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PIVMECILLINAM Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pivmecillinam hydrochloride 200 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of pivmecillinam hydrochloride. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White to off-white, round shaped, biconvex, film coated tablets debossed with F on one side and 48 on the other side.

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 ...

Contraindications

Pivmecillinam hydrochloride is contra-indicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to penicillins or cephalosporins. ...

Special warnings and precautions for use

Pseudomembranous colitis caused by Clostridium difficile may occur. If diarrhoea occurs after use, the possibility of pseudomembranous colitis should be considered, and appropriate precaution should be ...

Interaction with other medicinal products and other forms of interaction

Simultaneous administration of probenecid reduces the excretion of mecillinam and hence increases the blood level of the antibiotic. Clearance of methotrexate from the body can be reduced by concurrent ...

Fertility, pregnancy and lactation

Pregnancy A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of pivmecillinam/mecillinam. Pivmecillinam can be used during ...

Effects on ability to drive and use machines

Pivmecillinam hydrochloride has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The estimation of the frequency of undesirable effects is based on an analysis of pooled data from clinical studies and spontaneous reporting. The most frequently reported adverse reactions are nausea ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, penicillins with extended spectrum ATC code: J01CA08 Mechanism of action Pivmecillinam hydrochloride is an orally active antibiotic, containing ...

Pharmacokinetic properties

Absorption, Distribution, Biotransformation Pivmecillinam hydrochloride is the pro-drug of mecillinam that is hydrolysed in the body to mecillinam, the active antibacterial agent (see section 5.1). Following ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development. No genotoxicity or carcinogenicity ...

List of excipients

Tablet core: Cellulose microcrystalline Magnesium stearate Film coating: Hypromellose Triacetin

Incompatibilities

Not applicable.

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 ...

Special precautions for disposal and other handling

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

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization number(s)

PL 16363/0442

Date of first authorization / renewal of the authorization

07.10.2015

Date of revision of the text

30.07.2018

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