- phenelzine sulfate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16508/0052.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Nardil Tablets are and what are they 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:
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:
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 conditions:
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:
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:
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:
Uncommon side effects are:
Very rarely, other serious effects have been seen, these are:
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 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 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.
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
This leaflet was last revised in 02/2017.
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