Tranylcypromine 10mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Tranylcypromine sulfate

Fáanlegur frá:

Alliance Healthcare (Distribution) Ltd

ATC númer:

N06AF04

INN (Alþjóðlegt nafn):

Tranylcypromine sulfate

Skammtar:

10mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04030200

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANYLCYPROMINE 10MG TABLETS
(tranylcypromine sulphate)
The name of your medicine is Tranylcypromine 10mg Tablets but will be
referred to as Tranylcypromine Tablets throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Tranylcypromine Tablets are and what they are used for
2. What you need to know before you take Tranylcypromine Tablets
3. How to take Tranylcypromine Tablets
4. Possible side effects
5. How to store Tranylcypromine Tablets
6. Contents of the pack and other information
1. WHAT TRANYLCYPROMINE TABLETS ARE AND WHAT THEY ARE USED FOR
Tranylcypromine Tablets contains the active substance 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.
This medicine is used to treat moderate to severe depression in
adults. 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 TRANYLCYPROMINE TABLETS
DO NOT TAKE TRANYLCYPROMINE TABLETS IF:
•
you are allergic to tranylcypromine or any of the other ingredients of
this medicine (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 take them within the next three weeks
•
you suffer from porphyria (which is an inherited disease affecting
the nervous system and skin)
•
you have severe heart disease or any disease of the blood vessels
of the brain
•
you have pheochromocytoma which is a tumour of the adrenal
glands (glands near the kidneys) causing high blood pressure
•
you have been diagnosed with an overactive thyroid gland (a gland
in the neck)
•
you have known

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Parnate 10mg Tablets
Tranylcypromine 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains tranylcypromine sulfate equivalent to 10mg of
tranylcypromine base.
Excipients with known effect:
3.2mg of Ponceau 4R (E124) and 55.04mg of sucrose per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet.
Geranium red coloured, bi-convex, sugar-coated tablets.
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 `parnate' 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:
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
Tranylcypromine 10mg Tablets/ Parnate 10mg Tablets are for oral
administration only. Tablets should be swallowed whole with a 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 stopping
treatment
with other MAOIs.
Allow
3
weeks
to