CAMCOLIT 250 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lithium carbonate

Available from:

Essential Pharma (M) Limited

ATC code:

N05AN; N05AN01

INN (International Name):

Lithium carbonate

Dosage:

250 mg milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Lithium; lithium

Authorization status:

Not marketed

Authorization date:

2014-09-19

Patient Information leaflet

Cam250mgTab/PL/IE/6
1
Label
Camcolit

250
mg
Lithium Carbonate
100 film-coated tablets
EACH TABLET CONTAINS 250 MG LITHIUM CARBONATE
To be taken orally as directed by the doctor. Please read the pack
leaflet.
Do not store above 25°C.
Keep container tightly closed.
Keep out of the reach and sight of children
EP logo
Essential Pharma (M) Limited, Birkirkara, BKR 9037, Malta
PA 22644/001/001
POM
Peel here / EAN BAR CODE
Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAMCOLIT 250 MG FILM-COATED TABLETS LITHIUM CARBONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet.
You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects become serious, or you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What CAMCOLIT is and what it is used for
2. Before you take CAMCOLIT
3. How to take CAMCOLIT
4. Possible side effects
Cam250mgTab/PL/IE/6
2
5. How to store CAMCOLIT
6. Further information
1. WHAT CAMCOLIT IS AND WHAT IT IS USED FOR
CAMCOLIT 250 mg tablets contain lithium carbonate, which is used to
treat and prevent
mania or manic depressive illness and recurrent depression. It is
sometimes used to treat other
behavioural disorders.
2. BEFORE YOU TAKE CAMCOLIT
DO NOT TAKE CAMCOLIT IF YOU:

are hypersensitive (allergic) to lithium or to any of the other
ingredients.

have serious kidney disease.

have hypothyroidism (low thyroid hormones) that is difficult to treat.

have problems with the rhythm of your heart.

have a condition called Brugada syndrome (a hereditary syndrome that
affects the
heart), or if anyone in your family has had Brugada syndrome.

have low sodium levels in your body. This can happen if you are
dehydrated, on a low
sodium diet, or if you have an illness called ‘Addison

Summary of Product characteristics

Health Products Regulatory Authority
21 September 2022
CRN00D507
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CAMCOLIT 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Lithium Carbonate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White film-coated tablets
The tablets are engraved CAMCOLIT around one face and having a
scoreline on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment and prophylaxis of mania, bipolar affective disorders
and recurrent depression, and the treatment of aggressive
or self mutilating behaviour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
CAMCOLIT 250mg film coated tablets are usually administered according
to a twice daily regimen. When lithium levels have
stabilised, a once daily regimen may be preferred.
4.2.1 DOSAGE
Lithium carbonate has a narrow therapeutic window. The dose required
for treatment must be titrated and adjusted on the
basis of regular monitoring of the serum concentration of lithium (See
Section 4.4.1). Lithium therapy should not be initiated
unless adequate facilities for routine monitoring of plasma
concentrations are available. On initiation of treatment, plasma
therapy concentrations should be measured weekly until stabilisation
is achieved, then weekly for one month and at monthly
intervals thereafter.
Additional measurements should be made if signs of lithium toxicity
occur, on dosage alteration, development of significant
intercurrent disease, signs of manic depressions or depressive relapse
and if significant change in sodium or fluid intake occurs.
More frequent monitoring is required if patients are receiving any
drug treatment that affects renal clearance of lithium e.g.
diuretics and NSAID (See section 4.4 and section 4.5). As
bioavailability may vary between formulations, should a change of
prepar