Clobazam 10mg/5ml oral suspension sugar free

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Clobazam

Tilgjengelig fra:

Thame Laboratories Ltd

ATC-kode:

N05BA09

INN (International Name):

Clobazam

Dosering :

2mg/1ml

Legemiddelform:

Oral suspension

Administreringsrute:

Oral

Klasse:

Schedule 4 (CD Benz)

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04080100; GTIN: 5055935100481

Informasjon til brukeren

Package Leaflet: Information for the user
CLOBAZAM THAME 5MG/5ML ORAL SUSPENSION
CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION
(clobazam)
TURN OVER
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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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 of the side effects, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
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Medicines for epilepsy (such as phenytoin,
carbamazepine, stiripentol or valproic
acid).
Medicines for depression (Monoamine
Oxidase Inhibitors (MAOIs) such as
phenelzine and isocarboxazid or tricyclic
anti-depressants - such as trazodone) or
Selective Serotonin Re-uptake Inhibitors
(SSRIs) such as fluvoxamine or
paroxetine.

Medicines for severe mental illness called
‘antipsychotics’ (such as chlorpromazine,
haloperidol, clozapine and pimozide).
Painkillers (such as medicines containing
codeine, dihydrocodeine or morphine).
Sleeping tablets (such as zolpidem).
Tranquilisers (such as diazepam,
temazepam or lorazepam).
Muscle relaxants (such as baclofen).
Antihistamines that make you sleepy
(such as chlorphenamine, promethazine
or diphenenhydramine).
Lithium - used for a mental illness called
‘manic-depressive illness’ (mood changes
between a state of high excitability or
exaggerated emotions and depression).
Cimetidine - used to treat ulcers and
heartburn.
Omeprazole – used to treat the symptoms
of acid reflux such as heartburn or acid
regurgitation.
Ticlopidine – an antiplatelet medication
used in patients with an increased risk of
stroke.
Fluconazole – used in the treatment of
fungal conditions.
Dextromethorphan – used to relieve dry,
irritating cou

Preparatomtale

OBJECT 1
CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 20-Jun-2018 | Thame
Laboratories
1. Name of the medicinal product
Clobazam Thame 10mg/5ml Oral Suspension
2. Qualitative and quantitative composition
The active substance is clobazam.
Each 5ml of oral suspension contains 10mg clobazam.
_Excipients with known effect: _
Each 5ml of oral suspension contains 7.5mg of methyl
parahydroxybenzoate (E218), 10mg sucralose
(E955) and 2.24mg of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Suspension
White to off-white viscous suspension.
4. Clinical particulars
4.1 Therapeutic indications
Clobazam is a 1,5-benzodiazepine indicated for the short-term relief
(2-4 weeks) only of anxiety that is
severe, disabling or subjecting the individual to unacceptable
distress, occurring alone or in association
with insomnia or short term psychosomatic, organic or psychotic
illness. The use of clobazam to treat
short-term “mild” anxiety is inappropriate and unsuitable.
Before treatment of anxiety states associated with emotional
instability, it must first be determined
whether the patient suffers from a depressive disorder requiring
adjunctive or different treatment. Indeed,
in patients with anxiety associated with depression, clobazam must be
used only in conjunction with
adequate concomitant treatment. Use of benzodiazepine (such as
clobazam) alone, can precipitate suicide
in such patients.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazepines is recommended only
for adjunctive, i.e. not for primary treatment.
Clobazam may be used as adjunctive therapy in epilepsy.
4.2 Posology and method of administration
Posology
Treatment of anxiety
The usual anxiolytic dose for adults is 20-30mg daily in divided doses
or as a single dose given at night.
Doses up to 60mg daily have been used in the treatment of adult
in-patients with severe anxiety.
The lowest dose that can control symptoms should be used. After
improvement of the sympto