Teva Moclobemide 150mg Film-Coated Tablets
MOCLOBEMIDE 150 MG AND 300 MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER
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..
WHAT IS 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 futher 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 major depressive episodes. This medication is called a monoamine oxidase inhibitor antidepressant.
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 (listed in section 6).
• 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 in the section below called “Other medicines and Moclobemide” under heading "DO NOT take Moclobemide in combination with, or if you have recently taken”.
Warnings and precautions
Talk to your doctor before taking Moclobemide if you have any of the following:
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 adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
* Only marketed pack sizes will be included in the printed version of the PIL
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• 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.
If you stop taking other antidepressants you should usually wait for some time before starting to take Moclobemide. This is to avoid serotonin syndrome. Your doctor will tell you how long you must wait.
Excitation and nervousness (agitation)
If the main symptoms of your depression are excitation or nervousness (agitation) you should either:
• not take Moclobemide at all or
• only take Moclobemide together with a sedative and not for longer than 2 to 3 weeks.
Bipolar disorder
If you have bipolar disorder, you should use Moclobemide with caution. If you have bipolar disorder, there will be:
• times when you are feeling depressed (sad)
• times when you suffer from bouts of mania/hypomania Symptoms of mania/hypomania include:
being overexcited being overactive a feeling of elation
an excessive feeling of well-being and self-importance agitation
increased speed of thought and speech
If you suffer from a bout of mania you should stop taking Moclobemide
If you suffer with schizophrenia and similar mental disorders
You should not take Moclobemide unless you also take medication to treat your schizophrenia.
High blood pressure
Your doctor will monitor your blood pressure closely during treatment. You should take particular care if you have an overactive thyroid gland or pheochromocytoma. An overactive thyroid gland can product too much of a hormone called thyroxine (thyrotoxicosis). A pheochromocytoma is a tumour of the adrenal gland that produces hormones that can raise blood pressure).
Talk to your doctor before you start to take this medicine if you:
• have high blood pressure
• suffer from thyrotoxicosis (an overactive thyroid gland, often called Graves’ Disease)
• suffer from galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• have liver problems
• are pregnant or breast-feeding.
If you need an operation requiring an anaesthetic tell the hospital or dentist you are taking Moclobemide.
Other medicines and Moclobemide
DO NOT take Moclobemide in combination with, or if you have recently taken:
• selegiline (used to treat Parkinson’s disease)
• linezolid (used to treat serious infections of skin and soft tissues and respiratory tract infections)
• any other antidepressants e.g. clomipramine, fluoxetine, fluvoxamine, venlafaxine, citalopram, escitalopram, paroxetine, sertraline, bupropion, phenelzin, tranylcypromine. This combination of treatment can cause the development of serotonin syndrome which can be life-threatening.
Symptoms of serotonin syndrome include
• rise in body temperature
• confusion
• stiffness (rigidity)
• irritability (when you are easily angered or annoyed)
• increased heartbeat (tachycardia)
• rise in blood pressure
• shaking (tremors)
If you stop treatment with selective serotonin reuptake inhibitors SSRIs, you must wait for some time before starting to take Moclobemide (your doctor will tell you how long).
• In isolated cases severe reactions affecting the nervous system have occurred when dextromethorphan is taken with Moclobemide.
• pethidine (used to relieve pain during labour or after surgery)
• tramadol (used to relieve pain)
• triptans (used to treat migraine) e.g. sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan and eletriptan.). This combination of treatment can cause high blood pressure and chest pain (angina).
Tell your doctor if you are taking, have recently taken or might take any other
medicines:
• morphine, fentanyl, dextropropoxyphene (used to relieve pain) as your doctor may need to reduce the dose
• codeine (used to treat a cough) as your doctor may need to reduce the dose
• cimetidine, omeprazole(used to treat stomach ulcers or indigestion) as your doctor may need to reduce the dose of Moclobemide
• trimipramine and maprotiline (antidepressants)
• 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.
