Carbamazepine 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbamazepine

Available from:

Viatris UK Healthcare Ltd

ATC code:

N03AF01

INN (International Name):

Carbamazepine

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100; GTIN: 5016695292175

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Carbamazepine Tablets are and what they are used for
2. What you need to know before you take Carbamazepine Tablets
3. How to take Carbamazepine Tablets
4. Possible side effects
5. How to store Carbamazepine Tablets
6. Contents of the pack and other information
1. WHAT CARBAMAZEPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Carbamazepine, the active ingredient in Carbamazepine Tablets,
can affect the body in several different ways. It is an
anti-convulsant medicine (prevents fits), it can also modify some
types of pain and can control mood disorders.
Carbamazepine is used:
•
To treat some forms of epilepsy
•
To treat a painful condition of the face called trigeminal neuralgia
•
To help control serious mood disorders when some other
medicines don’t work.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAMAZEPINE TABLETS
DO NOT TAKE CARBAMAZEPINE TABLETS:
•
If you are allergic to carbamazepine or any of the other
ingredients of this medicine (listed in section 6). Signs of an
allergic reaction include swelling of the face or mouth
(angioedema), breathing problems, runny nose, skin rash,
blistering or peeling.
•
If you are allergic to similar kind of drugs as carbamazepine
such as oxcarbazepine (Trileptal), or to any of a related group
of drugs known as tricyclic antidepressants (such as
amitriptyline
or
imipramine).
If
you
are
allergic
to
carbamazepine there is a one in four (25%) chance that you
could also have an allergic reaction to o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbamazepine Medreich 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains 400 mg of Carbamazepine.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet: White to off white, flat, rod shaped, uncoated tablets with
bevelled edges,
having score line on both sides.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy - generalised tonic-clonic and partial seizures.
Note: Carbamazepine is not usually effective in absences (petit mal)
and myoclonic
seizures.
Moreover, anecdotal evidence suggests that seizure exacerbation may
occur in
patients with atypical absences.
The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Before deciding to initiate treatment, patients of Han Chinese and
Thai origin should
whenever possible be screened for HLA-B*1502 as this allele strongly
predicts the
risk of severe carbamazepine-associated Stevens-Johnson syndrome (See
information
on genetic testings and cutaneous reactions in section 4.4).
EPILEPSY:
The dose of carbamazepine should be adjusted to the needs of the
individual patient
to achieve adequate control of seizures. Determination of plasma
levels may help in
establishing the optimum dosage. In the treatment of epilepsy, the
dose of
carbamazepine usually requires total plasma-carbamazepine
concentrations of about 4
to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and
precautions).
_Adults: _
It is advised that with all formulations of carbamazepine, a gradually
increasing
dosage scheme is used and this should be adjusted to suit the needs of
the individual
patient.
Carbamazepine should be taken in a number of divided doses although
initially 100-
200mg once or twice daily is recommended. This may