10 mg, 20 mg film-coated tablets
tranylcypromine
What Tranylcypromine Glenmark is and what it is used for
Tranylcypromine Glenmark contains the active substance tranylcypromine, which belongs to a group of antidepressants known as monoamine oxidase inhibitors (MAOIs). They work by preventing the breakdown of two substances in the brain called serotonin and norepinephrine.
This medicine is used to treat severe depressive episodes in adult patients with a major depressive disorder where appropriate standard treatment with 2 antidepressants (including tricyclic antidepressants ) and augmentation with, for example, lithium has given an inadequate treatment response.
The tranylcypromine contained in Tranylcypromine Glenmark may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Tranylcypromine Glenmark
Do not take Tranylcypromine Glenmark if:
- you are allergic to the active substance or any other ingredient in this medicine (listed in section 6).
- you are taking or have taken other MAO inhibitors in the last two weeks (see below ‘other medicines and Tranylcypromine Glenmark’).
- you have pheochromocytoma, which is a tumor of the adrenal glands ( glands near the kidneys) that causes high blood pressure.
- you have severe heart disease ( cardiovascular ) or any disease in the blood vessels of the brain
- you have high blood pressure or vascular disease ( aneurysms )
- you have known liver damage or impaired kidney function
- you suffer from porphyria (an inherited disease that affects the nervous system and the skin).
- you have diabetes insipidus (pituitary gland disorder that leads to excessive thirst and large amounts of urine).
- you are taking any of the medicines listed under “Do not take” in the “Other medicines and Tranylcypromine Glenmark” section of this leaflet.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
Having suicidal thoughts and worsening your depression or anxiety disorder:
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide (see section 4 “Possible side effects”). These may increase when you start anti-depressants, as all these medicines take time to work, usually 2 weeks but sometimes longer.
You may be more likely to have these thoughts if you:
- have previously had thoughts of harming yourself or committing suicide.
- is a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under the age of 25 with psychiatric conditions who have been treated with antidepressants.
If, at any time, you have thoughts of harming yourself or committing suicide, contact a doctor or hospital immediately. It may help you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behavior.
Talk to your doctor or pharmacist before taking this medicine if you:
- are older
- have a mild heart problem that limits your activity
- suffering from convulsions/seizures ( epilepsy )
- will have surgery in the next few weeks
- have previously been addicted to drugs or alcohol.
- taking food, stimulants, or drinks containing high levels of tyramine (see below, Tranylcypromine Glenmark with food, drink, and alcohol)
- use other antidepressants such as ‘selective serotonin reuptake inhibitors (see below). There is a risk of triggering a condition called ‘serotonergic syndrome’, with symptoms such as increased blood pressure, irritability, and rising body temperature.
Although some of the above may seem obvious, your doctor must be aware of whether any of them apply to you.
Children and young people
Tranylcypromine Glenmark is not recommended for children and adolescents under the age of 18 (see section 3 “Use in children and adolescents”).
Other medicines and Tranylcypromine Glenmark
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 Glenmark with the following medicines:
- other antidepressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and selective serotonin reuptake inhibitors (clomipramine or imipramine). These medicines can raise blood pressure, and irritability and increase body temperature (serotonergic syndrome).
- medicines called sympathomimetics – such as ephedrine, pseudoephedrine, adrenaline, and norepinephrine (these can be found in medicines used to treat heart problems and asthma as well as in some decongestants and cough/cold medicines)
- bupropion, a medicine to help you quit smoking
- painkiller; pethidine and nefopam • anesthetics such as propofol, which is used in surgery
- other medicines used to treat depression (eg amitriptyline, imipramine, tryptophan)
- buspirone used to treat anxiety
Tranylcypromine Glenmark must be used with caution if you are taking any of the following medicines:
- other MAOIs such as isocarboxazid
- strong painkillers, e.g. codeine
- anticonvulsant/seizure medication, e.g. carbamazepine
- barbiturates are used to treat serious sleep problems, e.g. amylobarbitone
- SSRIs such as fluoxetine or sertraline (for depression). Taking this medicine together with these products can cause the following serious side effects: sweating, extreme restlessness, confusion, muscle stiffness
- medicines for high blood pressure (eg guanethidine, reserpine, methyldopa)
- diabetes medications ( eg insulin, metformin )
- antihistamines used to treat allergies, e.g. cetirizine.
Consult a doctor before taking Tranylcypromine Glenmark if you are taking or might take any of the above medicines.
Tranylcypromine Glenmark with food, drink, and alcohol
You should not drink alcohol (especially red wine) while taking Tranylcypromine Glenmark. The effects of alcohol may be enhanced when Tranylcypromine Glenmark is used at the same time. You should also avoid non-alcoholic beer or lager.
You must follow your doctor’s dietary advice strictly as the intake of certain foods and drinks has a major impact on tranylcypromine. A dietitian with specialist knowledge of psychiatric disorders and psychotropic drugs should discuss dietary advice with you.
Tranylcypromine Glenmark prevents the breakdown of a substance called tyramine which is found in large amounts in certain foods. If this substance is not broken down, it can cause very high blood pressure. Therefore, you should avoid the following foods while taking Tranylcypromine Glenmark:
- aged cheeses – (eg cheddar or processed cheese made from aged cheese)
- yeast extract (eg Bovril or Marmite) • meat, fish, or poultry that is not fresh or that is pickled
- broad beans
- banana peel.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Tranylcypromine Glenmark should NOT be used during pregnancy or breastfeeding unless your doctor thinks it is necessary. This medicine can pass into breast milk. Your doctor will decide whether you should gradually reduce or stop your treatment with Tranylcypromine Glenmark.
