Skip to Content

UK Edition. Click here for US version.

TRANYLCYPROMINE 10 MG COATED TABLETS

Active substance(s): TRANYLCYPROMINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET

Parnate® 10mg Coated Tablets

Revision Date: 23.02.2016
Leaflet Reference: TRAN10

(tranylcypromine)
Your medicine is known by the above name, but will be referred to as

suffer from low blood pressure or high blood pressure
Parnate® 10mg Tablets throughout this leaflet.

suffer from schizophrenia

have a history of dependence on drugs or alcohol.
Even though some of the above may be obvious, it is important that
Read all of this leaflet carefully before you start taking this
your doctor is aware if any of them apply to you.
medicine because it contains important
information for you.
If you are depressed and/or have anxiety disorders, you can
Keep this leaflet. You may need to read it again.
sometimes have thoughts of harming or killing yourself (see section 4
If you have any further questions, ask your doctor or pharmacist.
‘Possible side effects’). These may be increased when first starting
This medicine has been prescribed for you. Do not pass it on to others.
antidepressants, since these medicines all take time to work, usually
It may harm them, even if their signs of illness are the same as yours.
about two weeks but sometimes longer.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You may be more likely to think like this if you:

have previously had thoughts about killing or harming yourself.

are a young adult.
What is in this leaflet:
1. What Parnate® 10mg Tablets are and what they are used for
If you have thoughts of harming or killing yourself, at any time, contact
2. What you need to know before you take Parnate®10mg Tablets
your doctor or go to a hospital straight away. You may find it helpful to
3. How to take Parnate®10mg Tablets
tell a relative or close friend that you are depressed or have an anxiety
4. Possible side effects
disorder, and ask them to read this leaflet. You might ask them to tell
5. How to store Parnate®10mg Tablets
you if they think your depression or anxiety is getting worse, or if they
6. Contents of the pack and other information
are worried about changes in your behaviour.
1. WHAT PARNATE® 10MG TABLETS ARE AND WHAT THEY ARE
USED FOR

Children and adolescents
Tranylcypromine is not recommended for children under 18 years old
(see section 3 ‘Use in children and adolescents’).

®

Parnate 10mg Tablets contain 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. 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.

Other medicines and Parnate® 10mg Tablets
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicines.
Parnate® 10mg Tablets MUST NOT be taken with the following
medicines:

Medicines called sympathomimetic agents - these include
ephedrine, pseudoephedrine, adrenaline and noradrenaline (these
may be found in medicines used to treat heart problems and
asthma as well as some decongestants and cough/cold remedies
e.g. dextromethorphan bought without a prescription)

Bupropion, a medicine to help you stop smoking

Medicines for migraine e.g. 5HT1 agonists

Strong pain killers e.g. pethidine, morphine, codeine and nefopam

It should not be administered at the same time as, or within 14
days of treatment with other MAOIs such as isocarboxid

Medicines used to treat depression (e.g. clomipramine,
imipramine, venlafaxine).

Tranylcypromine should not be administered together with
clomipramine and imipramine. In the cases of clomipramine and
imipramine, 3 weeks should be left before starting tranylcypromine
therapy.

Tranylcypromine should not be administered in combination with
selective serotonin reuptake inhibitors (SSRIs) e.g., fluoxetine or
serotonin/noradrenaline reuptake inhibitors (SNRIs) e.g.
venlafaxine.

Buspirone, used to treat anxiety

Medicines to treat seizures/fits, e.g. carbamazepine

Perphenazine used to treat schizophrenia

Guanethidine used to treat high blood pressure

SSRIs such as fluoxetine, paroxetine or sertaline (for depression)

Medicines like altretamine used for the treatment of cancer

Doxapram used to increase the rate of breathing, especially during
surgery

Medicines like oxypertin, clozapine used for the treatment of
mental disorders like schizophrenia

Tetrabenazine used for the treatment of excessive restlessness.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARNATE®
10MG TABLETS
Do not take Parnate®10mg Tablets if:
You are allergic to tranylcypromine or any of the other ingredients
of this medicine (listed in section 6).

You are taking clomipramine, imipramine and venlafaxine. You
should wait three weeks before starting tranylcypromine after
stopping treatment with clomipramine, imipramine and venlafaxine.

