SPC Logo

Buccastem M

Last Updated on eMC 21-May-2015 View changes  | Alliance Pharmaceuticals Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000.



Buccastem M

PATIENT INFORMATION LEAFLET

Buccastem® M Buccal Tablets

(PROCHLORPERAZINE MALEATE 3 MG, EQUIVALENT TO 1.85 MG PROCHLORPERAZINE BASE)

INFORMATION FOR THE USER

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Buccastem M Tablets are and what they are used for
2. Before you take Buccastem M Tablets
3. How to take Buccastem M Tablets
4. Possible side effects
5. How to store Buccastem M Tablets
6. Further Information

1. What is this medicine and what is it used for?

Buccastem M Tablets are effective in treating nausea (feeling sick) and vomiting (being sick) associated with migraine.

Buccastem M Tablets contains Prochlorperazine maleate. Prochlorperazine belongs to a large group of drugs known as phenothiazines, which have a variety of effects.

2. Before taking Buccastem M Tablets

You should only use this medicine if migraine has previously been diagnosed by your doctor.

Do not take Buccastem M Tablets if you:

  • are allergic (hypersensitive) to prochlorperazine maleate or any of the other ingredients
  • are pregnant, or you think you might be pregnant, or breast feeding
  • have problems with your liver
  • have blood problems
  • suffer from epilepsy, Parkinson’s Disease or glaucoma
  • have problems with your prostate gland
  • are under 18 years of age

You should ask your doctor or pharmacist before taking Buccastem M Tablets if you:

  • are elderly
  • have risk factors for a blood clot such as high blood pressure, high cholesterol levels, diabetes or smoking
  • or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

Taking with other medicines

You should tell your doctor if you are already taking sedatives or tranquilisers, or you are being treated for high blood pressure (hypertension). Buccastem M Tablets may interact with these types of medicines.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking with food and drink

Buccastem M Tablets are best taken after food.

Do not drink alcohol when taking the tablets as it may interact with medicines like Buccastem M.

Pregnancy and breast feeding

If you are pregnant or thinking of becoming pregnant, you should not take Buccastem M Tablets. Experience with Buccastem M Tablets is limited. You should therefore not take the tablets if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Buccastem M Tablets can make you feel drowsy. Therefore you should avoid driving or using dangerous machines until you know how the tablets affect you.

Important information about some of the ingredients of Buccastem M Tablets

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to use Buccastem M Tablets

You must follow the instructions in this leaflet or as your doctor, pharmacist or nurse has given you about how much and when to take Buccastem M Tablets.

The usual dosage is one or two tablets twice a day for a maximum of 2 days, for adults aged 18 years or over.

Buccastem M Tablets are not recommended for children under 18 years of age.

INSTRUCTIONS FOR USE

Please read carefully before taking the tablet(s).

  • Place the tablet high up along your top gum, under the upper lip either side of your mouth as indicated above. The tablet must not be swallowed whole or chewed.
  • The tablet will soften and adhere to the gum. Allow it to dissolve slowly and completely - this may take between 1 and 2 hours. 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 too quickly.
  • If you wear dentures, the tablet may be placed in any comfortable position between your lip and gum.

The tablet(s) is best taken after meals.

If you take more Buccastem M Tablets than you should or if you accidentally take too many tablets you must seek medical attention immediately.

If you forget to take Buccastem M Tablets

If you forget to take a dose do not double the dose next time. Just carry on taking the medicine as the doctor, pharmacist or nurse has told you.

4. Possible side effects

Like all medicines, Buccastem M Tablets can cause side effects, although not everybody gets them.

If you have a high temperature, pale complexion, muscle stiffness and changes in levels of alertness, you may have developed a serious condition called neuroleptic malignant syndrome. If you have these symptoms while taking the tablets, you should immediately inform your doctor.

Other side effects include:

  • drowsiness
  • dizziness
  • dry mouth
  • inability to sleep (insomnia)
  • agitation
  • mild skin reactions
  • low blood pressure (this makes you feel dizzy or faint, particularly when you stand up), particularly in elderly or volume depleted patients (those who have lost both water and salts from the body).
  • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
  • In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking medicines of the same type as Buccastem M Tablets compared with those not taking these medicines.

Occasional

  • local irritation to the gum and mouth may occur.

Rare

  • jaundice (yellowing of the skin and/or the whites of the eyes)
  • blood problems.

Very rare

  • breast swelling (in men as well as in women)
  • 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store

Keep all medicines out of reach and sight of children.

Keep the blisters in the outer carton in order to protect from light.

This medicinal product does not require any special temperature storage condition.

Do not use after the expiry date (EXP month/year) shown on the outer carton and blister.

The expiry date refers to the last day of that month.

6. Further information

What Buccastem M Tablets contain

Each tablet contains 3 mg of the active ingredient prochlorperazine maleate.

The other ingredients are: compressible sugar (sucrose), povidone K30, xanthan gum, locust bean gum, talc, magnesium stearate and riboflavin sodium phosphate.

What Buccastem M Tablets look like and contents of the pack

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

This product is available from pharmacists in packs of 8 tablets.

Marketing Authorisation Holder:

Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK

Manufacturer:

Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
BD23 2RW
United Kingdom

Leaflet last revised 9 April 2015.

Buccastem is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Ltd 2015

Company contact details

Alliance Pharmaceuticals

Company image
Address

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Fax

+44 (0)1249 466 977

Telephone

+44 (0)1249 466 966

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

prochlorperazine maleate

Legal categories

P - Pharmacy

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue