Leaflet: information for the user

Manerix 300 mg film-coated tablets

moclobemide

Read 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 questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Manerix is and what it is used for

2.What you need to know before you start taking Manerix

3.How to take Manerix

4.Possible side effects

5.Storage of Manerix

6.Contents of the pack and additional information

Manerix contains the active ingredient moclobemide, which belongs to a group of medications called antidepressants.

Moclobemide increases the levels of substances responsible for the transmission of nerve impulses within the brain. The increase in these levels, to normal values, helps to improve your depression.

Manerix is indicated for major depression.

If you suffer from depression, you may experience depressive 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 uselessness, excessive or unnecessary feelings of guilt, or loss of concentration.

Do not take Manerix

-If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

-If you are taking medications that contain selegiline (used in Parkinson's disease), bupropion (used in smoking cessation), triptans (used in migraines), petidina and tramadol (used to relieve pain), dextromethorphan (used to relieve cough), linezolid (antibiotic).

-If you have acute confusion.

This medication should not be used in children.

Consult your doctor if you are unsure.

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 schizotypal disorders, as it may worsen these symptoms.

-Inform your doctor if the answer to any of the following questions is affirmative:

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 allergies?

-If you are taking a product containing St. John's Wort, as it may increase the risk of adverse effects.

-If you are taking other antidepressants that increase serotonin levels, (see "Other medications and Manerix").

• If you are taking buprenorphine, and this medication has been prescribed, consult your doctor, as it may cause serotonin syndrome, a potentially fatal disease (see "Other medications 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 the disease improves. Since it may take weeks for the treatment with Manerix to produce an 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 speech, delusions of grandeur, or feel impulsive, go to your doctor immediately.

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

Older adults:

No dose adjustment is necessary in older adults.

Children and adolescents:

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

Other medications and Manerix

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This medication may interact with other medications (interaction). For this reason, inform your doctor of the medications you are taking and do not use any medication without informing your doctor first.

• It may potentiate the effect of opioids (including morphine, dextropropoxyphene, fentanyl, or codeine), so it may be necessary to adjust the dose of these medications.
• Do not take this medication with selegiline (used in Parkinson's disease), bupropion (used in smoking cessation), triptans (used in migraines), petidina and tramadol (used to relieve pain), dextromethorphan (used to relieve cough), linezolid (antibiotic).
• Cimetidine increases the effect of Manerix. Therefore, the usual dose of Manerix will be approximately half if you are taking the mentioned medication.
• The effect of sympathomimetic agents (medications for the treatment of asthma) may be increased and prolonged by the concomitant administration with Manerix.
• Manerix increases the levels of medications that use CYP2C19 for their metabolism, such as omeprazole (used in the treatment of gastric ulcers), fluoxetine, fluvoxamine (used in depression).
• If you are taking Manerix with medications that increase serotonin (such as other antidepressants or buprenorphine, particularly combinations of several medications) or St. John's Wort, you should monitor for signs such as: involuntary muscle contractions, including those 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 (used to treat obesity), it may increase the effect produced by Manerix.

Use of Manerix with food, drinks, and alcohol

Your doctor will advise you to avoid taking large amounts of certain foods (such as strong cheese). Follow your doctor's instructions carefully.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Women who are breastfeeding should consult their doctor before taking this medication, as moclobemide passes in small amounts into breast milk. Your doctor will decide if you can take Manerix while breastfeeding your baby.

Driving and operating machinery

Generally, Manerix does not affect your ability to react. 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 medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Remember to take your medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

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

In most cases, the first signs of effectiveness 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 therefore 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 your response to treatment.

Never change the dose on your own. If you consider the medication's effect too weak or too strong, talk to your doctor. It is very important to keep your doctor informed periodically about how you feel.

Your doctor is the one who best knows when to stop taking Manerix. The treatment duration varies greatly from person to person, and it is the doctor who will decide when to stop treatment. There have been no reported symptoms of dependence or withdrawal.

You can take Manerix again later if your doctor prescribes it again.

If you take more Manerix than you should

The symptoms of overdose include progressive agitation, aggression, behavioral alteration, 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Manerix

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Manerix

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

Sleep disturbances, dizziness, headaches, dry mouth, nausea.

Frequent (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, confusion, altered taste (dysgeusia), visual disturbances, flushing, edema, 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)

Decreased appetite, decreased sodium in the blood, suicidal behavior, hallucinations, serotonin syndrome (in concomitant administration with other antidepressants), increased liver enzymes.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash.Deposit empty packaging and unused medications at the SIGRE collection point at your pharmacy. Please ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition of Manerix 300 mg

-The active ingredient of Manerix 300 mg is moclobemide. Each tablet contains 300 mg of moclobemide.

-The other components of the tablets are: lactose monohydrate, cornstarch, povidone, sodium carboxymethylcellulose (from potato), magnesium stearate, microcrystalline cellulose, macrogol 6000, hypromellose, talc, and the colorant titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Manerix 300 mg is presented in boxes containing 30 or 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Meda Pharma, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

CENEXI SAS

Rue Marcel and Jacques Gaucher, 52

Fontenay Sous Bois

France

or

MEDAPharma 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 medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:January 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/