Gamanil 70mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
16-10-2020
Summary of Product characteristics
(SPC)
30-07-2019
Active ingredient:
Lofepramine hydrochloride
Available from:
Creo Pharma Limited
ATC code:
N06AA; N06AA07
INN (International Name):
Lofepramine hydrochloride
Dosage:
70 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Non-selective monoamine reuptake inhibitors; lofepramine
Authorization status:
Marketed
Authorization date:
1984-05-14
Patient Information leaflet
1
Package leaflet: Information for the user
GAMANIL 70MG FILM-COATED TABLETS
lofepramine (as 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 Gamanil is and what it is used for
2. What you need to know before you take Gamanil
3. How to take Gamanil
4. Possible side effects
5. How to store Gamanil
6. Contents of the pack and other information
1. WHAT GAMANIL IS AND WHAT IT IS USED FOR
Gamanil belongs to a group of medicines called tricyclic
antidepressants.
Gamanil is used to treat symptoms of depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAMANIL
DO NOT TAKE GAMANIL IF YOU:
are allergic to lofepramine or any of the other ingredients of this
medicine (listed in section 6)
are allergic to other tricyclic antidepressants such as clomipramine
and imipramine
suffer from any mental illness other than depression (known as mania)
have serious liver or kidney problems
suffer from any serious heart problems, including irregular heart
rhythms or have recently had a heart
attack
have untreated glaucoma (raised pressure of the fluid inside the eye)
suffer from prostate problems with urinary retention
suffer from chronic constipation
are currently suffering from alcohol or drug poisoning or deliria
are taking medicines to treat depression known as
MONOAMINE OXIDASE INHIBITORS (MAOIS)
such as
phenelzine and iproniazid or you have taken MAOIs within the last 14
days
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gamani
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
29 July 2019
CRN0090YL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gamanil 70mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lofepramine hydrochloride 76.10mg
equivalent to 70.0mg lofepramine.
Excipient(s) with known effect
Each tablet contains 126.05mg lactose (as lactose monohydrate) and
1.15mg Ponceau 4R Red Aluminium Lake (E124).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, lacquered, brown-violet tablet, with occasional white dots,
with a spindle shaped score line on one side, approximately
10 mm in diameter.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gamanil 70mg film-coated tablets are indicated for the treatment of
symptoms of depressive illness. This includes
depression/anxiety states associated with panic disorder features.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ The usual dose is 70mg twice daily (140mg) or three times
daily (210mg) depending on the patient’s response. The daily
dose should always be given in divided doses not exceeding 70mg per
dose.
In the treatment of depression/anxiety states associated with panic
disorder features, the initial dosage should be 70mg daily
for the first week.
_Elderly patients: _Elderly patients may respond to lower doses in
some cases.
_Paediatric population: _The safety and efficacy of Gamanil in
children under 18 years of age have not been established. No data
are available. The use of Gamanil is not recommended in children and
adolescents under the age of 18.
Method of administration
Gamanil 70mg film-coated tablets are for oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Gamanil must not be used in patients hypersensitive to dibenzazepines.
Gamanil must not be used in patients:
He
Read the complete document
