INFORMATION FOR PARENTS

INFORMATION FOR PARENTS

What you need to know about Voltarol suppositories 25mg, 50mg, 100mg

Please read this leaflet carefully before you start to use your suppositories. It contains important information about your suppositories. If you are looking after a child who is using Voltarol suppositories 25mg, please read this leaflet on their behalf.

What’s in the suppositories

Voltarol suppositories contain diclofenac sodium. This is one of a group of medicines called non-steroidal anti-inflammatory analgesics. The suppositories come in three strengths containing 25mg, 50mg or 100mg of diclofenac sodium in a hard, fatty suppository base.

The suppositories do not contain any animal extracts.

Voltarol suppositories 25mg, 50mg and 100mg come in packs of 10.

Made by Ciba-Geigy Limited, Stein, Switzerland.

Product Licence holder: Ciba-Geigy plc, Hulley Road, Macclesfield Cheshire.

What these suppositories are used for

Voltarol suppositories are used to treat a number of painful conditions affecting the joints and muscles. Doctors sometimes prescribe Voltarol suppositories for other purposes; ask your doctor for information.

Before using your suppositories

· Do you have or have you ever had a stomach or duodenal ulcer?

· Have you had an allergic reaction, skin rash or wheezing after taking aspirin or any other medicine used to treat painful conditions?

· Do you suffer from any gut disorders, for example, ulcerative or inflammatory disease of the bowel, rectum (back passage) or anus?

If the answer to any of these questions is YES, DO NOT USE the suppositories without talking to your doctor again.

· Have you had stomach pains or heartburn after taking aspirin or any other medicine used to treat painful conditions?

· Do you suffer or have you ever suffered from any heart, kidney or liver disease?

If the answer to either of these questions is YES, tell your doctor or pharmacist.

· Are you pregnant or trying to become pregnant or breast feeding? If so, tell your doctor before you start using Voltarol suppositories.

Are you taking any of the following:

· Anticoagulants (blood-thinning tablets like warfarin)?

· Lithium or digoxin?

· Methotrexate?

· Steroid tablets?

· Diuretics (water tablets)?

· Any other medicines which your doctor does not know about?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Other special warnings

· Suppositories are designed for insertion into the back passage (rectum). Never take them by mouth.

· If you feel dizzy when you start to use Voltarol suppositories, do not drive or work machinery until these effects have worn off.

· Whilst you are using Voltarol suppositories, your doctor may want to give you a check-up from time to time.

· Voltarol suppositories 50mg and 100mg are not suitable for children. Voltarol suppositories 25mg may be used in children aged 1 year or over.

Using your suppositories

It is important that you follow your doctor’s instructions about when to use your suppositories. Read the label on the box carefully: it will tell you when to use them. The usual dosages are:

Adults:

Voltarol suppositories are normally inserted once, twice or three times each day up to a maximum total daily dose of 150mg.

Children aged 1 year or over

Doses vary with age and your doctor will have prescribed Voltarol suppositories 25mg at a dose suitable for your child. Follow his/her instructions carefully.

If you are not sure about the dose, check with your doctor or pharmacist.

Inserting a suppository

· If you need to empty your bowels, do so before inserting a suppository.

· Get your child to lie on their front or side.

· Wash your hands.

· Tear the foil wrapping apart at the notch and take out the suppository.

· Lie on one side with your knees pulled up towards your chest.

· Gently push the suppository pointed end first into your back passage (rectum) with your finger.

· Push the suppository in as far as possible.

· Lower your legs and, if possible, remain still for a few minutes.

· If you feel your body wanting to expel the suppository, try to resist this. Lie still and press your buttocks together. It is important to keep the suppository in the rectum to allow it to melt and the medicine to be absorbed. Pushing the suppository high into the rectum

with your finger will help to reduce this feeling.

· Wash your hands.

· If your doctor has prescribed Voltarol suppositories 25mg for your child, the procedure is very similar. After your child has emptied their bowels get them to lie on their front or side. Gently push the suppository into your child's back passage until it disappears. Try to stop your child moving around for a few minutes to reduce the risk of the suppository coming out.

After using your suppositories

Voltarol suppositories do not usually cause problems. However, they can sometimes cause unwanted effects in some people. If you get any of the following:

· Stomach pain, indigestion, heartburn or feeling sick for the first time.

· Any sign of bleeding in the stomach or intestine, for example passing black stools.

· Skin rash, itching or bruising.

· A sudden attack of wheezing or shortness of breath.

· Yellowing of the skin or the whites of the eyes.

· Persistent sore throat or high temperature.

· An unexpected change in the amount of urine produced and/or its appearance.

STOP using the suppositories and tell your doctor.

Other effects which are unusual but which may occur include:

· Itching or burning in the back passage.

· Headache, dizziness or tiredness.

Very rarely, these suppositories can have other effects on the nervous system causing, for example, sleeplessness or tinnitus (ringing in the ears).

These effects are often mild and may wear off after a few days’ treatment. If they are severe or last for more than a few days, tell your doctor. Also, if the suppositories upset you in any other way, tell your doctor.

Storing the suppositories

· The expiry date for these suppositories is given on the box. Do not use the suppositories after this date.

· Keep the suppositories in a cool place out of reach of children. Return any unused suppositories to your pharmacist.

REMEMBER: this medicine is for you or your child. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you.

The information in this leaflet applies only to Voltarol suppositories. This leaflet does not contain the complete information about your suppositories. If you have any questions or are not sure about anything, ask your doctor or pharmacist.