Clomipramine 10mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Clomipramine hydrochloride

Διαθέσιμο από:

Sigma Pharmaceuticals Plc

Φαρμακολογική κατηγορία (ATC):

N06AA04

INN (Διεθνής Όνομα):

Clomipramine hydrochloride

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030100

Φύλλο οδηγιών χρήσης

PHOBIAS AND OBSESSIVE STATES
•
Adults: initially 25 mg a day which may be gradually increased if
necessary.
•
Elderly: initially 10 mg a day which may be gradually increased if
necessary.
This medicine may take up to 4 weeks to work. You may feel more
anxious
at the start of treatment but this will normally decrease after
two weeks.
CATAPLEXY ASSOCIATED WITH NARCOLEPSY
•
Adults (including the elderly): Initially, 10 mg a day which may be
gradually increased if necessary, to between 10-75 mg a day.
Children and adolescents (0-17 years of age):
Clomipramine is not recommended for use in children and adolescents.
IF YOU TAKE MORE CLOMIPRAMINE THAN YOU SHOULD
If you (or someone else) take too many capsules all together, or if
you
think a child has swallowed any of the capsules, contact your nearest
hospital casualty department or your doctor immediately. An overdose
is likely to cause drowsiness, stupor, coma, difficulty in controlling
movements, agitation, enhanced reflexes, restlessness, fits, muscular
rigidity, involuntary jerky movements, shock, low blood pressure, a
fast or abnormal heart rate, vomiting, fever, dilated pupils,
breathing
problems, sweating, blue colour to the skin, passing little or no
urine.
Please take this leaflet, any remaining capsules and the container
with
you to the hospital or doctor so that they know which capsules were
consumed.
IF YOU FORGET TO TAKE CLOMIPRAMINE
If you forget to take a capsule, take one as soon as you remember,
unless
it is nearly time to take the next one. Do not take a double dose to
make
up for a forgotten dose. Take the remaining doses at the correct time.
IF YOU STOP TAKING CLOMIPRAMINE
Do not stop taking Clomipramine suddenly because this may cause
withdrawal side effects. If the decision is made by your doctor to
discontinue treatment, the dose you receive will be cut down gradually
to prevent the development of withdrawal symptoms. You may get
these side effects if you stop taking Clomipramine suddenly: feeling
or
being sick, stomach ache, diarrhoea, hea

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clomipramine 10 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg clomipramine hydrochloride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Size 4 gelatin capsule, brown cap and yellow body. Printed '1806'.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clomipramine capsules are indicated for the symptoms of depressive
illness, especially
where sedation is required, and obsessive and phobic states.
Clomipramine capsules are also indicated for cataplexy associated with
narcolepsy.
CHILDREN AND ADOLESCENTS
In children and adolescents, there is not sufficient evidence of
safety and efficacy of
clomipramine in the treatment of depressive states, phobias and
cataplexy associated
with narcolepsy. The use of clomipramine in children and adolescents
(0-17 years of
age) in these indications is therefore not recommended (see section
4.4 Special
Warnings and Precautions for use).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Before initiating treatment with clomipramine, hypokalemia should be
treated (see
4.4. Special Warnings and Precautions for use).
As a precaution against possible QTc prolongation and serotonergic
toxicity,
adherence to the recommended doses of clomipramine is advised and any
increase in
dose should be made with caution if other serotonergic agents are
co-administered
(see sections 4.4 Special Warnings and Precautions for use and 4.5
Interaction with
other Medicinal Products and other forms of Interaction).
DEPRESSION
_Adults_
Initially 10 mg daily, increasing gradually to 30 - 150 mg daily if
required, in divided
doses throughout the day, or as a single dose at bedtime. In most
patients the adequate
maintenance dose is 30 - 50 mg daily, although some patients may
require higher doses,
particularly those suffering from obsessional or phobic disorders. In
severe cases the
dosage may be increased up to 250 mg per day. Once a distinct
improvement has set in,
the daily dosage may be adjusted