Clomipramine 25

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Malta Medicines Authority

Ակտիվ բաղադրիչ:

CLOMIPRAMINE HYDROCHLORIDE

Հասանելի է:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC կոդը:

N06AA04

INN (Միջազգային անվանումը):

CLOMIPRAMINE HYDROCHLORIDE 25 mg

Դեղագործական ձեւ:

FILM-COATED TABLET

Կազմը:

CLOMIPRAMINE HYDROCHLORIDE 25 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

PSYCHOANALEPTICS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2006-11-23

Տեղեկատվական թերթիկ

Page 1 of 5
PATIENT INFORMATION LEAFLET
CLOMIPRAMINE 25 Film-coated tablets 25 mg
WHAT YOU NEED TO KNOW ABOUT CLOMIPRAMINE TABLETS
Please read this leaflet carefully before you start to use your
medicine. It contains important
information.
WHAT’S IN YOUR MEDICINE?
Clomipramine
tablets
contain
clomipramine
hydrochloride.
This
is
one
of
a
group
of
medicines called antidepressants. The tablets come in one strengths
containing 10 mg
clomipramine.
CLOMIPRAMINE TABLETS ALSO CONTAIN THE FOLLOWING INACTIVE INGREDIENTS:
Microcrystalline
Cellulose, Povidone, Maize Starch, Lactose, Sodium Starch Glycollate,
Colloidal Silicon
Dioxide, Magnesium Stearate, Talc, Hypromellose, Titanium Dioxide,
Macrogol 400, Red
Ferric Oxide E172.
CLOMIPRAMINE 25: This product is available in pack-sizes of 20, 100
and 1000 tablets.
NOT ALL PACK-SIZES MAY BE MARKETED.
MARKETING LICENCE HOLDER & MANUFACTURER:
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.
HOW DOES YOUR MEDICINE WORK?
Clomipramine is a tricyclic antidepressant. It is thought to work by
increasing the amount or
prolonging the effect of chemical “messengers” in the brain.
WHAT THIS MEDICINE IS USED FOR
Clomipramine is used to treat depression, obsessions and phobias, and
muscular weakness
(cataplexy) associated with recurrent attacks of extreme sleepiness
(narcolepsy).
BEFORE TAKING YOUR MEDICINE, ASK YOURSELF THE FOLLOWING QUESTIONS:
-Are you allergic to clomipramine or to any of the other ingredients
of Clomipramine?
-Have you ever had a rash or other possible allergic reaction whilst
taking any other
antidepressants?
-Are you pregnant or trying to become pregnant?
-Are you breast-feeding?
-Have you had a heart attack within the last 3 months?
-Do you suffer from any serious heart or liver disease?
-Do you suffer from any mental illness other than depression,
obsessions or phobias?
-Are you thinking about suicide?
-Do you suffer from glaucoma (increased eye pressure)?
-Do you have difficulty in passing urine?
-Are you taking, or have you taken within the las

Ապրանքի հատկությունները

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Clomipramine 25
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clomipramine 25: Each tablet contains 25mg of Clomipramine
Hydrochloride
3. PHARMACEUTICAL FORM
Film-Coated Tablets
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
In the management of endogenous depression including manic depression,
periodic and
involutional depression, reactive and neurotic depression, obsessional
and phobic states and
as an adjunctive treatment of 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 serotonergic toxicity, adherence to
the recommended doses
of Clomipramine is advised and any increase in dose should be made
with caution if other
Page 2 of 18
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).
Adults:
Depression:
The usual daily dosage is in the range of 30 to 75mg in single or
divided doses. Initial dosage
should be 10mg/day with gradual increments to 30-150mg/day in divided
doses or as a single
dose at bedtime. Dosage may exceed the stated range if necessary up to
a maximum of
250mg.
Obsessional/phobic states:
Doses in the higher range are generally required.
Adjunctive treatment of cataplexy associated with narcolepsy:
Initially 10mg, increasing to 50mg daily. Control of cataplexy should
be achieved within 24
hours of reaching o