Parnate 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARNATE® 10MG TABLETS (tranylcypromine sulphate)
Read all of this leaflet carefully before you start taking this medicine.
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 any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Parnate® 10mg Tablets are and what they are used for
2. Before you take Parnate® 10mg Tablets
3. How to take Parnate® 10mg Tablets
4. Possible side effects
5. How to store Parnate® 10mg Tablets
6. Further information
1. What Parnate® 10mg Tablets are and what they are used for
Parnate® 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.
Parnate® 10mg Tablets are used to treat moderate to severe depression. They can also help feelings of fear (phobia) which sometimes occurs in depression. This medicine is often used when other types of antidepressant medicines have not worked.
2. Before you take Parnate® 10mg Tablets DO NOT take Parnate® 10mg Tablets if:
• You know that you are allergic to tranylcypromine or any of the other ingredients of Parnate® 10mgTablets (see section 6 of this leaflet)
• You are taking clomipramine, imipramine and venlafaxine
• 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 known liver damage or a disorder affecting the blood cells (your doctor will know)
• You are pregnant, trying to become pregnant or breast-feeding
• You are in a manic phase
• You are taking any of the medicines listed under “Do not take” in the Taking Other Medicines section of this leaflet.
Please tell your doctor if any of the above applies to you.
Take special care with Parnate® 10mg Tablets and talk to your doctor if you:
• are elderly
• have a mild heart problem which restricts your activity
• suffer from seizures/fits (epilepsy)
• suffer from diabetes mellitus (sugar diabetes)
• suffer from blood disorders
• taking diuretics (water tablets)
• are due to have surgery in the next few weeks
• have depression or suicidal thoughts
• suffer from low blood pressure or high blood pressure
• suffer from schizophrenia
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Parnate® 10mg Tablets MUST NOT be taken 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 e.g. dextromethorphan bought without a prescription)
• Bupropion, a medicine to help you stop smoking
• Medicines for migraine e.g. 5HT1 agonists
• Strong pain killers e.g. pethidine, morphine, codeine and nefopam
• It should not be administered at the same time as, or within 14 days of treatment with other MAOIs such as isocarboxid, buspirone, or dibenzazepine derivative drugs (including tricyclic antidepressant agents, perphenazine or carbemazepine)
• Medicines used to treat depression (e.g. clomipramine, imipramine, venlafaxine).
• Tranylcypromine should not be administered together with clomipramine and imipramine. In the cases of clomipramine and imipramine, 3 weeks should be left before starting tranylcypromine therapy.
• Tranylcypromine should not be administered in combination with selective serotonin reuptake inhibitors (SSRIs) e.g., fluoxetine or serotonin/noradrenaline reuptake inhibitors (SNRIs) e.g. venlafaxine. Therefore SSRIs and SNRIs should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.
• Buspirone, used to treat anxiety
• Medicines to treat seizures/fits, e.g. carbamazepine
• Perphenazine used to treat schizophrenia
• Guanethidine used to treat high blood pressure
• SSRIs such as fluoxetine, paroxetine or sertaline (for depression)
• Medicines like altretamine used for the treatment of cancer
• Doxapram used to increase the rate of breathing, especially during surgery
• Medicines like oxypertin, clozapine used for the treatment of mental disorders like schizophrenia
• Tetrabenazine used for the treatment of excessive restlessness.
Parnate® 10mg Tablets must be taken with caution if you are taking the following medicines:
• Barbiturates used to treat severe sleeping problems, e.g. amylobarbitone
• Medicines used to treat depression (e.g. amitriptyline, imipramine, tryptophan, amfebutamone)
• Phenylpropanolamine used to treat nasal congestion associate with allergies
• Medicines for high blood pressure (e.g. reserpine, methyldopa)
• Medicines to control appetite, e.g. amphetamine and fenfluramine
• Antimuscarinics for motion sickness, muscle cramps in the gut or bladder
• Medicines that treat Parkinson’s disease, e.g. levodopa
• Dopamine, a medicine used to treat certain heart conditions
• Local anaesthetics e.g. lidocaine
• Medicines to treat diabetes (e.g. insulin, metformin).
At least 5 weeks should be allowed after stopping fluoxetine before starting Parnate.
At least 2 weeks should be allowed after stopping paroxetine before starting Parnate.
Taking Parnate® 10mg Tablets with food and drink
You should NOT take alcohol (especially red wine) whilst you are taking Parnate® 10mg Tablets. This includes non-alcoholic beer or lager.
