Moclobemide 300mg Film-Coated Tablets
MOCLOBEMIDE 150 mg and 300 mg FILM-COATED TABLETS
Patient Information Leaflet
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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any side effects not listed in the leaflet. See section 4.
IN THIS LEAFLET:
1. What Moclobemide is and what it is used for
2. What you need to know before you take Moclobemide
3. How to take Moclobemide
4. Possible side effects
5. How to store Moclobemide
6. Contents of the pack and other information
1. WHAT MOCLOBEMIDE IS AND WHAT IT IS USED FOR
Moclobemide belongs to a group of drugs known as antidepressants.
Moclobemide is used to treat:
• depression
• social phobia (a fear of social and public situations).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOCLOBEMIDE Do NOT take Moclobemide if you:
• are allergic (hypersensitive) to moclobemide or any of the other ingredients of this medicine
• suffer from confusion
• have a phaeochromocytoma (a tumour of the adrenal gland that produces hormones that can raise blood pressure)
• are under the age of 18
• are taking any of the medicines listed under “Other medicines and moclobemide; Do not take Moclobemide in combination with, or if you have recently taken”.
Warnings and precautions
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. 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 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.
Talk to your doctor before you start to take this medicine if you:
• have depression as a result of bipolar disorder (manic depression) or schizophrenia or if your depression is accompanied by anxiety. If you suffer from episodes of excitation or agitation, your doctor may also prescribe a sedative to be taken for 2 - 3 weeks
• have high blood pressure, your doctor will closely monitor your treatment
• suffer from thyrotoxicosis (an overactive thyroid gland, often called Grave’s Disease)
• suffer from galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• have liver problems
• are pregnant or breast-feeding
• suffer from a mental illness such as schizophrenia.
Tell the hospital or dentist you are taking Moclobemide if you need an operation requiring an anaesthetic. Allergic reactions may occur in some patients (including rash and swelling).
Other medicine and Moclobemide
DO NOT take Moclobemide in combination with, or if you have recently taken:
• selegiline (used to treat Parkinson’s disease)
• any other antidepressants e.g. clomipramine, fluoxetine, fluvoxamine or if you have taken any antidepressants within the last five days
• any cough or cold remedies containing dextromethorphan
• pethidine (used to relieve pain during labour or after surgery)
• tramadol (used to relieve pain)
• morphine, fentanyl, codeine (used to relieve pain)
• medication to treat migraine attacks e.g. sumatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan and eletriptan or rizatriptan, except naratriptan
• linezolid (antibiotic)
• dextromethorphan( used to relieve cough)
• MAO inhibitor (e.g. phenelzin, tranylcypromine, dextropropoxyphene).
Talk to your doctor if you are taking any of the following:
• drugs used to treat heart problems
• cimetidine (used to treat stomach ulcers or indigestion). It might be necessary that your doctor reduces your moclobemide dose.
• buspirone (used to treat anxiety)
• St. John’s Wort (Hypericum perforatum), a herbal remedy used for depression
• sympathomimetics e.g. adrenaline, noradrenaline, ephedrine, pseudoephedrine or phenylpropanolamine, or are currently taking cough or cold remedies which may contain some of these ingredients.
• proton pump inhibitors (e.g. omeprazole), fluoxetine and fluvoxamine
• anti-depressants such as venlafaxine, fluvoxamine, clomipramine, citalopram, escitalopram, paroxetine, sertraline, bupropion, trimipramine and maprotiline.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Moclobemide with food and drink
• DO NOT drink alcohol whilst you are taking Moclobemide.
• DO NOT eat large amounts of foods rich in tyramine e.g. mature cheese, red wine, yeast extracts and fermented soya bean products whilst you are taking Moclobemide.
Important information about some of the ingredients of Moclobemide
• Patients who are intolerant to lactose should note that Moclobemide Tablets contain a small amount of 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.
Pregnancy, breast-feeding and fertility
• If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.
Driving and using machines
• Your medicine is not expected to affect your ability to drive or operate machinery. However, if affected in any way you should not drive or operate machinery.