Effects of Tranylcypromine Glenmark on fertility are unknown
Driving ability and use of machinery
Tranylcypromine Glenmark may make you feel drowsy or dizzy or affect your concentration. Until you are sure that you do not get these side effects, you should not drive or operate machinery when you start taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tranylcypromine Glenmark contains lactose monohydrate
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tranylcypromine Glenmark
Always take this medicine exactly as directed by your doctor.
DO NOT take more than your doctor tells you. Ask your doctor or pharmacist if you are unsure.
Swallow the tablets whole with a glass of water. The tablets have a score. For the 10 mg tablet, the score is not for dividing the tablet into equal doses, but only to facilitate swallowing. The 20 mg tablet, on the other hand, can be divided into two equal parts.
Treatment should only take place as prescribed and under the medical supervision of a psychiatrist.
Dosage for adults
- The starting dose is 10 mg tranylcypromine once daily in the morning. The usual recommended dose is 20 to 40 mg of tranylcypromine per day. The daily dose can be taken divided into 1 to 3 doses.
- Try to take the last dose before 3 pm
- The dose may be adjusted by your doctor depending on how you respond to treatment. Take the extra tablet in the middle of the day.
- If you are older, your doctor will usually prescribe a lower dose for you.
When you start to feel better, your doctor may change your dose to 10 to 20 mg a day.
Do NOT take more than 60 mg (three 20 mg tablets) per day unless your doctor tells you to.
Use for children and adolescents
Tranylcypromine Glenmark is not recommended for children under the age of 18 (see section 2 “Children and adolescents”).
If you have taken too much Tranylcypromine Glenmark
If you think you or someone else has taken too many tablets, or if e.g. a child has ingested the medicine by mistake, you must immediately contact a doctor or hospital for an assessment of the risk and advice. Take any remaining tablets and this leaflet with you so that medical staff knows exactly what you have taken.
Symptoms of overdose are confusion, convulsions, fever, unconsciousness, difficulty breathing, irregular blood pressure, irregular heartbeat, and muscle cramps. Careful monitoring of blood pressure it is important. Patients must be closely monitored for at least one week following an overdose, as symptoms of overdose may be delayed or prolonged. Consultation with the Poisons Information Center is recommended.
If you forget to take Tranylcypromine Glenmark
If you forget a dose, wait until the next dose. Do not take a double dose to make up for a missed dose. Then continue as before.
Do not take more than one dose at a time
If you stop taking Tranylcypromine Glenmark
Do not stop taking Tranylcypromine Glenmark suddenly as withdrawal symptoms such as anxiety, restlessness, sleep disturbances, and drowsiness may occur. Consult your doctor before stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Tranylcypromine Glenmark and contact your doctor as soon as possible.
- manic episodes (abnormally elevated mood or irritable mood)
If you eat food or take medicines that interact with the active substance tranylcypromine, you can get very high blood pressure (a so-called hypertensive crisis).
Contact your doctor immediately if you notice any of the following symptoms:
- frequent or throbbing headaches, painful or stiff neck, changes in heart rate, pain in the middle of the chest, nausea or vomiting, sweating, pale or reddened skin, and enlarged pupils, which may make bright sunlight uncomfortable. Although very rare, muscle weakness or paralysis (loss of movement) can occur along one side of the body and there have been some deaths from hypertensive crisis
- suicidal thoughts and behavior early in treatment or shortly after treatment ends (see section 2 “Suicidal thoughts and worsening of your depression or anxiety”).
Sometimes patients feel anxious while taking this medicine and in rare cases, some patients become very agitated or irritable. Your doctor may reduce your dose if this happens.
Some patients develop low blood pressure and may feel dizzy when standing up. If this continues for a long time, your doctor may decide to stop your medication.
Other side effects that may occur include:
- difficulty sleeping, light headache, sleepiness, weakness, dizziness, fast heartbeat (palpitations), restlessness, dry mouth, blurred vision, nausea, fluid retention or swelling, weight gain, increased appetite, rash, and difficulty urinating
In rare cases, some patients may experience tenderness in the hands and feet, which may be a sign of inflamed nerves.
In rare cases, some patients may find that the relief from their depression decreases over time and that a higher dose of the active substance tranylcypromine is needed to achieve the same effect.
In very rare cases, liver problems (symptoms include yellowing of the skin and the whites of the eyes), bruising and blood changes have been reported. Therefore, tell your doctor if you develop a sore throat or high fever, become very tired and pale, or notice bruising and nosebleeds.
How to store Tranylcypromine Glenmark
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tranylcypromine. Each film-coated tablet contains 10 or 20 mg of tranylcypromine
- Other ingredients are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, anhydrous colloidal silicon dioxide, and magnesium stearate. The finished film coating consists of macrogol, titanium dioxide (E171), talc, and Allura red AC aluminum varnish (E129).
Appearance and package sizes of the medicine
Tranylcypromine Glenmark 10 mg tablets are pink to light pink, round (7 mm in diameter), and biconvex coated tablets debossed with ‘Y3’ on one side and with a score line on the other side. The break score is not for dividing the tablet into equal doses, but only to facilitate swallowing. Each tablet contains 82 mg of lactose monohydrate.
Tranylcypromine Glenmark 20 mg tablets are pink to pale pink, round (9 mm in diameter), biconvex, coated tablets debossed with ‘Y73’ on one side and with a score on the other side. The tablet can be divided into two equal doses. Each tablet contains 164 mg of lactose monohydrate.
They are supplied in white opaque PVC/PVDC Alu blister packs containing 10, 20, and 30 tablets or in HDPE cans of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industrystr. 31
82194 Gröbenzell
Germany
Manufacturer
Glenmark Pharmaceuticals s.r.o., Czech Republic
Fibichova 143,
566 17 Vysoké Mýto
Czech Republic