MOKLAR

Patient Information Leaflet

Moklar, 150 mg, film-coated tablets
Moclobemidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Moklar is and what it is 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 Moklar is and what it is used for

Moklar belongs to a group of medicines known as antidepressants and is used in the treatment of depressive disorders and social phobia. It contains the active substance moclobemide, which affects the brain's monoaminergic neurotransmitter systems—noradrenaline, dopamine, and serotonin. This action results in increased levels of these neurotransmitters in the extracellular space.

2. Important information before using Moklar

When not to use Moklar:

• if the patient is allergic to moklobemide or any of the other ingredients of this medicine (listed in section 6);
• if phaeochromocytoma (a tumour of the adrenal gland, sometimes referred to as "chromaffin tumour") has previously been diagnosed;
• during acute confusional states (disorientation);
• when taking selegiline (an antidepressant and also used in Parkinson's disease);
• when taking bupropion (an antidepressant);
• when taking triptans used for migraine headaches, e.g. sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan and eletriptan (this increases the effect of triptans);
• when taking meperidine (a medicine used to treat moderate to severe pain) – increases the risk of serotonin syndrome (confusion, fever, chills, increased reflexes, clonic muscle seizures, diarrhoea);
• when taking tramadol (a medicine used to treat moderate to severe pain);
• when taking any medicines containing dextromethorphan, e.g. over-the-counter cough medicines;
• when taking linezolid (an antibiotic used to treat serious bacterial infections);
• when taking serotonin reuptake inhibitors (e.g. tricyclic antidepressants), due to the risk of serotonin syndrome;
• in children.

Warnings and precautions
Before starting treatment with Moklar, discuss this with your doctor or pharmacist.
Exercise particular caution when using Moklar if:

• you are taking any medicines, including over-the-counter medicines for cough or colds containing ephedrine, pseudoephedrine or phenylpropanolamine;
• you are taking preparations containing St John’s wort (Hypericum perforatum) (increases the risk of serotonin syndrome);
• you have depression with agitation;
• you have bipolar affective disorder (risk of manic episodes);
• you have epilepsy;
• you have hypertension;
• you have hyperthyroidism;
• you have other psychiatric disorders such as schizophrenia (Moklar should not be used in patients with coexisting schizophrenia or organic schizoaffective disorders);
• you have acute or chronic pain or other conditions treated with buprenorphine. Concurrent use of this medicine with Moklar may lead to serotonin syndrome, a potentially life-threatening condition (see “Moklar with other medicines”).

Patients with suicidal tendencies should be closely monitored at the beginning of treatment.
During treatment with Moklar, hyponatraemia – reduced sodium concentration in plasma – may occur.
If rash or swelling occurs, which may be signs of hypersensitivity to Moklar, contact your doctor immediately.

Moklar with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Moklobemide enhances the effect of opioids (e.g. morphine, fentanyl, codeine), which may necessitate dose adjustments.
Avoid tyramine-rich foods – see section “Moklar with food or drink”.
When Moklar is taken after a meal, it causes less increase in blood pressure.
Exercise caution when using Moklar concomitantly with cimetidine. Your doctor may consider reducing the dose.
Exercise caution when using Moklar concomitantly with omeprazole (used in peptic ulcer disease) and antidepressants such as fluoxetine, fluvoxamine, trimipramine and maprotiline, as their effects may be enhanced when used together with moklobemide.
Exercise caution if a patient taking moklobemide is also using medicines that increase serotonin levels, such as many antidepressants (especially in combination). This includes the following antidepressants: venlafaxine, clomipramine, citalopram, escitalopram, paroxetine, sertraline, bupropion. In isolated cases, serious symptoms have occurred due to enhanced serotonergic activity (serotonin syndrome), such as agitation, hallucinations, coma, excessive sweating, tremor, increased muscle rigidity, hyperthermia (high fever – body temperature above 38°C), confusion, increased reflexes, clonic muscle seizures, involuntary rhythmic muscle contractions, including those affecting eye movements. If symptoms suggestive of serotonin syndrome occur, contact your doctor immediately for appropriate treatment.
Do not use Moklar together with buprenorphine without prior consultation with your doctor. This medicine may interact with Moklar and increase the risk of serotonin syndrome (see above).
Concurrent 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 effects of systemically administered sympathomimetic agents such as ephedrine, pseudoephedrine and phenylpropanolamine, which are present in many combined antipyretic and antitussive medicines.
As sibutramine enhances the effect of Moklar, concurrent use of these medicines is not recommended.
Concomitant use of dextropropoxyphene is not recommended, as moklobemide may enhance the effect of dextropropoxyphene.

Moklar with food or drink
Moklar should be taken after meals.
There are no specific dietary restrictions during treatment. However, since some individuals may be particularly sensitive to tyramine, it is advisable to avoid foods high in this substance, such as mature cheeses, yeast extract, or fermented soybean products (found in some Chinese cuisine). Dietary concerns can be discussed with your doctor.
Alcohol should be avoided while taking Moklar.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The safety of moklobemide during pregnancy has not been established. Therefore, your doctor should assess the potential benefits of treatment against the possible risks to the foetus.
Only a small amount of moklobemide passes into breast milk (approximately 0.03 of the maternal dose). Nevertheless, your doctor should evaluate the potential benefits of continuing treatment in breastfeeding mothers against the possible risks to the infant.

