Alimemazine 7.5mg/5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alimemazine tartrate

Available from:

Zentiva Pharma UK Ltd

ATC code:

R06AD01

INN (International Name):

Alimemazine tartrate

Dosage:

1.5mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5000283653929

Patient Information leaflet

1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
ALIMEMAZINE TARTRATE 7.5MG /
5 ML SYRUP
ALIMEMAZINE TARTRATE 30MG /
5 ML SYRUP
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leafl et. 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 symptoms are the same as yours
•
If you get any side eff ects, talk to your doctor
or pharmacist. This includes any possible side
eff ects not listed in this leafl et - see section 4.
WHAT IS IN THIS LEAFL ET
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 eff ects
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 Syrup or Alimemazine Tartrate
30mg/5ml Syrup (called alimemazine throughout
this leafl et). It contains the active ingredient
alimemazine tartrate and it belongs to a group
of medicines called phenothiazines and 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 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
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 rash,
swallowing or b

Summary of Product characteristics

OBJECT 1
ALIMEMAZINE TARTRATE 7.5MG/5ML SYRUP
Summary of Product Characteristics Updated 14-May-2015 | Zentiva
1. Name of the medicinal product
Alimemazine Tartrate 7.5mg/5ml Syrup
2. Qualitative and quantitative composition
Alimemazine tartrate 7.5mg per 5ml
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Syrup
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. It has powerful antihistamine and
anti-emetic actions. For the management
of urticaria and pruritus.
In pre-medication as a sedative before anaesthesia in children aged
between 2 to 7 years.
4.2 Posology and method of administration
For oral administration.
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 (approx. 6.5ml) two or three times daily; up to 100mg per
day have been used in intractable
cases.
Older people: dosage should be reduced to 10 mg (approx. 6.5ml) once
or twice daily.
Children over 2 years of age: 2.5-5 mg (approx. 1.7 – 3.3ml) three or
four times daily
As a sedative before anaesthesia
Children aged 2-7 years: the maximum dosage recommended is 2mg
(approx. 1.3ml) per kg bodyweight
1-2 hours before the operation.
4.3 Contraindications
Alimemazine should be avoided in patients with hepatic or renal
dysfunction, epilepsy, Parkinson's
disease, hypothyroidism, phaeochromocytoma, myasthenia gravis,
prostatic hypertrophy. It should be
avoided in patients known to be hypersensitive to phenothiazines or to
any of the excipients or with
history of narrow angle glaucoma.
Alimemazine is contraindicated for use in children less than 2 years
of age (see section 4.4)
4.4 Special warnings and precautions for use
Precautions for use
Alimemazine should be used with caution in:
• elderly or volume depleted patients who are more susceptible to
orthostatic hypotension (see section
4.8)
• Elderly pati