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.

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

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.

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

Talk to your doctor or pharmacist before taking Risedronate

• 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 or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance, you may have or 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 or have had 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.

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

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.

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.

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 this medicine) in pregnant women is unknown.

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

Risedronate 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 medicine (see section 2, “Warnings and precautions”).

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take one Risedronate tablet (30mg of risedronate sodium) once a day.

The recommended treatment duration is usually 2 months.

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 a 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.

• 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 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 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 tablet.

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

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 (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). 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 30mg risedronate sodium, equivalent to 27.8mg 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.

Risedronate are white, round, biconvex film-coated tablets with diameter of 11.2 mm, 4.5 mm in thickness and embossed with “30” on one side. They are supplied in blister packs of 14 and 28 film-coated tablets.

Not all pack sizes may be marketed.