Clomipramine 10mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Clomipramine hydrochloride

Saadav alates:

A A H Pharmaceuticals Ltd

ATC kood:

N06AA04

INN (Rahvusvaheline Nimetus):

Clomipramine hydrochloride

Annus:

10mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04030100; GTIN: 5025903003434

Infovoldik

Pharma code 546
BLACK
PANTONE® GREEN C
ZINC Ref:
EAS4843A LEA CLOMIPRAMINE 10MG 25MG 50MG CAP TUK
27 APRIL 2020
Version:
1
Colours Used:
Length:
Width:
Depth:
323 MM
210 MM
-
TEMPLATE
UK & Ireland Artwork Department
CLOMIPRAMINE 10 MG, 25 MG AND 50 MG CAPSULES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others.
It may harm them, even if their symptoms 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.
1. WHAT CLOMIPRAMINE IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE CLOMIPRAMINE
3. HOW TO TAKE CLOMIPRAMINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CLOMIPRAMINE
6. FURTHER INFORMATION
WHAT CLOMIPRAMINE IS AND WHAT IT IS USED FOR
Clomipramine belongs to a group of drugs called tricyclic
antidepressants.
Clomipramine is used:
•
to treat depression
•
to treat phobias and obsessive states
•
to treat cataplexy (collapse) associated with narcolepsy (a sleep
disorder).
BEFORE YOU TAKE CLOMIPRAMINE
DO NOT TAKE CLOMIPRAMINE IF YOU:
•
are allergic (hypersensitive) to clomipramine hydrochloride, tricyclic
antidepressants or any of the other ingredients of this medicine
•
have severe liver problems
•
have recently had a heart attack or you suffer from any other heart
problems
•
have difficulty in passing urine
•
have narrow angle glaucoma (loss of vision due to abnormally high
pressure in the eye)
•
suffer from mania (a mood disorder characterised by high levels of
excitement and activity)
•
are taking, or have taken within the last three weeks a medicine for
depression called a monoamine oxidase inhibitor (MAOI)
•
you are aged under 18.
TAKE SPECIAL CARE WITH CLOMIPRAMINE
Tell your doctor before you start to take this medicine if you:
•
suffer from epileptic fits

Toote omadused

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