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 known liver damage or a disorder affecting the blood
cells (your doctor will know)

You are pregnant, trying to become pregnant or breast-feeding.

You suffer from a mental health disorder and are in a manic phase.

You are taking any of the medicines listed under Other Medicines
and Parnate® 10mg Tablets.


You should also avoid certain drugs called guanethidine (used for high
blood pressure), dextromethorphan (cough suppressant), alcohol or
narcotic analgesics or pain killers (morphine or pethidine).
Warnings and precautions

Parnate® 10mg Tablets must be taken with caution if you are
taking the following medicines:

Talk to your doctor or pharmacist before taking this medicine if
you:









4

are elderly
have a mild heart problem which restricts your activity
suffer from seizures/fits (epilepsy)
suffer from diabetes mellitus (sugar diabetes)
suffer from blood disorders
taking diuretics (water tablets)
are due to have surgery in the next few weeks (including dental
surgery)
have depression, feeling low or have suicidal thoughts







1

Barbiturates used to treat severe sleeping problems, e.g.
amylobarbitone
Medicines used to treat depression (e.g. amitriptyline, imipramine,
tryptophan, amfebutamone)
Phenylpropanolamine used to treat nasal congestion associate
with allergies
Medicines for high blood pressure (e.g. reserpine, methyldopa)
Medicines to control appetite, e.g. amphetamine and fenfluramine

When you start to feel better, your doctor may change your dose to
one tablet a day.
Do NOT take more than three tablets each day unless your doctor tells
you.

Antimuscarinics for motion sickness, muscle cramps in the gut or
bladder

Medicines that treat Parkinson’s disease, e.g. levodopa

Dopamine, a medicine used to treat certain heart conditions

Local anaesthetics e.g. lidocaine

Medicines to treat diabetes (e.g. insulin, metformin).
At least 5 weeks should be allowed after stopping fluoxetine before
starting Parnate® 10mg Tablets.
At least 2 weeks should be allowed after stopping paroxetine before
starting Parnate® 10mg Tablets.


Use in children and adolescents
Tranylcypromine Tablets are not recommended for children under 18
years old.
If you take more Parnate® 10mg Tablets than you should:
If you think that you, or any other person, have taken too many tablets,
contact your doctor or hospital casualty department immediately. Take
any remaining tablets and this leaflet with you so that the medical staff
know exactly what you have taken.

Taking Parnate® 10mg Tablets with food and drink
You should NOT take alcohol (especially red wine) whilst you are
taking Parnate® 10mg Tablets. This includes non-alcoholic beer or
lager.
Parnate® 10mg Tablets stops the breakdown of a substance called
tyramine which is found in large amounts of certain foods. If this
substance is not broken down, it can cause very high blood pressure.
So, whilst you are taking Parnate® 10mg Tablets, you should avoid the
following foods:

Matured cheeses – cooked or plain (e.g. cheddar or processed
cheese made from mature cheese)

Yeast extracts (e.g. Bovril, Oxo, brewer’s yeast or Marmite)

Meat, fish or poultry which is not fresh or has been pickled or aged
e.g. hung game, pickled herrings

Broad bean pods

Flavored textured vegetable protein

Protein foods that are not fresh and whose preparation involved
hydrolysis, fermentation, pickling, hanging, smoking or bacterial
contamination e.g. dry sausage (salami, pepperoni etc.),
fermented soya bean extract, liver, yoghurt

Excessive amounts of chocolate

Excessive amounts of tea or coffee.

If you have accidently taken a very large dose than what has been
prescribed for you, you may experience euphoria and feeling over
excited followed by a coma with low blood pressure or extremely high
blood pressure with bleeding in your brain.
You may experience drowsiness, nausea (feeling sick), vomiting
(being sick), start seeing or feelings things that do not exist, headache,
clammy skin, fainting, fits or tiredness.
®

