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SPC, UK: FAMVIR Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Famvir 125 mg film-coated tablets. Famciclovir 125 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 125 mg of famciclovir. Excipient with known effects: Each film-coated tablet contains 26.85 mg of lactose, anhydrous. For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Film-coated tablet. White, round film-coated tablet, biconvex, bevelled edges, debossed with FV on one side and 125 on the reverse side.

Therapeutic indications

Varicella zoster virus (VZV) infections – herpes zoster Famvir is indicated for: the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section 4.4) the treatment of herpes ...

Posology and method of administration

Herpes zoster and ophthalmic zoster in immunocompetent adults 500 mg three times daily for seven days. Treatment should be initiated as soon as possible after a diagnosis of herpes zoster or ophthalmic ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to penciclovir.

Special warnings and precautions for use

Use in patients with renal impairment In patients with impaired renal function dose adjustment is necessary (see sections 4.2 and 4.9). Use in patients with hepatic impairment Famciclovir has not been ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on famciclovir No clinically significant interactions have been identified. Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, ...

Fertility, pregnancy and lactation

Women of child-bearing potential There are no data supporting any special recommendations in women of child-bearing potential. Patients with genital herpes should be advised to avoid intercourse when symptoms ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while ...

Undesirable effects

Headache and nausea have been reported in clinical studies. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse ...

Overdose

Overdose experience with famciclovir is limited. In the event of an overdose supportive and symptomatic therapy should be given as appropriate. Acute renal failure has been reported rarely in patients ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitor ATC code: J05AB09 Mechanism of action Famciclovir is the oral prodrug of penciclovir. Famciclovir is rapidly ...

Pharmacokinetic properties

General characteristics Absorption Famciclovir is the oral prodrug of the antivirally active compound penciclovir. Following oral administration, famciclovir is rapidly and extensively absorbed and converted ...

Preclinical safety data

General toxicity Studies on safety pharmacology and repeated dose toxicity reveal no special hazard for humans. Genotoxicity Famciclovir was not found to be genotoxic in a comprehensive battery of in vivo ...

List of excipients

Tablet core: Lactose, anhydrous Sodium starch glycolate (Type A) Hydroxypropyl cellulose Magnesium stearate Tablet coat: Hypromellose Titanium dioxide (E171) Macrogol 4000 Macrogol 6000

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Famvir is supplied in PVC/PCTFE/Aluminium blister packs containing 10 tablets.

Special precautions for disposal and other handling

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

Marketing authorization holder

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 00101/0625

Date of first authorization / renewal of the authorization

21 April 1995/08 July 2011

Date of revision of the text

15 October 2018

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