What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL15142/0104, PL15142/0103.

Manerix 150mg and 300mg

Patient Information Leaflet

Manerix®

150 mg and 300 mg film-coated Tablets

Moclobemide

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 ough 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 breastfeeding, 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.

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).

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

  • Manerix tablets do not need any special storage conditions.
  • Keep out of the reach and sight of children.
  • Do not use Manerix after the expiry date printed on the pack.
  • Do not throw away any left over tablets. Instead, return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.

6. FURTHER INFORMATION

What Manerix contains

The active substance in Manerix tablets is moclobemide. The tablets come in two different strengths:

  • Manerix 150 mg tablets – each tablet contains 150 mg (milligrams) of moclobemide.
  • Manerix 300 mg tablets – each tablet contains 300 mg (milligrams) of moclobemide.

Other ingredients in both tablets are: lactose, maize starch, povidone K30, sodium starch glycollate, magnesium stearate, hypromellose, ethylcellulose, polyethylene glycol 6000, talc and titanium dioxide (E171). The 150 mg tablets also contain yellow iron oxide (E172).

What Manerix looks like and contents of the pack

Manerix 150 mg tablets are oval and pale yellow in colour. They have a score line on one side and are marked 150 on the other.

Manerix 300 mg tablets are oval and white to off-white in colour. They have a score line on one side and are marked 300 on the other.

Manerix is supplied in blister packs containing either 28, 30, 60, 84 or 100 tablets. Not all pack sizes may be marketed.

The Marketing Authorisation holder is:

MEDA Pharmaceuticals Ltd.
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom

The manufacturer responsible for batch release is:

MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
Cenexi S.A.S.
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

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.

This leaflet was last revised in 11/2013.

Manerix is a registered trade mark.

56UK1953230-00