Alimemazine 10mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Alimemazine tartrate

Διαθέσιμο από:

Advanz Pharma

Φαρμακολογική κατηγορία (ATC):

R06AD01

INN (Διεθνής Όνομα):

Alimemazine tartrate

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 03040100; GTIN: 5060090470201

Φύλλο οδηγιών χρήσης

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
PATIENT INFORMATION LEAFLET
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 allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
•
You have liver or kidney problems.
•
You have epilepsy.
•
You have Parkinson’s disease.
•
You have thyroid problems (hypothyroidism).
•
You have a tumour on the adrenal gland (called phaeochromocytoma).
•
You have myasthenia gravis (a form of muscle weakness).
•
You have an enlarged prostate gland.
•
You have increased pressure in the eye (called narrow angle
glaucoma).
•
You have a history of a blood or bone marrow disorder called
agranuloc

Αρχείο Π.Χ.Π.

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.