Manerix 150 film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manerix 150 mg film-coated tablets

moclobemide

Read the entire leaflet carefully before you start taking this medicine because 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 the 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 the transmission of nerve impulses in the brain. Raising these levels to normal values 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 inappropriate 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 components 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 used to relieve cough), linezolid (an antibiotic).
• If you suffer from 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 this may worsen these symptoms.
• 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 disease 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 this 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 have been prescribed this medicine, 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 the 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 attention immediately.

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

Elderly people:

Dose adjustment is not necessary 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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 consulting 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 that may be part of some cold or cough medicines), linezolid (an antibiotic).
• Cimetidine increases the effect of Manerix. Therefore, the usual dose of Manerix should be approximately halved 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 for the treatment of gastric ulcer), fluoxetine, fluvoxamine (medicines used for depression).
• If you are taking Manerix together with medicines that increase serotonin (such as other antidepressants or buprenorphine, particularly combinations of several medicines) or St. John's Wort, you should monitor for signs such as: involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, 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 plan 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 this treatment affects you.

Manerix contains lactose

This medicine contains lactose. If your doctor has informed 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 your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is 2 tablets (300 mg) of moclobemide per day, divided into two separate doses.

The tablets have a score line, 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 that, your doctor may increase or reduce the dose if necessary. The total daily dose of Manerix 150 mg ranges from 2 to 4 tablets (300 to 600 mg). Each individual dose will therefore be 1 to 2 tablets.

Patients with hepatic impairment

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

Never change the dose on your own. If you think the medicine's effect 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 is the best person to decide 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 discontinue 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 may 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, stating the name of the medicine and the amount ingested.

If you forget to take Manerix

Do not take a double dose to make up for forgotten 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 will experience 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, confusion, taste disturbances (dysgeusia), visual disturbances, flushing, oedema, pruritus, urticaria, generalized feeling of fatigue (asthenia).

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

Loss of appetite, decreased 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 Pharmacovigilance System for 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 packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains 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 150 mg

• The active substance in Manerix 150 mg is moclobemide. Each tablet contains 150 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 agents titanium dioxide (E 171) and yellow iron oxide (E 172).

Appearance of the product and pack contents

Manerix 150 mg is available in boxes containing 30 or 100 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

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