Risedronate Sodium 75 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Risedronate sodium 75 mg Film-Coated 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 questions, 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 effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Risedronate sodium 75 mg Film-Coated Tablets are and what they are used for
2. Before you take Risedronate sodium 75 mg Film-Coated Tablets
3. How to take Risedronate sodium 75 mg Film-Coated Tablets
4. Possible side effects
5. How to store Risedronate sodium 75 mg Film-Coated Tablets
6. Further information
1. WHAT RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
What Risedronate sodium is
Risedronate sodium 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.
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.
What Risedronate sodium is used for
The treatment of osteoporosis in postmenopausal women.
2. BEFORE YOU TAKE RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS
Do NOT take Risedronate sodium
- If you are allergic to risedronate sodium or any of the other ingredients of Risedronate sodium 75 mg film-coated tablets (see section 6, “What Risedronate sodium 75mg film-coated tablets contain”)
- 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 planning to become pregnant
- If you are breast-feeding
- If you have severe kidney problems.
Take special care and talk to your doctor BEFORE you start taking Risedronate sodium
- 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 had or have 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.
Your doctor will advise you on what to do when taking Risedronate sodium if you have any of the above.
Children and adolescents
Risedronate sodium is not recommended for use in children below 18 due to insufficient data on safety and efficacy.
Taking other medicines
Medicines containing one of the following lessen the effect of Risedronate sodium 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 tablet.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Risedronate sodium with food and drink
It is very important that you do NOT take your Risedronate sodium 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, “Taking other medicines”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate sodium tablet.
Pregnancy and breast-feeding
Do NOT take Risedronate sodium if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Risedronate sodium”). The potential risk associated with the use of risedronate sodium 75 mg film-coated tablets (active substance in Risedronate sodium) in pregnant women is unknown.
Do NOT take Risedronate sodium if you are breast-feeding (see section 2, “Do not take Risedronate sodium”).
Risedronate sodium should only be used to treat postmenopausal women.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Risedronate sodium is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Risedronate sodium 75 mg film-coated tablets
This product 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 RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS
Dosage
Always take Risedronate sodium exactly as your doctor has told you. You should check with your doctor if you are not sure.
Usual dose:
Risedronate sodium tablets should be taken on the SAME two consecutive dates each month, e.g. on the 1st and 2nd of the month, or the 15 th and 16th.
Choose TWO dates in a row that best fit your schedule to take your Risedronate sodium tablets. Take ONE Risedronate sodium tablet in the morning of your first chosen date. Take the SECOND tablet in the morning of the following day.
Repeat every month keeping the same two consecutive dates. To help you remember when to take your tablets next, you can mark your calendar ahead of time with a pen or stickers. You can also write down the date in the space provided on the back of the box.
WHEN to take the Risedronate sodium tablet
Take your Risedronate sodium 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 tablet
- 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. Do not take your tablet with mineral water or drinks other than 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 than you should
If you or somebody else has accidentally taken more Risedronate sodium tablets than prescribed, drink one full glass of milk and seek medical attention.
If you FORGET to take Risedronate sodium
|
You forgot |
When |
What to do |
|
1st and 2nd tablets |
Next monthly dose is more than 7 days ahead |
Take 1st tablet the next morning and 2nd tablet the morning of the following day |
|
Next monthly dose is within 7 days |
Do not take the tablets you have forgotten | |
|
2nd tablet only |
Next monthly dose is more than 7 days ahead |
Take 2nd tablet the next morning |
|
Next monthly dose is within 7 days |
Do not take the tablet you have forgotten | |
|
The next month, take your tablets again as usual. | ||
In any case:
- If you miss your dose of Risedronate sodium in the morning, do NOT take it later in the day.
- Do NOT take three tablets within the same week.
If you STOP taking Risedronate sodium
If 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Risedronate sodium can cause side effects, although not everybody gets them.
Stop taking Risedronate sodium and contact a doctor immediately if you experience any of the
following:
- Symptoms of a severe allergic reaction such as
o Swelling of face, tongue or throat
o Difficulties in swallowing
o 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, “Take special care and talk to your doctor before you start taking Risedronate sodium”).
- Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.
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 (less than 1 in 10 but more than 1 in 100 patients)
- Indigestion, feeling sick, vomiting, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.
- Pain in your bones, muscles or joints.
- Headache.
Uncommon side effects (less than 1 in 100 but more than 1 in 1,000 patients)
- 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, “Take special care and talk to your doctor before you start taking Risedronate sodium”), 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).
- Fever and/or 'flu-like illness (within 5 days of the first dose).
Rare side effects (less than 1 in 1,000 patients)
- 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, skin rashes
- Liver disorders, some cases were severe
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.
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.
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 RISEDRONATE SODIUM 75 MG FILM-COATED TABLETS
- Keep out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the carton 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 Risedronate sodium 75 mg film-coated tablets contain :
- The active substance is risedronate sodium. Each tablet contains 75 mg risedronate sodium, equivalent to 69.6 mg risedronic acid.
- The other ingredients are lactose monohydrate, maize starch, starch pregelatinized (maize), silica colloidal anhydrous, sodium stearyl fumarate and magnesium stearate in the tablet core, and Opadry Pink 03B34103 containing hypromellose 6 cP, titanium dioxide (E171), macrogol 400 and iron oxide red (E172) in the film-coating.
What Risedronate sodium 75 mg film-coated tablets look like and contents of the pack
- Film-coated tablet
- Pink, round, biconvex, film-coated tablet engraved “R 75” on one side and plain on the other.
- The tablets are supplied in blister packs of 2, 4, 6, 8 or 12 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom