicines will interfere with the absorption lips, tongue and/or throat, possibly causing difficulty risk of spine and hip fractures. United Kingdom of Alendronic acid Tablets if taken at the same time. breathing or swallowing; severe skin reactions, • pain in the mouth, and/or jaw, swelling or sores inside Therefore, it is important that you follow the advice Ireland Alendronic acid is a once weekly treatment. the mouth, numbness or a feeling of heaviness in the given in section 3 How to take Alendronic acid Tablets. Accord Healthcare Ireland Limited jaw, or loosening of a tooth. These could be signs of Euro House What is osteoporosis? Certain medicines for rheumatism or long-term pain bone damage in the jaw (osteonecrosis) generally Osteoporosis is a thinning and weakening of the Euro Business Park called NSAIDs (e.g. acetylsalicyclic acid or ibuprofen) associated with delayed healing and infection, often bones. It is common in women after the menopause. Little Island might cause digestive problems. Therefore, caution following tooth extraction. Contact your doctor and At the menopause, the ovaries stop producing the Cork T45 K857 should be used when these medicines are taken at the dentist if you experience such symptoms. female hormone, oestrogen, which helps to keep a Ireland same time as Alendronic acid Tablets. • Unusual fracture of the thigh bone particularly in woman’s skeleton healthy. As a result, bone loss patients on long-term treatment for osteoporosis may Manufacturer occurs and bones become weaker. The earlier a occur rarely. Contact your doctor if you experience Alendronic Acid Tablets with food and drink Accord Healthcare Limited woman reaches the menopause, the greater the risk of pain, weakness or discomfort in your thigh, hip or groin Sage House, 319 Pinner Road osteoporosis. as this may be an early indication of a possible It is likely that food and beverages (including mineral North Harrow, Middlesex, HA1 4HF water) will make Alendronic acid Tablets less effective if fracture of the thigh bone. Early on, osteoporosis usually has no symptoms. If left United Kingdom taken at the same time. Therefore, it is important that • bone, muscle and/or joint pain which is severe. untreated, however, it can result in broken bones. you follow the advice given in section 3 How to take Although these usually hurt, breaks in the bones of the Accord Healthcare Polska Sp.z o.o., Alendronic Acid Tablets. Other side effects include ul. Lutomierska 50,95-200 Pabianice, Poland spine may go unnoticed until they cause height loss. Very Common (may affect more than 1 in 10 people): Broken bones can happen during normal, everyday , breast-feeding and fertility This leaflet was last revised in 03/2019. activity, such as lifting, or from minor injury that would • bone, muscle and/or joint pain which is not generally break normal bone. Broken bones Alendronic acid tablet is only intended for sometimes severe usually occur at the hip, spine, or wrist and can lead not use in postmenopausal women. If you are only to pain but also to considerable problems like pregnant or breast-feeding, think you may Common (may affect up to 1 in 10 people): stooped posture (‘dowager’s hump’), and loss of be pregnant or are planning to have a baby, mobility. ask your doctor or pharmacist for advice • joint swelling before taking this medicine. • abdominal pain; uncomfortable feeling in How can osteoporosis be treated? the stomach or belching after eating; Driving and using machines constipation; full or bloated feeling in the stomach; As well as your treatment with Alendronic acid Tablet, diarrhoea; flatulence; your doctor may suggest you make changes to your There have been side effects (including blurred vision, • headache; dissiness, lifestyle to help your condition, such as: dizziness and severe bone, muscle or joint pain) • hair loss; itching reported with alendronic acid tablets that may affect • tiredness; swelling in the hands or legs Stopping smoking: Smoking appears to your ability to drive or operate machinery. Individual increase the rate at responses to alendronic acid tablets may vary (See Uncommon(may affect up to 1 in 100 people): which you lose bone setion 4.) and, therefore, may • nausea; increase your risk of Alendronic Acid Tablets contains lactose • vomiting broken bones. • irritation or inflammation of the gullet (oesophagus – Exercise: Like muscles, bones If you have been told by your doctor that you have the tube that connects your mouth with your need exercise to stay intolerance to some sugars, contact your doctor before stomach) or stomach strong and healthy. taking this medicine. • black or tar-like stools Consult your doctor • rash; redness of the skin before you begin any 3. How to take Alendronic Acid • blurred vision; pain or redness in the eye, exercise programme. • transient flu-like symptoms, such as aching muscles, Eating a