Isocarboxazid 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isocarboxazid

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N06AF01

INN (International Name):

Isocarboxazid

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOCARBOXAZID TABLETS 10MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Isocarboxazid tablets are and what they are used for
2.
What you need to know before you take Isocarboxazid tablets
3.
How to take Isocarboxazid tablets
4.
Possible side effects
5.
How to store Isocarboxazid tablets
6.
Contents of the pack and other information
1. WHAT ISOCARBOXAZID TABLETS ARE AND WHAT THEY ARE USED FOR
Isocarboxazid is one of the group of medicines known as Monoamine
Oxidase Inhibitors (MAOIs). These are
drugs that block the action of a substance called monoamine oxidase
which is present in the brain and which
plays an important part in controlling mood.
Isocarboxazid tablets are used in the treatment of depression.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOCARBOXAZID TABLETS
DO NOT TAKE THESE TABLETS IF:
•
You are allergic to Isocarboxazid or any of the other ingredients of
this medicine (listed in section 6).
•
You have severe heart disease or any disease of the blood vessels of
the brain
•
You have phaeochromocytoma which is a tumour of the adrenal glands
causing high blood pressure
•
You have known liver damage
•
You are taking any medications for the treatment of depression and/or
anxiety.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking these tablets if you:
•
are elderly or in a weak state of health
•
have any sort of heart problem
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isocarboxazid Tablets 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Isocarboxazid
.
Excipient(s) with known effect
Each tablet contains 100mg Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the symptoms of depressive illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Isocarboxazid Tablets are for oral administration.
Adults
A daily dose of 30mg, in single or divided doses, should be given
until
improvement is obtained. The maximal effect is only observed after a
period
varying from 1 - 4 weeks. If no improvement has been seen by 4 weeks,
doses
up to 60mg may be tried, according to the patient’s tolerance, for
no longer
than 4 - 6 weeks, provided the patient is closely monitored because of
the
increased risk of adverse reactions occurring.
Once the optimal effect is achieved, the dose should be reduced to the
lowest
possible amount sufficient to maintain the improvement. Clinical
experience
has shown this to be usually 10 - 20mg daily but up to 40mg daily may
be
required in some cases.
The elderly
The elderly are more likely to experience adverse reactions such as
agitation,
confusion and postural hypotension. Half the normal maintenance dose
may
be sufficient to produce a satisfactory clinical response.
Children
Isocarboxazid Tablets are not indicated for paediatric use.
4.3
CONTRAINDICATIONS
Isocarboxazid is contra-indicated in patients with any impairment of
hepatic function,
cerebrovascular disorders or severe cardiovascular disease, and in
those with actual or
suspected phaeochromocytoma.
Selective serotonin reuptake inhibitors (SSRIs): Cases of serious and
sometimes fatal
reactions (serotonin syndrome) have been reported in patients
receiving monoamine
oxidase inhibitors (MAOIs) in combination with SSRIs, and in patients
who have
recently discontinued an SSRI and have been started on a MAOI.
Treatment w