Rastinon Tablets

Please read this carefully before you start to take your medicine. This leaflet only provides a summary of the information available on your medicine. If you have any questions. or are not sure about anything, ask your doctor or pharmacist.

What is Rastinon?

The name of your medicine is Rastinon. Rastinon tablets are round and white and contain 500 milligrams tolbutamide as their active ingredient. Each tablet also contains maize starch, talc and magnesium stearate as the inactive substances.

Rastinon is one of a group of medicines called oral hypoglycaemics. These are used to control blood sugar levels in some types of diabetes.

Rastinon is available in plastic tubs of 100 tablets.

The Product Licence for Rastinon is held by Hoechst UK Limited, Hoechst House, Salisbury Road, Hounslow, Middlesex, TW4 6J H .

Rastinon is made by Cox Pharmaceuticals, Barnstaple, Devon.

Why use Rastinon?

It is used to treat diabetes of the non insulin dependent type which does not respond to dietary measures. This generally only occurs in adults. It lowers the sugar content in your blood if this is too high. Ask you doctor for information if you have any questions or if your medicine seems to have no effect.

Before taking your medicine

Have you told your doctor everything about your condition especially if you have experienced unusual breathing, strong smelling breath, or suffered from confusion, fainting or even coma as a result of your illness.

At the start of treatment your vision may be affected (i.e. blurred) if this happens, do not drive or operate machinery.

Tell your doctor if you have had any problems with taking medicines in the past especially medicines used to treat a high blood sugar content, sulphonamide antibiotics or if you have ever reacted badly to Rastinon.

Tell your doctor if you suffer from acute porphyria.

Ask your doctor or pharmacist about your specific dietary requirements.

Tell your doctor as soon as possible that you are being treated with Rastinon if you become pregnant or if you are breast-feeding a baby. Never give Rastinon to children.

Remind your doctor if you have kidney or liver problems, or specific hormone requirements.

If you need to have an operation, have an infection or are under particular stress, tell your doctor.

Remind your doctor if you are taking any other medicines, including oral contraceptives (the pill), medicines for the heart, analgesics, antibacterials, antihistamine, diuretics, medicines for gout or medicines that you can buy without a prescription.

How should I use Rastinon?

Your doctor will tell you when and how to take your medicine. Unless your doctor has told you differently, take your tablets with or immediately after breakfast or the first main meal of the day. Swallow them with a glass of water.

The usual starting dose to take is two Rastinon tablets daily, but your doctor may advise you to increase or

reduce this until he/she is satisfied that your blood sugar is properly under control.

Usually the tablets should all be taken at the same time after breakfast, but sometimes you may have to take them more than once a day. Ask your doctor if this is not made clear to you.

Your doctor will inform you on your specific dosage needs if you are changing over from other medicines which you have been taking for this condition or it Rastinon must be used together with another medicine to keep your illness in control.

If you are run-down or elderly or suffer from kidney problems, you will be advised specifically on how many and how often to take the tablets.

If you miss a dose take another as soon as you remember unless it is nearly time for the next dose. Never double-up on the next dose to make up for the one missed.

If you take too much Rastinon, this may result in a very low blood sugar level which may make you feel very ill. Tell your doctor at once or go to your nearest hospital casualty department where you may he given sugar water. In certain cases you may also need an injection or intravenous drip.

What undesirable effects may occur?

Any medicine can have side-effects. Side-effects to Rastinon may include an upset stomach, itchy skin or rash. Your sight may be affected, but this should soon improve. Tell your doctor if you notice anything unusual or unexpected, or if these symptoms are bad or they last for a long time.

It is important that you know what to do and what symptoms to expect when hypoglycaemia (low blood sugar) occurs as this is a common side effect. Ask your doctor or pharmacist for more information if you are not sure how to recognise these. The symptoms may include sweating, paleness, headache, faintness or drowsiness. Tell your doctor if you notice any such symptoms.

If you notice a rash itching or a high temperature, tell your doctor and ask if you should continue taking the tablets.

Tell your doctor if you get a lot of infections with sore throats or mouth ulcers, if you bruise more easily while you are on this medicine or if you look very pale.

In rare cases your liver may be affected by this medicine making you fell nauseous or you may notice your skin or eyes appear yellowish.

How should I store this medicine?

Keep your tablets below 25°C in the container in which they are packed.

Keep the container in a safe place where children cannot reach it. Your tablets could harm them.

Do not use your tablets after the expiry date shown on the label. If your tablets go out of date, or if your doctor decides to stop the treatment, take any leftover tablets to your pharmacist so that he/she can dispose of them safely.

REMEMBER this medicine is for YOU. Only a doctor can prescribe it for you. Never give it to other people. It may harm them, even if they have the same symptoms as you .

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Rastinon.

Date of last revision: 21/11/94.