Alimemazine tartrate 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALIMEMAZINE TARTRATE

Available from:

Key Pharmaceuticals Ltd

ATC code:

R06AD01

INN (International Name):

ALIMEMAZINE TARTRATE

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

alimemazine

Authorization status:

Marketed

Authorization date:

2020-12-18

Patient Information leaflet

Space for
Pharmacode
10mm
10mm
10mm
Front
160 mm
330 mm
Back
Space for
Pharmacode
10mm
10mm
10mm
160 mm
330 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALIMEMAZINE TARTRATE 10 MG FILM-COATED TABLETS
alimemazine tartrate
Your medicine is called Alimemazine tartrate 10 mg
film-coated tablets, but it 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) in adults
2. WHAT DO YOU NEED TO KNOW BEFORE YOU
TAKE ALIMEMAZINE TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR 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 r

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2020
CRN008SYP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alimemazine tartrate 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of alimemazine tartrate
Excipients with known effect
Each film-coated tablet contains 38 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Blue, round, biconvex film-coated tablets, debossed with "A" on one
side and "1" on other side, approximately 6.5 mm in
diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aliememazine tartrate 10 mg film-coated tablets is used for
second-line treatment in the symptomatic relief of urticaria and
pruritus in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_
10 mg two or three times daily.
_Elderly:_
Dose should be reduced to 10 mg once or twice daily.
_Paediatric population:_
Children over 3 years of age: The use of Alimemazine Syrup is
recommended.
Children less than 3 years of age: Contraindicated (see sections 4.3
and 4.4)
Method of administration:
The product is administered orally.
DO NOT exceed the recommended dose (see also section 4.9).
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
Health Products Regulatory Authority
18 December 2020
CRN008SYP
Page 2 of 6
Alimemazine is contraindicated for use in children less than 3 years
of age (see section 4.4).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients are strongly advised not to consume alcoholic beverages or
medicines containing alcohol throughout treatment (see
section 4.5).
Exposure to sunlight should be avoided during