balanced diet: Your doctor can Tablets generally feeling unwell and sometimes with fever advise you about your usually at the start of treatment, diet or whether you Always take this medicine exactly as youe doctor or • taste disturbance. should take any pharmacist has told you. Chek with your doctor or dietary supplements pharmacist if you are not sure. Rare (may affect up to 1 in 1000 people): (especially calcium and ). Take one Alendronic Acid Tablet once a week. • symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation 2. What you need to know before Follow these instructions carefully to make sure you in the fingers or around the mouth will benefit from alendronic acid. you take Alendronic Acid • stomach or peptic ulcers (sometimes severe or with bleeding) Tablets 1) Choose the day of the week that best fits your • narrowing of the gullet (oesophagus – the tube that schedule. Every week, take one alendronic acid tablet connects your mouth with your stomach) Do not take Alendronic Acid Tablets on your chosen day. • rash made worse by sunlight • mouth ulcers when the tablets have been chewed or • if you are allergic to alendronic acid or any of the It is very important to follow instructions 2), 3), 4) and sucked other ingredients of this medicine (listed in section 6) 5) to help the alendronic acid tablet reach your • if you have certain problems with your gullet stomach quickly and help reduce the chance of Very rare (may affect up to 1 in 10,000 people): (oesophagus – the tube that connects your mouth irritating your gullet (oesophagus - the tube that with your stomach) such as narrowing or difficulty connects your mouth with your stomach). • Talk to your doctor if you have ear pain, discharge swallowing from the ear, and/or an ear infection. These could be • if you cannot to stand or sit upright for at least 30 2) After getting up for the day and before taking any signs of bone damage in the ear. minutes food, drink, or other medicine, swallow your alendronic • if your doctor has told you that you have low blood acid tablet with a full glass of water only (not mineral Reporting of side effects calcium water) (not less than 200 ml). If you get any side effects, talk to your doctor, • Do not take with mineral water (still or sparkling). pharmacist or nurse. This includes any possible side If you think any of these apply to you, do not take the • Do not take with coffee or tea. effects not listed in this leaflet. By reporting side tablets. Talk to your doctor first and follow the advice • Do not take with juice or milk. effects, you can help provide more information on the given. safety of this medicine. Do not crush or chew the tablet or allow it to dissolve Warnings and precautions in your mouth. For UK: You can also report side effects directly via the Yellow Card Scheme Talk to your doctor or pharmacist before taking 3) Do not lie down — stay fully upright (sitting, Website: www.mhra.gov.uk/yellowcard. Alendronic acid standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your For IE: You can also report side effects directly It is important to tell your doctor before taking first food of the day. via HPRA Pharmacovigilance Alendronic Acid Tablets if 4) Do not take alendronic acid bedtime or before Earlsfort Terrace getting up for the day. IRL - Dublin 2 • you suffer from problems 5) If you develop difficulty or pain upon swallowing, Tel: +353 1 6764971 • you have any swallowing or digestive problems chest pain, or new or worsening heartburn, stop taking Fax: +353 1 6762517 • your doctor has told you that you have Barrett's alendronic acid and contact your doctor. Website: www.hpra.ie oesophagus (a condition associated with changes in the 6) After swallowing your alendronic acid tablet, wait at e-mail: [email protected]. cells that line the lower oesophagus) least 30 minutes before taking your first food, drink, or • you have been told you have low blood calcium other medicine of the day, including antacids, calcium

Front Side

(693420) Date: 27/02/2019, 25/03/2019 Artwork No. - Colours Used Customer Accord Pantone Black Description Alendronic Acid 70 mg Market UK / IE Language English Size 170 x 550 mm (PIL) Min. Font Size 9 Version No. 8 (Page 2 of 2) (IB020) Date 23_03_17 (Alendronic Acid 70 mg (ACC-UK)IB020-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

