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SPC, UK: CHAMPIX Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CHAMPIX 0.5 mg film-coated tablets. CHAMPIX 1 mg film-coated tablets.

Qualitative and quantitative composition

Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate). Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate). For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Film-coated tablets. 0.5 mg film-coated tablets of 4 mm x 8 mm: White, capsular-shaped, biconvex tablets debossed with Pfizer on one side and CHX 0.5 on the other side. 1 mg film-coated tablets of 5 mm ...

Therapeutic indications

CHAMPIX is indicated for smoking cessation in adults.

Posology and method of administration

Posology The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1–3: 0.5 mg once daily. Days 4–7: 0.5 mg twice daily. Day 8–End of treatment: 1 mg twice ...

Contraindications

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

Special warnings and precautions for use

Effect of smoking cessation Physiological changes resulting from smoking cessation, with or without treatment with CHAMPIX, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, ...

Interaction with other medicinal products and other forms of interaction

Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions. No dosage adjustment of CHAMPIX or co-administered medicinal products listed ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1). Animal studies have shown reproductive toxicity (see section ...

Effects on ability to drive and use machines

CHAMPIX may have minor or moderate influence on the ability to drive and use machines. CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability ...

Undesirable effects

Summary of the safety profile Smoking cessation with or without treatment is associated with various symptoms. For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; ...

Overdose

No cases of overdose were reported in pre-marketing clinical trials. In case of overdose, standard supportive measures should be instituted as required. Varenicline has been shown to be dialyzed in patients ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other nervous system drugs; Drugs used in addictive disorders; Drugs used in nicotine dependence ATC code: N07BA03 Mechanism of action Varenicline binds with high affinity and ...

Pharmacokinetic properties

Absorption Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration. Following administration of multiple oral doses to healthy volunteers, steady-state conditions ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, fertility and embryo-foetal development. In male rats dosed ...

List of excipients

Tablets' core: __0.5 mg and 1 mg Tablets Cellulose, microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Film coating: _0.5 mg Tablet ...

Incompatibilities

Not applicable.

Shelf life

Shelf life Bottles: 2 years. Blisters: 3 years.

Special precautions for storage

Blisters: Store below 30°C. HDPE Bottle: This medicinal product does not require any special storage conditions.

Nature and contents of container

Treatment initiation packs: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 0.5 mg film-coated tablets and a second clear blister of 14 1 mg film-coated tablets in secondary ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization number(s)

0.5 mg tablets: EU/1/06/360/001 EU/1/06/360/006 EU/1/06/360/007 EU/1/06/360/017 EU/1/06/360/018 1mg tablets: EU/1/06/360/002 EU/1/06/360/004 EU/1/06/360/005 EU/1/06/360/009 EU/1/06/360/010 EU/1/06/360/011 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 September 2006 Date of latest renewal: 29 June 2016

Date of revision of the text

07/2019

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