PENICILLIN VK Film-coated tablet Ref.[7791] Active ingredients: Phenoxymethylpenicillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Tyrol, Austria

Therapeutic indications

For use in the treatment of mild to moderately severe infections caused by penicillin sensitive organisms.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Adults

The dosage is 250-500 mg every six hours.

Elderly

The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.

Prophylactic Use

The dosage is 250 mg daily for long term prophylaxis of rheumatic fever.

Paediatric population

Children 1-5 years: 125 mg every six hours.

6-12 years: 250 mg every six hours.

To avoid late complications (rheumatic fever), infections with β-haemolytic streptococci should be treated for 10 days.

The treatment of acute otitis media with penicillin V should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications.

Method of administration

Penicillin VK Tablets 250 mg/Phenoxymethylpenicillin 250 mg Film-Coated Tablets are for oral use.

Each tablet should be swallowed whole with water, at least 30 minutes before food, as ingestion of phenoxymethylpenicillin with meals slightly reduces the absorption of the drug.

Overdose

A large overdose may cause nausea, vomiting and diarrhoea. Rarely major motor seizures may occur. There is no known antidote. Symptomatic and supportive therapy is recommended. It is advisable to monitor blood levels in patients with renal malfunction. Phenoxymethylpenicillin may be removed by haemodialysis.

Shelf life

Shelf life: This medicinal product as packaged for sale has a shelf life of two years.

Special precautions for storage

The following applies to the storage of Penicillin VK Tablets 250 mg/Phenoxymethylpenicillin 250 mg Film-Coated Tablets:

  • "Do not store above 25°C"
  • “Store in the original packaging” (when packaged in blisters)
  • “Keep the container tightly closed” (when packaged in securitainers)

Nature and contents of container

The 250 mg film coated tablets are presented in the following containers:

  • Amber glass bottles with polyethylene twist off closures containing 50 or 100 tablets.
  • Polypropylene containers with polyethylene snap on caps containing 50, 500 or 1000 tablets.
  • Blister strips of 10, 14, 20, 21, 28 or 30 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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