PIVMECILLINAM Film-coated tablet Ref.[8310] Active ingredients: Pivmecillinam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Therapeutic indications

Treatment of adults with acute uncomplicated cystitis due to mecillinam sensitive organisms.

Posology and method of administration

Posology

Adults

The usual dose is 200 mg two times daily for 7 days, alternatively 200 mg 3 times daily for 5 days.

Paediatric population

Pivmecillinam hydrochloride should not be used in children and adolescents below 18 years because the efficacy and safety have not yet been established.

Dosage in the elderly

Renal excretion of mecillinam is delayed in the elderly, but significant accumulation of the drug is not likely at the recommended adult dosage of Pivmecillinam hydrochloride tablets. Dosage adjustment is not necessary (see section 5.2).

Renal impairment

Renal excretion of mecillinam is delayed in patients with reduced kidney function, but significant accumulation of the drug is not likely at the recommended adult dosage of Pivmecillinam hydrochloride. Dosage adjustment is not necessary (see section 5.2).

Hepatic impairment

Dosage adjustment is not necessary.

Method of administration

Pivmecillinam hydrochloride must be taken with at least half a glass of liquid. Pivmecillinam hydrochloride may be taken with food

Overdose

There is no experience of overdose with Pivmecillinam hydrochloride tablets. However, excessive doses are likely to induce nausea, vomiting abdominal pain and diarrhoea. Treatment should be restricted to symptomatic and supportive measures.

Shelf life

2 years.

Special precautions for storage

Store below 30°C.

Store in the original package in order to protect from moisture.

Nature and contents of container

Pivmecillinam hydrochloride film-coated tablets are available in PVC/OPA/aluminum/PVC/Paper/PET/aluminum foil blister pack.

Pack sizes: 2, 10, 14 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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