Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nardil 15 mg film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Phenelzine sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Nardil contains the active ingredient phenelzine, which belongs to a group of medicines called monoamine oxidase inhibitors, or MAOIs. Nardil 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. Nardil 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 it
e Nardil
Do not take Nardil • 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. Warnings and precautions 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. Other medicines and Nardil 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 with food, drink and alcohol 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. 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. 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. Driving and using machines Nardil might cause drowsiness or blurred vision. Do not drive or operate machinery until you know if the tablets affect you in this way. Nardil contains sunset yellow (E110) and sodium 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 'sodiumfree'. 3.
How to take it
Nardil
Always take Nardil 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 Nardil 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 Nardil may react with (see section 2 "Other medicines and Nardil"). Use in children 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 take more Nardil 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 Nardil 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 Nardil 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, Nardil can cause side effects, although not everybody gets them.
Possible 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 "Nardil 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 it
Nardil
Keep this medicine out of the sight and reach of children. Store the tablets in a refrigerator between 2oC and 8oC. Tablets in use may be stored at normal room temperature (below 25oC) for short periods (e.g. when travelling or at work). Keep in the original pack and protect from light. Do not use Nardil after the expiry date which is stated on the carton after 'Expiry:' and on the 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 Nardil contains 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). What Nardil looks like and contents of the pack Orange film-coated tablets. The tablets are supplied in child-resistant white HDPE plastic bottles containing 100 tablets. Marketing Authorisation Holder Neon Healthcare Limited 8 The Chase John Tate Road Hertford, SG13 7NN, UK Manufacturer Eirgen Pharma Limited Westside Business Park Old Kilmeaden Road Waterford X91 YV67 Ireland This leaflet was last revised in 06/2025.
Frequently asked questions about Nardil 15 mg film-coated tablets
How do I take Nardil 15 mg film-coated tablets?
Nardil 15 mg film-coated tablets comes as tablet containing 15mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Nardil 15 mg film-coated tablets?
The active substance in Nardil 15 mg film-coated tablets is phenelzine sulfate.
Are there equivalent medicines to Nardil 15 mg film-coated tablets?
Medicines with the same active substance, strength and form include: Phenelzine 15 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nardil 15 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Nardil 15 mg film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: phenelzine sulfate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Phenelzine is a monoamine oxidase inhibitor (MAOI). It has been found to be effective in depressed patients clinically characterised as 'atypical', 'non endogenous', 'neurotic' or where treatment with other antidepressants has failed. These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features.
4.2. Posology and method of administration
Posology
Adults
One 15 mg tablet three times a day. A response is usually seen within the first week. If no response is evident after two weeks, the dosage may be increased to a maximum of one 15mg tablet four times a day. Doses of up to two 15mg tablets three times a day may be used in hospitals. The effectiveness of the drug may not become apparent in less than 4 weeks therapy. After a satisfactory response has been achieved, the dosage may be reduced very gradually to a suitable maintenance level. This may be as low as one 15mg tablet every other day.
Elderly (over 65 years)
As for adults.
Postural hypotension may be an unwanted effect of MAOIs in the elderly. Elderly patients as a group tend to receive multiple drug therapies and the possibility of increased risk of drug interactions should be borne in mind. This medicine should only be used with great caution in elderly patients.
Despite these problems, MAOIs (including phenelzine) have been found to be useful in the treatment of depression in the elderly.
Paediatric population
This medicine is not indicated for children under 16 years of age.
Method of administration
Oral administration.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Phenelzine should not be used in patients with phaeochromocytoma, cerebrovascular disease, congestive heart failure, a history of liver disease or with abnormal liver function tests.
Phenelzine should not be used in combination with other MAOI, 5HT1 agonists, dibenzazepine derivative drugs or other antidepressants [see section 4.5].
Phenelzine should not be used in combination with guanethidine, dextromethorphan, or with CNS depressants such as alcohol and narcotic analgesics. Death has been reported in patients receiving a single dose of pethidine [see section 4.5].
Patients taking phenelzine should not undergo elective surgery [see sections 4.4 and 4.5].
Phenelzine is not indicated in the manic phase.
4.4. Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
General
Phenelzine should be withdrawn two weeks before elective surgery/dentistry [see section 4.5].
Phenelzine should only be used with great caution in agitated patients or these who have cardiovascular disease, epilepsy, blood dyscrasias, porphyria or diabetes; and in patients taking diuretics.
Blood pressure should be observed frequently to detect any pressor response and therapy discontinued if palpitations or frequent headaches occur.
Patients should also be closely followed for symptoms of postural hypotension. Hypotensive side effects have occurred in hypertensive as well as normotensive and hypotensive patients.
