Anafranil 25mg Capsules

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Clomipramine hydrochloride

Dostupné z:

Novartis Pharmaceuticals UK Ltd

ATC kód:

N06AA; N06AA04

INN (Medzinárodný Name):

Clomipramine hydrochloride

Dávkovanie:

25 milligram(s)

Forma lieku:

Capsule

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Non-selective monoamine reuptake inhibitors; clomipramine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1978-04-01

Príbalový leták

Package leaflet: Information for the user
ANAFRANIL
® 10MG CAPSULES
ANAFRANIL
® 25MG CAPSULES
ANAFRANIL
® 50MG CAPSULES
CLOMIPRAMINE HYDROCHLORIDE
This medicine will be referred to as Anafranil in this leaflet.
READ ALL OF THIS INFORMATION CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have 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 symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET
1. What Anafranil is and what it is used
for……………………………………………….......
2
2. What you need to know before you take
Anafranil…………………………………………………………………..
3
3. How to take
Anafranil…………………………………………………………………........
5
4. Possible side
effects………………………………………………………………………....
6
5. How to store
Anafranil……………………………………………………………………...
8
6. Further
information……………………………………………………………………….....
8
1
WHAT ANAFRANIL IS AND WHAT IT IS USED FOR
Anafranil contains a medicine called clomipramine hydrochloride. This
belongs to a group of medicines called
“tricyclic
antidepressants”.
Anafranil
is
thought
to
work
either
by
increasing
the
amount
of
chemical
“messengers” in the brain or by making their effects last longer.
Anafranil is used to treat depression, obsessions and phobias
(irrational fears). It is also used to treat muscular
weakness (cataplexy) associated with repeat attacks of extreme
sleepiness (narcolepsy) in adults.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANAFRANIL
DO NOT

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anafranil 25mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25mg clomipramine hydrochloride.
Also contains lactose monohydrate, 123.0mg per capsule
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
Size No. 4, opaque hard gelatin capsules with a caramel cap and a
brownish-orange body, imprinted with the ‘GEIGY’
logo and containing a white powder.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before initiating treatment with Anafranil, 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
Anafranil 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).
The dosage should be adapted to the individual patient’s condition.
The aim is to achieve an optimum effect while
keeping the doses as low as possible and increasing them cautiously.
After a response has been obtained, maintenance
therapy should be continued at the optimum dose to avoid relapse.
Patients with a history of recurrent depression
require maintenance treatment for a longer duration. Duration of
maintenance treatment and need for further treatment
should be reviewed periodically.
Abrupt discontinuation of Anafranil therapy should be avoided because
of possible withdrawal symptoms. Therefore,
dosage should be stopped gradually after regular use for long duration
and the patient should be monitored ca