Skip to Content

UK Edition. Click here for US version.

PARNATE 10MG COATED TABLETS

Active substance(s): TRANYLCYPROMINE SULPHATE / TRANYLCYPROMINE SULPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PARNATE 10MG COATED TABLETS
(tranylcypromine sulphate)

Your medicine is available using the name Parnate 10mg
Coated Tablets but will be referred to as Parnate throughout
this 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 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.
2.
3.
4.
5.
6.

What Parnate is and what it is used for
What you need to know before you take Parnate
How to take Parnate
Possible side effects
How to store Parnate
Contents of the pack and other information

1. What Parnate is and what it is used for
Parnate 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 have feelings of fear (phobia) which
sometimes occurs in depression. This medicine is often used
when other types of antidepressant medicines have not
worked.

Thoughts of suicide and worsening of your
depression or anxiety disorder:

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.
You may be more likely to think like this if you:

have previously had thoughts about killing or harming
yourself

are a young adult. Information from clinical trials has
shown an increased risk of suicidal behaviour in adults
aged less than 25 years with psychiatric conditions who
were treated with an antidepressant.
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.

Children and adolescents

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

Other medicines and Parnate:

Parnate 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

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.

3. How to take Parnate

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.











are elderly

have a mild heart problem which restricts your activity

suffer from seizures/fits (epilepsy)

are due to have surgery in the next few weeks

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.

Driving and using machines:

DO NOT take Parnate with the following medicines:

Do not take Parnate if:

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

Parnate should NOT be used during pregnancy or breastfeeding unless your doctor thinks it is essential. This medicine
may pass into breast milk. Your doctor will decide whether
you should ablactate (gradually reduce) or stop therapy with
Parnate. Effects of Parnate on fertility is unknown.

Always take this medicine exactly as your doctor has told
you. Do NOT take more than your doctor tells you to. Check
with your doctor or pharmacist if you are not sure.




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

you are taking any of the medicines listed under ‘Do not
take’ in the ‘Other Medicines and Parnate’ section of this
leaflet
Please tell your doctor if any of the above apply to you, and
do not take Parnate.

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.

Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.

2. What you need to know before you take
Parnate


Pregnancy and breast-feeding:



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)
bupropion, a medicine to help you stop smoking
medicines to control appetite, e.g. amphetamine and
fenfluramine
medicines that treat Parkinson’s disease, e.g. levodopa
dopamine, a medicine used to treat certain heart
conditions
the pain killers pethidine and nefopam
general anaesthetics such as propofol, which are used in
surgery
other medicines used to treat depression (e.g.
amitriptyline, imipramine, tryptophan)
buspirone, used to treat anxiety.

Parnate must be taken with caution if you are
taking the following medicines:

other MAOIs such as isocarboxazid
strong pain killers e.g. codeine
medicines to treat seizures/fits, e.g. carbamazepine
barbiturates used to treat severe sleeping problems, e.g.
amylobarbitone

SSRIs such as fluoxetine or sertraline (for depression).
Taking your medicine with these products may cause the
following serious side effects: sweating, extreme
agitation, confusion, muscle stiffness

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

medicines to treat diabetes (e.g. insulin, metformin)

antihistamines used to treat allergies, e.g. cetirizine.
Consult your doctor before you take Parnate if you are taking
or might be taking any of these.





Parnate with food, drink and alcohol:

You should NOT take alcohol (especially red wine) whilst you
are taking Parnate. This includes non-alcoholic beer or lager.
Parnate 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, you should avoid
the following foods:

matured cheeses (e.g. cheddar or processed cheese
made from mature cheese)

yeast extracts (e.g. Bovril or Marmite)

meat, fish or poultry which is not fresh or has been
pickled

broad bean pods

banana skins.

Page 1 of 2

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 to.

Use in children and adolescents:

Parnate is not recommended for children under 18 years old
(see section 2 ‘Children and adolescents’).

If you take more Parnate 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.

If you forget to take Parnate:

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

Continue to take Parnate 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 and difficulty in sleeping.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Parnate can 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).
If you notice any of the following symptoms please see your
doctor immediately:

frequent or throbbing headaches, painful or stiff neck,
changes in heart rate, pain in the middle of the chest,
feeling sick or being sick, sweating, paleness, or flushing
of the skin and enlarged pupils which may make bright
sunlight uncomfortable. Although very rare, there may
be muscle weakness or paralysis (loss of movement)
down one side of the body and there have been a few
deaths from hypertensive crisis

thoughts of suicide and suicidal behaviour early on in
treatment or shortly after stopping treatment (see
section 2 ‘Thoughts of suicide and worsening of your
depression or anxiety disorder’).
Sometimes patients feel anxious whilst taking this medicine
and rarely some patients will become very agitated or
irritable. Your doctor may reduce your dose if this happens.
Some patients get low blood pressure and may feel dizzy on
standing up. If this continues for a long time, your doctor
may stop your medicine.
Other side effects which may occur include:

difficulty in sleeping, mild headache, sleepiness,
weakness, dizziness, fast heart beat (palpitations),
restlessness, dry mouth, blurred vision, feeling sick,
water retention or swelling, weight gain, increased
appetite, rash and difficulty in passing water.
Rarely some patients experience soreness in the hands and
feet, which may be a sign of inflamed nerves.
Rarely, some patients may find the relief of their depression
decreases with time and higher doses of the active ingredient,
tranylcypromine, are needed to get the same effect.
Very rarely, liver problems (symptoms include yellowing of
the skin and the whites of the eyes), bruising and changes in
blood have been reported. Therefore, if you get a bad sore
throat or high fever or become very tired and pale or notice
bruises and nose bleeds, tell your doctor.

6. Contents of the pack and other
information
What Parnate contains

Each coated tablet contains tranylcypromine sulphate
equivalent to 10mg of tranylcypromine.
Parnate also contains the following inactive ingredients:

Tablet core: sucrose, maize starch,
calcium sulphate dihydrate, carmellose sodium,
magnesium stearate (E572).

Tablet coating: gelatine, 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).

Printing ink: shellac, black iron oxide (E172),
soya lecithin (E322) and trace amounts of
dimethyl siloxane.

What Parnate looks like and contents of the pack

Parnate are geranium-red coloured, bi-convex, sugar-coated
tablets marked FW 251 on one face and plain on the reverse.
Parnate is available in white containers of 28 tablets.

Manufacturer

Manufactured by:
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate,
Keighley Road, Skipton, North Yorkshire, BD23 2RW.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0496

POM

Leaflet revision and issue date: 05.08.16
Parnate® is a registered trademark of Goldshield Group PLC.

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 Website: 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
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Parnate after the expiry date which is stated on
the box. 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.
Do not store above 25°C (normal room temperature).
Store in the original package and protect from light and
moisture. Keep container tightly closed.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
If your doctor decides to stop treatment, return any leftover
tablets to the pharmacist. Only keep them if your doctor tells
you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Page 2 of 2

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