Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: ZYBAN Prolonged release tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Zyban 150 mg prolonged release tablets.

Qualitative and quantitative composition

Each tablet contains bupropion hydrochloride 150 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Prolonged release tablet. White, film-coated, biconvex, round tablet printed on one side with GX CH7 and plain on the other side.

Therapeutic indications

Zyban tablets are indicated as an aid to smoking cessation in combination with motivational support in nicotine-dependent patients.

Posology and method of administration

Posology Use in Adults It is recommended that treatment is started while the patient is still smoking and a target stop date set within the first two weeks of treatment with Zyban, preferably in the second ...

Contraindications

Zyban is contraindicated in patients with hypersensitivity to bupropion or any of the excipients listed in section 6.1. Zyban is contraindicated in patients with a current seizure disorder or any history ...

Special warnings and precautions for use

Seizures The recommended dose of Zyban must not be exceeded, since bupropion is associated with a dose-related risk of seizure. At doses up to the maximum recommended daily dose (300mg of Zyban daily), ...

Interaction with other medicinal products and other forms of interaction

In patients receiving medicinal products known to lower the seizure threshold, Zyban must only be used if there is a compelling clinical justification for which the potential medical benefit of smoking ...

Fertility, pregnancy and lactation

Pregnancy Some epidemiological studies of pregnancy outcomes following maternal exposure to bupropion in the first trimester have reported an association with increased risk of certain congenital cardiovascular ...

Effects on ability to drive and use machines

As with other CNS acting drugs bupropion may affect ability to perform tasks that require judgement or motor and cognitive skills. Zyban has also been reported to cause dizziness and lightheadedness. Patients ...

Undesirable effects

The list below provides information on the undesirable effects identified from clinical experience, categorised by incidence and System Organ Class body system. It is important to note that smoking cessation ...

Overdose

Acute ingestion of doses in excess of 10 times the maximum therapeutic dose has been reported. In addition to those events reported as Undesirable Effects, overdose has resulted in symptoms including drowsiness, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antidepressants ATC code: N06AX12 Mechanism of action Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal ...

Pharmacokinetic properties

Absorption After oral administration of 150 mg bupropion hydrochloride as a prolonged release tablet to healthy volunteers, maximum plasma concentrations (C<sub>max</sub>) of approximately 100 nanograms ...

Preclinical safety data

Reproduction toxicity studies conducted in rats at exposures similar to those obtained at the maximum recommended human dose (based on systemic data on exposure) revealed no adverse effects on fertility, ...

List of excipients

Tablet core: Microcrystalline cellulose Hypromellose Cysteine hydrochloride monohydrate Magnesium stearate Film coat: Hypromellose Macrogol 400 Titanium dioxide (E171) Carnauba wax Printing ink: Iron oxide ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

Cartons containing cold form foil/foil child-resistant blister packs (PA-Alu-PVC/Paper-Alu). 30, 40, 50, 60 or 100 tablets are supplied in each pack. Each blister strip contains 10 tablets. Not all pack ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Glaxo Wellcome UK Ltd. trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, UK

Marketing authorization number(s)

PL 10949/0340

Date of first authorization / renewal of the authorization

7 June 2000/1 Dec 2004

Date of revision of the text

21 March 2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 103,6 KB