MANERIX 300 FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Manerix 300 mg Film-Coated Tablets

moclobemide

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Manerix and what is it 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. The increase in these levels, up to normal values, helps to improve your depression.

Manerix is indicated for major depression.

If you are suffering from depression, you may have 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, excessive or inappropriate guilt, or loss of concentration.

2. What you need to know before you take Manerix

Do not take Manerix

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

This medicine should not be used in children.

Consult your doctor if you are unsure about any of the above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manerix

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

Do you have liver problems?

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

Do you have any other disease?

Do you have any allergies?

• If you are taking a product that contains St. John's Wort, as it may increase side 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 disease (see "Other medicines and Manerix").
• If you have suicidal thoughts or self-harm. Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. This risk may persist until improvement of the disease occurs. Since it may take weeks from the start of treatment with Manerix to achieve this improvement, 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, increased talkativeness, delusions of grandeur, or impulsive urges, go to the doctor immediately.

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

Elderly people:

No dose adjustment is necessary in elderly patients.

Children and adolescents:

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

Other medicines and Manerix

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This medicine may affect the action of other medicines (interaction). For this reason, tell your doctor about the medicines you are using and do not use any medicine without telling your doctor first.

• 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 with selegiline (a medicine used in Parkinson's disease), bupropion (a medicine used in smoking cessation), triptans (medicines used in migraines), pethidine and tramadol (medicines used to relieve pain), dextromethorphan (a compound that may be part of some cold or cough medicines), or 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 be increased and prolonged by concomitant administration with Manerix.
• Manerix increases blood levels of medicines that use CYP2C19 for their metabolism, such as omeprazole (a medicine used in the treatment of gastric ulcers), fluoxetine, and fluvoxamine (medicines used in depression).
• If you are taking Manerix 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 muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• If you are taking sibutramine (a medicine to treat obesity), it may increase the effect produced by Manerix.

Using Manerix with food, drinks, and alcohol

Your doctor will advise you to avoid taking excessive amounts of certain foods (such as aged 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.

Women who are breastfeeding 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 your baby.

Driving and using machines

Manerix usually does not modify reaction capacity. However, during treatment with Manerix, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with 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 them before taking this medicine.

3. How to take Manerix

Remember to take your medicine.

Follow exactly the administration instructions of this medicine indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

The tablets have a score line, making it very easy to divide them into two halves.

In most cases, the first signs of efficacy are seen during the first two weeks of treatment. From then on, your doctor may increase or decrease the dose if necessary. The total daily dose of Manerix 300 mg is 1 to 2 tablets (300 to 600 mg). Each individual dose will be half or 1 tablet.

Patients with liver disorders

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

Never change the dose yourself. 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 informed about how you feel.

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 the doctor who decides when to end the treatment. So far, no symptoms of dependence or withdrawal have been described.

Later, you may take Manerix again if your doctor prescribes it to you again.

If you take more Manerix than you should

Symptoms of overdose include progressive agitation, aggression, behavioral changes, and gastrointestinal irritation.

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

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Depending on the frequency, the side effects are:

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 (paresthesia), decreased blood pressure, vomiting, diarrhea, 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 disorders (dysgeusia), visual disturbances, flushing, edema, 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, decreased sodium in the blood, suicidal behavior, hallucinations, serotonin syndrome (in combination with other antidepressants), increased liver enzymes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side 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 package.

No special storage conditions are required.

Do not use this medicine after the expiry date that appears on the packaging 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. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Manerix 300 mg

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

Appearance of the product and pack contents

Manerix 300 mg is available in boxes containing 30 or 60 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:January 2023

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