Risedronate Sodium 5 Mg Film-Coated Tablets
GB 723-1012-APIL
Package leaflet: Information for the user
Risedronate sodium 5 mg film-coated tablets
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.
• lf 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 signs of illness 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.
What is in this leaflet
1. What Risedronate sodium 5 mg is and what it is used for
2. What you need to know before you take Risedronate sodium 5 mg
3. How to take Risedronate sodium 5 mg
4. Possible side effects
5. How to store Risedronate sodium 5 mg
6. Contents of the pack and other information
1. What Risedronate sodium 5 mg is and what it is used for
Risedronate sodium 5 mg belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. lt works directly on your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.
Osteoporosis is a disease that causes bones to become more fragile.
Osteoporosis is common in women after the menopause and is also more likely to occur in women who have reached the menopause earlier. Long-term steroid treatment can also lead to osteoporosis.
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The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
Risedronate sodium 5 mg is used:
• to reduce the risk of vertebral fractures in women with postmenopausal osteoporosis. It also reduces the risk of hip fractures in women with established postmenopausal osteoporosis.
• to prevent osteoporosis in postmenopausal women with an increased risk of osteoporosis.
• to maintain or increase bone mass in postmenopausal women who have been on high doses of steroid drugs for a long time.
2. What you need to know before you take Risedronate sodium 5 mg
Do not take Risedronate sodium 5 mg:
• if you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level);
• if you may be pregnant, are pregnant or are planning to become pregnant;
• if you are breast-feeding;
• if you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate sodium 5 mg
• if you are unable to stay in an upright position (sitting or standing) for at least 30 minutes;
• if you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level);
• if you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food, or you have previously been told that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus);
• if you have been told by your doctor that you have an intolerance to some sugars (such as lactose);
• if you have or ever had pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth;
• if you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate sodium 5 mg.
Your doctor will advise you on what to do when taking Risedronate sodium 5 mg if you have any of the above.
Children and adolescents
Risedronate sodium 5 mg tablets should not be taken by children under 18 years of age.
Other medicines and Risedronate sodium 5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines containing any of the following lessen the effect of Risedronate sodium 5 mg if taken at the same time:
• calcium;
• magnesium;
• aluminium (for example some indigestion mixtures);
• iron.
Take these medicines at least 30 minutes after your Risedronate sodium 5 mg tablet.
Risedronate sodium 5 mg with food and drink
lt is very important that you do not take your Risedronate sodium 5 mg tablet with food or drinks (other than plain water) so that it can work properly.
Products containing one of the following: calcium (including dairy products such as milk), magnesium, aluminium (for example, some indigestion mixtures) or iron lessen the effect of this medicine.
These products should be taken at a different time to Risedronate sodium 5 mg tablets.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The potential risk associated with the use of risedronate sodium in pregnant women is unknown.
Do not take Risedronate sodium 5 mg if you are breast-feeding (see section 2, “Do not take Risedronate sodium 5 mg”).
Risedronate sodium 5 mg should only be used to treat postmenopausal women.
Driving and using machines
Risedronate sodium 5 mg is not known to affect your ability to drive and use machines.
Risedronate sodium 5 mg contains lactose
Risedronate sodium 5 mg contains a small amount of lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Risedronate sodium 5 mg.
3. How to take Risedronate sodium 5 mg
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose:
Take one Risedronate sodium 5 mg tablet once a day.
lt is very important that you do not take Risedronate sodium 5 mg with food or drinks (other than plain water) so that it can work properly.
When to take the Risedronate sodium 5 mg
It is best to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
If you are unable to take your Risedronate sodium 5 mg tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
• Between meals: at least 2 hours after your last food, drink (other than plain water) or medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.
• ln the evening: at least 2 hours after the last food, drink (other than plain water) or medicine of the day. Risedronate sodium 5 mg should be taken at least 30 minutes before going to bed.
