Buccastem 3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prochlorperazine maleate

Available from:

DE Pharmaceuticals

ATC code:

N05AB04

INN (International Name):

Prochlorperazine maleate

Dosage:

3mg

Pharmaceutical form:

Buccal tablet

Administration route:

Buccal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000

Patient Information leaflet

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 TABLETS THAN YOU SHOULD
If you accidentally take too many tablets YOU MUST seek medical
attention immediately. Show any left-over
medicines or the empty packet to the doctor.
IF YOU FORGET TO TAKE BUCCASTEM TABLETS
If you forget to take a dose do not double the dose next time. Just
carry on taking the medicine as the doctor
has told you. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Buccastem Tablets can cause side effects, although
not everybody gets them.
SERIOUS SIDE EFFECTS
If you experience any of the following side effects, you should STOP
TAKING BUCCASTEM TABLETS AND CONTACT
YOUR DOCTOR IMMEDIATELY:
• Symptoms of an allergic reaction such as rash and swelling of the
face, tongue or throat.
• A high temperature, pale complexion, muscle stiffness and changes
in levels of alertness, you may have
developed a serious condition called neuroleptic malignant syndrome.
• Convulsions (fits).
• Signs of infection such as shivering, headache, sweating, high
temperature, flushing, a sore throat or mouth
and swollen glands.
• 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.
• Symptoms of decreased sodium concentration in the blood, such

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Buccastem 3 mg Buccal Tablets
Prochlorperazine 3 mg Buccal Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each buccal tablet contains 3.0 mg prochlorperazine maleate.
Excipients with known effect:
Compressible sugar (contains sucrose) 49.493 mg
3
PHARMACEUTICAL FORM
Buccal tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of vertigo due to Ménière's Disease,
Labyrinthitis and
other causes. For nausea and vomiting from whatever cause. In the
treatment
of migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To be placed in the buccal cavity, high up along the top gum under the
upper
lip, until dissolved. Do not chew or swallow the tablet.
Adults and children aged 12 years and over: One or two tablets twice a
day.
Children under 12 years: Not recommended.
Elderly patients: There is no evidence that dosage need be modified
for the
elderly.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1
•
Impaired liver function
•
Existing blood dyscrasias
•
Epilepsy
•
Parkinsons Disease
•
Prostatic hypertrophy
•
Narrow angle glaucoma
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Buccastem/Prochlorperazine 3 mg Buccal Tablets should be avoided in
patients with stroke risk factors and myasthenia gravis.
Agranulocytosis has been reported with phenothiazines. The occurrence
of
unexplained infections or fever may be evidence of blood dyscrasia
(see
section 4.8), and requires immediate haematological investigation.
It has been reported that patients with AIDS may be particularly
susceptible to
antipsychotic-induced extrapyramidal effects.
Because of the risk of photosensitisation, patients should be advised
to avoid
exposure to direct sunlight and use sunscreen (see section 4.8).
Hypotension, usually postural, may occur, particularly in elderly or
volume
depleted patients.
Nausea and vomiting as a sign of organic disease may be masked by the
anti-
emetic acti