supplements and vitamins. Alendronic Acid is effective only if taken when your stomach 5. How to store Alendronic is empty. Acid Tablets If you take more Alendronic Acid Tablets than you should • Keep this medicine out of the sight and reach of children. If you take too many tablets by mistake, • This medicinal product does not require drink a full glass of milk and contact your Read all of this leaflet carefully before you start • you have poor dental health, gum disease, a any special storage conditions doctor immediately. Do not make yourself vomit, and taking this medicine because it contains important planned dental extraction or you don’t receive routine • Do not take this medicine after the expiry date which do not lie down. information for you. dental care is stated on the carton and the blister after EXP. The • Keep this leaflet. You may need to read it again. • You have cancer expiry date refers to the last day of that month. • If you have any further questions, ask your doctor or • You are undergoing chemotherapy or radiotherapy If you forget to take Alendronic Acid Tablets pharmacist. • You are taking angiogenesis inhibitors (such as • Do not throw away any medicines via wastewater or • This medicine has been prescribed for you only. Do bevacizumab, or thalidomide) If you miss a dose, just take one Alendronic Acid household waste. Ask your pharmacist how to throw not pass it on to others. It may harm them, even if • You are taking corticosteroids (such as prednisone or Tablets 70 mg on the morning after you remember. Do away medicines you no longer use. These measures their symptoms are the same as yours. dexamethasone) not take a double dose to make up for a forgotten will help protect the environment. • If you get any side effects, talk to your doctor or • You are or have been a smoker (as this may dose. Return taking one tablet once a week, as pharmacist. This includes any possible side effects increase the risk of dental problems) originally scheduled on your chosen day. 6. Contents of the pack and other not listed in this leaflet. See section 4. information • It is particularly important to understand the You may be advised to have a dental check-up before If you stop taking Alendronic Acid Tablets It is important that you continue taking Alendronic Acid information in section 3. How to take Alendronic Acid, starting treatment with Alendronic acid Tablets. What Alendronic Acid Tablets contain before taking this medicine. Tablets for as long as your doctor prescribes the It is important to maintain good oral hygiene when medicine. Since it is known how long you should take Alendronic Acid Tablets, you should discuss the need The active substance is alendronic acid (as sodium What is in this leaflet being treated with Alendronic Acid Tablets. You should alendronate). 1. What Alendronic Acid Tablets are and what they are have routine dental check-ups throughout your to stay on this medicine with your doctor periodically to used for treatment and you should contact your doctor or determine if Alendronic acid tablets are still right for you. Each tablet contains 70mg alendronic acid (as 2. What you need to know before you take Alendronic dentist if you experience any problems with your alendronate sodium ) Acid Tablets mouth or teeth such as loose teeth, pain or swelling. 3. How to take Alendronic Acid Tablets If you have any further questions on the use of this medicine, ask your doctor or pharmacist. The other ingredients are lactose anhydrous, cellulose 4. Possible side effects Irritation, inflammation or ulceration of the gullet microcrystalline (E460), croscarmellose sodium and 5. How to store Alendronic Acid Tablets (oesophagus – the tube that connects your mouth with magnesium stearate. 6. Contents of the pack and other information your stomach) often with symptoms of chest pain, 4. Possible side effects heartburn, or difficulty or pain upon swallowing may What Alendronic Acid Tablets look like and content Like all medicines, this medicine can cause side 1. What Alendronic Acid Tablets occur, especially if patients do not drink a full glass of of the pack: water and/or if they lie down less than 30 minutes after effects, although not everybody gets them. are and what they are used for taking Alendronic Acid Tablets. These side effects may Alendronic Acid 70 mg Tablets are available as white See your doctor immediately if you notice any of the worsen if patients continue to take Alendronic Acid to off-white, oval, biconvex tablet debossed with ‘AHI’ What is Alendronic acid? following side effects, which may be serious, and for Tablets after developing these symptoms. on one side and plain on other side. Alendronic acid tablet is a tablets containing the active which you may need urgent medicinal treatment: substance alendronic acid (commonly called Children and adolescents Common (may affect up to 1 in 10 people): alendronate) and belongs to a group of non-hormonal Alendronic Acid 70 mg Tablets are available in OPA-Al-PVC/Al blister packs containing 4 tablets or medicines called bisphosphonates. Alendronic acid • heartburn; difficulty swallowing; pain upon Alendronic acid Tablets should not be given to children 12* tablets. prevents the loss of bone that occurs in women after swallowing; ulceration of the gullet (oesophagus – and adolescents. Not all pack sizes may be marketed they have been through the menopause, and helps to the tube that connects your mouth