TETRALYSAL

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

LYMECYCLINE

Boleh didapati daripada:

Galderma (UK) Ltd

Kod ATC:

J01AA04

INN (Nama Antarabangsa):

LYMECYCLINE

Dos:

300 Base Milligrams

Borang farmaseutikal:

Capsules Hard

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

lymecycline

Status kebenaran:

Marketed

Tarikh kebenaran:

1982-02-26

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tetralysal 300mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 408 mg Lymecycline equivalent to 300 mg of
tetracycline base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule (Capsule).
Hard gelatin capsule, red cap and yellow body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tetralysal 300 is for the treatment of acne.
As Tetralysal 300 contains a broad spectrum antibiotic, it is also
recommended for the treatment of infections due to
micro-organisms sensitive to tetracyclines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paediatric population
The safety and efficacy of Tetralysal in children aged under 12 years
of age have not been established. No data are
available.
For children over the age of 12 years, the adult dosage may be given.
For children under the age of 8 years, see section
4.3.
Adults and children over 12 years of age or 50kg.bw:
_Acne:_
The usual dosage for the chronic treatment of acne is 1 capsule daily:
treatment should be continued for at least 8
weeks.
_Tetracycline sensitive infections:_
The usual daily dosage is two capsules in divided doses (1 capsule,
twice daily). This may be increased to four capsules
daily if required.
Elderly
As with other tetracyclines, no specific dose adjustment is required.
Method of administration
The capsules should be taken with a glass of water in order to reduce
the risk of oesophageal irritation and ulceration
(see section Special warnings and precautions for use).
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