Due to the possibility of patients undergoing “Withdrawal Syndrome” [see section 4.8] abrupt withdrawal of phenelzine should be avoided where possible.
Phenelzine may cause excessive stimulation in schizophrenic patients; in manic- depressive states it may result in a swing from a depressive to a manic phase.
Caution should be exercised if the patient undergoes concurrent electroconvulsive therapy (ECT).
4.5. Interaction with other medicinal products and other forms of interaction
Patients should be warned against self medication, particularly cold cures, cough cures, hay fever medications, anti-appetite medicines, weight reducing preparations and “pep” pills and about potential food interactions.
Patients under treatment with phenelzine should avoid high protein food that has undergone breakdown by aging, fermentation, pickling, smoking or bacterial contamination. Patients should avoid cooked or plain cheese, Oxo, Bovril, Marmite, brewer's yeast, etc. during treatment and up to 14 days after ceasing treatment.
Flavoured textured vegetable protein, hung game, pickled herrings, dry sausage (salami, pepperoni etc.), liver, yoghurt, broad bean pods, fermented soya bean extract, and excessive amounts of chocolate may also present a hazard. Patients should not consume alcoholic drink or non-alcoholic beers, lagers and wines and excessive amounts of tea and coffee should be avoided.
Where a reaction between phenelzine and certain foodstuffs occurs the intensity of the reaction is usually related to the tyramine content of the food. The reaction is now well recognised and serious hypertensive episodes are extremely rare. Should such a reaction occur, the hypertension should be controlled promptly by slow administration of phentolamine 5-10mg I.V. repeated if necessary. Care should be taken to administer this drug slowly to avoid an excessive hypotensive effect.
The potentiation of sympathomimetic substances and related compounds by MAO inhibitors may result in hypertensive crises. Therefore, patients being treated with phenelzine should not take sympathomimetic or related compounds.
Phenelzine should be discontinued at least 14 days prior to elective surgery. Phenelzine should not be given with cocaine or local anaesthesia containing sympathomimetic vasoconstrictors. Patients taking phenelzine should not undergo elective surgery requiring general anaesthesia. The possible combined hypotensive effects of phenelzine and spinal anaesthesia should be kept in mind.
Phenelzine should not be administered at the same time as, or within 14 days of, treatment with other MAOIs, 5HT1 agonists (including amfebutanone (bupropion) or buspirone), dibenzazepine derivative drugs (including tricyclic antidepressant agents, perphenazine or carbamazepine) or pizotifen. In the cases of clomipramine and imipramine, 3 weeks should be left before starting phenelzine therapy. It is recognised that there is some division of consultant opinion with respect to concomitant use of MAOIs and tricyclic antidepressants.
Phenelzine should be avoided in patients receiving medicinal products that enhance serotonergic transmission because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome. Phenelzine should not be used in combination with serotonin reuptake inhibitors or serotonin/noradrenaline inhibitors (e.g. venlafaxine). A sufficient amount of time must be allowed for clearance of these drugs and their metabolites. For example, 5 weeks in the case of fluoxetine and 2 weeks with paroxetine. Conversely, these drugs should not be started before at least 10 days of discontinuing phenelzine. Methylthioninium chloride and 5HT3 antagonists should also be avoided.
Phenelzine may potentiate the effects of alcohol. Phenelzine may also potentiate the action of pethidine, morphine, adrenaline, amphetamines and other sympathomimetic amines such as fenfluramine, ephedrine, phenylpropanolamine, dopamine and levodopa. Phenelzine may also potentiate the effects of antihypertensives, hypoglycaemic agents, sympathomimetics, anti-Parkinson drugs, antimuscarinics, local anaesthetics and CNS depressants, including barbiturates. See section 4.3.
It is suggested that MAOIs are not administered at the same time as anti-epileptics, altretamine, doxapram, tetrabenazine, oxypertine or clozapine.
The combination of MAOIs and tryptophan has been reported to cause behavioural and neurological symptoms.
4.6. Fertility, pregnancy and lactation
Pregnancy
Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons. There is no evidence as to drug safety in human pregnancy nor is there evidence from animal work that it is free from hazard.
Breastfeeding
It is not known if phenelzine is excreted in breast milk. Because of the potential for serious adverse effects to the infant, a decision should be made whether to discontinue the drug or not to breast-feed.
4.7. Effects on ability to drive and use machines
Produces adverse effects on driving ability
4.8. Undesirable effects
Side-effects tend to be mild or moderate in severity, often subsiding as treatment continues, and can be minimised by adjusting dosage; rarely is it necessary to discontinue phenelzine.
