PATIENT INFORMATION LEAFLET

Buccastem 3mg Tablets

(PROCHLORPERAZINE MALEATE)

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING ASK YOUR PHARMACIST OR DOCTOR.

1. WHAT ARE BUCCASTEM 3 mg TABLETS?

Buccastem 3 mg is a medicine used to treat nausea (feeling sick) and vomiting (being sick) from whatever cause, and in the treatment of migraine and dizziness.

Each buccal tablet contains 3 mg of the active ingredient prochlorperazine maleate. The other ingredients are compressible sugar, povidone K30, xanthan gum, locust bean gum, talc, magnesium stearate and riboflavin sodium phosphate.

The product is only available on prescription in packs of 50 tablets.

The tablet is pale yellow and has JI on one side and is plain on the other.

2. WHAT ARE BUCCASTEM 3 mg TABLETS USED FOR?

Prochlorperazine belongs to a large group of drugs known as phenothiazines, which have a variety of effects. Buccastem 3 mg is a product which is effective in treating nausea (feeling sick) and vomiting (being sick) from whatever cause, in the treatment of migraine and dizziness due to ear problems and other causes.

3. BEFORE TAKING BUCCASTEM 3 mg TABLETS

You should only take Buccastem 3 mg Tablets when your doctor prescribes them for you. Do not take this medicine if you are allergic to any of the ingredients. Do not take alcohol, tranquillisers, sedatives or drugs for high blood pressure (alpha adrenoreceptor blockers) without seeking medical advice as they can interact with this class of drug. Do not drive or operate machinery if affected by drowsiness.

You should ask your doctor before taking Buccastem 3 mg Tablets if:

• you are elderly
• you are pregnant or breast feeding
• you have problems with your liver
• you have blood problems
• you have epilepsy or Parkinson's disease
• you have glaucoma
• you have problems with your prostate gland

4. HOW TO USE BUCCASTEM 3 mg TABLETS

You must follow the instructions that your doctor has given you about how much and when to take Buccastem 3 mg Tablets.

Place the tablet high up along the top gum under the upper lip either side of your mouth as indicated above and allow it to dissolve slowly and completely. The tablet will soften and adhere to the gum, taking, for example, between 1 and 2 hours to dissolve completely. Most people find that after a few minutes they no longer notice the tablet. The tablet should not be moved about the mouth with the tongue as this will cause it to dissolve more quickly. The tablet(s) is best taken after meals. If you wear dentures, the tablet(s) may be placed in any comfortable position between lip and gum.

The usual dosage is one or two tablets twice a day for adults and children over 12 years of age.

Buccastem 3 mg Tablets are not recommended for children under 12 years of age.

If you forget to take a dose it is not necessary to double the dose next time. Just carry on taking the medicine at the recommended dose.

If you accidentally take too many tablets you must seek medical attention at once.

5. WHAT SIDE-EFFECTS MAY OCCUR?

Side-effects that may occur with Buccastem 3 mg Tablets are drowsiness, dizziness, dry mouth, inability to sleep (insomnia), agitation, mild skin reactions and low blood pressure, particularly in elderly or volume depleted patients (this makes you feel dizzy or faint, particularly when you stand up). Occasionally, local irritation to the gum and mouth may occur. Rarely, jaundice (yellowing of the skin and/or the whites of the eyes) and blood problems may occur. Also, rarely, medicines of this type may cause breast swelling (in men as well as in women) and abnormal movements, tremors and muscle rigidity, and unusual movements of the face and tongue. These reactions are unlikely to happen with the low dose of prochlorperazine in this medicine. A combination of high temperature, pale complexion, muscle stiffness and changes in levels of alertness are symptoms of a serious condition called neuroleptic malignant syndrome.

If you develop these symptoms you should immediately inform your doctor.

Do not drive or operate machinery if affected by drowsiness.

Tell your doctor or pharmacist if you have any undesirable effect after using this product.

6. STORAGE

Keep all medicines safely away from children.

Do not use after the expiry date shown on the pack.

Protect from light. Store in the original container.

7. MARKETING AUTHORISATION HOLDERS:

8. MANUFACTURERS:

9. PRODUCT LICENCE NUMBER:

PL 0063/0011

10. DATE OF PREPARATION:

September 2003