Alimemazine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alimemazine tartrate

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

R06AD01

INN (International Name):

Alimemazine tartrate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALLERGAN
® 10MG TABLETS/
ALIMEMAZINE TARTRATE 10MG TABLETS
(alimemazine tartrate)
Your medicine is known by any of the above names, but will be referred
to
as alimemazine tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section
4.
WHAT IS IN THIS LEAFLET
1. What alimemazine tablets are and what they are used for
2. What you need to know before you take alimemazine tablets
3. How to take alimemazine tablets
4. Possible side effects
5. How to store alimemazine tablets
6. Contents of the pack and other information
1. WHAT ALIMEMAZINE TABLETS ARE AND WHAT THEY ARE USED
FOR
Alimemazine tablets contain the active ingredient alimemazine tartrate
and belongs to a group of medicines called phenothiazines. It works by
blocking a natural substance (histamine) that your body makes during
an
allergic reaction. It also works directly on the brain to help you
feel more
relaxed.
WHAT ALIMEMAZINE TABLETS ARE USED FOR

To treat itching (pruritus) or an itchy, lumpy rash (urticaria)

As a sedative for children aged between 2 and 7 years. This is a
medicine given to reduce awareness or make the child feel relaxed and
at ease before an operation
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIMEMAZINE
TABLETS
DO NOT TAKE ALIMEMAZINE TABLETS IF:

You are allergic (hypersensitive) to:

alimemazine tartrate or any of the other ingredients of this medicine
(listed in section 6).

any other similar medicines (phenothiazines) such as chlorpromazine.
The signs of an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alimemazine Tartrate 10mg Film Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alimemazine tartrate 10mg
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Circular, film coated biconvex tablet with bevelled edge, dark blue in
colour, one face
impressed V/10. The reverse side is plain
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alimemazine has a central sedative effect comparable to that of
chlorpromazine but
largely devoid of the latter’s anti adrenaline action.
In adults and children of 3 years and over:
- Pre-medication before general anaesthesia and before stressful or
painful process.
- Second-line treatment of the signs and symptoms of allergic
rhinitis, conjunctivitis
and urticaria
- Second-line treatment in symptomatic relief of allergic and pruritic
dermatological
disorders
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Not recommended for children less than 3 years old (see also sections
4.3 and 4.4).
DO NOT exceed the recommended dose (see also section 4.9).
Urticaria and pruritus
Adults: 10 mg (approx. 6.5 ml) two or three times daily; up to 100 mg
per day have
been used in intractable cases.
Elderly: Dose should be reduced to 10 mg (approx. 6.5 ml) once or
twice daily.
Children over 3 years of age: 2.5 – 5 mg (approx. 1.7 – 3.3 ml)
three or four times
daily.
Sedative premedication before general anaesthesia
Children aged 3 – 7 years: The maximum dosage recommended is 2 mg
(approx. 1.3
ml) per kg bodyweight 1 – 2 hours before the operation.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Alimemazine is contraindicated in patients with:
•
Known hypersensitivity to phenothiazines or to any of the excipients
listed in
section 6.1.
•
Hepatic or renal dysfunction
•
Epilepsy
•
Parkinson’s disease
•
Hypothyroidism
•
Phaeochromocytoma
•
Myasthenia gravis
•
History of narrow angle glaucoma
•
History of agranulocytosis
•
Prostatic hypertrophy.