Risedronate Sodium 35 Mg Film-Coated Tablets
GB 723-1046-APIL
Package leaflet: Information for the user
Risedronate sodium 35 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.
• 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 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 35 mg is and what it is used for
2. What you need to know before you take Risedronate sodium 35 mg
3. How to take Risedronate sodium 35 mg
4. Possible side effects
5. How to store Risedronate sodium 35 mg
6. Contents of the pack and other information
1. What Risedronate sodium 35 mg is and what it is used for
Risedronate sodium 35 mg belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It 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.
Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.
Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
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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 35 mg is used for the treatment of osteoporosis:
- in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures;
- in men.
2. What you need to know before you take Risedronate sodium 35 mg
Do not take Risedronate sodium 35 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);
• ifyou 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 35 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 35 mg.
Your doctor will advise you on what to do when taking Risedronate sodium 35 mg if you have any of the above.
Children and adolescents
Risedronate sodium 35 mg tablets should not be taken by children under 18 years of age.
Other medicines and Risedronate sodium 35 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 35 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 35 mg tablet.
Risedronate sodium 35 mg with food and drink
It is very important that you do not take your Risedronate sodium 35 mg tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Other medicines and Risedronate sodium 35 mg”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate sodium 35 mg tablet.
Pregnancy and breast-feeding
Do not take Risedronate sodium 35 mg if you are pregnant, think you may be pregnant or are planning to have a baby (See section 2, "Do not take Risedronate sodium 35 mg"). 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 35 mg if you are breast-feeding (see section 2, “Do not take Risedronate sodium 35 mg”).
Risedronate sodium 35 mg should only be used to treat postmenopausal women and men.
Driving and using machines
Risedronate sodium 35 mg is not known to affect your ability to drive and use machines.
Risedronate sodium 35 mg contains lactose
Risedronate sodium 35 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 35 mg.
3. How to take Risedronate sodium 35 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 35 mg tablet once a week.
Choose one day of the week that best fits your schedule. Every week, take the Risedronate sodium 35 mg tablet on your chosen day.
When to take the Risedronate sodium 35 mg
Take your Risedronate sodium 35 mg tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
How to take the Risedronate sodium 35 mg
• Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn.
• 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.
Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.
If you take more Risedronate sodium 35 mg than you should
If you or somebody else has accidentally taken more Risedronate sodium 35 mg tablets than prescribed, drink one full glass of milk and seek medical attention.
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If you forget to take Risedronate sodium 35 mg
If you have forgotten to take your tablet on your chosen day, take it on the day you remember. Return to taking one tablet once a week on the day the tablet is normally taken.
Do not take two tablets in one day to make up for the tablet you missed.
If you stop taking Risedronate sodium 35 mg
lf you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
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.
Stop taking Risedronate sodium 35 mg and contact a doctor immediately if you
experience any of the following:
• Symptoms characteristic of severe tissue swelling (angioedema reaction):
- Swelling of face, tongue or throat
- Difficulties in swallowing
- Hives and difficulties in breathing.
• Severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following side effects:
• Eye inflammation, usually with pain, redness and light sensitivity.
• Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, “Warnings and precautions”).
• Symptoms from the oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.
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.
However, in clinical studies, the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.
Common side effects (may affect up to 1 in 10 people)
• Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea;
• Pain in your bones, muscles or joints;
• Headache.
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 stomach and duodenum (bowel draining the stomach);
• Inflammation of the coloured part of the eye (iris) (red, painful eyes with a possible change in vision).
Rare side effects (may affect up to 1 in 1,000 people)
• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach);
• Abnormal liver tests have been reported. These can only be diagnosed from a blood test.
During post-marketing experience, the following have been reported (unknown frequency):
• Hair loss;
• Liver disorders, some cases were severe.
Rarely, at the beginning of treatment, a patient's blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Risedronate sodium 35 mg
Keep this medicine out of the sight and reach of children.
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.
No special storage conditions required.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Risedronate sodium 35 mg contains
The active substance is risedronate sodium.
Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.
The other ingredients are:
Tablet core: lactose monohydrate, crospovidone, magnesium stearate and microcrystalline cellulose.
Film coating: iron oxide yellow (E172), iron oxide red (E172), hypromellose, macrogol, hydroxypropyl cellulose, colloidal anhydrous silica and titanium dioxide (E171).
What Risedronate sodium 35 mg looks like and contents of the pack
Risedronate sodium 35 mg film-coated tablets are light-orange coloured round film-coated tablets debossed with “35 ” on one side and plain on the other side.
The tablets are supplied in blister packs of 4 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sovereign Medical Sovereign House,
Miles Gray Road,
Basildon, Essex SS14 3FR,
United Kingdom.
Manufacturer:
Waymade Plc Sovereign House,
Miles Gray Road,
Basildon, Essex SS14 3FR,
United Kingdom.
This leaflet was last revised in: November 2015
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Medical