CAMCOLIT Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Camcolit 400 mg, controlled release Lithium Carbonate.
2. Qualitative and quantitative composition
Each film-coated tablet contains 400 mg lithium carbonate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets. White film coated tablet, engraved CAMCOLIT-S around one face and having a score line on the reverse. The tablet is a controlled release formulation. The score line is only to facilitate ...
4.1. Therapeutic indications
The treatment and prophylaxis of mania, manic-depressive illness and recurrent depression, and the treatment of aggressive or self mutilating behaviour.
4.2. Posology and method of administration
Camcolit 400 mg tablets are usually administered according to a twice daily regimen. When lithium levels have stabilised, a once daily regimen may be preferred Lithium carbonate has a narrow therapeutic ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severely impaired renal function. Untreated or untreatable hypothyroidism. Cardiac disease associated with rhythm ...
4.4. Special warnings and precautions for use
Lithium carbonate has a narrow therapeutic window. The dose required for treatment must be titrated and adjusted on the basis of regular monitoring of serum concentration of lithium. Lithium therapy should ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions may occur as a result of increased or decreased lithium levels, or may act through other mechanisms, the most important being neurotoxicity which may occur at therapeutic levels when other ...
4.6. Fertility, pregnancy and lactation
Pregnancy Lithium therapy should not be used during pregnancy, especially during the first trimester, unless considered essential. There is epidemiological evidence that it may be harmful to the foetus ...
4.7. Effects on ability to drive and use machines
Camcolit has minor to moderate influence on the ability to drive and use machines. As lithium may cause disturbances of the CNS, patients should be warned of the possible hazards when driving or operating ...
4.8. Undesirable effects
Side effects are usually related to serum lithium concentrations and are less common in patients with plasma lithium concentrations below 1.0 mmol/l. Initial Therapy: fine tremor of the hands, polyuria ...
4.9. Overdose
Lithium carbonate has a narrow therapeutic window. Symptoms of lithium overdose (Lithium intoxication) can therefore occur due to intercurrent illness, iatrogenic causes, and self poisoning. Any overdose ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psycholeptics, antipsychotics <b>ATC-code:</b> N05AN01 Mechanism of action The precise mechanism of action of lithium as a mood-stabilising agent remains unknown, although ...
5.2. Pharmacokinetic properties
Distribution It crosses the placenta and is excreted in breast milk. The pharmacokinetics of lithium are extremely well documented. A single oral dose of CAMCOLIT 400 gives a peak plasma level approximately ...
5.3. Preclinical safety data
Lithium is teratogenic in rats and mice. In rats, lithium caused a reduction in fetal weights, numbers of live fetuses, delayed development of the skeleton and kidney toxicity in newborns at maternally ...
6.1. List of excipients
Maize starch Acacia Magnesium stearate Sodium laurilsulfate Hypromellose Macrogol 400 Opaspray M-1-7111B
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Keep the container tightly closed. Keep out of the sight and reach of children.
6.5. Nature and contents of container
Polypropylene containers containing 56, 100 or 500 film-coated tablets. For hospital use only, screw-cap amber glass bottles containing 50 or 100 film-coated tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Essential Pharma, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom
8. Marketing authorization number(s)
PL 41871/0003
9. Date of first authorization / renewal of the authorization
13 June 1997
10. Date of revision of the text
28/09/2020
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