• sibutramine (used to help weight loss)
Moclobemide with food, drink and alcohol
• DO NOT drink alcohol whilst you are taking Moclobemide.
• DO NOT eat large amounts of foods rich in tyramine. Tyramine is a chemical found naturally in food, especially fermented foods such as mature cheese, red wine, yeast extracts and fermented soya bean products.
Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have babay, ask your doctor for advice before taking this medicine.
Driving and using machines
• Moclobemide may cause dizziness or vision problems. If you are affected do not drive or use machinery.
Moclobemide contains lactose
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.
3. HOW TO TAKE MOCLOBEMIDE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how long you should take Moclobemide. You should take Moclobemide for at least 4 to 6 weeks. This is so your doctor can judge how well it is working. During treatment your doctor may want to monitor you closely, especially at the beginning of treatment and also if the dose is changed.
Ideally you should take Moclobemide until you have had no symptoms of depression for 4 to 6 months. Your doctor will then gradually reduce and stop your treatment.
The tablets should be swallowed preferably with a glass of water. The recommended dose is:
• Adults (including the elderly):
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.
• 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. You may suffer serious effects, especially if you have taken other medicines, for example, other medicines that affect the nervous system.
An overdose is likely to cause increasing agitation, aggressiveness, changes in behaviour or stomach upset. Overdose in some cases has been life-threatening.
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, this can cause withdrawal symptoms.
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.
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 lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. 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 serotonin syndrome and has been reported rarely when Moclobemide is given in combination with other antidepressants such as clomipramide and selective serotonin re-uptake inhibitors (SSRIs). You must not take Moclobemide together with SSRIs or clomipramine (see section 2, subheading "Do NOT take Moclobemide if you:”.
If you stop taking SSRIs you must wait for some time before starting to take Moclobemide. This is to avoid Serotonin syndrome. Your doctor will tell you how long you must wait.
The following effects may occur during the first few weeks of therapy but will usually disappear with improvement of your depression:
• feelings of anxiety, agitation or irritability
• mood changes characterised by excitement, exaggerated high mood and activity
• mood changes characterised by disorganised thinking and incoherent or rambling speech.
The following side effects have been reported at the approximate frequencies shown:
Very common: may affect more than 1 in 10 people
• Sleep disorder
• Dizziness
• Headache
• Nausea (feeling sick)
• Dry mouth.
Common: may affect up to 1 in 10 people
• Anxiety, agitation, irritability
• Restlessness
• Pins-and-needles or numbness
• Low blood pressure (hypotension)
• Stomach upset e.g. diarrhoea, constipation, vomiting (being sick)
• Rash
Uncommon: may affect up to 1 in 100 people
• Cases of suicidal thoughts and suicidal behaviours have been reported during moclobemide therapy or early after treatment has been stopped.
• Confusion may be experienced, but this disappears when the treatment is stopped.
• Taste disorder (Dysgeusia)
• Problems with vision
• Flushing
• Oedema (fluid retention e.g. hands and feet)
• Skin reactions such a nettle rash, itching
• Asthenia
Rare: may affect up to 1 in 1000 people
• Decreased appetite
• Low level of natrium in your blood
• Suicidal behaviour, delusion
• Abnormal liver function tests (detected by a blood test) have also been reported.
Very rare: may affect upto 1 in 10,000 people
• Spontaneous production of breast milk which is not due to pregnancy or breast-feeding
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 out of the sight and reach of children.
No special precautions for storage.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.
Do not through away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Moclobemide Tablets contain:
• The active substance is moclobemide.
150mg: Each film-coated tablet contains 150mg moclobemide.
300mg: Each film-coated tablet contains 300 mg 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: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Company responsible for manufacture: Pharmachemie B.V., Haarlem, The Netherlands
This leaflet was last revised: June 2015 PL 14776/0060-61
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