Risedronate Sodium 5 Mg Film-Coated Tablets
60 mm
60 mm
Risedronate 5 mg - Leaflet - UK
Review - 3
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PHARMACEUTICALS
Package Leaflet: Information for the user
Risedronate sodium 5 mg film-coated tablets
Risedronate sodium
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.
What is in this leaflet:
1. What Risedronate sodium is and what it is used for
2. What you need to know before you take Risedronate sodium
3. How to take Risedronate sodium 5 mg film-coated tablets
4. Possible side effects
5. How to store Risedronate sodium
6. Content of the pack and other information
1. WHAT RISEDRONATE SODIUM IS AND WHAT IT IS USED FOR
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.
Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
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 film-coated tablets is used to treat the following: 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 SODIUM
Do NOT take Risedronate sodium
• If you are allergic to risedronate sodium or any of the other ingredients of Risedronate sodium tablets (listed in section 6, “Content of the pack and other information”)
• 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.
Warning and precautions:
Talk to your doctor or pharmacist before 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 been told by your doctor that you have an intolerance to some sugars (such as lactose).
• 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.
Other medicines and Risedronate sodium
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any 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.
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, “Other medicines and Risedronate sodium”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate sodium tablet.
Pregnancy, breast-feeding and fertility
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 (active substance in Risedronate sodium tablets) 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.
Driving and using machines
Risedronate sodium is not known to affect your ability to drive and use machines.
Risedronate sodium contains lactose
Risedronate sodium tablets contain lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE RISEDRONATE SODIUM 5 MG FILM-COATED TABLETS
Dose
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose:
Take one 5 mg Risedronate sodium tablet once a day.
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.
If you are unable to take your Risedronate sodium tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
EITHER:
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.
OR:
In the evening: at least 2 hours after your last food, drink (other than plain water) or medicine of the day. Risedronate sodium should be taken at least 30 minutes before going to bed.
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.
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Risedronate 5 mg - Leaflet - UK
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• 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
Do not take two tablets on one day to make up for the tablet you missed.
If you have forgotten 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)
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 medicine, ask your doctor or pharmacist.
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.
5. HOW TO STORE RISEDRONATE SODIUM
• 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 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 you no longer use. These measures will help protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
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POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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
• 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, “Warning and precautions”).
• 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 (may affect up to 1 in 10 people)
• 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 (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.
Very Rare side effects (may affect up to 1 in 10,000 people)
• Talk to your doctor if you have ear pain, discharge from the ear, and/ or an ear infection. These could be signs of bone damage in the ear.
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.
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.
What Risedronate sodium contains
The active substance is risedronate sodium.
Each film-coated tablet contains 5 mg risedronate sodium (as risedronate sodium hemipentahydrate), equivalent to 4.64 mg risedronic acid.
The other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline cellulose, crospovidone (type A), hydroxyl propyl cellulose and magnesium stearate.
Film coating: hypromellose, macrogol 400, macrogol 8000, hydroxy propyl cellulose, titanium dioxide (E171), iron oxide yellow (E172) and silica colloidal anhydrous.
What Risedronate sodium looks like and contents of the pack
Risedronate sodium 5 mg film-coated tablets are yellow coloured, circular shaped, beveled edge, film-coated biconvex tablets debossed with ‘X’ on one side and ‘61’ on the other side.
Risedronate sodium 5 mg film-coated tablets are available in blister packs of 14, 28 (2 x 14), 84 (6 x 14) and 98 (7 x 14) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited.,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
This leaflet was last revised in: 10/2015
Ref. AW: P1509885 Size: 210 x 360 mm Font type: Helvetica TT
Font size: 8 pt.
5 mm Date: 23/10/15
h—h
10 mm
Black
k+
5 mm