CONSION XL Prolonged-release capsule, hard (2018)
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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
<u>Capsule content (Prolonged-release tablets):</u> Cellulose microcrystalline Hypromellose Ethylcellulose Magnesium stearate <u>Capsule shell:</u> Gelatin Titanium dioxide (E171)
Incompatibilities
Not applicable.
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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