Risedronate Sodium 5 Mg Film-Coated Tablets
Package leaflet: Information for the user
Risedronate Sodium 5mg 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 or nurse. 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. 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 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 this medicine (listed in section 6).
- 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 are planning to become pregnant.
- if you are breast-feeding.
- if you have severe kidney problems.
Warnings and precautions
• 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.
Your doctor will advise you on what to do when taking Risedronate 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
Medicines containing one of the following lessen the effect of Risedronate if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron
Take these medicines at least 30 minutes after taking Risedronate.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking 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 (see section 2, “Other medicines and Risedronate”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablet.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do NOT take Risedronate if you may be pregnant, are pregnant or are planning to become pregnant (see section 2 “Do not take Risedronate”). The potential risk associated with the use of risedronate sodium (active substance in Risedronate) in pregnant women is unknown.
Do NOT take Risedronate if you are breast-feeding (see section 2 “Do not take Risedronate”).
Driving and using machines
Risedronate is not known to affect your ability to drive and use machines. Risedronate 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 (see section 2, “Warnings and precautions”).
3. How to take Risedronate
Dosage
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual dose
Take ONE Risedronate (5mg risedronate sodium) once a day.
When to take your Risedronate tablet:
IT IS BEST to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
If in particular instance 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, in one of the following ways:
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 your Risedronate 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.
Swallow it whole. Do not suck or chew the tablet.
Do not lie down for 30 minutes after taking the 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 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).
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.
4. Possible side effects
Like all medicines, this medicine 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
• 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 oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn.
Very rare:
• 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.
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 (affects 1 to 10 users in 100):
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 (affects 1 to 10 users in 1,000):
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, “Warnings 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 (affects 1 to 10 users in 10,000):
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.
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.
During post-marketing experience, the following have been reported (unknown frequency);
Allergic reactions of the skin such as urticaria (hives), skin rash, swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing. Severe skin reactions including vesiculation (blistering) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leukocytoclastic vasculitis); a serious illness called Stevens Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a severe illness called toxic epidermal necrolysis (TEN) which causes a red rash over many parts of the body and/or loss of the outer layer of skin. Hair loss. Allergic reactions (hypersensitivity). Serious liver disorders, mainly if you are treated with other medicinal products known to cause liver problems. Inflammation of the eye which causes pain and redness.
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 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 (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.
This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
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 to protect the environment.
6. Contents of the pack and other information
What Risedronate contains
- The active substance is Risedronate sodium. Each tablet contains 5mg risedronate sodium, equivalent to 4.64mg risedronic acid.
- The other ingredients are:
Tablet core: Starch, pregelatinised (maize); Cellulose, microcrystalline; Crospovidone; Magnesium stearate.
Film coating: Hypromellose, Lactose monohydrate, Titanium dioxide (E171), Macrogol 4000.
What Risedronate looks like and contents of the pack
Risedronate are white round biconvex film-coated tablets with diameter of 6.1mm and 2.6mm in thickness. They are supplied in blister packs containing 14, 28, 84, 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer Pharmathen SA 6 Dervenakion str,
15351 Pallini Attiki Greece Distributor:
Aspire Pharma Limited Bellamy House Winton Road Petersfield Hampshire GU32 3HA United Kingdom
This leaflet was last revised in 11/2015.
Aspire
P1010050-P9.4 Pharma
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Artwork for: |
Aspire Pharma Limited |
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Product name: |
Risedronate 5mg |
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Size: | |
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PL/PA no: |
PL17277/0237 |
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Type: |
Leaflet |
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Artwork dimensions: |
250mm x 170mm |
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Profile supplied: |
Yes |
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Date of first artwork: |
7 June 2010 |
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Reason for request: |
Artwork in Pharmathen User-Tested style: text edits |
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Version no: |
9.4 |
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Date of revision: |
3 November 2015 |
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Colours: |
As swatch(es) |
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Font(s): |
Text 8pt Arial Narrow Headings 9pt Arial Narrow |
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Artwork software: |
InDesign CS6 |
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S836 (formerly R645) |
