Manerix 150mg Tablets
Manerix® 150mg Tablets Moclobemide 150mg Tablets
(moclobemide)
Your medicine is known by one of the above names, but will be referred to as Manerix throughout this:
Patient Information Leaflet
Please 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. 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 Manerix is and what it is used for
2) What you need to know before you take Manerix
3) How to take Manerix
4) Possible side effects
5) How to store Manerix
6) Contents of the pack and other information
7) More information about your condition
1) What Manerix is and what it is used for
Manerix contains a medicine called moclobemide. This belongs to a group of medicines called antidepressants.
Manerix is used to treat depression and social phobia. For further information about these conditions, see Section 7.
Manerix works by increasing the levels of important chemical messengers in your brain. This increase can help your depression or social phobia.
2) What you need to know before you take Manerix Do not take Manerix if:
• You are allergic to moclobemide or any of the other ingredients of this medicine (listed in Section 6).
• You have a severe mental problem which may make you confused, lose contact with reality or become unable to think and judge clearly.
• You have a growth on one of your adrenal glands (phaeochromocytoma).
• You are taking or have recently stopped taking any other medicines to treat your depression or anxiety, such as fluoxetine, paroxetine or clomipramine. See the section ‘Taking other medicines'.
• You are taking dextromethorphan, which is found in many cough medicines. See the section ‘Taking other medicines'.
• You are taking pethidine (for pain relief). See the section ‘Taking other medicines'.
• You are taking selegiline (for Parkinson's disease). See the section ‘Taking other medicines'.
Children
• Manerix is not suitable for children or adolescents
Do not take Manerix if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Manerix.
Take special care with Manerix
Check with your doctor or pharmacist before taking Manerix if:
• You have a ‘bi-polar disorder', sometimes call manic depression.
• You have ever thought about, or tried to harm or kill yourself.
• You have an overactive thyroid.
• You have serious liver disease.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Manerix.
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.
•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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Manerix can affect the way some medicines work.
Also some other medicines can affect the way Manerix works.
Do not take Manerix, and tell your doctor or pharmacist, if you are taking the following:
• Other medicines for your depression or anxiety, such as fluoxetine Bupropion, paroxetine or clomipramine.
• Dextromethorphan, which is found in many cough medicines.
• Pethidine (for pain relief).
• Selegiline (for Parkinson's disease).
• Triptans (for migraines)
• Tramadol (for pain relief)
• Linezolid (for the treatment of infections)
• St John's Wort (for anxiety)
Tell your doctor or pharmacist if you are taking any of the following medicines:
• Cimetidine (used to treat stomach ulcers and acid indigestion or reflux).
• Ephedrine, pseudoephedrine and phenylpropanolamine, found in many cough and cold medicines.
• Morphine, Codeine or fentanyl (for pain relief).
Taking Manerix with food and drink
Do not eat large quantities of foods containing tyramine when you are taking Manerix. These include:
• Mature cheese
• Yeast extract
• Fermented soya bean products.
If you are not sure about this talk to your doctor or pharmacist before you take Manerix.
Pregnancy and breast-feeding
Do not take Manerix if you are pregnant, trying to get pregnant or are breastfeeding, unless your doctor has told you to.
Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Important information about some of the ingredients of Manerix
This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3) How to take Manerix
Always take Manerix exactly as your doctor has told you. You should check with your doctor if you are not sure.
Manerix is not suitable for children or adolescents.
Take your tablets at the end of a meal.
Swallow each tablet with a drink of water.
Depression:
• The usual starting dose is 300 mg a day, split into two - three doses.
• Your doctor will adjust the dose up or down to find the right dose for you.
• The maximum dose is 600 mg a day.
Social phobia:
• The usual starting dose is 150 mg twice a day for three days.
• Your doctor will increase the dose to 300 mg twice a day.
People with severe liver disease:
Your doctor will decide the right dose for you. This will usually be lower than the doses stated above.
If you take more Manerix than you should
If you take more Manerix than you should or someone else takes your medicine by mistake, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Manerix
• If you forget to take a dose, take it as soon as you remember.
• If it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Manerix
Even when you start to feel better, you should keep taking your tablets for as long as your doctor tells you to. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4) Possible side effects
Like all medicines Manerix can cause side effects, although not everyone will get them.
Some side effects could be serious. If you have any of the side effects listed below, stop taking this medicine and seek urgent medical advice:
• swelling of your throat, face, lips and mouth. This may make it difficult to breath or swallow.
• sudden swelling of your hands, feet or ankles.
• A raised, itchy skin rash (hives), itchy skin or flushing.
Other side effects include the following, if they get serious, please tell your doctor:
Very common (affects more than 1 in 10 people):
• Trouble sleeping
• Headache
• Feeling dizzy
• Dry mouth
• Feeling sick
Common (affects 1 in 100 people):
• Feeling nervous, twitchy (restless), anxious or bad-tempered (irritable)
• Pins and needles or numbness of your hands and feet
• Low blood pressure (hypotension)
• Being sick
• Diarrhoea
• Constipation
Uncommon (affects 1 in 1,000 people):
• Thoughts about killing yourself
• Feeling confused and lost (disorientated)
• Loss of taste in your mouth
• Changes to your eyesight (vision)
• Swelling (fluid retention)
• Feeling weak or tired
Rare (affects 1 in 10,000 people):
• Loss of appetite
• Not enough sodium in your blood. Signs of this may be feeling sleepy, confused or having fits (seizures)
• Attempting to kill yourself
• Delusion
• Serotonin syndrome Signs of this may be High fever, irregular heartbeat, losing consciousness or having fits (seizures)
Reporting 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 Manerix
• Keep all medicines out of the sight and reach of children.
• Do not store above 30°C. Store in a dry place.
• Do not take Manerix after the expiry date printed on the pack.
• If your doctor decides to stop your treatment, take any leftover tablets back to the pharmacy.
• If your tablets appear 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 that are no longer required. This will help to protect the environment.
6) Contents of the pack and other information What Manerix contains
Each film-coated tablet contains 150mg of the active ingredient moclobemide.
Manerix 150mg tablets also contains the following ingredients: lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, methylhydroxypropyl cellulose, ethylcellulose, polyethylene glycol 6000, talc, titanium dioxide (E171) and yellow iron oxide (E172).
What Manerix looks like and contents of the pack
Manerix is available as a pale yellow, oblong film-coated tablets marked 150 on one side and a score line on the reverse.
Manerix 150mg tablets are available as blister packs of 30 or 100 tablets.
PL 10383/0515 |POMl
Who makes and repackages your medicine?
This product is manufactured by Cenexi SAS, Rue Marcel and Jacques Gaucher, 52, Fontenay Sous Bois, France. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
7) More information about your condition What is depression?
The signs of this problem (condition) can include extreme feelings of sadness, low mood, tearfulness, worry, changes in sleep pattern (such as difficulty sleeping) or difficulty enjoying life as you used to. If these feelings affect your everyday life or last for a long time it is important to get help from your doctor. Depression
is a common medical problem affecting around one in four women and one in ten men at some time in their lives.
What is social phobia?
Social phobia is a common medical problem that can affect both men and women. The signs of this condition are an extreme fear of being seen doing something embarrassing or humiliating. This can cause problems even when taking part in simple social activities such as eating, drinking, speaking, meeting people and going to parties. People with this condition will be too afraid to take part in social occasions.
Leaflet date: 13.09.2016
Manerix is a registered trademark of Meda AB, Sweden.