3. HOW TO TAKE MOCLOBEMIDE
Always take Moclobemide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably with a glass of water. The usual dose is:
Adults (including the elderly):
• Depression
Initially 300 mg a day taken in divided doses after meals. Your doctor may adjust your dose depending on your response to the drug. The minimum daily dose is 150 mg and the maximum daily dose is 600 mg.
• Social Phobia
Initially 300 mg a day taken as two divided doses after meals. On day 4 of your treatment this will be increased to 600 mg daily, taken as two divided doses. The length of treatment will be 8-12 weeks initially, but your doctor will monitor your condition to decide if you need further treatment.
Patients with liver problems
Your doctor will prescribe a lower dose.
Children:
Moclobemide is not recommended for use in children.
If you take more Moclobemide than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause increasing agitation, aggressiveness and changes in behaviour.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Moclobemide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.
If you stop taking Moclobemide
You should continue to take these tablets for as long as your doctor tells you to. DO NOT stop taking Moclobemide without talking to your doctor first, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Moclobemide can cause side effects, although not everybody gets them.
The following side effects have been reported at the approximate frequencies shown:
Very common (affects more than 1 in 10 people):
• dizziness, headache
• dry mouth, feeling sick, being sick
• sleeping disorder
Common (affects less than 1 in 10 people):
• feelings of anxiety, agitation or irritability, restlessness
• mood changes characterised by excitement, exaggerated high mood and activity
• mood changes characterised by disorganised thinking and incoherent or rambling speech.
• low blood pressure (hypotension)
• sensation of tingling, tickling, prickling, pricking, or burning on skin (paraesthesia)
• vomiting, diarrhoea, constipation
• skin reactions (rashes)
• irritability
Uncommon (affects less than 1 in 100 people):
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction- swelling of the face, lips, tongue, throat, or difficulty breathing or swallowing, sudden swelling of the ankles, skin reactions (including pruritus - itching, urticaria - rash from sudden release of histamine in the skin).
• redness of skin (flushing)
• suicidal ideation, confusional state (these have resolved quickly on discontinuation of therapy)
Other uncommon side effects are:
• bad taste (dysguesia)
• changes in vision (visual impairment)
• weakness (asthenia)
• oedema (fluid retention)
Rare (affects less than 1 in 1000 people):
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. Contact your doctor immediately if you experience:
• high body temperature, confusion, rigidity, irritability, fast heart rate, a rise in blood pressure and shaking. This may be a condition called serotonergic syndrome and has been reported rarely when Moclobemide is given in combination with other antidepressants.
• suicidal behaviours, delusion
Other rare side effects are:
• decreased appetite, low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma, electrolyte imbalance (hyponatraemia)
• in laboratory tests a low incidence of raised liver enzymes has been reported but without having any impact on the patient.
Very rare (affects less than 1 in 10,000 people):
• spontaneous production of breast milk which is not due to pregnancy or breast-feeding (Galactorrhoea)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
Keep this medicine out of the sight and reach of children.
Moclobemide Tablets should be stored in the package or container supplied. Do not transfer them to another container. Do not use Moclobemide after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Moclobemide Tablets contain:
• The active ingredient is moclobemide.
• The other ingredients are lactose monohydrate, maize starch, povidone, sodium starch glycolate, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171). The 150 mg tablets also contain ferric oxide yellow (E172) and ferric oxide black (E172).
What Moclobemide Tablets look like and contents of the pack:
• The Moclobemide Film-Coated Tablets 150 mg are beige, oval-shaped, bevel-edged, film-coated tablets. They have a deep breakline on one side and are engraved with ‘MCL 150’ on the other.
• The Moclobemide Film-Coated Tablets 300 mg are white to off-white, oval-shaped, bevel-edged, film-coated tablets. They have a deep breakline on one side and are engraved with ‘MCL 300’ on the other.
• The 150 mg tablets are available in pack sizes of 20, 28, 30, 50, 84 and 100 film-coated tablets. The 300 mg tablets are available in pack sizes of 15, 16, 20, 28, 30, 50, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: June 2014 PL00289/0369-0370
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