Alendronic Acid Once Weekly 70mg Tablets
Out of date information, search anotherS0363 LEAFLET Fosamax Weekly 20150514
PACKAGE LEAFLET: INFORMATION FOR THE USER FOSAMAX ONCE WEEKLY 70mg TABLETS
(alendronate sodium)
Your medicine is known by Fosamax Once Weekly 70mg Tablets but will be referred to as Fosamax throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- It is particularly important to understand the information in section 3. How to take Fosamax, before taking this medicine.
What is in this leaflet:
1. What Fosamax is and what it is used for
2. What you need to know before you take Fosamax
3. How to take Fosamax
4. Possible side effects 5 How to store Fosamax
6. Contents of the pack and other information
1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR
What is Fosamax?
Fosamax is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of nonhormonal medicines called bisphosphonates. Fosamax prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.
What is Fosamax used for?
Your doctor has prescribed Fosamax to treat your osteoporosis. Fosamax reduces the risk of spine and hip fractures.
Fosamax 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?
As well as your treatment with Fosamax, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Stopping smoking Smoking appears to increase the
rate at which you lose bone and, therefore, may increase your risk of broken bones.
Exercise 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSAMAX
Do not take Fosamax
• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your gullet (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
Warnings and precautions
Talk to your doctor or pharmacist before taking Fosamax.
It is important to tell your doctor before taking Fosamax if:
• you suffer from kidney problems,
• you have any swallowing or digestive problems,
• 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 been told you have low blood calcium,
• you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
• 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).
You may be advised to have a dental check-up before starting treatment with Fosamax.
It is important to maintain good oral hygiene when being treated with Fosamax. 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.
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Fosamax. These side effects may worsen if patients continue to take Fosamax after developing these symptoms.
Children and adolescents
Fosamax should not be given to children and adolescents less than 18 years of age.
Other medicines and Fosamax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Fosamax if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Fosamax.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Fosamax.
Fosamax with food and drink
It is likely that food and beverages (including mineral water) will make Fosamax less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Fosamax.
Pregnancy and breast-feeding
Fosamax is only intended for use in postmenopausal women. You should not take Fosamax if you are or think you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Fosamax that may affect your ability to drive or operate machinery. Individual responses to Fosamax may vary. (See section 4.)
Fosamax contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FOSAMAX
Always take Fosamax exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one Fosamax tablet once a week.
Follow these instructions carefully to make sure you will benefit from Fosamax.
1) Choose the day of the week that best fits your schedule. Every week, take one Fosamax tablet on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the Fosamax tablet reach your stomach quickly and help reduce the chance of irritating your gullet (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 Fosamax tablet whole with a full glass of water only (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 the tablet or allow it to dissolve 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 Fosamax 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 Fosamax and contact your doctor.
6) After swallowing your Fosamax tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Fosamax is effective only if taken when your stomach is empty.
If you take more Fosamax than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.
If you forget to take Fosamax
If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
If you stop taking Fosamax
It is important that you take Fosamax for as long as your doctor prescribes the medicine. Since it is not known how long you should take Fosamax, you should discuss the need to stay on this medicine with your doctor periodically to determine if Fosamax is still right for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
See your doctor immediately if you notice any of the following
side effects, which may be serious, and for which you may need
urgent medical treatment:
Common (may affect up to 1 in 10 people):
• heartburn; difficulty 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.
Rare (may affect up to 1 in 1,000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; 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.
• bone, muscle and/or joint pain which is severe.
Other side effects include
Very common (may affect more than 1 in 10 people):
• bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 100 people):
• 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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FOSAMAX
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• There are no special storage instructions for this medicine. However, do not put the tablets into another container; they might get mixed up. Do not remove the tablets from the blister pack until you are ready to take the medicine.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fosamax contains
• Each Fosamax contains 91.37mg of the active ingredient, alendronate sodium trihydrate equivalent to 70mg of alendronic acid.
• Fosamax also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and magnesium stearate.
What Fosamax looks like and contents of the pack
Fosamax are oval, white tablets marked with an outline of a bone image on one side and ‘31' on the other.
Fosamax are available as blister packs of 4 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Merck, Sharp & Dohme (Italia)
S.p.A, Via Emilia 21,27100 Pavia, Italy.
|POM | PL No: 19488/0363 Leaflet revision date: 14 May 2015
Fosamax is a registered trade mark of Merck & Co. Inc., USA.
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘FOSAMAX’?
This leaflet gives you the most important patient information about ‘Fosamax'. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.
For more information about osteoporosis, contact (in UK) The National Osteoporosis Society, Camerton, Bath BA2 0PJ.
Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 114 Pembroke Road, Garden Level, Ballsbridge, Dublin 4, Telephone (01)
6375050.
