Nardil 15 mg film-coated tablets

• Please 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 suffer from any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nardil is and what it is used for
2. What you need to know before you take Nardil
3. How to take Nardil
4. Possible side effects
5. How to store Nardil
6. Contents of the pack and other information

• if you are allergic to phenelzine or any of the other ingredients of this medicine (listed in section 6)
• if you have a growth on the adrenal glands near your kidneys which is causing high blood pressure (phaeochromocytoma)
• if you have liver disease – now or in the past
• if you have a disease affecting blood supply to your brain, such as stroke
• if you have heart disease
• if you are in a manic phase
• if you are pregnant or breast-feeding
• if you are below 16 years of age
• if you are going to have surgery or major dentistry
• if you are already taking, or have recently stopped, other antidepressants ie. MAOIs, tricyclics, Selective Serotonin Re-uptake Inhibitors (SSRI) or Serotonin Noradrenaline Re-uptake Inhibitors (SNRI)
• if you are taking strong pain killers, such as morphine or pethidine
• if you are taking guanethidine (used to treat high blood pressure), dextromethorphan (used in cough and cold medicines), medicines which affect the central nervous system and make you feel sleepy or medicine used to treat migraines.

If any of these apply to you, tell your doctor or pharmacist before taking Nardil. It is important to wait between using certain medicines and starting Nardil, read section 2 “Other medicines and Nardil” carefully.

Talk to your doctor or pharmacist before taking Nardil

• if you have agitation
• if you have epilepsy
• if you have porphyria (which may make the skin sensitive to sunlight, or may affect the nervous system, causing abdominal pain, vomiting, muscle weakness, fits and mental disturbances)
• if you have abnormalities of blood cells, this could be caused by many different diseases and symptoms can include bleeding problems, weakness or pale skin colour, or frequent infections
• if you have diabetes mellitus
• if you have schizophrenia
• if you have manic depression
• if you are taking diuretics (water tablets)
• if you are undergoing ECT (electroshock treatment)
• if you are going to have surgery or major dentistry: tell your doctor or dentist because Nardil may interact with certain anaesthetics and should not be taken for two weeks before surgery.

Your blood pressure should be monitored frequently by your doctor and Nardil should be stopped if palpitations or frequent headaches occur.

Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines, because Nardil may interact with them:

• cough and cold cures, cough medicines
• hay fever medications, asthma inhalant medications
• appetite-suppressing medicines, weight-reducing preparations and ‘pep’ pills
• strong pain killers (pethidine and morphine). This could be a serious reaction
• tryptophan, amphetamines and medicines of the type known as sympathomimetic amines (adrenaline, epinephrine, fenfluramine, ephedrine, phenylpropanolamine, dopamine and levodopa). Some of these may be in medicines bought without a prescription
• medicines used to treat high blood pressure (particularly guanethidine)
• diabetes medications
• antimuscarinic medicines, used to treat motion sickness, muscle cramps in the gut or bladder, or Parkinson’s disease
• anti-emetic medicines known as 5-HT3 antagonists which help to stop you feeling or being sick
• medicines which make you sleepy (including barbiturates and alcohol) and local anaesthetics including cocaine. The effect of these medicines may be increased by Nardil
• amfebutamone (to help you give up smoking). This should not be taken at the same time as, or within 14 days of, Nardil
• migraine medications known as 5-HT1 agonists or pizotifen. These should not be taken at the same time as, or within 14 days of, Nardil
• medicines to treat epilepsy, altretamine (for ovarian cancer), doxapram (to stimulate breathing in emergency situations), tetrabenazine (for Huntington’s chorea), oxypertine and clozapine (for schizophrenia and other similar illnesses), methylthioninium chloride (an antidote treat problems with your blood resulting from exposure to some medicines or chemicals that can cause a disease called methaemoglobinaemia)
• other antidepressants:
  • other MAOIs, buspirone or dibenzazepine derivative drugs (e.g. tricyclic antidepressants, perphenazine or carbamazepine), selective serotonin re-uptake inhibitors (SSRIs) or serotonin noradrenaline re-uptake inhibitors (SNRIs, e.g. venlafaxine). Nardil should not be taken for 14 days either before or after these medicines.
  • clomipramine or imipramine - 21 days should elapse before starting Nardil.

