Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
Tetralysal is indicated for the treatment of infections caused by tetracycline sensitive organisms (please see section 4.4 and 5.1) including the following:
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The usual dosage for the chronic treatment of acne is 1 capsule daily (300 mg/day): treatment should be continued for at least 8 weeks.
For other infections, the usual dosage is 1 capsule b.d. (600 mg/day). If higher doses are required, 3-4 capsules (900-1200 mg) may be given over 24 hours. Lower doses may be given for prophylaxis.
In the management of sexually transmitted disease both partners should be treated.
As for other tetracyclines, no specific dose adjustment is required.
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.
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).
Acute overdosage is rare with antibiotics and there is no specific treatment.
Supportive measure should be instituted as required and a high fluid intake maintained.
3 years (unopened).
Aluminium and polyethylene strips:
Do not store above 25°C.
Store in the original container.
Aluminium-PVC/PVDC calendar blister strips:
Do not store above 25°C.
Keep container in the outer carton.
As with all medicines, Tetralysal 300 should be kept out of the sight and reach of children.
Aluminium-PVC/PVDC calendar blister strips of 14 capsules; two strips per carton, pack size = 28 capsules or Aluminium and polyethylene strips 28 or 56 capsule pack size.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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