If you forget to take your Parnate 10mg Tablets:
If you miss a dose, wait until your next dose. Do not take the dose you
have missed. You can then carry on as before. Do not take more than
one dose at a time.
If you stop taking Parnate® 10mg Tablets
Continue to take Parnate® 10mg Tablets even if you no longer feel ill.
DO NOT STOP taking this medicine without talking with your doctor
first, especially if you have taken large doses for a long time.
When the time comes to stop your doctor will probably decrease your
dose gradually as stopping the tablets suddenly may cause ill-effects
such as nausea (feeling sick), vomiting (being sick), sweating, vivid
nightmares, fits, worsening of symptoms and difficulty in sleeping.
Symptoms will usually start 24 to 72 hours after you stop taking this
medicine abruptly.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Parnate® 10mg Tablets should NOT be used during pregnancy or
breast feeding unless your doctor thinks it is essential. This medicine
may pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Additional side effects:
Common:

Blurred vision

Nausea (feeling sick)

Vomiting (being sick)

Dry mouth

Constipation (difficulty in passing stools)

Tiredness

Increase in the level of liver enzymes on examination

Dizziness

Overactive or overresponsive reflexes

Uncontrollable movements of mouth, tongue and limbs

Difficulty sleeping

Difficulty in reaching an orgasm (only in women)

Altered driving ability

A fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting

Muscle twitching or jerking
Uncommon:

Purplish discoloring of the skin

Itching, tingling or pricking of skin,

Rash

Nervousness

Excessive happiness or excitement (euphoria),

Confusion

Difficulty in passing water

Inability to maintain erection

Glaucoma (increased pressure in the eyes)

Irregular heart beat

Weight gain

Increased appetite

Increased levels of salt in the body

Fits

Involuntary eye movements

Changes in the metabolism may occur

Sweating

Feeling jittery

Repetition or echoing of one's own spoken words

Shakiness

Headache

Do not store above 25°C Store in original container in order to protect
from light and moisture. Replace cap tightly after use.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Parnate® 10mg Tablets contain:
Each tablet contains tranylcypromine sulphate equivalent to 10mg of
tranylcypromine base.
Parnate® 10mg Tablets also contain sucrose, maize starch, calcium
sulphate dihydrate (E516), carmellose sodium, magnesium stearate
(E470b). The coating contains gelatin, sucrose, docusate sodium,
purified talc (E553b), light kaolin (E559), calcium carbonate (E170),
ethylcellulose, acacia (E414), carmoisine (E122), ponceau 4R (E124),
maize starch, titanium dioxide (E171), carnauba wax (E903) and edible
ink [shellac, iron oxide black (E172), soya lecithin (E322) and trace
amounts of dimethyl siloxane].
What Parnate® 10mg Tablets look like and contents of the pack
Parnate® 10mg tablets are bi-convex, geranium-red sugar-coated
tablets marked with “FW 251” on one side. The tablets are in white
plastic containers with a cap and a security tag containing a desiccant
cartridge.
Parnate® 10mg Tablets are available in containers of 28 tablets.
Who manufactured your medicine
Parnate® 10mg tablets are manufactured by Dales Pharmaceuticals
Ltd., Snaygill Industrial Estate, Keighly Road, Skipton, North Yorkshire,
BD23 2RW, UK. Procured from within the EU and repackaged by
Product Licence Holder: Beachcourse Limited, 20 Alliance Court,
Alliance Road, London W3 0RB.
PL
16378/0551
Revision date: 23.02.2016
Leaflet reference: PAR10
Parnate® is a registered trade mark of Mercury Pharma Group

Rare:
4. POSSIBLE SIDE EFFECTS

Driving and using machines
®

Like all medicines, Parnate 10mg Tablets can sometimes cause side
effects, although not everybody gets them.
If you eat foods or take medicines which interact with the active
ingredient, tranylcypromine, you may get very high blood pressure (a
hypertensive crisis).
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
If you notice any of the following symptoms, please stop taking your
medicine and see your doctor immediately.

Although very rare, muscle rigidity, fever and irregular body
movements (i.e. neuroleptic malignant syndrome)

Severe problems with the heart and breathing, feeling of a lump in
the throat, increased muscular movements, thought of suicide and
suicidal behaviour early on in treatment or shortly after stopping
treatment.

You may being seeing, hearing, smelling, tasting or feeling things
that don't exist outside their mind or have disorganized speech
(signs of a condition called schizophrenia) (Rare)

You may experience fatigue, weakness, shortness of breath, fever
or you may bleed or bruise easily indicating you may have a blood
disorder (uncommon).

