Carbamazepine 100mg/5ml oral suspension sugar free

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Carbamazepine

Beschikbaar vanaf:

Sun Pharma UK Ltd

ATC-code:

N03AF01

INN (Algemene Internationale Benaming):

Carbamazepine

Dosering:

20mg/1ml

farmaceutische vorm:

Oral suspension

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Caution - AMP level prescribing advised

Product samenvatting:

BNF: 04080100; GTIN: 5060011720002

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBAMAZEPINE SUN 100 MG/5 ML ORAL SUSPENSION
carbamazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, please 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 SUN is and what it is used for
2.
What you need to know before you take Carbamazepine SUN
3.
How to take Carbamazepine SUN
4.
Possible side effects
5.
How to store Carbamazepine SUN
6.
Contents of the pack and other information
1.
WHAT CARBAMAZEPINE SUN IS AND WHAT IT IS USED FOR
Carbamazepine SUN is a pale orange suspension that contains
carbamazepine, the active ingredient.
Carbamazepine SUN is an anti-convulsant medicine (prevents fits), it
can also modify some types of pain and
can control mood disorders.
Carbamazepine SUN 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 SUN
DO NOT TAKE CARBAMAZEPINE SUN
-
if you are allergic to carbamazepine or similar drugs such as
oxcarbazepine (Trileptal), or to any of a related
group of drugs known as tricyclic antidepressants (such as
amitriptyline or imipramine) or any of the other
ingredients of this medicine (listed in section 6). If you are
allergic to carbamazepine there is a one in four
(25%) chance that you could also have an allergic reaction to
oxcarbazepine
-
if you have any heart problems
-
if you have ever had problems with your bone marrow
-
if you have a blood disorder called p

Productkenmerken

OBJECT 1
CARBAMAZEPINE 100 MG/5 ML ORAL SUSPENSION
Summary of Product Characteristics Updated 04-Sep-2017 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Carbamazepine SUN 100 mg/5 ml Oral Suspension
2. Qualitative and quantitative composition
Each 5 ml of the oral suspension contains 100 mg carbamazepine.
Excipients with known effect:
Sorbitol (E420) and orange yellow S
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral suspension.
An orange to pale orange suspension.
4. Clinical particulars
4.1 Therapeutic indications
Carbamazepine is indicated for
- 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
- the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium therapy.
4.2 Posology and method of administration
POSOLOGY
Since a given dose of carbamazepine oral suspension will produce
higher peak levels than the same dose
in tablet form, it is advisable to start with low doses of the liquid
and to increase them slowly so as to
avoid adverse effects on the central nervous system such as dizziness
and lethargy.
When switching a patient from tablets to liquid the same overall dose
may be used but in smaller, more
frequent, doses.
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