Moclobemide 300mg Film-Coated Tablets
MANERIX® 300MG FILM-COATED TABLETS
(moclobemide)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Manerix Film-Coated Tablets come in two strengths: 150mg and 300mg. Manerix 300mg Film-Coated Tablets will be referred to as Manerix throughout this leaflet.
Please read all of this leaflet carefully before you start taking this medicine.
■ 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 symptoms are the same as yours.
■ If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Manerix is and what it is used for
2. Before you take Manerix
3. How to take Manerix
4. Possible side effects
5. How to store Manerix
6. Further 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. Before you take Manerix Do not take Manerix if:
■ You are allergic (hypersensitive) to moclobemide or any of the other ingredients of Manerix (listed in Section 6: Further information).
■ 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'.
■ 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, paroxetine or clomipramine.
■ Dextromethorphan, which is found in many cough medicines.
■ Pethidine (for pain relief).
■ Selegiline (for Parkinson's disease).
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 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 breast-feeding, unless your doctor has told you to.
Driving and using machines
Manerix is not likely to affect your ability to drive or use any tools or machines. Talk to your doctor if you notice any effects that might affect driving, or using tools or machines, particularly when you start taking Manerix.
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.
POM
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.
Allergic reactions:
If you have an allergic reaction, stop taking Manerix and see a doctor straight away. The signs may include:
■ Swelling of your throat, face, lips and mouth. This may make it difficult to breathe or swallow.
■ Sudden swelling of your hands, feet or ankles.
■ A raised, itchy skin rash (hives), itchy skin or flushing.
Other possible side effects:
■ Trouble sleeping.
■ Feeling nervous, twitchy (restless), anxious or bad-tempered (irritable).
■ Feeling confused and lost (disorientated).
■ Pins and needles or numbness of your hands and feet.
■ Feeling dizzy.
■ Headache.
■ Dry mouth.
■ Changes to your eyesight (vision).
■ Feeling sick or being sick.
■ Diarrhoea or constipation.
■ Not enough sodium in your blood. Signs of this may be feeling sleepy, confused or having fits (seizures).
■ Changes to your liver (shown up in a blood test).
If any of the side effects become serious or troublesome, 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 Manerix
■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Store in the original package.
■ Do not use 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. Further information
What Manerix contains
The active substance is moclobemide.
Each film-coated tablet contains 300mg of moclobemide.
Other ingredients are: lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, ethylcellulose, macrogol, hypromellose, talc and titanium dioxide (E171).
What Manerix looks like and contents of the pack
Manerix are oval, white to off-white tablets with a score line on one side and marked '300' on the other.
Manerix is supplied in blister packs containing 30 and 60 tablets.
Manufacturer
Manufactured by:
CENEXI SAS, Rue Marcel and Jacques Gaucher 52,
Fontenay Sous Bois, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0530
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 issue and revision date: 21.04.15
Manerix® is a registered trademark of Roche Products Limited.
MOCLOBEMIDE 300MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Moclobemide Film-Coated Tablets come in two strengths: 150mg and 300mg. Moclobemide 300mg Film-Coated Tablets will be referred to as Moclobemide throughout this leaflet.
Please read all of this leaflet carefully before you start taking this medicine.
■ 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 symptoms are the same as yours.
■ If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Moclobemide is and what it is used for
2. Before you take Moclobemide
3. How to take Moclobemide
4. Possible side effects
5. How to store Moclobemide
6. Further information
7. More information about your condition
1. What Moclobemide is and what it is used for
Moclobemide belongs to a group of medicines called antidepressants.
Moclobemide is used to treat depression and social phobia. For further information about these conditions, see Section 7.
Moclobemide works by increasing the levels of important chemical messengers in your brain. This increase can help your depression or social phobia.
2. Before you take Moclobemide Do not take Moclobemide if:
■ You are allergic (hypersensitive) to moclobemide or any of the other ingredients of Moclobemide (listed in Section 6: Further information).
■ 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'.
■ Moclobemide is not suitable for children or adolescents
Do not take Moclobemide if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Moclobemide.
Take special care with Moclobemide
Check with your doctor or pharmacist before taking Moclobemide 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 Moclobemide.
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 Moclobemide can affect the way some medicines work. Also some other medicines can affect the way Moclobemide works.
Do not take Moclobemide, and tell your doctor or pharmacist, if you are taking the following:
■ Other medicines for your depression or anxiety, such as fluoxetine, paroxetine or clomipramine.
■ Dextromethorphan, which is found in many cough medicines.
■ Pethidine (for pain relief).
■ Selegiline (for Parkinson's disease).
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 or fentanyl (for pain relief).
Taking Moclobemide with food and drink
Do not eat large quantities of foods containing tyramine when you are taking Moclobemide. 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 Moclobemide.
Pregnancy and breast-feeding
Do not take Moclobemide if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Driving and using machines
Moclobemide is not likely to affect your ability to drive or use any tools or machines. Talk to your doctor if you notice any effects that might affect driving, or using tools or machines, particularly when you start taking Moclobemide.
Important information about some of the ingredients of Moclobemide
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 Moclobemide
Always take Moclobemide exactly as your doctor has told you. You should check with your doctor if you are not sure.
Moclobemide 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.
POM
If you take more Moclobemide than you should
If you take more Moclobemide 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 Moclobemide
■ 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 Moclobemide
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 Moclobemide can cause side effects, although not everyone will get them.
Allergic reactions:
If you have an allergic reaction, stop taking Moclobemide and see a doctor straight away. The signs may include:
■ Swelling of your throat, face, lips and mouth. This may make it difficult to breathe or swallow.
■ Sudden swelling of your hands, feet or ankles.
■ A raised, itchy skin rash (hives), itchy skin or flushing.
Other possible side effects:
■ Trouble sleeping.
■ Feeling nervous, twitchy (restless), anxious or bad-tempered (irritable).
■ Feeling confused and lost (disorientated).
■ Pins and needles or numbness of your hands and feet.
■ Feeling dizzy.
■ Headache.
■ Dry mouth.
■ Changes to your eyesight (vision).
■ Feeling sick or being sick.
■ Diarrhoea or constipation.
■ Not enough sodium in your blood. Signs of this may be feeling sleepy, confused or having fits (seizures).
■ Changes to your liver (shown up in a blood test).
If any of the side effects become serious or troublesome, 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 OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Store in the original package.
■ Do not use Moclobemide 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. Further information
What Moclobemide contains
The active substance is moclobemide.
Each film-coated tablet contains 300mg of moclobemide.
Other ingredients are: lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, ethylcellulose, macrogol, hypromellose, talc and titanium dioxide (E171).
What Moclobemide looks like and contents of the pack
Moclobemide are oval, white to off-white tablets with a score line on one side and marked '300' on the other.
Moclobemide is supplied in blister packs containing 30 and 60 tablets.
Manufacturer
Manufactured by:
CENEXI SAS, Rue Marcel and Jacques Gaucher 52, Fontenay Sous Bois, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0530
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 issue and revision date: 21.04.15
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