MOKLAR 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Moklar, 150 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Moklar and what is it used for
4. Important information before taking Moklar
   1. When not to take Moklar:
   2. Warnings and precautions
   3. Patients with a history of suicidal thoughts should be closely monitored during the initiation of treatment.
   4. Moklar and other medicines
   5. Moklar with food or drink
   6. Pregnancy and breastfeeding
   7. Using Moklar in children
   8. Using Moklar in patients with renal and/or hepatic impairment
   9. Using Moklar in the elderly
   10. Driving and using machines
   11. Moklar contains lactose monohydrate
5. How to take Moklar
   1. Taking a higher dose of Moklar than recommended
   2. Missing a dose of Moklar
6. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1000 people)
   5. Reporting side effects
7. How to store Moklar
8. Contents of the pack and other information
   1. What Moklar contains
   2. What Moklar looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information, contact your local representative of the marketing authorization holder:

Package Leaflet: Information for the Patient

Moklar, 150 mg, Coated Tablets

Moclobemide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 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, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Moklar and what is it used for
• 2. Important information before taking Moklar
• 3. How to take Moklar
• 4. Possible side effects
• 5. How to store Moklar
• 6. Contents of the pack and other information

1. What is Moklar and what is it used for

Moklar belongs to a group of antidepressant medicines and is used to treat depressive disorders and social phobia. It contains the active substance moclobemide, which affects the brain's monoaminergic neurotransmitter system - norepinephrine, dopamine, and serotonin. This action increases the amount of these neurotransmitters in the extracellular space.

2. Important information before taking Moklar

When not to take Moklar:

• if you are allergic to moclobemide or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with a pheochromocytoma (your doctor may have used the name "phaeochromocytoma" or "chromaffin tumor");
• in case of acute confusion (disorientation);
• when taking selegiline (an antidepressant and used in Parkinson's disease);
• when taking bupropion (an antidepressant);
• when taking triptans used for migraine headaches, such as sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan, and eletriptan (increased effect of triptans);
• when taking pethidine (a medicine used to treat moderate to severe pain) - increases the risk of serotonin syndrome (confusion, fever, chills, increased reflexes, clonic muscle spasms, diarrhea);
• when taking tramadol (a medicine used to treat moderate to severe pain);
• when taking any medicines containing dextromethorphan, such as cough medicines available at the pharmacy without a prescription;
• when taking linezolid (an antibiotic used to treat severe bacterial infections);
• when taking serotonin reuptake inhibitors (e.g., tricyclic antidepressants), due to the possibility of serotonin syndrome;
• in children.

Warnings and precautions

Before starting treatment with Moklar, discuss it with your doctor or pharmacist. When to be particularly cautious when taking Moklar:

• taking any medicines. This also applies to medicines available without a prescription, used to treat coughs or colds, containing ephedrine, pseudoephedrine, or phenylpropanolamine;
• concomitant use of preparations containing St. John's Wort (Hypericum perforatum- increases the risk of serotonin syndrome);
• presence of depressive disorders with agitation in the clinical picture.
• presence of bipolar affective disorder (risk of manic episodes);
• presence of epilepsy;
• presence of hypertension;
• presence of hyperthyroidism;
• presence of other mental disorders, such as schizophrenia (the medicine should not be used in patients with concomitant schizophrenia or schizoaffective organic disorders);
• if the patient has acute or chronic pain or other conditions treated with buprenorphine. Taking this medicine with Moklar may lead to serotonin syndrome, a potentially life-threatening condition (see "Moklar and other medicines").

Patients with a history of suicidal thoughts should be closely monitored during the initiation of treatment.

During treatment with Moklar, hyponatremia may occur - a decrease in sodium levels in the blood. In case of rash and swelling, which may be symptoms of hypersensitivity to Moklar, contact your doctor immediately.

