Tranylcypromine 10 mg Film-coated Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Tranylcypromine tablets are and what they are used for
2. What you need to know before you take Tranylcypromine tablets
3. How to take Tranylcypromine tablets
4. Possible side-effects
5. How to store Tranylcypromine tablets
6. Contents of the pack and other information

• you are allergic to the active substance or any of the ingredients of this medicine (listed in section 6).
• you are taking other MAOIs or have taken other MAOIs within the last two weeks
• you have taken clomipramine or imipramine within the last three weeks or are planning to take them within the next three weeks
• you suffer from porphyria (which is an inherited disease affecting the nervous system and skin).
• you have severe heart disease or any disease of the blood vessels of the brain
• you have pheochromocytoma which is a tumour of the adrenal glands (glands near the kidneys) causing high blood pressure
• you have been diagnosed with an overactive thyroid gland ( a gland in the neck)
• you have known liver damage or other liver diseases or a disorder affecting the blood cells (your doctor will know)
• you are taking any of the medicines listed under ‘Do not take’ in the ‘Other medicines and tranylcypromine tablets’ section of this leaflet

Please tell your doctor if any of the above apply to you, and do not take Tranylcypromine tablets.

Talk to your doctor or pharmacist before taking this medicine if you:

• are elderly
• have a mild heart problem which restricts your activity
• suffer from seizures/fits (epilepsy)
• are due to have surgery in the next few weeks
• have a history of dependence on drugs or alcohol.
• have severe kidney diseases

Even though some of the above may be obvious, it is important that your doctor is aware if any of them apply to you.

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself (see section 4 ‘Possible side effects’). 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
• 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.

Tranylcypromine tablets are not recommended for children and adolescents under 18 years old.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

DO NOT take Tranylcypromine tablets with the following medicines:

• medicines called sympathomimetic agents-these include ephedrine, pseudoephedrine, adrenaline and noradrenaline (these may be found in medicines used to treat heart problems and asthma as well as some decongestants and cough/cold remedies)
• bupropion, a medicine to help you stop smoking
• medicines to control appetite, e.g. amphetamine and fenfluramine
• medicines that treat Parkinson’s disease, e.g. levodopa
• dopamine, a medicine used to treat certain heart conditions
• the pain killers pethidine and nefopam
• general anaesthetics such as propofol, which are used in surgery
• other medicines used to treat depression (e.g. amitriptyline, imipramine, tryptophan)
• buspirone, used to treat anxiety
• metrizamide, used as a nonionic radiopaque contrast agent.

Tranylcypromine tablets must be taken with caution if you are taking the following medicines:

• other MAOIs such as isocarboxazid
• strong pain killers, e.g. codeine
• medicines to treat seizures/fits, e.g. carbamazepine
• barbiturates used to treat severe sleeping problems, e.g. amylobarbitone
• SSRIs such as fluoxetine or sertraline (for depression). Taking your medicine with these products may cause the following serious side effects: sweating, extreme agitation, confusion, muscle stiffness
• medicines for high blood pressure (e.g. guanethidine, reserpine, methyldopa)
• medicines to treat diabetes (e.g. insulin, metformin)
• antihistamines used to treat allergies, e.g. cetirizine.

Consult your doctor before you take Tranylcypromine tablets if you are taking or might be taking any of these.

You should NOT take alcohol (especially red wine) whilst you are taking Tranylcypromine tablets. This includes non-alcoholic beer or lager.

Tranylcypromine tablets stops the breakdown of a substance called tyramine which is found in large amounts of certain foods. If this substance is not broken down, it can cause very high blood pressure. So, whilst you are taking Tranylcypromine tablets, you should avoid the following foods:

• matured cheeses – (e.g. cheddar or processed cheese made from mature cheese)
• yeast extracts (e.g. Bovril or Marmite)
• meat, fish or poultry which is not fresh or has been pickled
• broad bean pods
• banana skins.

These tablets should NOT be used during pregnancy or breast feeding unless your doctor thinks it is essential. This medicine may pass into breast milk. Your doctor will decide whether you should gradually reduce or stop treatment with Tranylcypromine tablets.

The effects of this medicine on fertility are unknown.

Tranylcypromine tablets may make you feel drowsy or dizzy or affect your concentration. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine also contains allura red AC (E129) which may cause allergic reactions.

If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you miss a dose, wait until your next dose. Do not take a double dose to make up for a forgotten tablet. You can then carry on as before.

Do not take more than one dose at a time.

Stopping the tablets suddenly may cause nausea (feeling sick), vomiting (being sick), sweating and difficulty in sleeping.

You should continue to take the tablets even if you no longer feel ill. DO NOT STOP taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time. When the time comes to stop your doctor will probably decrease your dose gradually.

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.

Tranylcypromine 10 mg tablets are Pink to light pink, round (diameter 7 mm) biconvex coated tablets debossed with ‘Y3’ on one side and score line on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

They are available as:

Blister pack: White opaque PVC/PVDC-Aluminium blister packs in aluminium pouch with molecular sieve desiccant further packed in cardboard cartons. The desiccant is not for ingestion. Pack sizes includes 10, 20, 30 tablets.

Container pack: HDPE containers with child resistant closures containing molecular sieve as desiccant. Pack size includes 28 tablets.

The tablets packed in blister pack and in containers include a desiccant protecting the tablets from moisture. The desiccant available is not for ingestion.

Not all pack sizes may be marketed.

Other sources of information:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

Product name Reference Number

Tranylcypromine 10 mg film-coated tablets PL 25258/0313

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