Manerix 300 film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Manerix 300 mg film-coated tablets

moclobemide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Manerix is and what it is used for
2. What you need to know before taking Manerix
3. How to take Manerix
4. Possible adverse effects
5. How to store Manerix
6. Contents of the pack and other information

1. What Manerix is and what it is used for

Manerix contains the active substance moclobemide, which belongs to a group of medicines called antidepressants.

Moclobemide increases the levels of substances responsible for transmitting nerve impulses in the brain. By raising these levels to normal values, it helps improve your depression.

Manerix is indicated for major depression.

If you suffer from depression, you may experience a depressed mood and/or loss of interest or pleasure in your usual activities. You may also experience one or more of the following symptoms: significant weight gain or loss without dieting, sleep disturbances, restlessness, apathy, loss of energy, feelings of worthlessness, feelings of excessive or unnecessary guilt, or difficulty concentrating.

2. What you need to know before taking Manerix

Do not take Manerix

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines containing selegiline (a medicine used in Parkinson's disease), bupropion (a medicine used for smoking cessation), triptans (medicines used for migraines), meperidine and tramadol (medicines used to relieve pain), dextromethorphan (a medicine to relieve cough), linezolid (an antibiotic).
• If you have acute confusion.

This medicine should not be used in children.

Consult your doctor if you are unsure about the above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Manerix

• If you have depression with excitement or agitation, although your doctor may consider it appropriate to prescribe an additional sedative or tranquilizer for no more than 2–3 weeks.
• If you have schizophrenia or schizophrenic disorders, as these symptoms may worsen.
• Inform your doctor if you answer "yes" to any of the following questions:

Do you have liver problems?

Do you have hyperthyroidism or pheochromocytoma (a disorder of the adrenal glands)?

Do you have any other illness?

Do you have allergies?

• If you are taking a product containing St. John's wort, as it may increase adverse effects.
• If you are taking other antidepressant medicines that increase serotonin levels (see “Other medicines and Manerix”).
  • If you are taking buprenorphine, and this medicine has been prescribed for you, consult your doctor, as it may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Manerix”).
  • If you have suicidal or self-harming thoughts. Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. This risk may persist until your condition improves. Since it may take several weeks after starting treatment with Manerix for improvement to occur, your doctor will closely monitor you during this time.

Contact your doctor or go to the hospital immediately if you have any thoughts of self-harm or suicide.

• If you feel hyperactive, talk more than usual, have delusions of grandeur, or feel reckless impulses, seek medical advice immediately.

It may be helpful to inform a close friend or relative that you are depressed. You may ask them to tell you if they notice your depression worsening or if they are concerned about changes in your behavior.

Elderly people:

There is no need to modify the dose in elderly patients.

Children and adolescents:

Do not use in children, as there is insufficient clinical experience in this patient group.

Other medicines and Manerix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine may affect the action of other medicines (interaction). For this reason, inform your doctor about all medicines you are taking and do not take any medicine without first informing your doctor.

• It may enhance the effect of opioids (including morphine, dextropropoxyphene, fentanyl, or codeine), so it may be necessary to adjust the dose of these medicines.
• Do not take this medicine together with selegiline (a medicine used in Parkinson's disease), bupropion (a medicine used for smoking cessation), triptans (medicines used for migraines), meperidine and tramadol (medicines used to relieve pain), dextromethorphan (a compound found in some cold or cough medicines), linezolid (an antibiotic).
• Cimetidine increases the effect of Manerix. Therefore, the usual dose of Manerix will be approximately half if you are taking the aforementioned medicine.
• The effect of sympathomimetic agents (medicines for the treatment of asthma) may possibly be increased and prolonged by concomitant administration with Manerix.
• Manerix increases blood levels of medicines metabolized by CYP2C19, such as omeprazole (a medicine used in the treatment of gastric ulcer), fluoxetine, fluvoxamine (medicines used in depression).
• If you are taking Manerix together with medicines that increase serotonin (such as other antidepressants or buprenorphine, especially combinations of several medicines) or St. John's wort, you should watch for signs such as: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle stiffness, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• If you are taking sibutramine (a medicine for treating obesity), it may increase the effect of Manerix.

Use of Manerix with food, drinks, and alcohol

Your doctor will advise you to avoid consuming excessive amounts of certain foods (such as mature cheese). Follow your doctor's instructions carefully.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding women should consult their doctor before taking this medicine, as moclobemide passes into breast milk in small amounts. Your doctor will decide whether you can take Manerix while breastfeeding.

Driving and using machines

Generally, Manerix does not usually affect reaction ability. However, during treatment with Manerix you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Manerix affects you.

Manerix contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Manerix

Remember to take your medication.

Always follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again.

It is recommended that Manerix be taken after meals, swallowing the tablets whole, without chewing, with water or another non-alcoholic drink.

The recommended starting dose is 1 tablet (300 mg) of moclobemide per day, divided into two separate doses.

The tablets are scored, making them easy to split into two halves.

In most cases, the first signs of effectiveness appear during the first two weeks of treatment. After this period, your doctor may increase or reduce the dose if necessary. The total daily dose of Manerix 300 mg ranges from 1 to 2 tablets (300 to 600 mg). Each individual dose will therefore be half or one tablet.

Patients with hepatic impairment

If you have a liver problem, your doctor may prescribe a lower dose and monitor your response to treatment.

Never change the dose on your own. If you think the effect of the medicine is too weak or too strong, talk to your doctor. It is very important that you keep your doctor regularly informed about how you are feeling.

Your doctor knows best when you should stop taking Manerix. The duration of treatment varies greatly from person to person, and it is your doctor who will decide when to end treatment. To date, no symptoms of dependence or withdrawal have been reported.

Later on, you may take Manerix again if your doctor prescribes it once more.

If you take more Manerix than you should

Symptoms of overdose include increasing agitation, aggressiveness, behavioral disturbances, and gastrointestinal irritation.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Manerix

Do not take a double dose to make up for missed doses.

If you stop taking Manerix

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Depending on their frequency, the adverse effects are as follows:

Very common (occur in more than 1 in 10 people):

Sleep disorders, dizziness, headache, dry mouth, nausea.

Common (occur in more than 1 in 100 people and less than 1 in 10 people):

Agitation, anxiety, restlessness, tingling (paraesthesia), decreased blood pressure, vomiting, diarrhoea, constipation, skin rash, irritability.

Uncommon (occur in more than 1 in 1,000 people and less than 1 in 100 people):

Suicidal thoughts, confusional states, taste disturbances (dysgeusia), visual disturbances, flushing, oedema, pruritus, urticaria, generalized feeling of tiredness (asthenia).

Rare (occur in more than 1 in 10,000 people and less than 1 in 1,000 people)

Decreased appetite, low blood sodium levels, suicidal behaviour, hallucinations, serotonin syndrome (when administered concomitantly with other antidepressants), increased liver enzymes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Manerix

Keep this medicine out of the sight and reach of children.

Store in the original packaging.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manerix 300 mg

• The active substance in Manerix 300 mg is moclobemide. Each tablet contains 300 mg of moclobemide.
• The other components of the tablets are: lactose monohydrate, maize starch, povidone, sodium carboxymethyl starch (from potato), magnesium stearate, ethylcellulose, macrogol 6000, hypromellose, talc, and the colouring agent titanium dioxide (E 171).

Appearance of the product and contents of the pack

Manerix 300 mg is presented in packs containing 30 or 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

CENEXI SAS

Rue Marcel and Jacques Gaucher, 52

Fontenay Sous Bois

France

or

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent review of this leaflet: January 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)