TOREM 5mg Tablet Ref.[49789] Active ingredients: Torasemide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

4.1. Therapeutic indications

Essential hypertension; oedema due to congestive heart failure; hepatic, pulmonary or renal oedema.

4.2. Posology and method of administration

Adults

Essential hypertension

A dose of 2.5mg torasemide once daily is recommended. If necessary, the dose may be increased to 5mg once daily. Studies suggest that doses above 5mg daily will not lead to further reduction in blood pressure. The maximum effect is exhibited after approximately twelve weeks of continuous treatment.

Oedema

The usual dose is 5mg once daily. If necessary, the dose can be increased stepwise up to 20mg once daily. In individual cases, as much as 40mg torasemide/day has been administered.

Elderly

No special dosage adjustments are necessary.

Children

There is no experience of torasemide in children.

4.9. Overdose

Symptoms and signs

No typical picture of intoxication is known. If overdosage occurs, then there may be marked diuresis with the danger of loss of fluid and electrolytes which may lead to somnolence, confusion, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, hemoconcentration dehydration and circulatory collapse. Gastrointestinal disturbances may occur.

Treatment

No specific antidote is known. Symptoms and signs of overdosage require the reduction of the dose or withdrawal of torasemide, and simultaneous replacement of fluid and electrolytes.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

No special precautions for storage.

6.5. Nature and contents of container

Blister packs, PVC/aluminium, containing 14, 28, 100 or 112 tablets.

6.6. Special precautions for disposal and other handling

Not applicable.

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