Moklar and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Moclobemide enhances the effect of opioids (e.g., morphine, fentanyl, codeine), which may require a change in dosage. It is recommended to avoid foods rich in tyramine, see section "Moklar with food or drink". When Moklar is taken after a meal, it causes less of an increase in blood pressure. Caution should be exercised when taking medicines such as cimetidine. Your doctor will consider the need to reduce the dose. Caution should be exercised when taking medicines such as omeprazole used in gastric ulcer disease and antidepressants such as fluoxetine, fluvoxamine, trimipramine, and maprotiline, as their effect may be enhanced when taken with moclobemide. Caution should be exercised if the patient taking moclobemide is also taking medicines that increase serotonin levels, such as many antidepressants (especially in combination). This applies to the following antidepressants: venlafaxine, clomipramine, citalopram, escitalopram, paroxetine, sertraline, and bupropion. In individual cases, many serious symptoms have occurred, such as: agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, hyperthermia (high fever - body temperature above 38°C), confusion, increased reflexes, clonic muscle spasms, involuntary, rhythmic muscle contractions, including those affecting eye movements, resulting from enhanced serotonin effects (serotonin syndrome). If symptoms indicating serotonin syndrome occur, contact your doctor immediately, who will start appropriate treatment. Moklar should not be taken with buprenorphine without prior consultation with a doctor. This medicine may interact with Moklar and increase the risk of serotonin syndrome (see above). Concomitant use with St. John's Wort (Hypericum perforatum) is not recommended, as it increases the risk of serotonin syndrome. Moklar may enhance and prolong the effect of systemically administered sympathomimetic medicines, such as ephedrine, pseudoephedrine, and phenylpropanolamine, which are contained in many complex anti-cold and anti-cough medicines. Since sibutramine enhances the effect of Moklar, concomitant use of these medicines is not recommended. Concomitant use of dextropropoxyphene is not recommended, as moclobemide may enhance its effect.

Moklar with food or drink

Moklar should be taken after a meal. There are no special dietary restrictions during treatment. However, as some people may be particularly sensitive to tyramine, it is recommended to avoid foods containing large amounts of this compound, such as mature cheeses, yeast extract, or fermented soybean products (found in some Chinese dishes). The dietary issue can be discussed with your doctor. During treatment with Moklar, you should avoid consuming alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. The safety of moclobemide in pregnant women has not been established. Therefore, your doctor should assess the ratio of possible benefits of taking the medicine during pregnancy to the risk to the fetus. Only a small amount of moclobemide passes into breast milk (about 0.03 of the dose taken by the mother), but your doctor should assess the ratio of possible benefits of continuing treatment in breastfeeding mothers to the risk to the child.

Using Moklar in children

Moklar should not be used in children.

Using Moklar in patients with renal and/or hepatic impairment

Patients with reduced renal function do not require dose adjustment of Moklar. Patients with liver function disorders may require a dose reduction (depending on the degree of liver damage).

Using Moklar in the elderly

During treatment of this group of patients, caution should be exercised due to the possibility of hyponatremia (decrease in sodium levels in the blood), probably due to inadequate secretion of antidiuretic hormone. Symptoms of hyponatremia include: drowsiness, confusion (disorientation), or convulsions.

Driving and using machines

It is unlikely that Moklar will cause disturbances in performing tasks that require full alertness (e.g., driving vehicles). However, during the initial treatment period, individual patient reaction to the medicine should be monitored.

Moklar contains lactose monohydrate

The medicine contains lactose. If you have been informed by your doctor that you have an intolerance to some sugars, contact your doctor before taking Moklar.