with your rebuild bone. It reduces the risk of spine and hip * Not for UK market Other medicines and Alendronic acid Tablets stomach) which can cause chest pain, heartburn or fractures. difficulty or pain upon swallowing. Marketing Authorisation Holder Tell your doctor or pharmacist if you are taking, have United Kingdom What are Alendronic Acid Tablets used for? Rare (may affect up to 1 in 1,000 people): recently taken or might take any other medicines. Accord Healthcare Limited Your doctor has prescribed alendronic acid tablets to Sage House, 319 Pinner Road It is likely that calcium supplements, antacids, and • allergic reactions such as hives; swelling of the face, treat your osteoporosis. Alendronic acid reduces the North Harrow, Middlesex, HA1 4HF some oral medicines will interfere with the absorption lips, tongue and/or throat, possibly causing difficulty risk of spine and hip fractures. United Kingdom of Alendronic acid Tablets if taken at the same time. breathing or swallowing; severe skin reactions, • pain in the mouth, and/or jaw, swelling or sores inside Therefore, it is important that you follow the advice Ireland Alendronic acid is a once weekly treatment. the mouth, numbness or a feeling of heaviness in the given in section 3 How to take Alendronic acid Tablets. Accord Healthcare Ireland Limited jaw, or loosening of a tooth. These could be signs of Euro House What is osteoporosis? Certain medicines for rheumatism or long-term pain bone damage in the jaw (osteonecrosis) generally Osteoporosis is a thinning and weakening of the Euro Business Park called NSAIDs (e.g. acetylsalicyclic acid or ibuprofen) associated with delayed healing and infection, often bones. It is common in women after the menopause. Little Island might cause digestive problems. Therefore, caution following tooth extraction. Contact your doctor and At the menopause, the ovaries stop producing the Cork T45 K857 should be used when these medicines are taken at the dentist if you experience such symptoms. female hormone, oestrogen, which helps to keep a Ireland same time as Alendronic acid Tablets. • Unusual fracture of the thigh bone particularly in woman’s skeleton healthy. As a result, bone loss patients on long-term treatment for osteoporosis may Manufacturer occurs and bones become weaker. The earlier a occur rarely. Contact your doctor if you experience Alendronic Acid Tablets with food and drink Accord Healthcare Limited woman reaches the menopause, the greater the risk of pain, weakness or discomfort in your thigh, hip or groin Sage House, 319 Pinner Road osteoporosis. as this may be an early indication of a possible It is likely that food and beverages (including mineral North Harrow, Middlesex, HA1 4HF water) will make Alendronic acid Tablets less effective if fracture of the thigh bone. Early on, osteoporosis usually has no symptoms. If left United Kingdom taken at the same time. Therefore, it is important that • bone, muscle and/or joint pain which is severe. untreated, however, it can result in broken bones. you follow the advice given in section 3 How to take Although these usually hurt, breaks in the bones of the Accord Healthcare Polska Sp.z o.o., Alendronic Acid Tablets. Other side effects include ul. Lutomierska 50,95-200 Pabianice, Poland spine may go unnoticed until they cause height loss. Very Common (may affect more than 1 in 10 people): Broken bones can happen during normal, everyday Pregnancy, breast-feeding and fertility This leaflet was last revised in 03/2019. activity, such as lifting, or from minor injury that would • bone, muscle and/or joint pain which is not generally break normal bone. Broken bones Alendronic acid tablet is only intended for sometimes severe usually occur at the hip, spine, or wrist and can lead not use in postmenopausal women. If you are only to pain but also to considerable problems like pregnant or breast-feeding, think you may Common (may affect up to 1 in 10 people): stooped posture (‘dowager’s hump’), and loss of be pregnant or are planning to have a baby, mobility. ask your doctor or pharmacist for advice • joint swelling before taking this medicine. • abdominal pain; uncomfortable feeling in How can osteoporosis be treated? the stomach or belching after eating; Driving and using machines constipation; full or bloated feeling in the stomach; As well as your treatment with Alendronic acid Tablet, diarrhoea; flatulence; your doctor may suggest you make changes to your There have been side effects (including blurred vision, • headache; dissiness, lifestyle to help your condition, such as: dizziness and severe bone, muscle or joint pain) • hair loss; itching reported with alendronic acid tablets that may affect • tiredness; swelling in the hands or legs Stopping smoking: Smoking appears to your ability to drive or operate machinery. Individual increase the rate at responses to alendronic acid tablets