You may experience liver problems (symptoms include yellowing
of the skin and the whites of the eyes). You may get a sore throat
or high fever or become very tired and pale or notice bruises and
nose bleeds.

You may experience lupus-like syndrome seen as joint pain,
swelling, and rashes on face, wrists, hands or maybe extreme
tiredness (uncommon).

Parnate® 10mg Tablets may make you feel drowsy or dizzy or affect
your concentration. You should not drive or use machines when you
first start to take this medicine until you are certain that you are not
getting these side effects. If in any doubt, speak to your doctor before
you drive or use machines.
Important information about some of the ingredients of Parnate®
10mg Tablets
This medicine also contains carmoisine (E122) and Ponceau 4R
(E124) which may cause allergic reactions.
This medicine also contains sucrose (a sugar). If you have been told
by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
If you have an operation or you need to go to the Dentist:
Parnate® 10mg Tablets are not normally taken for two weeks before an
operation or major dentistry.
Check with your doctor or dentist and alert them to your medication.
3. HOW TO TAKE PARNATE® 10MG TABLETS
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a glass of water.
The recommended dose for adults is:

One tablet in the morning and one tablet in the afternoon each day

Try to take the last dose before 3 o’clock in the afternoon

This dose may be increased by your doctor to three tablets a day.
Take the extra tablet at mid-day

If you are elderly your doctor will usually prescribe you a lower
dose.

2

POM


Difficulty in controlling movements

Anxiety
Not known:

Water retention or swelling

Flushing

Agitation

Irritable

Painful or stiff neck

Pain in the middle of the chest
Rarely some patients experience soreness in the hands and feet which
may be a sign of inflamed nerves, spasm of the axial muscles.
You may find it helpful to tell a relative or close friend that you are
depressed or have anxiety disorder, and to ask them to read this
leaflet. You might ask them to tell you if they think your depression or
anxiety is becoming worse or if they are worried about changes in your
behaviour.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE PARNATE® 10MG TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Parnate® 10mg Tablets after the expiry date which is stated
on the carton and label after EXP. The expiry date refers to the last
day of that month.
If your tablets are out of date, take them to your pharmacist who will
get rid of them safely.

3

PATIENT INFORMATION LEAFLET

Tranylcypromine 10mg Coated Tablets

Your medicine is known by the above name, but will be referred to as
Tranylcypromine 10mg Tablets throughout this leaflet.

Revision Date: 23.02.2016
Leaflet Reference: TRAN10

are due to have surgery in the next few weeks (including dental
surgery)

have depression, feeling low or have suicidal thoughts

suffer from low blood pressure or high blood pressure

suffer from schizophrenia

have a history of dependence on drugs or alcohol.
Even though some of the above may be obvious, it is important that
your doctor is aware if any of them apply to you.
If you are depressed and/or have anxiety disorders, you can
sometimes have thoughts of harming or killing yourself (see section 4
‘Possible side effects’). These may be increased when first starting
antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.


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. 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.
What is in this leaflet:
1. What Tranylcypromine 10mg Tablets are and what they are used for
2. What you need to know before you take Tranylcypromine 10mg
Tablets
3. How to take Tranylcypromine 10mg Tablets
4. Possible side effects
5. How to store Tranylcypromine 10mg Tablets
6. Contents of the pack and other information




You may be more likely to think like this if you:
have previously had thoughts about killing or harming yourself.
are a young adult.
If you have thoughts of harming or killing yourself, at any time, contact
your doctor or go to a hospital straight away. You may find it helpful to
tell a relative or close friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might ask them to tell
you if they think your depression or anxiety is getting worse, or if they
are worried about changes in your behaviour.

1. WHAT TRANYLCYPROMINE 10MG TABLETS ARE AND WHAT
THEY ARE USED FOR

Children and adolescents
Tranylcypromine 10mg Tablets contain 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. 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.

