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SPC, UK: CARBAMAZEPINE Oral suspension (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Carbamazepine SUN 100 mg/5 ml Oral Suspension.

Qualitative and quantitative composition

Each 5 ml of the oral suspension contains 100 mg carbamazepine. Excipients with known effect: Sorbitol (E420) and orange yellow S For the full list of excipients, see section 6.1.

Pharmaceutical form

Oral suspension. An orange to pale orange suspension.

Therapeutic indications

Carbamazepine is indicated for: Epilepsy (generalised tonic-clonic and partial seizures). Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal ...

Posology and method of administration

Posology Since a given dose of carbamazepine oral suspension will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses of the liquid and to increase them ...

Contraindications

Known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) or any of the excipients listed in section 6.1. Patients with atrioventricular block, a history of ...

Special warnings and precautions for use

Warnings Agranulocytosis and aplastic anaemia have been associated with carbamazepine; however, due to the very low incidence of these conditions, meaningful risk estimates for carbamazepine are difficult ...

Interaction with other medicinal products and other forms of interaction

Cytochrome P4503A4 (CYP3A4) is the main enzyme catalysing formation of the active metabolite carbamazepine 10, 11-epoxide. Co-administration of inhibitors of CYP3A4 may result in increased plasma concentrations ...

Fertility, pregnancy and lactation

Pregnancy Offspring of epileptic mothers with untreated epilepsy are known to be more prone to developmental disorders, including malformations. Developmental disorders and malformations, including spina ...

Effects on ability to drive and use machines

The patients ability to react may be impaired by the medical condition resulting in seizures and adverse reactions including dizziness, drowsiness, ataxia, diplopia, impaired accommodation and blurred ...

Undesirable effects

Summary of the safety profile Particularly at the start of treatment with carbamazepine, or if the initial dosage is too high, or when treating elderly patients, certain types of adverse reaction occur ...

Overdose

Signs and symptoms The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular, respiratory systems and the adverse drug reactions mentioned under section 4.8. Central nervous ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-epileptic, neurotropic and psychotropic agent ATC Code: N03AF01. Dibenzazepine derivative. As an antiepileptic agent its spectrum of activity embraces: partial seizures ...

Pharmacokinetic properties

Absorption Carbamazepine is absorbed almost completely but relatively slowly from the tablets. The conventional tablets yield mean peak plasma concentrations of the unchanged substance within 12 hours ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, local tolerance, genotoxicity and carcinogenic potential. Reproductive toxicity ...

List of excipients

Sucralose Poloxamer 188 Xanthan gum Potassium sorbate Propylene glycol Citric acid monohydrate Orange yellow S Sorbitol (E420) Natural and artificial flavour orange Water, purified

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Keep the bottle tightly closed between doses.

Nature and contents of container

PET/Glass bottles using a polypropylene child resistant plastic cap. Pack sizes: 300 ml & 500 ml. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization number(s)

PL 31750/0096

Date of first authorization / renewal of the authorization

25.03.2008

Date of revision of the text

04/02/2019

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