Alimemazine tartrate 10mg Film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Alimemazine tartrate

Dostępny od:

Primegen Limited

Kod ATC:

R06AD01

INN (International Nazwa):

Alimemazine tartrate

Dawkowanie:

10mg

Forma farmaceutyczna:

Film-coated tablets

Droga podania:

Oral use

Sztuk w opakowaniu:

28 tablets

Typ recepty:

Product subject to prescription which may be renewed (B)

Grupa terapeutyczna:

Phenothiazine derivatives

Wskazania:

It has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. It may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years

Status autoryzacji:

Authorised

Data autoryzacji:

2015-07-31

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alimemazine tartrate 10mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg of alimemazine tartrate.
Also contains lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Dark blue, circular, biconvex and film coated tablet. One side of tablet is marked with AL and other side is plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and
pruritus.
Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years.
The alimemazine syrup formulation is suitable for these indications in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Not recommended for infants less than 2 years old.
Do NOT exceed the recommended dose (see also section 4.9).
_Urticaria and pruritus_
Adults: 10mg two or three times daily.
Elderly: Dosage should be reduced to 10mg once or twice daily.
Children over 2 years of age: The use of Alimemazine Syrup is recommended.
_As a sedative before anaesthesia_
The use of Alimemazine Syrup is recommended.
4.3 CONTRAINDICATIONS
Use in patients with hepatic or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, phaeochromocytoma,
myasthenia gravis, and prostatic hypertrophy.
Use in patients known to be hypersensitive to phenothiazines or to any of the excipients listed in section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/07/2015_
_CRN 2165723_
_page number: 1_
Use in patients with a history of narrow angle glaucoma.
Use i