Alfresed 30mg/5ml Syrup

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

ALIMEMAZINE TARTRATE

Sẵn có từ:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

Mã ATC:

R06AD01

INN (Tên quốc tế):

ALIMEMAZINE TARTRATE 30 mg/5ml

Dạng dược phẩm:

SYRUP

Thành phần:

ALIMEMAZINE TARTRATE 30 mg/5ml

Loại thuốc theo toa:

POM

Khu trị liệu:

ANTIHISTAMINES FOR SYSTEMIC USE

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2019-06-17

Tờ rơi thông tin

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFRESED 30MG/5ML SYRUP
alimemazine tartrate
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 symptoms 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.
The name of your medicine is Alfresed 30mg/5ml Syrup, but it will be
referred to as Alfresed
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Alfresed is and what it is used for
2.
What you need to know before you take Alfresed
3.
How to take Alfresed
4.
Possible side effects
5.
How to store Alfresed
6.
Contents of the pack and other information
1. WHAT ALFRESED IS AND WHAT IT IS USED FOR
Alfresed contains the active substance 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 ALFRESED 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 ALFRESED
DO NOT TAKE ALFRESED 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

have liv

Đặc tính sản phẩm

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alfresed 30mg/5ml Syrup
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains 30mg alimemazine tartrate.
Excipients with known effect:
Each 5ml of syrup contains 3400mg sucrose, 2mg methyl
parahydroxybenzoate (E218),
5mg sodium sulfite anhydrous (E221) and 5mg sodium metabisulfite
(E223).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Syrup
A clear, colourless to pale yellow syrupy liquid with caramel odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alfresed has powerful antihistamine and anti-emetic actions and is
used in the management
of urticaria and pruritus. Alfresed 7.5mg/5ml syrup should be used for
this indication in
children.
Alfresed may be used in pre-medication as a sedative before
anaesthesia in children aged
between 2 to 7 years. Alfresed 30mg/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
POSOLOGY
Not recommended for infants less than 2 years old.
DO NOT exceed the recommended dose (see section 4.9).
Urticaria and pruritus
Adults: 10mg (approx. 1.7ml) two or three times daily; up to 100mg per
day have been used
in intractable cases.
Elderly: dosage should be reduced to 10mg (approx. 1.7ml) once or
twice daily.
Children over 2 years of age should be prescribed Alfresed syrup of a
lower strength
(7.5mg/5ml) for the indication of urticaria and pruritus.
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As a sedative before anaesthesia
Children aged 2-7 years: the maximum dosage recommended is 2mg
(approx. 0.33ml) per
kg bodyweight 1-2 hours before the operation.
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
Alfresed 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 exc