Parnate® 10mg 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 Parnate® 10mg Tablets, you should avoid the following foods:
• Matured cheeses - cooked or plain (e.g. cheddar or processed cheese made from mature cheese)
• Yeast extracts (e.g. Bovril, Oxo, brewer’s yeast or Marmite)
• Meat, fish or poultry which is not fresh or has been pickled or aged e.g. hung game, pickled herrings
• Broad bean pods
• Flavored textured vegetable protein
• Protein foods that are not fresh and whose preparation involved hydrolysis, fermentation, pickling, hanging, smoking or bacterial contamination e.g. dry sausage (salami, pepperoni etc.), fermented soya bean extract, liver, yoghurt
• Excessive amounts of chocolate
• Excessive amounts of tea or coffee.
Pregnancy and breast feeding
Please let the doctor know if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding. Parnate® 10mg Tablets should NOT be used during pregnancy or breast feeding unless your doctor thinks it is essential. This medicine may pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Parnate® 10mg 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.
Important information about some of the ingredients of Parnate® 10mg Tablets
This medicine also contains carmoisine (E122) and Ponceau 4R (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.
If you have an operation or you need to go to the Dentist:
Parnate® 10mg Tablets are not normally taken for two weeks before an operation or major dentistry. Check with your doctor or dentist and alert them to your medication.
3. How to take Parnate® 10mg Tablets
Always take Parnate® 10mg Tablets exactly as your doctor has told you. Do NOT take more than your doctor tells you to. You should 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.
Children: Tranylcypromine Tablets are not recommended for children under 18 years old.
If you take more Parnate® 10mg Tablets than you should:
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 forget to take your Parnate® 10mg Tablets:
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 Parnate® 10mg Tablets
Continue to take Parnate® 10mg 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 as stopping the tablets suddenly may cause ill-effects such as nausea (feeling sick), vomiting (being sick), sweating, vivid nightmares, fits, worsening of symptoms 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, Parnate® 10mg Tablets can sometimes 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 headaches, shakiness, nervousness, excessive happiness or excitement (euphoria), 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, muscle twitching, muscle jerks, increased reflexes, feeling nervous or uneasy. Although very rare, muscle rigidity, fever and irregular body movements (i.e. neuroleptic malignant syndrome), severe problems with the heart and breathing, changes in the metabolism may occur, feeling of a lump in the throat, increased muscular movements, coma
• thought of suicide and suicidal behaviour early on in treatment or shortly after stopping treatment.
If this occurs contact your doctor or go to a hospital straight away.
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. 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.
Other side effects which may occur include:
• difficulty in sleeping, mild headache, sleepiness, weakness, dizziness, fast or irregular heart beat (palpitations), restlessness, dry mouth, inability to normally open mouth, blurred vision, feeling sick, water retention or swelling, difficulty in passing stools, other tummy problems, swelling, increase in the level of liver enzymes on examination, squint in the eyes, decrease in the blood cell count in the body, sexual problems, confusion, reduced or increased levels of salt in the body, repetition or echoing of one's own spoken words, fits, glaucoma (increased pressure in the eyes) itching, tingling or pricking of skin, altered driving abilities, weight gain, increased appetite, rash, being sick, diarrhoea, fatigue, hallucinations and difficulty in passing water.
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.
Rarely some patients experience soreness in the hands and feet which may be a sign of inflamed nerves, spasm of the axial muscles.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
You may find it helpful to tell a relative or close friend that you are depressed or have anxiety disorder, and to ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is becoming worse or if they are worried about changes in your behaviour. Also you can help to make sure that 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 from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Parnate® 10mg Tablets
Keep out of the sight and reach of children.
Do not use Parnate® 10mg Tablets after the expiry date which is stated on the box. The expiry date refers to the last day of that month. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
Do not store above 25°C. Store in the original container in order to protect from light and moisture. Replace cap tightly after use
If your tablets appear to be discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
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
Each tablet contains tranylcypromine sulphate equivalent to 10mg of tranylcypromine.
Parnate® 10mg Tablets also contains sucrose, maize starch, calcium sulphate dihydrate (E516), carmellose sodium, magnesium stearate (E470b). The coating contains gelatin, sucrose, docusate sodium, purified talc (E553b), light kaolin (E559), calcium carbonate (E170), ethylcellulose, acacia (E414), carmoisine (E122), ponceau 4R (E124), maize starch, titanium dioxide (E171), carnauba wax (E903) and edible ink (shellac, iron oxide (E172), soya lecithin (E322) and trace amounts of dimethyl siloxane).
What Parnate® 10mg Tablets look like and contents of the pack
Parnate® 10mg tablets are geranium-red coloured, bi-convex, sugar-coated tablets marked FW 251 on one face and plain on the reverse. They are packed in plastic containers with a cap and security tag containing desiccant cartridge with 28 tablets.
Manufacturer:
Dales Pharmaceuticals Ltd.,
Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW. UK
Procured from within the EU by the Product Licence holder: Millsdale Pharmaceuticals, John Street, Warrington, Cheshire,WA2 7UB, UK.
PL No. 08811/0041 POM
This leaflet was prepared 26th November 2013.
Parnate® is a registered trademark of Goldshield Group PLC.