Use of Moklar in children
Moklar should not be used in children.

Use of Moklar in patients with renal and/or hepatic impairment
Patients with reduced kidney function do not require dose adjustment of Moklar. Patients with impaired liver function may require a reduced dose (depending on the degree of liver damage).

Use of Moklar in elderly patients
Exercise caution when treating elderly patients due to the possible occurrence of hyponatraemia (reduced sodium concentration in plasma), likely due to inappropriate antidiuretic hormone secretion. Symptoms of hyponatraemia include drowsiness, confusion (disorientation), or seizures.

Driving and operating machinery
It is unlikely that Moklar will impair the ability to perform tasks requiring full alertness (e.g. driving vehicles). However, during the initial phase of treatment, individual response to the medicine should be monitored.

Moklar contains lactose monohydrate
This medicine contains lactose. If you have been advised by your doctor that you have an intolerance to certain sugars, consult your doctor before taking Moklar.

3. How to use Moklar

This medicine should always be taken as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The coated tablets are intended for oral use.
The tablets should be taken after a meal.

Usual dosage:
Adults
Depressive 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 cases of severe depression, your doctor may increase the dose up to 600 mg per day.
The dose should not be increased before the end of the first week of treatment, as the bioavailability of moclobemide increases during this period.
The dose may be adjusted downward depending on the individual patient's response to treatment. To fully assess treatment efficacy, 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 an individual patient can only be evaluated after 8–12 weeks of treatment.
Your doctor will consider whether treatment should continue, as social phobia is a chronic condition and clinical studies have confirmed the efficacy of long-term treatment with this medicine. Patients should be periodically reviewed to determine the need for continued therapy.

Use in elderly patients
There is no need to adjust the dosage of Moklar in elderly patients.

Use in children and adolescents
Due to lack of clinical data in this patient group, Moklar should not be used in children.

Use in patients with impaired kidney and/or liver function
No dosage adjustment is required in patients with impaired kidney function. In case of liver disease or concomitant use of drugs that inhibit liver enzyme activity (e.g. cimetidine), your doctor may recommend reducing the dose of Moklar by half or to one-third.

If you feel the effect of Moklar is too strong or too weak, consult your doctor.

Taking more Moklar than prescribed
If you have taken more than the prescribed dose, seek immediate medical advice from your doctor or pharmacist.
Overdose with moclobemide alone causes mild and transient symptoms affecting the central nervous system (CNS) and gastrointestinal tract. As with other antidepressants, overdose with moclobemide in combination with other drugs (e.g. CNS-acting medicines) may be life-threatening.

If you forget to take Moklar
Contact your treating doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Very common adverse effects (may occur in more than 1 in 10 people)
Sleep disturbances, dizziness, headache, dryness of the oral mucosa, nausea.
Common adverse effects (may occur in no more than 1 in 10 people)
Excitation, anxiety, restlessness, paraesthesiae (abnormal sensations such as tingling, pricking, burning), hypotension, vomiting, diarrhoea, constipation, rash, irritability.
Uncommon adverse effects (may occur in no more than 1 in 100 people)
Suicidal thoughts, confusion states (a syndrome of disturbed consciousness characterised by disordered thinking, complete disorientation, anxiety, and disorganised motor agitation – resolved after discontinuation of treatment), taste disturbances, visual disturbances, redness (especially of the face), oedema and skin reactions such as itching and urticaria, feeling of fatigue.
Rare adverse effects (may occur in no more than 1 in 1000 people)
Decreased appetite*, decreased sodium concentration in blood* (hyponatraemia), suicidal behaviour, hallucinations*, serotonin syndrome*, increased liver enzyme activity (without clinical consequences).
*Adverse effects reported after marketing authorization (not reported during clinical trials)
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as such medicines usually take effect after about 2 weeks, sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously experienced suicidal thoughts or thoughts of self-harm;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are treated with antidepressant medicines.

If a patient experiences suicidal thoughts or thoughts of self-harm, immediate contact should be made with the attending physician or the patient should go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family members or friends for help and request them to inform the patient if they notice worsening of depression or anxiety disorders or the appearance of concerning changes in behaviour.
If insomnia or nervousness occurs at the beginning of treatment with Moklar, the physician may consider reducing the dose or initiating treatment for these symptoms.
If affective disturbances or hypomania occur, or early signs of these reactions appear (e.g. delusions of grandeur, excessive activity including verbal activity, impulsiveness), the physician will discontinue treatment with Moklar and replace it with another medicine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, they should be reported to the physician or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting of adverse effects helps to provide more information on the safety of the medicine.

5. How to store Moklar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
"Expiry date (EXP)" and on the blister after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must 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 is moclobemide. Each tablet contains 150 mg of moclobemide.
• Other ingredients are:
  Tablet core: monohydrate lactose, maize starch, magnesium stearate, sodium carboxymethyl starch (type A), povidone K29/32;
  Tablet coating: hypromellose, titanium dioxide (E 171), monohydrate lactose, 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 film-coated tablets are yellow, round and biconvex.
Pack sizes available:
Moklar 150 mg is packed in blisters contained in a cardboard box with
30 tablets.
Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw