Tranylcypromine 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANYLCYPROMINE 10MG TABLETS
EAD ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• 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.
What is in this leaflet
1. What Tranylcypromine 10mg Tablets are and what are they used for
2. What you need to know before you take Tranylcypromine 10mg Tablets
How to take Tranylcypromine 10mg Tablets Possible side effects
5. How to store Tranylcypromine 10mg Tablets
6. Contents of the pack and other information
1. WHAT TRANYLCYPROMINE 10MG TABLETS ARE
AND WHAT THEY ARE USED FOR_
Tranylcypromine 10mg Tablets contain the active substance tranylcypromine which belongs to a group of antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). It works by stopping the breakdown of two substances in the brain called serotonin and noradrenaline. Your medicine should help bring these substances back to normal levels.
Tranylcypromine 10mg Tablets are used to treat moderate to severe depression in adults. They can also help feelings of fear (phobia), which sometimes occur in depression. This medicine is often used when other types of antidepressant medicines have not worked.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRANYLCYPROMINE 10MG TABLETS_
Do not take Tranylcypromine if you:
- are allergic to tranylcypromine or any of the other ingredients of this medicine (listed in section 6)
- are taking other MAOIs or have taken other MAOIs within the last two weeks
- have taken clomipramine or imipramine within the last three weeks or are planning to take them within the next three weeks
- suffer from porphyria (an inherited disease affecting the nervous system and skin)
- have severe heart disease or any disease of the blood vessels of the brain
- have phaeochromocytoma, which is a tumour of the adrenal glands (glands near the kidneys) causing high blood pressure
- have been diagnosed with an overactive thyroid gland (a gland in the neck)
- have known liver damage or a disorder affecting the blood cells (your doctor will know)
- are taking any of the medicines listed under "Do not take" in the Other Medicines and Tranylcypromine section of this leaflet.
t lease tell your doctor if any of the above apply to you, and do not take ranylcypromine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tranylcypromine 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
Even though some of the above may be obvious, it is important that
your doctor is aware if any of them apply to you.
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 (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. |
Children and adolescents
Tranylcypromine is not recommended for children under 18 years old (see section 3 ‘Use in children and adolescents’).
Other medicines and Tranylcypromine
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 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.
Tranylcypromine must be taken with caution if you are taking the following medicines:
- other MAOIs such as isocarboxid
- 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 sertaline (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 if you are takin or might be taking any of these.
Tranylcypromine with food, drink and alcohol
You should NOT drink alcohol (especially red wine) whilst you are taking Tranylcypromine. This includes non-alcoholic beer or lager. Tranylcypromine 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, 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.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, are planning to have a baby, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Tranylcypromine should NOT be used during pregnancy unless you doctor thinks it is essential. This medicine may pass into breast milk. Your doctor will decide whether you should ablactate (gradually reduce) or stop therapy with Tranylcypromine.
Effects of Tranylcypromine on fertility are unknown.
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Driving and using machines
Tranylcypromine 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.
Tranylcypromine contains aspartame (E951), carmoisine lake (E122) and ponceau 4R lake (E124) and sucrose
This medicine contains aspartame (E951) which contains a source of phenylalanine which may be harmful for people with phenylketonuria This medicine contains carmoisine lake (E122) and ponceau 4R lake (E124), which may cause allergic reactions.
This medicine also contains sucrose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE TRANYLCYPROMINE 10MG TABLETS_
Always take Tranylcypromine exactly as your doctor has told you. Do NOT take more than your doctor tells you to. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a glass of water.
USUAL DOSE (Adults only)
- One tablet in the morning and one tablet in the afternoon each day.
- Try to take the last dose before 3 o’clock in the afternoon.
- This dose may be increased by your doctor to three tablets a day. Take the extra tablet at midday.
- If you are elderly your doctor will usually prescribe you a lower dose.
- When you start to feel better, your doctor may change your dose to one tablet a day.
Do NOT take more than three tablets each day unless your doctor tells you to.
Use in children and adolescents
Tranylcypromine is not recommended for children under 18 years old (see section 2 ‘Children and adolescents’).
If you take more Tranylcypromine than you should
If you think that you, or any other person, may 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 knows exactly what you have taken.
If you forget to take Tranylcypromine
If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.
If you stop taking Tranylcypromine
Continue to take Tranylcypromine 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,
Es stopping the tablets suddenly may cause side effects such as ausea (feeling sick), vomiting (being sick), sweating and difficulty in sleeping.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS_
Like all medicines, Tranylcypromine can cause side effects, although not everybody gets them.
If you eat foods or take medicines which interact with the active ingredient tranylcypromine, you may get very high blood pressure (a hypertensive crisis).
If you notice any of the following symptoms please see your doctor immediately:
- frequent or throbbing headaches, painful or stiff neck, changes in heart rate, pain in the middle of the chest, feeling sick or being sick, sweating, paleness, or flushing of the skin and enlarged pupils which may make bright sunlight uncomfortable. Although very rare, there may be muscle weakness or paralysis (loss of movement) down one side of the body and there have been a few deaths from hypertensive crisis
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- thoughts of suicide and suicidal behaviour early on in treatment or shortly after stopping treatment (see section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder’).
Sometimes patients feel anxious whilst taking this medicine and rarely some patients will become very agitated or irritable. Your doctor may reduce your dose if this happens.
Some patients get low blood pressure and may feel dizzy on standing up. If this continues for a long time, your doctor may stop your medicine.
Other side effects which may occur include:
- difficulty in sleeping, mild headache, sleepiness, weakness, dizziness, fast heart beat (palpitations), restlessness, dry mouth, blurred vision, feeling sick, water retention or swelling, weight gain, increased appetite, rash and difficulty in passing water.
Rarely some patients experience soreness in the hands and feet, which may be a sign of inflamed nerves.
Rarely, some patients may find the relief of their depression decreases with time and higher doses of the active ingredient, tranylcypromine, are needed to get the same effect.
Very rarely, liver problems (symptoms include yellowing of the skin and the whites of the eyes), bruising and changes in blood have been reported. Therefore, if you get a bad sore throat or high fever or become very tired and pale or notice bruises and nose bleeds, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also help make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available between 10am - 2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
5. HOW TO STORE TRANYLCYPROMINE 10MG
TABLETS_
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the carton and bottle label or blister. The expiry date refers to the last day of the month.
• Do not store above 25°C. Store in the original package to protect from light and moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION_
What Tranylcypromine contains
The active substance is tranylcypromine. Each tablet contains 10mg of tranylcypromine.
The other ingredients are: cellulose microcrystalline, pregelatinised starch, carmellose sodium, calcium sulfate dihydrate, croscarmellose sodium and magnesium stearate. The coating contains opalglos clear (which contains shellac (E904)), calcium carbonate (E170), hypromellose, polyethylene glycol, talc, titanium dioxide (E171), ponceau 4R lake (E124), carmoisine lake (E122), aspartame (E951), sucrose and edible ink. The ink contains shellac (E904), black iron oxide (E172), propylene glycol and ammonium hydroxide.
What Tranylcypromine 10mg Tablets look like and contents of the pack
Tranylcypromine 10mg Tablets are red, round, biconvex coated tablets imprinted in black with TRN on one side and plain on the other side. They are supplied in either bottles or blisters of 20, 28, 45, 90 or 250 tablets. Not all pack sizes are marketed.
Marketing Authorisation Holder
Lime Pharma Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK
Manufacturer
NRIM Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United Kingdom.
This leaflet was prepared in 09/2014
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