Patient leaflet - Phenelzine 15 mg film-coated tablets

1. What Phenelzine is and what it is used for

The full name of your medicine is Phenelzine 15 mg film-coated tablets. It is referred to as

Phenelzine throughout this leaflet.

Phenelzine contains the active ingredient phenelzine sulfate, which belongs to a group of medicines called monoamine oxidase

inhibitors, or MAOIs.

Phenelzine is used to treat certain types of depression. It works by changing the way messages are sent from one nerve to another in the brain. Phenelzine is especially helpful when:

depression does not follow the typical pattern
anxiety or fear is a main symptom
treatment with other
antidepressants has failed

2. What you need to know before you take Phenelzine

Do not take Phenelzine

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 i.e. 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 Phenelzine. It is important to wait between using certain medicines and starting Phenelzine, read section 2 “Other medicines and Phenelzine” carefully.

Warnings and precautions

Talk to your doctor or pharmacist before taking Phenelzine

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 Phenelzine 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 Phenelzine should be stopped if palpitations or frequent headaches occur.

Other medicines and Phenelzine

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 Phenelzine 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 Phenelzine
- amfebutamone (to help you give up smoking). This should not be taken at the same time as, or within 14 days of, Phenelzine
- migraine medications known as 5-HT1 agonists or pizotifen. These should not be taken at the same time as, or within 14 days of, Phenelzine
- 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). Phenelzine should not be taken for 14 days either before or after these medicines.

clomipramine or imipramine - 21 days should elapse before starting Phenelzine.

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

Phenelzine with food, drink and alcohol

Phenelzine 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 Phenelzine, or within 14 days of taking Phenelzine, 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.

Pregnancy and breast-feeding

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.

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

Do not breast-feed if you are taking Phenelzine.

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

Driving and using machines

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

Phenelzine contains sodium

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

3. How to take Phenelzine

Always take Phenelzine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many tablets to take and for how long you should take them.

Swallow the tablets with some water. You can take them with or without food.

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

Use in adults

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.

Use in the elderly (over 65 years)

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 Phenelzine may react with (see section 2 “Other medicines and Phenelzine”).

Use in children

Phenelzine 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. UK 675-7702-08

Product Name	Phenelzine Waymade 15 mg
PIP Code	UK 675-7702-08
Old PIP Code
Variation No.	Initial Application
Customer	Waymade PLC
Market	UK
Language	English
Version No.	8
Date	20/03/26
File Name	Phenelzine UK 675-7702-PIL

)

180 mm

5 mm

If you take more Phenelzine than you should

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 Phenelzine

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.

If you stop taking Phenelzine

Do not stop taking Phenelzine 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 Phenelzine is stopped suddenly. This may happen one to three days after stopping Phenelzine 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 Phenelzine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Phenelzine can cause side effects, although not everybody gets them.

Side effects are usually mild or moderate in severity and tend to disappear as treatment continues.

The most serious side effects are high blood pressure, which usually happens when the wrong food is eaten (see section 2 “Phenelzine with food, drink and alcohol”), and neuroleptic malignant syndrome (a serious, sometime

life-threatening, condition which results in fever, faster breathing and pulse rate, sweating, muscle stiffness, changes in blood pressure and reduced consciousness). If you feel this is happening to you, STOP TAKING the tablets and tell your doctor or go to your nearest hospital accident and emergency department immediately.

Common side effects are:

drowsiness, dizziness, weakness, tiredness and blurred vision (see section 2 “Driving and using machines”)
low blood pressure when standing or sitting up. You may feel giddy and about to faint. This effect is more common in the elderly
water retention (can cause swollen ankles)
- nausea, vomiting, dry mouth, constipation
- insomnia (difficulty in sleeping)
- twitching, increased reflexes
- difficulty in achieving an orgasm
- changes in the blood related to liver problems (this may be identified in a blood test)

Uncommon side effects are:

headache, nervousness, excitement, jitteriness, shaking, confusion, seeing or hearing things which are not there, fits
changes in normal behaviour, speech changes (repeating the last word of a sentence), unusual eye movements
loss of feeling in hands and feet
rash, itching, sweating, nerve pain, bruising
a feeling of pins and needles
changes in the rhythm of the heart
increased appetite and weight
difficulty in passing urine
impotence, delayed ejaculation
high levels of sodium (salt) in the blood, symptoms may be tiredness, weakness, irritability and swelling
abnormalities of blood cells, symptoms can include bleeding problems, weakness or pale skin colour, or frequent infections
high pressure in the eye
(glaucoma)
lupus-like illness (a disease affecting the immune system)
high levels of liver enzymes (this may be identified in a blood test)

Very rarely, other serious effects have been seen, these are:

loss of co-ordination
coma (being unconscious) delirium (disorientation, seeing or hearing things which are not there, delusions, and incoherent speech)
neuroleptic malignant syndrome (a serious, sometimes
life-threatening, condition which results in fever, faster breathing and pulse rate, sweating, muscle stiffness, changes in blood pressure and reduced
consciousness)
mania (excessive feeling of well being), rapidly developing anxiety
schizophrenia, in people already at risk of developing it
heart and lung problems following electroshock therapy (ECT)
jaundice (yellowing of the skin), liver damage which may be serious or even fatal
increased metabolism
swollen glottis (top of the wind-pipe).

Too little sodium (salt) in the blood has been seen with all types of antidepressants. This may cause drowsiness, confusion or fits. It is more usually seen in the elderly.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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. 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.

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 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.

5. How to store Phenelzine

Keep this medicine out of the sight and reach of children.

Blister pack: Do not store above 30°C.

HDPE bottle: This medicinal product does not require any special storage conditions.

Use within 60 days after first opening the bottle.

Do not use Phenelzine after the expiry date which is stated on the carton, foil and bottle after ‘EXP’. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Phenelzine contains

Each film-coated tablet contains 15 mg phenelzine (as phenelzine sulfate).

The other ingredients are:

Core: mannitol (E421),

Croscarmellose Sodium (E468), Povidone, Disodium Edetate, Sodium stearyl fumarate.

Coating: Polyvinyl Alcohol (E1203), Talc (E553b), Quinoline Yellow Aluminum Lake (E104), Titanium Dioxide (E171), Glyceryl

monocaprylocaprate (Type I), Sodium Lauryl Sulfate, Iron Oxide Red (E172).

What Phenelzine looks like and contents of the pack

Pale orange coloured, round shaped, biconvex, film coated tablets debossed with ‘P15’ on one side and plain on the other side with approximate diameter 8.8 mm.

The tablets are supplied in the following packs:

White, opaque, high-density polyethylene (HDPE) bottle fitted with a child-resistant white, polypropylene (PP) cap with induction heat sealed liner containing silica gel and activated carbon canister, with

60 film-coated tablets.

Alu-Alu blisters in a carton containing 30 and 100 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Waymade PLC

Sovereign House

Miles Gray Road, Basildon Essex SS14 3FR United Kingdom

Manufacturer

Waymade PLC