Anafranil SR 75 mg Prolonged-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clomipramine hydrochloride

Available from:

zr pharma& GmbH

ATC code:

N06AA; N06AA04

INN (International Name):

Clomipramine hydrochloride

Dosage:

75 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Non-selective monoamine reuptake inhibitors; clomipramine

Authorization status:

Marketed

Authorization date:

1988-09-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANAFRANIL
® SR 75 MG PROLONGED RELEASE TABLETS
Clomipramine hydrochloride
READ ALL OF THIS LEAFLET 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 any 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 signs of illness 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.
WHAT IS IN THIS LEAFLET
1.
What Anafranil is and what it is used for
2.
Before you take Anafranil
3.
How to take Anafranil
4.
Possible side effects
5.
How to store Anafranil
6.
Contents of the pack and other information
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 TAKE ANAFRANIL IF:
−
you are allergic (hypersensitive) to clomipramine or any of the other
ingredients of Anafranil
(listed in Section 6 below)
−
you have ever had a rash or other allergic reaction to any other
antidepressants
−
you have had a heart attack within the last 3 months
−
you have any serious heart disease
−
you have any serious liver disease
−
you have any other mental illness apart from depression, obsessions or
phobias
−
you have glaucoma (increased eye pressure)
−
you have difficulty in passing urine
−
you are pregna

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DW42
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anafranil SR 75 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg clomipramine hydrochloride.
Excipient with known effect
Each tablet contains 235 micrograms polyoxyl hydrogenated castor oil.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release, film-coated tablet.
Pink, capsule shaped, biconvex, film-coated tablet, scored on both
sides. One side debossed with 'CG' and the other 'GD'.
The tablets should not be broken.
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 avoid