The most important reaction associated with phenelzine is the occurrence of hypertensive crises, which have been associated with intracranial bleeding and have sometimes been fatal.
Cases of suicidal ideation and suicidal behaviours have been reported during phenelzine therapy or early after treatment discontinuation [see section 4.4].
The undesirable effects reported with phenelzine during clinical trials and post- marketing surveillance are shown in the table below. They are listed by System- Organ Class (SOC) and in order of frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Frequency of adverse events
SOC
Frequency
Event
Blood and lymphatic system disorders
Uncommon
Purpura, blood disorders
Very rare
Reversible jaundice
Immune system disorders
Uncommon
Lupus-like syndrome
Metabolism and nutrition disorders
Uncommon
Hypernatraemia
Very rare
Hypermetabolism
Psychiatric disorders
Common
Insomnia, anorgasmia
Uncommon
Nervousness, euphoric mood, behavioural disorder, confusional state, hallucinations
Very rarely
Coma, delirium, mania, anxiety reaction, schizophrenia aggravated
Unknown
Suicidal ideation, suicidal behaviour
Nervous system disorders
Common
Dizziness, drowsiness, hyperreflexia
Uncommon
Headache, paraesthesia, seizure, neuropathy peripheral, repetitive speech
Very rare
Ataxia, neuroleptic malignant syndrome (occasionally fatal)
Eye disorders
Common
Vision blurred
Uncommon
Glaucoma, nystagmus
Cardiac disorders
Uncommon
Arrhythmia
Very rare
Circulatory depression1
Vascular disorders
Common
Orthostatic hypotension
Unknown
Hypertension
Respiratory, thoracic and mediastinal disorders
Very rare
Respiratory depression1
Gastrointestinal disorders
Common
Nausea, vomiting, dry mouth, constipation
Uncommon
Increased appetite
Hepatobiliary disorders
Uncommon
Elevated liver enzymes
Very rare
Fatal progressive necrotising hepatocellular damage
Skin and subcutaneous disorders
Common
Oedema
Uncommon
Rash, pruritis, hyperhidrosis
Very rare
Laryngeal oedema
Musculoskeletal and connective tissue disorders
Common
Myoclonic jerks
Uncommon
Tremor
Very rare
Hypertonia
Renal and urinary disorders
Uncommon
Dysuria
Reproductive system and breast disorders
Uncommon
Erectile dysfunction, ejaculation delayed
General disorders and administration site conditions
Uncommon
Feeling jittery
Common
Asthenia, fatigue
Very rare
Pyrexia
Investigations
Common
Serum transaminase increased
Uncommon
Weight increased
1 Transient, following ECT.
DESCRIPTION OF SELECTED ADVERSE REACTIONS
Withdrawal may be associated with nausea, vomiting and malaise. An uncommon withdrawal syndrome following abrupt withdrawal of phenelzine has been infrequently reported. Signs and symptoms of this syndrome generally commence 24 to 72 hours after drug discontinuation and may vary from vivid nightmares and agitation to frank psychosis and convulsions. This syndrome generally responds to reinstitution of low- dose phenelzine therapy followed by cautious downward titration and discontinuation.
Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Signs and symptoms may be absent or minimal during the initial 12-hour period following ingestion and may develop slowly thereafter, reaching a maximum in 24 to 48 hours. Death has been reported following overdosage, therefore immediate hospitalisation with continuous patient observation and monitoring throughout this period is essential.
Large doses may produce hypomania, euphoria, followed by coma with hypotension, or acute hypertension sometimes with subarachnoid haemorrhage. In a few cases extra-pyramidal symptoms have been recorded.
Other symptoms may be: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, rigidity, convulsions, rapid and irregular pulse, precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis and cool, clammy skin.
Treatment
Gastric lavage with instillation of charcoal slurry may be helpful in early poisoning (tablets dissolve slowly in stomach).
Absolute bed rest, raise feet in hypotension. Vasopressors are best avoided.
Hypertension should be urgently controlled with phentolamine IV. Avoid hypnotics, such as morphine, pethidine, barbiturates. Body temperature should be monitored, and fever managed by cooling.
Use intravenous therapy to maintain fluid and electrolyte balance and use a slow IV injection of diazepam for any CNS stimulation. In deep coma and severe hypotension hydrocortisone by injection may be tried.
There is no specific antidote for phenelzine. Haemodialysis, peritoneal dialysis and charcoal haemoperfusion may be of value in massive overdosage, but sufficient data are not available to recommend their routine use in these cases.
💬 Ask about this leaflet
Ask anything about Nardil 15 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.