Risedronate sodium 30 mg film-coated tablets

• 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. See section 4.

The name of your medicine is Risedronate sodium 30 mg film-coated tablets (referred to as Risedronate tablets throughout this leaflet).

1. What Risedronate tablets is and what it is used for
2. What you need to know before you take Risedronate tablets
3. How to take Risedronate tablets
4. Possible side effects
5. How to store Risedronate tablets
6. Contents of the pack and other information

Risedronate tablets 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.

Paget’s disease occurs when this process, called remodeling, happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Risedronate tablets changes the bone remodeling process back to normal, returning the strength to the bone structure.

Treatment of Paget’s disease of the bone (osteitis deformans).

• 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 planning to become pregnant.
• If you are breast-feeding.
• If you have severe kidney problems.

Talk to your doctor or pharmacist before taking Risedronate tablets.

• 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 tablets.

Your doctor will advise you on what to do when taking Risedronate tablets if you have any of the above.

Risedronate sodium is not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy.

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 tablets 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 tablets.

It is very important that you do NOT take your Risedronate tablets 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 tablets”).

Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablets.

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 tablets if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Risedronate tablets”). The potential risk associated with the use of risedronate sodium (active substance in Risedronate tablets) in pregnant women is unknown.

Do not take Risedronate tablets if you are breast-feeding (see section 2, “Do not take Risedronate tablets”).

Risedronate tablets is not known to affect your ability to drive and use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

It is best to take your Risedronate tablets 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 tablets 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 tablets should be taken at least 30 minutes before going to bed.

• 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 or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention.

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 a double dose to make up for a forgotten dose.

Please talk to your doctor if you consider stopping treatment before the end of prescribed duration

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 national reporting system listed in 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.

The active substance is risedronate sodium. Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid).

The other ingredients are:

Tablet core: Lactose monohydrate, crospovidone, hydroxy propyl cellulose, magnesium stearate and cellulose microcrystalline.

Film coating: Hypromellose, titanium dioxide (E171), macrogol 400, hydroxy propyl cellulose.

Film-coated tablet.

White to off-white coloured, circular shaped film coated biconvex tablets debossed with ‘L’ on one side and ‘30’ on the other side.

Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs of 14 or 28 tablets.

Not all pack sizes may be marketed.

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