Parnate 10 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRANYLCYPROMINE SULFATE

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

N06AF; N06AF04

INN (International Name):

TRANYLCYPROMINE SULFATE

Dosage:

10 Base Milligrams

Pharmaceutical form:

Coated tablet

Prescription type:

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

Therapeutic area:

Monoamine oxidase inhibitors, non-selective; tranylcypromine

Authorization status:

Not marketed

Authorization date:

1978-04-01

Patient Information leaflet

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,
pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet (See section 4).
WHAT IS IN THIS LEAFLET
1. What Parnate tablets are and what they are used for
2. What you need to know before you take Parnate
3. How to take Parnate Tablets
4. Possible side effects
5. How to store Parnate Tablets
6. Contents of the pack and other information
1. WHAT PARNATE TABLETS ARE AND WHAT THEY
ARE USED FOR
Parnate 10mg Tablets will be referred to as Parnate or
Parnate Tablets throughout this leaflet.
Parnate Tablets contain the active substance called
tranylcypromine
which
belongs
to
a
group
of
antidepressant
medicines
known
as
monoamine
oxidase inhibitors (MAOIs). It works by stopping the
breakdown of two substances in the brain called
serotonin and noradrenaline. Your medicine should help
bring these substances back to normal levels.
Parnate tablets are used to treat moderate to severe
depression in adults. These tablets are not suitable for
use in situations which make someone feel slightly
depressed or apprehensive. It can also help you if you
are having feelings of fear (phobia) which sometimes
occurs in depression. This medicine is often used when
other types of antidepressant medicines have not worked.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PARNATE
DO NOT TAKE PARNATE IF
•you are allergic to tranylcypromine or any of the other
ingredients of Parnate (listed in section 6)
•you are taking other MAOIs or have taken other MAOIs
within the last two weeks
•you have taken clomipramine or imipramine within the
last three weeks or are planning to tak

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Parnate 10 mg coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 10 mg tranylcypromine as tranylcypromine
sulphate.
Excipients: contains 3.2 mg Ponceau 4R (E124) and 55.04 mg of sucrose
per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
Geranium-red coloured, biconvex, sugar -coated tablets marked
‘FW251’ on one side only.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tranylcypromine is a non-hydrazine monoamine oxidase inhibitor for the
treatment of symptoms of depressive illness
especially where phobic symptoms are present or where treatment with
other types of anti-depressants has failed. It is
not recommended for mild depressive states resulting from temporary
situational difficulties.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults_
Initially, 1 tablet morning and afternoon. If the response is not
adequate after the first week add a further tablet at
midday, and continue for at least a week. A dosage of 3 tablets a day
should only be exceeded with caution. When a
satisfactory response has been obtained, dosage may be reduced to
maintenance level often of 1 tablet a day.
When given with a tranquillizer, the dosage of ‘tranylcypromine’
is not affected when given concurrently with
electroconvulsive therapy; the usual dosage is 1 tablet twice a day
during the series and 1 tablet a day afterwards as
maintenance therapy.
Elderly (over 65 years):
Use with great caution and at a lower dosage
_Paediatric population:_
Tranylcypromine is not indicated for children under 18 years of age.
Method of administration:
Parnate 10mg Tablets are for oral administration only.
The coated tablets should be taken with some liquid (preferably with
half a glass to a full glass of water).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Do not give tranylcypromine until at least two weeks after stop