Risedronate Sodium 35 Mg Film-Coated Tablets
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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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed foryou 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 is and what it is used for
2. What you need to know before you take Risedronate
3. How to take Risedronate
4. Possible side effects
5. How to store Risedronate
6. Contents of the pack and other information
1. What Risedronate is and what it is used for
What Risedronate is
Risedronate 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 is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
In osteoporosis, the spine, hip and wrist are the most likely bones to break, but 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 is used for
The treatment of osteoporosis
• in postmenopausal women
• The prevention of osteoporosis
• in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis).
• in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
2. What you need to know before you take Risedronate
Do not take Risedronate if
• you are allergic to risedronate sodium or any of the other ingredients of Risedronate (see section 6)
• your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)
• you have severe kidney problems
• you may be pregnant, are pregnant or planning to become pregnant
• you are breast-feeding
Take special care and talk to your doctor
before you start taking Risedronate if you
are unable to stay in an upright position
(sitting or standing) for at least 30 minutes
• have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium)
• 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
• have had or have pain, swelling or numbness of the jaw ora “heavyjaw feeling” or loosening of a tooth
• are having dental treatment or are to have dental surgery. Some people taking bisphosphonate drugs like
Risedronate develop jaw problems after tooth extraction due to delayed healing and infection. Therefore you should tell your dentist you are taking Risedronate.
• you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
Children and adolescents
Risedronate is not recommended for use in children below 18 due to insufficient data on safety and efficacy.
Other medicines and Risedronate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines containing one of the following reduce the effect of Risedronate if taken at the same time:
• calcium, magnesium
• aluminium (for example some indigestion mixtures)
• iron.
Therefore, you should take any such medicines at least 30 minutes after your Risedronate tablet.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Risedronate with food and drink
It is very important that you do not take your Risedronate 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, which reduces the effect of Risedronate. Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablet.
Pregnancy and breast-feeding
You must not take Risedronate if you are or think you may be pregnant, or if you are breast-feeding. The potential risk associated with the use of risedronate in pregnant women is unknown. Risedronate should only be used to treat postmenopausal women.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Risedronate is not known to affect the ability to drive and use machines.
Risedronate contains lactose
Risedronate contains a small amount of a sugar called lactose. If a doctor has told you that you have an intolerance to sugars, check with your doctor before taking this medicine.
3. How to take Risedronate
Always take Risedronate exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose
Take one Risedronate tablet (5 mg of risedronate sodium) once a day.
When to take
Take your Risedronate 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 tablet at this time, you may take it on an empty stomach, at the same time every day,
• EITHER between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.
• OR in the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day.
Risedronate should be taken at least 30 minutes before going to bed.
How to take
• To avoid heartburn, take the tablet whilst you are in an upright position (you may sit or stand).
• 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 than you should
If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention.
If you forget to take Risedronate
If you forget to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening). Do NOT take two tablets in one day to make up for the tablet you missed.
If you stop taking Risedronate
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 medicine ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Risedronate can cause side effects, although not everybody gets them.
Stop taking Risedronate and contact a doctor immediately if you experience any of the following:
• symptoms of a severe allergic reaction such as swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing and hives
• severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience any of the following side effects:
• eye inflammation, usually with pain, redness and sensitivity to light and a possible change in vision
• pain, swelling or numbness of the jaw or a “heavy jawfeeling” or loosening of a tooth (osteonecrosis) associated with delayed healing and infection often after tooth extraction, (see section 2, ‘Take special care and talk to your doctor before you start taking Risedronate')
• pain or difficulties when you swallow, new or worsened heartburn, chest pain or (signs of inflammation, ulcers or narrowing of the oesophagus -the tube that connects your mouth with your stomach).
Tell your doctor if any of the following effects become serious or if you notice any effects not listed.
Common side effects (less than 1 in 10 but
more than 1 in 100 patients)
• 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 (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')
• inflammation of the stomach and duodenum (bowel draining the stomach) causing abdominal pain
• inflammation ofthe coloured part of the eye (iris) (red painful eyes with a possible change in vision).
Rare side effects (less than 1 in 1,000 patients)
• inflammation of the tongue (red swollen, possibly painful), narrowing ofthe
oeso p hagus (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 side-effects have been reported (unknown frequency):
• hair loss
• 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.
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, website: 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
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Risedronate tablets contain
The active substance is risedronate sodium. Each film-coated tablet contains 5 mg risedronate sodium (as risedronate sodium hemipentahydrate).
The other ingredients are: lactose monohydrate, cellulose microcrystalline, crospovidone, povidone K-30, magnesium stearate. The coating contains hypromellose, macrogol 400, macrogol 8000, hydroxy propyl cellulose, colloidal silicon dioxide, titanium dioxide, iron oxide yellow, iron oxide red.
What Risedronate tablets look like and contents of the pack
Risedronate sodium 5 mg tablets are yellow, film-coated, round, biconvex tablets d eboss ed with “R5” on one side and plain on the other side.
Pack sizes: 14 or 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire. HU17 0LD, UK
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Risedronate sodium 5 mg film-coated Tablets (PL 08553/0357)