If you are not sure which medicines you are already taking, please ask your doctor or pharmacist.

Nardil reacts with a substance called tyramine which is found in some foods and drinks (see lists below).

If you eat or drink anything containing tyramine while you are taking Nardil, or within 14 days of taking Nardil, you may have a very severe rise in blood pressure.

This will happen soon after eating the food and you may get a violent headache, pounding heart, stiff neck, flushing, sweating or you may be sick. The severity of the reaction depends on the amount of tyramine you eat and may be mild or could be dangerous, even fatal.

If you feel such a reaction happening, tell your doctor or go to your nearest hospital accident and emergency department immediately.

Do not eat:

Cheese (cooked or plain), liver, yoghurt, yeast/meat extracts (e.g. Marmite, Oxo, Bovril or Brewer’s yeast), flavoured textured vegetable protein, broad bean pods, protein which has been allowed to age, degrade or ferment (e.g. hung game, pickled herrings or dry sausage such as salami or pepperoni), fermented soya bean extract, excessive amounts of chocolate.

Do not drink:

Alcohol, non-alcoholic beer, lager or wine. You may drink a reasonable amount of tea or coffee but not to excess.

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nardil is not recommended for use during pregnancy, especially during the first and last trimesters.

Do not breast-feed if you are taking Nardil.

As with any medicine, ask your doctor or pharmacist for advice.

Nardil might cause drowsiness or blurred vision. Do not drive or operate machinery until you know if the tablets affect you in this way.

Sunset yellow (E110), a colouring agent in the film coating of Nardil, may cause an allergic reaction.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The usual starting dose is one tablet three times a day. Your doctor will decide what dose is best for you. Follow the instructions on the label and do not change the dose unless your doctor tells you to.

The dosage is the same as for adults, but elderly patients may have an increased risk of side effects and are more likely to be taking other medicines which Nardil may react with (see section 2 “Other medicines and Nardil”).

Nardil is not recommended for use in children under 16 years old.

Important – It may take four weeks before you feel the full effect of the tablets.

If these tablets are not helping you after you have taken them for about two weeks, your doctor may increase the dose to a maximum of one tablet four times a day.

In hospitals, doses of up to two tablets three times a day may be used.

Once the tablets are helping your depression, your doctor may slowly lower the dose. This may be as low as one tablet every other day.

If you accidentally take more tablets than you were told to, or you suspect that a child has swallowed the tablets, contact your doctor straight away or go to your nearest hospital accident and emergency department immediately. Take this leaflet and the pack of tablets along with you, if you can.

If you forget to take your tablets, take your next dose at the usual time and continue taking the tablets according to your doctor’s instructions. Do not take a double dose to make up for a forgotten individual dose.

If in doubt about what you should do, please contact your doctor or pharmacist.

Do not stop taking Nardil suddenly unless your doctor tells you to. This may make you feel sick or unwell.

A few people may experience a more serious effect if Nardil is stopped suddenly. This may happen one to three days after stopping Nardil and symptoms may include:

• vomiting, nausea and feeling generally unwell
• nightmares, agitation, psychosis (seeing or hearing things that are not there, or believing things which are not true) and fits.

If this happens, tell your doctor immediately. Your doctor may give you a lower dose until your symptoms improve.

It is important to continue to follow all of the instructions contained within this leaflet for 14 days after you stop taking Nardil.

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. 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.
• If you 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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each tablet contains 15 mg of the active substance phenelzine (in the form of phenelzine sulfate).

The other ingredients are:

Core: mannitol, povidone, magnesium stearate and maize starch.

Coating: polyvinyl alcohol (E1203), talc (E553b), sunset yellow (E110), glyceryl monocaprylocaprate, glyceryl dicaprylocaprate, sodium lauryl sulfate, titanium dioxide (E171) and carmine (E120).

(See end of section 2 “Nardil contains sunset yellow (E110) and sodium” for information on sunset yellow).

Orange film-coated tablets.

The tablets are supplied in child-resistant white HDPE plastic bottles containing 100 tablets.