Tranylcypromine is not recommended for children under 18 years old
(see section 3 ‘Use in children and adolescents’).
Other medicines and Tranylcypromine 10mg Tablets
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicines.
Tranylcypromine 10mg Tablets MUST NOT be taken with the
following medicines:

Medicines called sympathomimetic agents - these include
ephedrine, pseudoephedrine, adrenaline and noradrenaline (these
may be found in medicines used to treat heart problems and
asthma as well as some decongestants and cough/cold remedies
e.g. dextromethorphan bought without a prescription)

Bupropion, a medicine to help you stop smoking

Medicines for migraine e.g. 5HT1 agonists

Strong pain killers e.g. pethidine, morphine, codeine and nefopam

It should not be administered at the same time as, or within 14
days of treatment with other MAOIs such as isocarboxid

Medicines used to treat depression (e.g. clomipramine,
imipramine, venlafaxine).

Tranylcypromine should not be administered together with
clomipramine and imipramine. In the cases of clomipramine and
imipramine, 3 weeks should be left before starting tranylcypromine
therapy.

Tranylcypromine should not be administered in combination with
selective serotonin reuptake inhibitors (SSRIs) e.g., fluoxetine or
serotonin/noradrenaline reuptake inhibitors (SNRIs) e.g.
venlafaxine.

Buspirone, used to treat anxiety

Medicines to treat seizures/fits, e.g. carbamazepine

Perphenazine used to treat schizophrenia

Guanethidine used to treat high blood pressure

SSRIs such as fluoxetine, paroxetine or sertaline (for depression)

Medicines like altretamine used for the treatment of cancer

Doxapram used to increase the rate of breathing, especially during
surgery

Medicines like oxypertin, clozapine used for the treatment of
mental disorders like schizophrenia

Tetrabenazine used for the treatment of excessive restlessness.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRANYLCYPROMINE 10MG TABLETS
Do not take Tranylcypromine 10mg Tablets if:
You are allergic to tranylcypromine or any of the other ingredients
of this medicine (listed in section 6).

You are taking clomipramine, imipramine and venlafaxine. You
should wait three weeks before starting trancylpromine after
stopping treatment with clomipramine, imipramine and venlafaxine.

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 known liver damage or a disorder affecting the blood
cells (your doctor will know)

You are pregnant, trying to become pregnant or breast-feeding.

You suffer from a mental health disorder and are in a manic phase.

You are taking any of the medicines listed under Other Medicines
and Tranylcypromine 10mg Tablets.


You should also avoid certain drugs called guanethidine (used for high
blood pressure), dextromethorphan (cough suppressant), alcohol or
narcotic analgesics or pain killers (morphine or pethidine).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if
you:







4

Tranylcypromine 10mg Tablets must be taken with caution if you
are taking the following medicines:

are elderly
have a mild heart problem which restricts your activity
suffer from seizures/fits (epilepsy)
suffer from diabetes mellitus (sugar diabetes)
suffer from blood disorders
taking diuretics (water tablets)




1

Barbiturates used to treat severe sleeping problems, e.g.
amylobarbitone
Medicines used to treat depression (e.g. amitriptyline, imipramine,
tryptophan, amfebutamone)

Phenylpropanolamine used to treat nasal congestion associate
with allergies

Medicines for high blood pressure (e.g. reserpine, methyldopa)

Medicines to control appetite, e.g. amphetamine and fenfluramine

Antimuscarinics for motion sickness, muscle cramps in the gut or
bladder

Medicines that treat Parkinson’s disease, e.g. levodopa

Dopamine, a medicine used to treat certain heart conditions

Local anaesthetics e.g. lidocaine

Medicines to treat diabetes (e.g. insulin, metformin).
At least 5 weeks should be allowed after stopping fluoxetine before
starting Tranylcypromine 10mg Tablets.
At least 2 weeks should be allowed after stopping paroxetine before
starting Tranylcypromine 10mg Tablets.

This dose may be increased by your doctor to three tablets a day.
Take the extra tablet at mid-day

If you are elderly your doctor will usually prescribe you a lower
dose.
When you start to feel better, your doctor may change your dose to
one tablet a day.
Do NOT take more than three tablets each day unless your doctor tells
you.





