ALIMEMAZINE TARTRATE

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

TRIMEPRAZINE (ALIMEMAZINE) TARTRATE

Dostopno od:

Mercury Pharmaceuticals (Ireland) Ltd

Koda artikla:

R06AD01

INN (mednarodno ime):

TRIMEPRAZINE (ALIMEMAZINE) TARTRATE

Odmerek:

30 MG/5ml

Farmacevtska oblika:

Syrup

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

alimemazine

Status dovoljenje:

Not Marketed

Datum dovoljenje:

2015-01-30

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALIMEMAZINE TARTRATE 7.5MG/5ML & 30MG/5ML SYRUP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHAT IS IN THIS LEAFLET:
1.
What Alimemazine is and what it is used for
2.
What you need to know before you take Alimemazine
3.
How to take Alimemazine
4.
Possible side effects
5.
How to store Alimemazine
6.
Contents of the pack and other information
1. WHAT ALIMEMAZINE IS AND WHAT IT IS USED FOR
The name of your medicine is Alimemazine tartrate 7.5mg/5ml or
30mg/5ml Syrup (called Alimemazine
throughout this leaflet). This 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 IS USED FOR:

to treat itching (pruritus) or an itchy, lumpy rash (urticaria)

as a sedative before anaesthesia for children aged between 2 and 7
years. This medicine is given
to reduce awareness or make the child feel relaxed and at ease before
an operation. (Alimemazine
tartrate 30mg/5ml Syrup only).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIMEMAZINE
DO NOT TAKE ALIMEMAZINE 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 rash, swallowing or
breathing problems, swelling of
your lips, face, throat or tongue.

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alimemazine tartrate 30mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml dose contains 6mg of Alimemazine tartrate.
Also contains
Sucrose
680 mg/ml
Sodium sulphite anhydrous (E221)
1.0 mg/ml
Sodium metabisulphite (E223)
1.0 mg/ml
Ethanol
40.2 mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Clear, colourless to pale yellow, syrupy liquid.
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 tartrate 7.5mg / 5ml syrup should be used for
this indication in children.
Alimemazine may be used in pre-medication as a sedative before
anaesthesia in children aged between 2 to 7 years.
Alimemazine tartrate 30 mg / 5ml syrup can be used for the specific
indication of pre-anaesthesia sedation in children
(see Section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Alimemazine is not recommended for children less than 2 years old.
Do NOT exceed the recommended dose (see also section 4.9).
_Urticaria and pruritus_
Adults and adolescents 12-17 years: 10mg (approx. 1.6ml) two or three
times daily.
Elderly: Dosage should be reduced to 10mg (approx. 1.6ml) once or
twice daily.
Children less than 12 years of age should be prescribed alimemazine in
a lower strength (7.5 mg/5 ml) syrup
formulation for the indication of urticaria and pruritus.
_As a sedative before anaesthesia_
(Children aged 2-7 years:) the maximum dosage recommended is 2mg
(approx. 0.33 ml) per kg bodyweight 1-2 hours
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__