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CONSION XL Prolonged-release capsule, hard (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Consion XL 8 mg prolonged-release capsules, hard.

Qualitative and quantitative composition

Each 8 mg prolonged-release capsule contains 8 mg galantamine (as hydrobromide). For the full list of excipients, see section 6.1.

Pharmaceutical form

Prolonged-release capsule, hard. Opaque white size 2 hard gelatin capsules containing one round biconvex prolonged- release tablet of 8 mg.

Therapeutic indications

Consion XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.

Posology and method of administration

Posology Adults/Elderly Before start of treatment The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4). Starting ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Since no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh ...

Special warnings and precautions for use

Types of dementia Consion XL is indicated for patients with mild to moderately severe dementia of the Alzheimer type. The benefit of galantamine in patients with other types of dementia or other types ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics (such as ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine ...

Fertility, pregnancy and lactation

Pregnancy For galantamine no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). Caution should be exercised when prescribing to pregnant ...

Effects on ability to drive and use machines

Galantamine has minor or moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.

Undesirable effects

The table below reflects data obtained with galantamine in eight placebo-controlled, double-blind clinical trials (N=6,502), five open-label clinical trials (N=1,454), and from postmarketing spontaneous ...

Overdose

Symptoms Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antidementia drugs ATC code: N06DA04 Mechanism of action Galantamine, a tertiary alkaloid is a selective, competitive and reversible inhibitor of acetylcholinesterase. In addition, ...

Pharmacokinetic properties

Galantamine is an alkalinic compound with one ionisation constant (pKa 8.2). It is slightly lipophilic and has a partition coefficient (Log P) between n-octanol/buffer solution (pH 12) of 1.09. The solubility ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Reproduction toxicity studies ...

List of excipients

Capsule content (Prolonged-release tablets): Cellulose microcrystalline Hypromellose Ethylcellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

transparent PVC/PE/PVDC Aluminum blister. Pack sizes: 7, 28, 30, 56, 84, 98, 100 prolonged-release capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pharmathen S.A., Dervenakion 6, Pallini, Attiki, 153 51, Greece

Marketing authorization number(s)

PL 17277/0254

Date of first authorization / renewal of the authorization

16/01/2018

Date of revision of the text

16/01/2018

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