Use in children and adolescents
Tranylcypromine Tablets are not recommended for children under 18
years old.
If you take more Tranylcypromine 10mg Tablets than you should:
If you think that you, or any other person, have taken too many tablets,
contact your doctor or hospital casualty department immediately. Take
any remaining tablets and this leaflet with you so that the medical staff
know exactly what you have taken.

Taking Tranylcypromine 10mg Tablets with food and drink
You should NOT take alcohol (especially red wine) whilst you are
taking Tranylcypromine 10mg Tablets. This includes non-alcoholic
beer or lager.
Tranylcypromine 10mg Tablets stops the breakdown of a substance
called tyramine which is found in large amounts of certain foods. If this
substance is not broken down, it can cause very high blood pressure.
So, whilst you are taking Tranylcypromine 10mg Tablets, you should
avoid the following foods:

Matured cheeses – cooked or plain (e.g. cheddar or processed
cheese made from mature cheese)

Yeast extracts (e.g. Bovril, Oxo, brewer’s yeast or Marmite)

Meat, fish or poultry which is not fresh or has been pickled or aged
e.g. hung game, pickled herrings

Broad bean pods

Flavored textured vegetable protein

Protein foods that are not fresh and whose preparation involved
hydrolysis, fermentation, pickling, hanging, smoking or bacterial
contamination e.g. dry sausage (salami, pepperoni etc.),
fermented soya bean extract, liver, yoghurt

Excessive amounts of chocolate

Excessive amounts of tea or coffee.

If you have accidently taken a very large dose than what has been
prescribed for you, you may experience euphoria and feeling over
excited followed by a coma with low blood pressure or extremely high
blood pressure with bleeding in your brain.
You may experience drowsiness, nausea (feeling sick), vomiting
(being sick), start seeing or feelings things that do not exist, headache,
clammy skin, fainting, fits or tiredness.
If you forget to take your Tranylcypromine 10mg Tablets:
If you miss a dose, wait until your next dose. Do not take the dose you
have missed. You can then carry on as before. Do not take more than
one dose at a time.
If you stop taking Tranylcypromine 10mg Tablets
Continue to take Tranylcypromine 10mg Tablets even if you no longer
feel ill. DO NOT STOP taking this medicine without talking with your
doctor first, especially if you have taken large doses for a long time.
When the time comes to stop your doctor will probably decrease your
dose gradually as stopping the tablets suddenly may cause ill-effects
such as nausea (feeling sick), vomiting (being sick), sweating, vivid
nightmares, fits, worsening of symptoms and difficulty in sleeping.
Symptoms will usually start 24 to 72 hours after you stop taking this
medicine abruptly.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Tranylcypromine 10mg Tablets should NOT be used during pregnancy
or breast feeding unless your doctor thinks it is essential. This
medicine may pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

4. POSSIBLE SIDE EFFECTS

Driving and using machines
Like all medicines, Tranylcypromine 10mg Tablets can sometimes
cause side effects, although not everybody gets them.
If you eat foods or take medicines which interact with the active
ingredient, tranylcypromine, you may get very high blood pressure (a
hypertensive crisis).
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
If you notice any of the following symptoms, please stop taking your
medicine and see your doctor immediately.

Although very rare, muscle rigidity, fever and irregular body
movements (i.e. neuroleptic malignant syndrome)

Severe problems with the heart and breathing, feeling of a lump in
the throat, increased muscular movements, thought of suicide and
suicidal behaviour early on in treatment or shortly after stopping
treatment.

You may being seeing, hearing, smelling, tasting or feeling things
that don't exist outside their mind or have disorganized speech
(signs of a condition called schizophrenia) (Rare)

You may experience fatigue, weakness, shortness of breath, fever
or you may bleed or bruise easily indicating you may have a blood
disorder (uncommon).

You may experience liver problems (symptoms include yellowing
of the skin and the whites of the eyes). You may get a sore throat
or high fever or become very tired and pale or notice bruises and
nose bleeds.

