Clomipramine 25mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Clomipramine hydrochloride

Mevcut itibaren:

Sigma Pharmaceuticals Plc

ATC kodu:

N06AA04

INN (International Adı):

Clomipramine hydrochloride

Doz:

25mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04030100

Bilgilendirme broşürü

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
•
have brain damage
•
had a brain injury
•
have irregular heartbeat or other problems with
your heart
•
have you been diagnosed as having a low level of
potassium in your blood
•
have a blood disorder
•
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Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clomipramine 25 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg clomipramine hydrochloride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Size 4 gelatin capsule, brown cap and orange body. Printed '1807'.
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