Recipharm Limited Vale of Bardsley Ashton-under-Lyne Lancashire OL79RR United Kingdom
• 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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NARDIL TABLETS
Keep out of the sight and reach of children.
Store the tablets in a refrigerator between 2°C and 8°C. Tablets in use may be stored at normal room temperature (below 25°C) 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.
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.
6. FURTHER INFORMATION
What Nardil Tablets contain
Each tablet contains 15 mg of the active substance phenelzine (in the form of phenelzine sulfate). The other ingredients are:
mannitol, povidone, magnesium stearate, maize starch, hydroxypropylcellulose (E463), hypromellose (E464), talc, polyvinylacetatephthalate, stearic acid, sunset yellow (E110), erythrosine (E127) and titanium dioxide (E171)
(see end of Section 2 “Further information about some of the other ingredients of Nardil Tablets” for sunset yellow).
What Nardil Tablets look like and contents of the pack Orange film-coated tablets.
The tablets are supplied in tamper-evident child-resistant white HDPE plastic bottles containing 100 tablets.
Marketing Authorisation Holder
Archimedes Pharma UK Limited
Galabank Business Park
This leaflet was last revised in 04/2015.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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 symptoms are the same as yours.
• If you suffer from any side effect that gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nardil Tablets are and what they are used for
2. Before you take Nardil Tablets
3. How to take Nardil Tablets
4. Possible side effects
5. How to store Nardil Tablets
6. Further information
1. WHAT NARDIL TABLETS ARE AND WHAT THEY ARE USED 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. BEFORE YOU TAKE NARDIL TABLETS
Do not take Nardil Tablets and tell your doctor or pharmacist if any of the following applies to you:
• an allergy to phenelzine or any of the other ingredients of Nardil (see Section 6 or end of Section 2 “Important information about some of the ingredients of Nardil Tablets”)
• a growth on the adrenal glands near your kidneys which is causing high blood pressure (phaeochromocytoma)
• liver disease - now or in the past
• a disease affecting blood supply to your brain, such as stroke
• heart disease
• you are in a manic phase
• you are pregnant or breast-feeding
• you are below 16 years of age
• 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). It is important to wait between using certain antidepressants and starting Nardil Tablets, read section 2: Taking other medicines carefully.
• you are taking strong pain killers, such as morphine or pethidine
• you are taking guanethidine (used to treat high blood pressure), dextromethorphan (used in cough and cold medicines) or medicines which affect the central nervous system and make you feel sleepy.
If any of these apply to you, tell your doctor or pharmacist before taking Nardil tablets.
Take special care with Nardil tablets
You should consult your doctor or pharmacist before taking Nardil if you have any of the following
• 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)
• 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
• diabetes mellitus
• 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.
Taking other medicines
Please tell your doctor, dentist or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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
• 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. 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)
• other antidepressants:
o 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. o 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.
Taking Nardil Tablets with food and drink
Nardil tablets react 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
Nardil is not recommended for use during pregnancy, especially during the first and last trimesters.
If you are pregnant, think you might be pregnant or are planning to become pregnant, you should talk to your doctor.
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.
Important information about some of the ingredients of Nardil Tablets
Sunset yellow (E110), a colouring agent in the film coating of Nardil, may cause an allergic reaction.
3. HOW TO TAKE NARDIL TABLETS
Always take Nardil exactly as your doctor has told you. You should 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.
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.
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 “Taking other medicines ”).
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 forget to take Nardil Tablets
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 take more Nardil Tablets 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 stop taking Nardil Tablets
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 Tablets.
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.
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 “Taking Nardil Tablets with food and drink”), 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
YELLOWDOT DESIGN Artwork Technical Specifications
Nardil Tablets PIL UK (Recipharm)
INTERNAL CODE No.
REASON FOR CHANGE
Change address to Galabank Business Park...
285mm wide x 320mm high
ITC New Baskerville