may vary (See Uncommon(may affect up to 1 in 100 people): which you lose bone setion 4.) and, therefore, may • nausea; increase your risk of Alendronic Acid Tablets contains lactose • vomiting broken bones. • irritation or inflammation of the gullet (oesophagus – Exercise: Like muscles, bones If you have been told by your doctor that you have the tube that connects your mouth with your need exercise to stay intolerance to some sugars, contact your doctor before stomach) or stomach strong and healthy. taking this medicine. • black or tar-like stools Consult your doctor • rash; redness of the skin before you begin any 3. How to take Alendronic Acid • blurred vision; pain or redness in the eye, exercise programme. • transient flu-like symptoms, such as aching muscles, Eating a balanced diet: Your doctor can Tablets generally feeling unwell and sometimes with fever advise you about your usually at the start of treatment, diet or whether you Always take this medicine exactly as youe doctor or • taste disturbance. should take any pharmacist has told you. Chek with your doctor or dietary supplements pharmacist if you are not sure. Rare (may affect up to 1 in 1000 people): (especially calcium and Vitamin D). Take one Alendronic Acid Tablet once a week. • symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation 2. What you need to know before Follow these instructions carefully to make sure you in the fingers or around the mouth will benefit from alendronic acid. you take Alendronic Acid • stomach or peptic ulcers (sometimes severe or with bleeding) Tablets 1) Choose the day of the week that best fits your • narrowing of the gullet (oesophagus – the tube that schedule. Every week, take one alendronic acid tablet connects your mouth with your stomach) Do not take Alendronic Acid Tablets on your chosen day. • rash made worse by sunlight • mouth ulcers when the tablets have been chewed or • if you are allergic to alendronic acid or any of the It is very important to follow instructions 2), 3), 4) and sucked other ingredients of this medicine (listed in section 6) 5) to help the alendronic acid tablet reach your • if you have certain problems with your gullet stomach quickly and help reduce the chance of Very rare (may affect up to 1 in 10,000 people): (oesophagus – the tube that connects your mouth irritating your gullet (oesophagus - the tube that with your stomach) such as narrowing or difficulty connects your mouth with your stomach). • Talk to your doctor if you have ear pain, discharge swallowing from the ear, and/or an ear infection. These could be • if you cannot to stand or sit upright for at least 30 2) After getting up for the day and before taking any signs of bone damage in the ear. minutes food, drink, or other medicine, swallow your alendronic • if your doctor has told you that you have low blood acid tablet with a full glass of water only (not mineral Reporting of side effects calcium water) (not less than 200 ml). If you get any side effects, talk to your doctor, • Do not take with mineral water (still or sparkling). pharmacist or nurse. This includes any possible side If you think any of these apply to you, do not take the • Do not take with coffee or tea. effects not listed in this leaflet. By reporting side tablets. Talk to your doctor first and follow the advice • Do not take with juice or milk. effects, you can help provide more information on the given. safety of this medicine. Do not crush or chew the tablet or allow it to dissolve Warnings and precautions in your mouth. For UK: You can also report side effects directly via the Yellow Card Scheme Talk to your doctor or pharmacist before taking 3) Do not lie down — stay fully upright (sitting, Website: www.mhra.gov.uk/yellowcard. Alendronic acid standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your For IE: You can also report side effects directly It is important to tell your doctor before taking first food of the day. via HPRA Pharmacovigilance Alendronic Acid Tablets if 4) Do not take alendronic acid bedtime or before Earlsfort Terrace getting up for the day. IRL - Dublin 2 • you suffer from kidney problems 5) If you develop difficulty or pain upon swallowing, Tel: +353 1 6764971 • you have any swallowing or digestive problems chest pain, or new or worsening heartburn, stop taking Fax: +353 1 6762517 • your doctor has told you that you have Barrett's alendronic acid and contact your doctor. Website: www.hpra.ie oesophagus (a condition associated with changes in the 6) After swallowing your alendronic acid tablet, wait at e-mail: [email protected]. cells that line the lower oesophagus) least 30 minutes before taking your first food, drink, or • you have been told you have low blood calcium other medicine of the day, including antacids, calcium INP113 10 1989 1 693420

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(693420) Date: 27/02/2019, 25/03/2019