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How to take the Risedronate sodium 5 mg |
associated with delayed healing and |
Rarely, at the beginning of treatment, a patient's |
Marketing Authorisation Holder and |
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• Take the tablet whilst you are in an upright |
infection, often following tooth extraction |
blood calcium and phosphate levels may fall. |
Manufacturer |
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position (you may sit or stand) to avoid |
(see section 2, “Warnings and precautions”). |
These changes are usually small and cause no |
Marketing Authorisation Holder: |
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heartburn. |
• Symptoms from the oesophagus such as |
symptoms. |
Sovereign Medical |
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• Swallow it with at least one glass (120 ml) of plain water. • Swallow it whole. Do not suck or chew it. • Do not lie down for 30 minutes after taking your tablet. |
pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn. |
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side |
Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom. |
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Unusual fracture of the thigh bone particularly in |
effects not listed in this leaflet. You can also | ||
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patients on long-term treatment for osteoporosis |
report side effects directly via the Yellow Card |
Manufacturer: | |
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Your doctor will tell you if you need calcium and |
may occur rarely. Contact your doctor if you |
Scheme at: www.mhra.gov.uk/yellowcard. |
Waymade Plc |
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vitamin supplements, if you are not taking |
experience pain, weakness or discomfort in your |
By reporting side effects you can help provide |
Sovereign House, |
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enough from your diet. |
thigh, hip or groin as this may be an early |
more information on the safety of this medicine. |
Miles Gray Road, |
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If you take more Risedronate sodium 5 mg than you should lf you or somebody else has accidentally taken |
indication of a possible fracture of the thigh bone. |
5. How to store Risedronate sodium 5 mg |
Basildon, Essex SS14 3FR, United Kingdom. |
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However, in clinical studies, the other side |
Keep this medicine out of the sight and reach of |
This leaflet was last revised in | |
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more Risedronate sodium 5 mg tablets than prescribed, drink one full glass of milk and seek medical attention. |
effects that were observed were usually mild and did not cause the patient to stop taking their tablets. |
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. |
November 2015 |
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If you forget to take Risedronate sodium 5 mg |
Common side effects (may affect up to 1 in 10 people) |
No special storage conditions required. | |
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lf you have forgotten to take your tablet, you can |
• Indigestion, feeling sick, stomach ache, |
Do not throw away any medicines via | |
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take it before breakfast, between meals, or in |
stomach cramps or discomfort, constipation, |
wastewater or household waste. Ask your | |
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the evening according to the instructions above. |
feelings of fullness, bloating, diarrhoea; |
pharmacist how to throw away medicines you | |
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Do not take a double dose to make up for a forgotten tablet. |
• Pain in your bones, muscles or joints; • Headache. |
no longer use. These measures will help protect the environment. | |
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lf you stop taking Risedronate sodium 5 mg lf you stop treatment you may begin to lose bone mass. Please talk to your doctor before |
Uncommon side effects (may affect up to 1 in 100 people) • Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, “Warning and precautions”), inflammation of the |
6. Contents of the pack and other information What Risedronate sodium 5 mg contains | |
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you consider stopping treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. |
The active substance is risedronate sodium. Each tablet contains 5 mg risedronate sodium, equivalent to 4.64 mg risedronic acid. | ||
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4. Possible side effects |
stomach and duodenum (bowel draining the |
The other ingredients are: | |
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stomach); |
Tablet core: lactose monohydrate, crospovidone, | ||
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Like all medicines, this medicine can cause side |
• Inflammation of the coloured part of the eye |
magnesium stearate and microcrystalline | |
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effects, although not everybody gets them. |
(iris) (red, painful eyes with a possible |
cellulose. | |
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Stop taking Risedronate sodium 5 mg and |
change in vision). |
Film coating: hypromellose, titanium dioxide | |
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contact a doctor immediately if you |
Rare side effects (may affect up to 1 in 1,000 |
(E171), macrogol, hydroxypropyl cellulose, iron | |
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experience any of the following: |
people) |
oxide yellow (E172) and colloidal anhydrous | |
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• Symptoms characteristic of severe tissue |
• Inflammation of the tongue (red, swollen, |
silica. | |
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swelling (angioedema reaction): - Swelling of face, tongue or throat - Difficulties in swallowing |
possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach); |
What Risedronate sodium 5 mg looks like and contents of the pack Risedronate sodium 5 mg film-coated tablets are light-yellow coloured round film-coated tablets debossed with “5 ” on one side and plain on the other side. | |
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- Hives and difficulties in breathing. |
• Abnormal liver tests have been reported. | ||
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• Severe skin reactions that can include blistering of the skin. |
These can only be diagnosed from a blood test. | ||
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Tell your doctor promptly if you experience the |
During post-marketing experience, the following |
The tablets are supplied in blister packs of 14, | |
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following side effects: |
have been reported (unknown frequency): |
20, 28, 30, 84 or 98 tablets. | |
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• Eye inflammation, usually with pain, redness |
• Hair loss; |
Not all pack sizes may be marketed. | |
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and light sensitivity. • Bone necrosis of the jaw (osteonecrosis) |
• Liver disorders, some cases were severe. |
1% SOVEREIGN Medical |