Risedronate Sodium 35 Mg Film-Coated Tablets
Out of date information, search another|
TEVA UK Ref: 231-30-88164-F LEA RISEDRONATE 35MG TAB TUK |
Version: 1 |
29 May 2014 |
PAGE 1: FRONT FACE (INSIDE OF REEL)
RISEDRONATE SODIUM 35 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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 prescribedforyou. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
INTHIS LEAFLET:
1. What Risedronate Sodium Film-Coated Tablets are and what they are used for
2. Before you take Risedronate Sodium Film-Coated Tablets
3. How to take Risedronate Sodium Film-Coated Tablets
4. Possible side effects
5. How to store Risedronate Sodium Film-Coated Tablets
6. Further information
OWHAT RISEDRONATE SODIUM
FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
What risedronate sodium is
Risedronate sodium belongs to a group of nonhormonal 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.
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 Film-Coated Tablets are used for
The treatment of osteoporosis ♦ inpostmenopausalwomen,evenif osteoporosis is severe. It reduces the risk of spinal and hip fractures.
♦ in men.
©BEFORE YOU TAKE RISEDRONATE SODIUM FILM-COATED TABLETS
Do NOT take Risedronate Sodium Film-Coated Tablets
♦ Ifyou are allergic(hypersensitive) to risedronate sodium or any of the other ingredients of Risedronate Sodium Film-Coated Tablets (see section 6, "What Risedronate Sodium Film-Coated Tablets contain”)
♦ Ifyour doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)
♦ Ifyou may be pregnant, are pregnant or planning to become pregnant ♦ Ifyouarebreast-feeding ♦ Ifyouhaveseverekidneyproblems.
Take special care and talk to your doctor BEFORE you start taking Risedronate Sodium Film-Coated Tablets
♦ If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes ♦ Ifyou have abnormal bone and mineral metabolism (forexample 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 byyourdoctorthat you have an intolerance to some sugars (such as lactose) or to sunset yellow aluminium lake (E110)
♦ If you have had or have pain, swelling or numbness ofthe 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 Film-Coated Tablets are 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 Film-Coated Tablets with food and drink
It is very important that you do NOT take your Risedronate Sodium Film-Coated 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 drink (other than plain water) at least 30 minutes after your Risedronate Sodium Film-Coated Tablet.
Pregnancy and breast-feeding
Do NOT take risedronate sodium ifyou may be pregnant, are pregnant or planning to become pregnant (see section 2, "Do NOT take Risedronate Sodium Film-Coated Tablets”). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.
Do NOT take risedronate sodium ifyou are breast-feeding (see section 2, "Do not take Risedronate Sodium Film-Coated Tablets”).
Risedronate Sodium Film-Coated Tablets should only be used to treat postmenopausal women and men.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Risedronate Sodium Film-Coated Tablets is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Risedronate Sodium Film-Coated Tablets
Risedronate Sodium Film-Coated Tablets contain a small amount of lactose. They also contain sunset yellow aluminium lake (E110) and may cause allergic reactions (see section 2, "Take special care and talk to your doctor before you start taking Risedronate Sodium Film-Coated Tablets”).
OHOW TO TAKE RISEDRONATE SODIUM FILM-COATED TABLETS
Dosage
Always take Risedronate Sodium Film-Coated Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.
|
TEVA UK Ref: 231-30-88164-F LEA RISEDRONATE 35MG TAB TUK |
Version: 1 |
29 May 2014 |
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Usual dose:
Take ONE tablet (35 mg of risedronate sodium) once a week. Choose one day of the week that best fits your schedule. Every week, take the Risedronate Sodium Film-Coated Tablet on your chosen day.
WHEN to take Risedronate Sodium Film-Coated Tablets
Take your 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 Film-Coated Tablets
♦ 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 Film-Coated Tablets than you should
If you or somebody else has accidentally taken more tablets than prescribed, drink one full glass of milk and seek medical attention.
If you FORGET to take Risedronate Sodium Film-Coated Tablets
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 Film-Coated Tablets
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
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:
♦ Swellingofface,tongueorthroat
♦ 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, oftenfollowing tooth extraction (see section 2, "Take special care and talk to your doctor before you start taking Risedronate Sodium Film-Coated Tablets”).
♦ 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 (fewerthan 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 (fewerthan 1 in 100 but
morethan 1 in 1,000 patients)
♦ Inflammation or ulcer ofthe 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 Film-Coated Tablets”), inflammation of the stomach and duodenum (bowel draining the stomach).
♦ Inflammation ofthe coloured part ofthe eye (iris) (red painful eyes with a possible change in vision).
Rare side effects (fewer than 1 in 1,000 patients)
♦ Inflammation ofthe 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
♦ Liverdisorders, 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 oftreatment, 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, 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.
HOW TO STORE RISEDRONATE SODIUM FILM-COATED TABLETS
♦ Keep out of the reach and sight of children.
♦ Do not use this medicine afterthe 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 ofvia 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 Film-Coated Tablets contain
♦ The active substance is risedronate sodium. Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.
♦ The other ingredients are lactose monohydrate, maize starch, pregelatinized starch (maize), silica colloidal anhydrous, sodium stearyl fumarate, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), polysorbate 80 (E433), sunset yellow aluminium lake (E110), iron oxide red (E172).
What Risedronate Sodium Film-Coated Tablets looks like and contents of the pack
♦ Risedronate Sodium Film-CoatedTablets are orange, round, film-coated tablets, debossed with "R35” on one side and plain on the other.
♦ Thetablets are supplied in blister packs of1,2, 4,8,10,12,12 (3x4), 14,16,16(4x4) or30 tablets.
♦ Hospitalpacks:4x1,10x1,50x1.
♦ Notallpacksizesmaybemarketed.
Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in 05/2014.
PL 00289/1322
TEVA UK LIMITED 160x323