Tranylcypromine 10mg Tablets may make you feel drowsy or dizzy or
affect your concentration. You should not drive or use machines when
you first start to take this medicine until you are certain that you are not
getting these side effects. If in any doubt, speak to your doctor before
you drive or use machines.
Important information about some of the ingredients of
Tranylcypromine 10mg Tablets
This medicine also contains carmoisine (E122) and Ponceau 4R
(E124) which may cause allergic reactions.
This medicine also contains sucrose (a sugar). If you have been told
by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
If you have an operation or you need to go to the Dentist:
Tranylcypromine 10mg Tablets are not normally taken for two weeks
before an operation or major dentistry.
Check with your doctor or dentist and alert them to your medication.
3. HOW TO TAKE TRANYLCYPROMINE 10MG TABLETS
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a glass of water.
The recommended dose for adults is:

One tablet in the morning and one tablet in the afternoon each day

Try to take the last dose before 3 o’clock in the afternoon

2



If your tablets are out of date, take them to your pharmacist who will
get rid of them safely.
Do not store above 25°C Store in original container in order to protect
from light and moisture. Replace cap tightly after use.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

You may experience lupus-like syndrome seen as joint pain,
swelling, and rashes on face, wrists, hands or maybe extreme
tiredness (uncommon).
Additional side effects:
Common:

Blurred vision

Nausea (feeling sick)

Vomiting (being sick)

Dry mouth

Constipation (difficulty in passing stools)

Tiredness

Increase in the level of liver enzymes on examination

Dizziness

Overactive or overresponsive reflexes

Uncontrollable movements of mouth, tongue and limbs

Difficulty sleeping

Difficulty in reaching an orgasm (only in women)

Altered driving ability

A fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting

Muscle twitching or jerking
Uncommon:

Purplish discoloring of the skin

Itching, tingling or pricking of skin,

Rash

Nervousness

Excessive happiness or excitement (euphoria),

Confusion

Difficulty in passing water

Inability to maintain erection

Glaucoma (increased pressure in the eyes)

Irregular heart beat

Weight gain

Increased appetite

Increased levels of salt in the body

Fits

Involuntary eye movements

Changes in the metabolism may occur

Sweating

Feeling jittery

Repetition or echoing of one's own spoken words

Shakiness

Headache

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tranylcypromine 10mg Tablets contain:
Each tablet contains tranylcypromine sulphate equivalent to 10mg of
tranylcypromine base.
Tranylcypromine 10mg Tablets also contain sucrose, maize starch,
calcium sulphate dihydrate (E516), carmellose sodium, magnesium
stearate (E470b). The coating contains gelatin, sucrose, docusate
sodium, purified talc (E553b), light kaolin (E559), calcium carbonate
(E170), ethylcellulose, acacia (E414), carmoisine (E122), ponceau 4R
(E124), maize starch, titanium dioxide (E171), carnauba wax (E903)
and edible ink [shellac, iron oxide black (E172), soya lecithin (E322)
and trace amounts of dimethyl siloxane].
What Tranylcypromine 10mg Tablets look like and contents of the
pack
Tranylcypromine 10mg tablets are bi-convex, geranium-red sugarcoated tablets marked with “FW 251” on one side. The tablets are in
white plastic containers with a cap and a security tag containing a
desiccant cartridge.
Tranylcypromine 10mg Tablets are available in containers of 28
tablets.
Who manufactured your medicine
Tranylcypromine 10mg tablets are manufactured by Dales
Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighly Road,
Skipton, North Yorkshire, BD23 2RW, UK. Procured from within the EU
and repackaged by Product Licence Holder: Beachcourse Limited, 20
Alliance Court, Alliance Road, London W3 0RB.
PL
16378/0551
Revision date: 23.02.2016
Leaflet reference: TRAN10

Rare:

Difficulty in controlling movements

Anxiety
Not known:

Water retention or swelling

Flushing

Agitation

Irritable

Painful or stiff neck

Pain in the middle of the chest
Rarely some patients experience soreness in the hands and feet which
may be a sign of inflamed nerves, spasm of the axial muscles.
You may find it helpful to tell a relative or close friend that you are
depressed or have anxiety disorder, and to ask them to read this
leaflet. You might ask them to tell you if they think your depression or
anxiety is becoming worse or if they are worried about changes in your
behaviour.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE TRANYLCYPROMINE 10MG TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Tranylcypromine 10mg Tablets after the expiry date which
is stated on the carton and label after EXP. The expiry date refers to
the last day of that month.

3

POM

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide