Moclobemide 150mg Tablets
|
148x420 Merckle 17.03.2003 16 : 16 Uhr S |
rite 1 148 mm |
A
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Moclobemide 150 mg film-coated ratiopharm tablets
For use in adults
Read all of this leaflet carefully before you start taking 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. See section 4.
Vorderseite / Frontside
Die Textrichtung (quer-oder hochstehendes Format) und die Anzahl der Textspalten konnen frei gestaltet werden.
The direction of the text (landscape or portrait) and the number of columns is not specified.
What is in this leaflet
1. What Moclobemide film-coated tablets is and what it is used for
2. What you need to know before you take Moclobemide film-coated tablets
3. How to take Moclobemide film-coated tablets
4. Possible side effects
5. How to store Moclobemide film-coated tablets
6. Contents of the pack and other information
1. What Moclobemide film-coated tablets is and what it is used for
Moclobemide belongs to a group of medicines called selective monoamine oxidase inhibitors (MAOIs) or antidepressants.
Your doctor has prescribed this medicine in order to relieve the symptoms of depression.
2. What you need to know before you take Moclobemide film-coated tablets
Do not take Moclobemide film-coated tablets:
• if you are allergic to moclobemide or to any of the other ingredients of this medicine (listed in section 6.). Allergic reactions may include wheezing, swelling of the face or tongue, intense itching or severe skin rashes
• if you are under the age of 18 years
• if you suffer from a condition that makes you feel confused
• if you have phaeochromocytoma (a rare tumour of the adrenal glands which usually causes attacks of headache, sweating, palpitations, flushing of the face or pains in the chest)
• if you are taking selegiline (a medicine used in Parkinson's disease)
• if you are taking other medicines for your depression (e.g. tricyclic antidepressants (e.g. clomipramine and amitriptyline), venlafaxine, fluoxetine, fluvoxamine, citalopram, escitalopram, paroxetine, sertraline, phenelzin and tranylcypromine) or if you have stopped taking these medicines just recently or some weeks ago, as the drugs may be still in your body. Moclobemide film-coated tablets should not be taken with other antidepressants, as this can cause serotonin syndrome (symptoms include a rise in temperature, confusion, stiffness, irritability, rise in blood pressure, rapid heart beat, and tremors)
• if you are taking linezolid (an antibiotic)
• if you are taking triptanes (medicines used to treat migraine, e.g. sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan and eletriptan)
• if you are taking pethidine or tramadol (strong painkillers)
• if you are taking bupropion (a medicine used to treat depression and to help to stop smoking)
• if you are taking any medicines containing dextromethorphan, which is found in many cough medicines.
Check with your pharmacist or doctor if you are not sure.
Warnings and precautions
Talk to your doctor before taking Moclobemide film-coated tablets if:
• you have liver disease
• you know you have an overactive thyroid (thyreotoxicosis)
• you have high blood pressure, your doctor will closely monitor your treatment
• you have a 'bi-polar disorder', sometimes called manic depression
• you suffer from a mental illness such as schizophrenia
• you suffer from cardiac arrhythmia (risk of QT-prolongation).
Tell your doctor immediately if you develop overactive behaviour or thoughts (mania/hypomania), sleeping problems or nervousness.
Tell your doctor if you need to have an operation while taking this medicine.
Allergic reactions may occur in some patients (including rash and swelling).
Thoughts of suicide and worsening of your depression
If you are depressed 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 previously had thoughts about killing or harming yourself
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young 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 and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Children and adolescents
Moclobemide film-coated tablets should not be given to children and adolescents under the age of 18 years old.
Other medicines and Moclobemide film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Moclobemide and tell your doctor or pharmacist if you are taking
• any of the medicines listed in section "2. What you need to know before you take Moclobemide film-coated tablets" under the heading "Do not take Moclobemide film-coated tablets"
Tell your doctor or pharmacist if you are taking any of the following medicines
• Medicines known to prolong the QT interval
• Cimetidine (used for heartburn or stomach ulcers). It might be necessary that your doctor reduces your moclobemide dose
• Morphine, fentanyl or codeine (strong pain killers)
• Buspirone (to treat anxiety)
• Medicines given by injection containing epinephrine or norepinephrine
• Ephedrine, phenylpropanolamine or pseudoephedrine or dextromethorphan (usually found in medicines for coughs and colds)
• The herbal remedy St John's wort, since this may result in an increase in side effects
• Omeprazole (used for heartburn or stomach ulcers)
• Trimipramine and maprotiline (antidepressants)
• Sibutramine (used to treat obesity)
• Dextropropoxyphene (pain killer).
Check with your pharmacist or doctor if you are not sure.
Moclobemide film-coated tablets with food, drink and alcohol
You are advised not to drink alcohol while you are being treated with this medicine. The tablets should be swallowed with some water and should always be taken after meals.
Some patients may be especially sensitive to tyramine (a naturally occurring substance in the body that raises blood pressure). It is important that you do not eat large amounts of food containing tyramine (e.g. mature cheese, red wine, yeast extracts, fermented soya bean products - contained in some Chinese foods) whilst taking Moclobemide film-coated tablets. Pregnancy and breast-feeding
Do not take moclobemide if you are pregnant, planning to become pregnant or breast-feeding, unless your doctor has told you to.
V
-<->»
12 mm
|
148x420 Merckle 17.03.2003 16 : 16 Uhr Se |
rite 2 148 mm |
A
Driving and using machines
Do not drive or operate machinery if you feel less alert or drowsy. These side effects are more likely to occur at the start of treatment.
Moclobemide film-coated tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Moclobemide film-coated tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults including the elderly:
The usual starting dose is 300 mg of moclobemide per day. This is to be taken throughout the day. Your doctor may decide to prescribe a different dose for you. Based on personal circumstances, the daily dose can range from 150 mg to 600 mg of moclobemide a day.
The tablets should be swallowed with some water and should always be taken after meals.
If you have liver problems your doctor may decide on a lower dose.
If you take more Moclobemide film-coated tablets than you should
If you take more Moclobemide film-coated tablets than you should, contact your doctor or nearest hospital casualty department immediately as an overdose can be life threatening.
If you forget to take Moclobemide film-coated tablets
If you forget to take Moclobemide film-coated tablets, take it as soon as you remember. Then go on as before. Do not take two doses at the same time.
If you stop taking Moclobemide film-coated tablets
Remember that you may need to take these tablets for 2 or more weeks before you begin to feel better. Do not stop taking this medicine if you begin to feel better. Treatment should carry on for 4 to 6 months once symptoms have improved. This will help stop the symptoms coming back.
If you are worried or feel your depression is getting worse, please see your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking your medicine and seek immediate medical advice if you experience any of the following side effects:
• Allergic reaction - swelling of the face, lips, tongue, throat, or difficulty breathing or swallowing, sudden swelling of the ankles, skin reactions (including rash, pruritus -itching, urticaria - rash from sudden release of histamine in the skin, and flushing).
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Serotonin syndrome may occur if Moclobemide film-coated tablets is given concomitantly with other medicines, for example other medicines to treat depression (see "Do not take Moclobemide film-coated tablets" and "Other medicines and Moclobemide film-coated tablets"). Tell your doctor if you experience high fever, trembling (tremor), sudden movements of the muscles and agitation, because these symptoms may indicate the development of this condition. Treatment with Moclobemide film-coated tablets should be discontinued immediately.
Other side effects
Some effects such as feeling anxious, agitated or irritable and other mood changes, often go away after the first few weeks of treatment.
Very common (may affect more than 1 in 10 people)
• sleeping problems
• dizziness
• headache
• dry mouth
• feeling sick
Common (may affect up to 1 in 10 people)
• agitation, feelings of anxiety, restlessness
• numbness and tingling
• low blood pressure
• being sick, diarrhoea, constipation
• rash
• irritability
Uncommon (may affect up to 1 in 100 people)
• suicidal ideation
• confusion (this side effect quickly disappears after treatment is stopped)
• change in taste
• changes to your eyesight
• flushing
• oedema (accumulation of fluid in the body)
• skin reactions (itching, hives)
• weakness.
Rare (may affect up to 1 in 1,000 people)
• decreased appetite
• low levels of sodium in the blood
• suicidal behaviour
• delusion
• serotonin syndrome
• in laboratory tests a low incidence of raised liver enzymes has been reported but without having any impact on the patient.
Very rare (may affect up to 1 in 10,000 people)
• leaking of milk from the breasts.
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 at: 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 Moclobemide film-coated 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. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicine via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Moclobemide film-coated tablets contain
• The active substance is moclobemide.
• Each tablet contains 150 mg or 300 mg of moclobemide.
• Both strengths are film-coated and contain the following excipients:
• Lactose, maize starch, sodium starch glycolate, povidone and magnesium stearate.
• The 150 mg tablets also contain:
• Lactose monohydrate, hypromellose, titanium dioxide (E171), glyceryl triacetate and ferric oxide yellow (ET72).
What Moclobemide film-coated tablets looks like and contents of the pack
The 150 mg tablets are yellow, oval tablets, scored on one side and marked 'P 150' on the other. The tablets are scored so they can easily be broken in half.
Your tablets are available in PVC/alu blister packs containing 10, 20, 28, 30, 40, 50, 60, 84, 90, 100, 100x1,500 (10 x 50 as hospital pack only) film-coated tablets.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany Revision date: October 2015
Ruckseite / Backside
Die Textrichtung (quer-oder hochstehendes Format) und die Anzahl der Textspalten konnen frei gestaltet werden.
The direction of the text (landscape or portrait) and the number of columns is not specified.
ratiopharm
20117-H
V
-<—>»
12 mm
12 mm