Lithicarb FC

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Lithium carbonate 250mg;  ; Lithium carbonate 250mg

Verfügbar ab:

Viatris Limited

INN (Internationale Bezeichnung):

Lithium carbonate 250 mg

Dosierung:

250 mg

Darreichungsform:

Film coated tablet

Zusammensetzung:

Active: Lithium carbonate 250mg   Excipient: Carnauba wax Clear film coat 5544 Lactose monohydrate Magnesium stearate Maize starch Povidone Sodium starch glycolate Active: Lithium carbonate 250mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hypromellose E-15 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified water Sodium starch glycolate

Einheiten im Paket:

Bottle, plastic, HDPE, 500 tablets

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

FMC Corporation

Produktbesonderheiten:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Berechtigungsdatum:

1988-09-26

Gebrauchsinformation

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LITHICARB FC
_LITHIUM CARBONATE TABLETS, FILM-COATED 250 MG AND 400MG _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LITHICARB FC. It
does not contain all the information
available on this medicine. It does
not take the place of talking to your
doctor or pharmacist. All medicines
have risks and benefits. Your doctor
has weighed the risks of using
LITHICARB FC against the benefits
expected it will have for you. If you
have any concerns about using this
medicine, ask your doctor or
pharmacist.
Keep this leaflet. You may want to
read it again.
WHAT LITHICARB FC
IS USED FOR AND HOW
IT WORKS
Your LITHICARB FC tablets contain
the active ingredient lithium
carbonate. Lithium carbonate
provides a source of lithium ions,
which compete with sodium ions at
various sites in the body.
LITHICARB FC is used to treat
patients with mental conditions (e.g.
over-activity and mood changes)
and recurring bipolar disorder.
LITHICARB FC is also used in the
prevention of mood problems.
Your doctor may, however,
prescribe LITHICARB FC for
another reason. Ask your doctor if
you have any questions about why
LITHICARB FC has been
prescribed for you.
There is no evidence that
LITHICARB FC is addictive.
LITHICARB FC is available on
prescription from your doctor.
BEFORE YOU TAKE
LITHICARB FC
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE LITHICARB FC IF:
•
YOU ARE ALLERGIC TO LITHIUM
CARBONATE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
•
YOU HAVE A HEART OR KIDNEY
PROBLEM
•
YOU HAVE LOW ACTIVITY OF THE
ADRENAL GLAND (EG ADDISON’S
DISEASE)
•
YOU HAVE AN UNDERACTIVE
THYROID GLAND
•
IF YOU HAVE LOW LEVELS OF
SODIUM IN YOUR BODY (EG IF YOU
ARE DEHYDRATED OR ON A LOW
SALT DIET)
•
IF YOU ARE PREGNANT OR
BREASTFEEDING
•
IF YOU INTEND TO BECO

Fachinformation

Page 1 of 10
NEW ZEALAND DATA SHEET
LITHICARB FC
1. PRODUCT NAME
LITHICARB FC 250 mg and 400 mg, film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 250 mg or 400 mg of lithium
carbonate.
LITHICARB FC tablets contain lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
LITHICARB 250 mg tablets are clear film coated, white biconvex
tablets, 11.1 mm diameter,
imprinted “LC” breakline over “250” on one side.
LITHICARB 400 mg tablets are clear film coated, white biconvex
tablets, 12.7 mm diameter,
imprinted “LC” breakline over “400” on one side.
LITHICARB FC tablets are scored, therefore they can be divided
accurately to provide dosage
adjustments as small as 125 mg._ _
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
1. Treatment of mania and hypomania.
2. Lithium may also be tried in the treatment of some patients with
recurrent bipolar depression, for
which treatment with other antidepressants has been unsuccessful.
3. Prophylactic treatment of recurrent affective disorders.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
A simple treatment schedule has been evolved which, except for some
minor variations, should be
followed whether using LITHICARB FC therapeutically or
prophylactically. The minor variations to
this schedule depend on the elements of the illness being treated and
these are described later.
1. In patients of average weight (70 kg) an initial dose of 400-1,200
mg of LITHICARB FC may be
given as a single daily dose in the morning or on retiring.
Alternatively, the dose may be divided
and given morning and evening. The tablets should not be crushed,
chewed or swallowed with
hot liquids. When changing from other lithium preparations serum
lithium levels should first be
checked, then LITHICARB FC therapy commenced at a daily dose as close
as possible to the
Page 2 of 10
dose of the other form of lithium. As bioavailability varies from
product to product (particularly
with regard to retard or slow release