3. How to take Moklar

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist. The coated tablets are for oral use. The tablets should be taken after a meal. The usual dose is: AdultsDepressive disorders: The recommended dose of Moklar is 300 to 600 mg per day, usually in 2 or 3 divided doses. The initial dose is 300 mg per day, and in the case of severe depression, your doctor may increase the dose to 600 mg per day. Do not increase the dose before the first week of treatment, as the bioavailability of moclobemide increases during this period. The dose of the medicine can be reduced depending on the individual patient's response to treatment. To fully assess the effectiveness of treatment, Moklar should be administered for at least 4-6 weeks. Social phobia: It is recommended to take 600 mg of Moklar per day, in 2 divided doses. The effectiveness of treatment in a given patient can be assessed only after 8-12 weeks of taking the medicine. Your doctor will consider the possibility of continuing treatment, as social phobia is a chronic disease, and clinical trials confirm the effectiveness of the medicine taken long-term. Patients should be periodically examined to determine the need for further treatment. Use in elderly patientsThere is no need to adjust the dose of Moklar in elderly patients. Use in children and adolescentsDue to the lack of clinical trials in this group of patients, Moklar should not be used in children. Use in patients with renal and/or hepatic impairmentIn patients with renal impairment, there is no need to adjust the dose. In the case of liver disease or taking a medicine that inhibits liver enzyme activity (e.g., cimetidine), your doctor may recommend reducing the dose of Moklar by half or to one-third. If you feel that the effect of Moklar is too strong or too weak,contact your doctor.

Taking a higher dose of Moklar than recommended

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately. Overdose of moclobemide itself causes mild and transient symptoms from the central nervous system (CNS) and gastrointestinal tract. Like other antidepressants, overdose of moclobemide with other medicines (e.g., CNS-acting medicines) can be life-threatening.

Missing a dose of Moklar

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

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people)

Sleep disorders, dizziness, headaches, dryness of the oral mucosa, nausea.

Common side effects (may affect up to 1 in 10 people)

Agitation, feeling of anxiety, restlessness, paresthesia (sensations of unusual character, e.g., tingling, prickling, burning), hypotension, vomiting, diarrhea, constipation, rash, irritability.

Uncommon side effects (may affect up to 1 in 100 people)

• )Suicidal thoughts, confusion (a syndrome of consciousness disorders characterized by disorders of thought, complete disorientation, fear, uncontrolled motor agitation - subsided after discontinuation of treatment), taste disorders, vision disorders, flushing (especially of the face), swelling, and skin reactions, such as itching and urticaria, feeling of fatigue.

Rare side effects (may affect up to 1 in 1000 people)

Decreased appetite*, decreased sodium levels in the blood* (hyponatremia), suicidal behavior, hallucinations*, serotonin syndrome*, increased liver enzyme activity (without clinical consequences). *side effects reported after marketing authorization (not reported during clinical trials) Suicidal thoughts, worsening of depression or anxiety disordersPeople with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later. The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

If you experience suicidal thoughts or self-harm, contact your doctor immediately or go to the hospital. It may be helpful to inform your relatives or friends about your depression or anxiety disorders and ask them to read this leaflet. You can ask your relatives or friends for help and ask them to inform you if they notice that your depression or anxiety disorders have worsened or if there are worrying changes in your behavior. If you experience insomnia or nervousness at the beginning of treatment with Moklar, your doctor will consider reducing the dose or starting treatment for these symptoms. If affective disorders or hypomania occur, or if early symptoms of these reactions appear (delusions of grandeur, excessive activity, including verbal activity, impulsiveness), your doctor will discontinue treatment with Moklar and replace it with another medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moklar

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Moklar contains

• The active substance of the medicine is moclobemide. Each tablet contains 150 mg of moclobemide.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, magnesium stearate, sodium carboxymethylcellulose (type A), povidone K29/32; Tablet coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 300, triacetin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172).

What Moklar looks like and contents of the pack

Moklar 150 mg coated tablets are yellow, round, and biconvex. Available pack sizes Moklar, 150 mg is packaged in blisters placed in a carton containing 30 tablets.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH Elisabeth-Selbert Str. 23 40764 Langenfeld Germany

Manufacturer

Glenmark Pharmaceuticals s.r.o. Fibichova 143 566 17 Vysoké Mýto Czech Republic

For more information, contact your local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o. ul. Poleczki 35 02-822 Warsaw Date of last revision of the leaflet: