Mobemid

Package leaflet: information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Mobemid is and what it is used for

Mobemid is an antidepressant medicine containing the active substance moclobemidum. The medicine improves mood and psychomotor drive, and alleviates feelings of exhaustion and fatigue. During the first few days of treatment, it may also improve sleep quality in some patients with depression, but it is not a sedative medicine.
Therapeutic effects are usually observed between the 1st and 3rd week of treatment.
Indications
Treatment of depressive disorders and social phobia.

2. Important information before using Mobemid

When not to use Mobemid:

• if the patient is allergic to the active substance (moclobemide) or to any of the other ingredients of this medicine (listed in section 6);
• in acute confusional states (disorientation);
• in phaeochromocytoma;
• in patients under 18 years of age;
• during concomitant use of any of the following medicines: selegiline (used in the treatment of Parkinson's disease), pethidine (used to treat pain), dextromethorphan (a component of cough medicines), selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants (used in the treatment of depression).

Warnings and precautions
Before starting treatment with Mobemid, you should discuss this with your doctor, pharmacist, or nurse.
This medicine should be used with caution in patients:

• with hyperthyroidism (due to the risk of increased blood pressure);
• with bipolar disorders (moclobemide may trigger manic episodes);
• with liver impairment (dose reduction is required);
• who are agitated or excited, unless they are also receiving benzodiazepines (sedatives), but only for a period not exceeding 2–3 weeks.

As with other antidepressant medicines, patients with suicidal tendencies taking moclobemide should remain under close medical supervision.
Exercise caution if the patient is agitated or excited, unless they are simultaneously receiving benzodiazepines. In patients in whom the excited phase is predominant, the medicine may be given together with sedatives (e.g. benzodiazepines) for a period not exceeding 2–3 weeks.

Children and adolescents
Mobemid should not be used in children and adolescents due to lack of clinical data.

Mobemid and other medicines
Moclobemide must not be used concomitantly with other antidepressant medicines. An appropriate washout period must be observed when switching from previous antidepressant treatments.

After discontinuation of selective serotonin reuptake inhibitors (SSRIs) and before starting treatment with moclobemide, a 2-week washout period is required for paroxetine and sertraline, and at least a 5-week washout period for fluoxetine. Moclobemide may be administered no earlier than at least one week after discontinuation of MAO inhibitors (phenelzine, tranylcypromine) and tricyclic antidepressants (amitriptyline, nortriptyline, imipramine, clomipramine, protriptyline, amoxapine).

Concomitant use of serotonin reuptake inhibitors, MAO inhibitors, and tricyclic antidepressants may lead to a potentially dangerous condition known as serotonin syndrome.
Symptoms of serotonin syndrome include: high fever (hyperthermia), altered mental status, increased reflexes, and muscle spasms or contractions.

If such symptoms occur, the patient must be placed under immediate medical supervision.

Safety of concomitant use of moclobemide and other medicines:

Mobemid with food, drink and alcohol
Treatment with Mobemid does not require a special diet. Some patients may be sensitive to tyramine; therefore, patients taking moklobemid should avoid foods rich in tyramine, especially smoked fish, smoked meats, certain types of yellow cheese (Cheddar, Camembert, Gruyere), chocolate, wine, beer, yeast products and soy.
Alcoholic beverages should not be consumed during treatment.

Pregnancy, breastfeeding and effects on fertility
If a patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
This medicinal product may be used in pregnant women only if clearly necessary.

Breastfeeding
This medicinal product should not be used during breastfeeding, as moklobemid passes into breast milk.

Driving and operating machinery
This medicine is not expected to impair psycho-physical performance; however, during the initial phase of treatment, driving vehicles or operating machinery is not recommended.

Mobemid contains monohydrate lactose and sodium.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Mobemid.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Mobemid

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.

Recommended dose
In depressive disorders: The recommended initial dose is 300 mg per day, administered in divided doses.
Depending on the severity of depressive symptoms, the dose may be increased to 600 mg per day.
To achieve the full therapeutic effect, the medicine should be administered for a period of 4–6 weeks.

In the treatment of social phobia: The initial dose of moclobemide is 300 mg.
After 3 days, the dose should be increased to 600 mg per day, given in two divided doses.
Treatment with a dose of 600 mg should be continued for 8–12 weeks to assess treatment efficacy.
The maximum daily dose must not exceed 600 mg per day.
Your doctor will periodically evaluate your condition and the need for continued therapy.

