INFORMATION FOR PARENTS

INFORMATION FOR PARENTS

What you need to know about Voltarol suppositories 12.5mg

Your doctor has prescribed Voltarol suppositories 12.5mg for your child. This leaflet contains important information about the suppositories. Please read it carefully before your child starts using them.

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 contain 12.5mg of diclofenac sodium in a hard, fatty suppository base.

The suppositories do not contain any animal extracts.

Voltarol suppositories 12.5mg 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 12.5mg are used to treat arthritis in children. Doctors sometimes prescribe Voltarol suppositories for other purposes; ask your doctor for information .

Before using the suppositories

Talk to your doctor before using the suppositories if your child:

· Has had any disease causing ulceration of the stomach or duodenum.

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

· Suffers from any gut disorders, for example, ulcerative or inflammatory disease of the bowel, rectum (back passage) or anus.

Also tell your doctor if your child:

· Has experienced stomach discomfort, felt like being sick or had heartburn after taking aspirin or any other medicine used to treat painful conditions.

· Suffers from any heart, kidney or liver disease.

Is taking:

· steroid tablets.

· any medicines for heart conditions.

· methotrexate.

· any other medicines which your doctor does not know about.

Pregnancy information if relevant can be obtained from your doctor.

Other special warnings

· Suppositories are designed for insertion into the back passage (rectum). They must never be taken by mouth.

· Whilst your child is using Voltarol suppositories, your doctor may want to give them a check-up from time to time.

· Voltarol suppositories 12.5mg are not suitable for children under the age of 1 year.

Using the suppositories

It is important that you follow your doctor’s instructions about when to give your child their suppositories. Read the label on the box carefully: it will tell you when to use them. The usual dose is one suppository inserted two or three times each day, but this will vary according to the age of your child.

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

Inserting a suppository

· If your child needs to empty their bowels, make sure they do so before you give them a suppository.

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

· Wash your hands and then tear the foil wrapping apart at the notch and take out the suppository.

· Gently push the suppository pointed end first into your child’s back passage (rectum) until it disappears.

· Try to stop your child moving around for a few minutes. It is important to keep the suppository in the rectum to allow it to melt and the medicine to be absorbed.

· Wash your hands.

Date of preparation: February 1994

After using the suppositories

Voltarol suppositories do not usually cause problems. However, they can sometimes cause unwanted effects in some people. If your child gets 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 your child 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 your child. Only a doctor can prescribe it. Never give it to someone else. It may harm them even if they have the same symptoms as your child.

The information in this leaflet applies only to Voltarol suppositories 12.5mg. This leaflet does not contain the complete information about the suppositories. If you have any questions or are not sure about anything, ask your doctor or pharmacist.