The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.
S0363 LEAFLET Fosamax Weekly 20150514
Rare (may affect up to 1 in 1000 people):
• 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,
• mouth ulcers when the tablets have been chewed or sucked.
Exercise
Eating a balanced diet
S0363 LEAFLET Alendronic acid 20150514
PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID ONCE WEEKLY 70mg TABLETS (alendronate sodium)
Your medicine is known by Alendronic Acid Once Weekly 70mg
Tablets but will be referred to as Alendronic Acid throughout the
following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- It is particularly important to understand the information in section 3. How to take Alendronic Acid, before taking this medicine.
What is in this leaflet:
1. What Alendronic Acid is and what it is used for
2. What you need to know before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5 How to store Alendronic Acid
6. Contents of the pack and other information
1. WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR
What is Alendronic Acid?
Alendronic Acid is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.
What is Alendronic Acid used for?
Your doctor has prescribed Alendronic Acid to treat your osteoporosis. Alendronic Acid reduces the risk of spine and hip fractures.
Alendronic Acid 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?
As well as your treatment with Alendronic Acid, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Stopping smoking 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.
Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID
Do not take Alendronic Acid
• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your gullet (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
Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronic Acid.
It is important to tell your doctor before taking Alendronic Acid if:
• you suffer from kidney problems,
• you have any swallowing or digestive problems,
• 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 been told you have low blood calcium,
• you have poor dental health, gum disease, a planned dental extraction or you don't receive routine dental care,
• 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).
You may be advised to have a dental check-up before starting treatment with Alendronic Acid.
It is important to maintain good oral hygiene when being treated with Alendronic Acid. 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.
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid. These side effects may worsen if patients continue to take Alendronic Acid after developing these symptoms.
Children and adolescents
Alendronic Acid should not be given to children and adolescents less than 18 years of age.
Other medicines and Alendronic Acid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Alendronic Acid.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid.
Alendronic Acid with food and drink It is likely that food and beverages (including mineral water) will make Alendronic Acid less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Alendronic Acid.
Pregnancy and breast-feeding
Alendronic Acid is only intended for use in postmenopausal women. You should not take Alendronic Acid if you are or think you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary. (See section 4.)
Alendronic Acid contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ALENDRONIC ACID
Always take Alendronic Acid exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one Alendronic Acid tablet once a week.
Follow these instructions carefully to make sure you will benefit from Alendronic Acid.
1) Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid tablet on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic Acid tablet reach your stomach quickly and help reduce the chance of irritating your gullet (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 Alendronic Acid tablet whole with a full glass of water only (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 the tablet or allow it to dissolve 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 Alendronic Acid 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 Alendronic Acid and contact your doctor.
6) After swallowing your Alendronic Acid tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid is effective only if taken when your stomach is empty.
If you take more Alendronic Acid than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.
If you forget to take Alendronic Acid
If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
If you stop taking Alendronic Acid
It is important that you take Alendronic Acid for as long as your doctor prescribes the medicine. Since it is not known how long you should take Alendronic Acid, you should discuss the need to stay on this medicine with your doctor periodically to determine if Alendronic Acid is still right for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
See your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
• heartburn; difficulty 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.
Rare (may affect up to 1 in 1,000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; 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.
• bone, muscle and/or joint pain which is severe.
Other side effects include
Very common (may affect more than 1 in 10 people):
• bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):
• 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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ALENDRONIC ACID
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• There are no special storage instructions for this medicine. However, do not put the tablets into another container; they might get mixed up. Do not remove the tablets from the blister pack until you are ready to take the medicine.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alendronic Acid contains
• Each Alendronic Acid contains 91.37mg of the active ingredient, alendronate sodium trihydrate equivalent to 70mg of alendronic acid.
• Alendronic Acid also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and magnesium stearate.
What Alendronic Acid looks like and contents of the pack
Alendronic Acid are oval, white tablets marked with an outline of a bone image on one side and ‘31' on the other.
Alendronic Acid are available as blister packs of 4 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Merck, Sharp & Dohme (Italia)
S.p.A, Via Emilia 21,27100 Pavia, Italy.
|POMl PL No: 19488/0363
Leaflet revision date: 14 May 2015
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘ALENDRONIC ACID’?
This leaflet gives you the most important patient information about ‘Alendronic Acid'. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information. For more information about osteoporosis, contact (in UK) The National Osteoporosis Society, Camerton, Bath BA2 0PJ.
Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 114 Pembroke Road, Garden Level, Ballsbridge, Dublin 4, Telephone (01)
6375050.
The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.
S0363 LEAFLET Alendronic acid 20150514
Uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1000 people):
• 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,
• mouth ulcers when the tablets have been chewed or sucked.