Method of administration
Mobemid is taken orally.
The medicine should be taken immediately after meals. Take care not to take the last dose too late in the evening.
The maintenance dose of 150 mg should be taken once daily in the morning hours.
There is no need to adjust the dosage in elderly patients or in patients with renal impairment.
In patients with hepatic impairment, the metabolism of moclobemide is reduced. Your doctor will reduce the daily dose of Mobemid to half or even one-third of the normally recommended dose.

Use in children and adolescents
This medicine should not be used in children and adolescents.

Taking more Mobemid than recommended
Overdose of moclobemide usually causes mild and transient symptoms affecting the central nervous system (drowsiness, speech and orientation disturbances, amnesia) and gastrointestinal irritation (nausea, vomiting). In case of overdose, immediate gastric lavage and (or) administration of activated charcoal is recommended.
Overdose of moclobemide together with other medicines that depress the central nervous system may be life-threatening. In such cases, the patient should be hospitalized and kept under medical supervision.
In case of overdose, seek immediate medical advice.

If you forget to take Mobemid
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 in 10,000 people
very rare: less than 1 in 10,000 people
frequency not known: frequency cannot be estimated from the available data

Central and peripheral nervous system disorders
Common: headache, insomnia, sleep disturbance, dizziness, tremor, increased excitability,
anxiety, nervousness, somnolence, fatigue, sedation, increased anxiety, acute anxiety state,
weakness or fainting.
Uncommon: migraine, extrapyramidal disorders, tinnitus, paresthesia, dysarthria (slurred speech).

Gastrointestinal disorders
Common: nausea, constipation, abdominal pain, epigastric discomfort, vomiting, diarrhea,
dry mouth, feeling of fullness in the stomach, abdominal pain, vomiting.
Uncommon: heartburn, gastritis, bloating, dyspepsia.

Cardiac disorders
Common: tachycardia, palpitations, orthostatic hypotension, hypotension.
Uncommon: hypertension, bradycardia, extrasystoles, angina pectoris, chest pain.

General disorders and administration site conditions
Common: sweating, blurred vision, increased or decreased appetite.
Uncommon: malaise, musculoskeletal pain, altered taste sensation, facial flushing, feeling of warmth, scotoma (visual field defects), dyspnea.

Eye disorders
Rare: blurred vision, conjunctivitis.

Musculoskeletal and connective tissue disorders
Rare: muscle tremor.

Psychiatric disorders
Uncommon: difficulty falling asleep, nightmares, hallucinations, memory impairment, disorientation, worsening of depression, excitement/irritability, hypomanic symptoms, aggressive behavior, apathy, nervous tension, hypomania, confusion.
Cases of suicidal thoughts and behavior have been reported during treatment with moklobemid, as well as shortly after discontinuation of the product.

Vascular disorders
Uncommon: symptoms of phlebitis.

Skin and subcutaneous tissue disorders
Uncommon: rash, allergic skin reaction, pruritus, gingivitis, stomatitis, dry skin.

Renal and urinary disorders
Uncommon: urinary disorders (painful or difficult urination, polyuria, painful urge to urinate).

Reproductive system and breast disorders
Uncommon: genital bleeding, prolonged menstruation.

Investigations
Uncommon: in laboratory tests performed in 1401 patients, slight decreases in leukocyte count and alanine aminotransferase and aspartate aminotransferase activity were observed, but these findings have no clinical significance.

Some of these symptoms are related to the underlying disease and in most cases resolve with continued treatment.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take up to 2 weeks, or sometimes longer, to start working.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm;
• the patient is a young adult: clinical data indicate an increased risk of suicidal behavior 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, contact a doctor immediately or go to a 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 or friends for help and request them to inform him/her if they notice worsening of depression or anxiety, or any concerning changes in behavior.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Mobemid

The medicine should be stored below 25°C.
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: Expiry date. The expiry date refers to the last day of the stated month.
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 Mobemid contains

• The active substance is moclobemide. One coated tablet contains 150 mg of moclobemide.
• The other ingredients (excipients) are: lactose monohydrate, maize starch, povidone, sodium carboxymethyl starch (type A), magnesium stearate. Coating ingredients: hypromellose, macrogol 6000, hydroxypropylcellulose, talc, titanium dioxide (E 171), iron oxide yellow (E 172), simethicone.

What Mobemid looks like and contents of the pack
Mobemid is yellow-orange, round, biconvex coated tablets.
Pack: blisters in a cardboard box.
2 blisters containing 15 tablets each.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21
Tel.: (075) 643 31 00
Fax.: (075) 752 44 55
e-mail: [email protected]