Mobemid

Package Leaflet: Information for the Patient

MOBEMID, 150 mg, coated tablets

Moclobemide

Read the 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, pharmacist, or nurse.
• -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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Mobemid and what is it 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 is Mobemid and what is it used for

Mobemid is an antidepressant that contains the active substance moclobemide. The medicine improves mood and psychomotor drive, alleviates feelings of exhaustion and fatigue. During the first days of treatment, it also improves sleep quality in some patients with depression, but it is not a sedative.

Indications for use

Treatment of depressive disorders and social phobia.

2. Important information before taking Mobemid

When not to take Mobemid:

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

Warnings and precautions

Before starting treatment with Mobemid, discuss it with your doctor, pharmacist, or nurse.

• with hyperthyroidism (due to the possibility of causing an increase in blood pressure);
• with bipolar disorders (moclobemide may cause manic episodes);
• with liver damage (the dose should be reduced);
• excited or agitated, unless they are also taking benzodiazepines (sedatives), but for no longer than 2-3 weeks.

As with other antidepressants, patients with a history of suicidal thoughts and taking moclobemide should be under close medical supervision.

Children and adolescents

The medicine should not be used in children and adolescents due to the lack of clinical trials.

Mobemid and other medicines

Moclobemide should not be used concomitantly with other antidepressants. An appropriate interval should be maintained in case of previous use of antidepressants.

Mobemid with food, drink, and alcohol

Treatment with Mobemid does not require a special diet. Some patients may exhibit hypersensitivity to tyramine, so patients taking moclobemide are advised to

avoid tyramine-rich foods, especially smoked fish, smoked meat, some types of yellow cheese (Cheddar, Camembert, Gruyere), chocolate, wine, beer, yeast products, soy.

Do not drink alcoholic beverages during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The medicine should not affect your ability to drive or use machines, but it is not recommended to drive or operate machinery during the initial treatment period.

Mobemid contains lactose monohydrate and sodium

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking Mobemid.

3. How to take Mobemid

Always take this medicine exactly as your doctor or pharmacist has told you.

Recommended dose

In depressive disordersthe initial recommended dose is 300 mg per day, given in divided doses.

Depending on the severity of the symptoms, the dose can be increased to 600 mg per day.

To achieve the full therapeutic effect, the medicine should be taken for 4-6 weeks.

In the treatment of social phobiathe initial dose of moclobemide is 300 mg.

After 3 days, the dose is 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 the effectiveness of the treatment.

The maximum daily dose should not exceed 600 mg per day.

Your doctor will periodically assess your condition and the need for further therapy.

Method of administration

Mobemid is taken orally.

The medicine should be taken immediately after meals.

Remember not to take the last dose of the medicine too late in the evening.

The maintenance dose of 150 mg should be taken once a day, in the morning.

No dose adjustment is necessary in elderly patients or in patients with renal impairment.

In patients with liver impairment, the metabolism of moclobemide is reduced. The doctor will reduce the daily dose of Mobemid to half or even one-third of the usual recommended dose.

Use in children and adolescents

The medicine should not be used in children and adolescents.

Overdose of Mobemid

Overdose of moclobemide usually causes mild and short-term symptoms from the central nervous system (drowsiness, speech and orientation disorders, amnesia) and gastrointestinal irritation (nausea, vomiting).

In case of overdose, gastric lavage and/or administration of activated charcoal is recommended.

Overdose of moclobemide with other medicines that depress the central nervous system may be life-threatening.

Missed dose of Mobemid

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Mobemid

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

4. Possible side effects

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

Side effects may occur with the following frequencies:

Nervous system disorders

Frequently: headache, insomnia, sleep disorder, dizziness, tremor, increased excitability, anxiety, nervousness, drowsiness, fatigue, sedation, increased anxiety, state of acute anxiety, weakness or fainting.

Gastrointestinal disorders

Frequently: nausea, constipation, abdominal pain, discomfort in the upper abdomen, nausea, diarrhea, dryness of the oral mucosa, feeling of fullness in the stomach, abdominal pain, vomiting.

Cardiovascular disorders

Frequently: tachycardia, palpitations, orthostatic hypotension, hypotension.

General disorders and administration site conditions

Frequently: sweating, blurred vision, increased or decreased appetite.

Ocular disorders

Rarely: blurred vision, conjunctivitis.

Musculoskeletal and connective tissue disorders

Rarely: muscle tremor.

Psychiatric disorders

Insomnia, nightmares, hallucinations, memory impairment, disorientation, worsening of depression, excitement/irritability, symptoms of hypomania, aggressive behavior, apathy, nervous tension, hypomania, confusion.

There have been reports of suicidal thoughts and behaviors during treatment with moclobemide, as well as shortly after discontinuation of the product.

Vascular disorders

Phlebitis.

Skin and subcutaneous tissue disorders

Rash, allergic skin reaction, itching, gingivitis, oral inflammation, dry skin.

Renal and urinary disorders

Urination disorders (painful or difficult urination, polyuria, painful urge to urinate).

Reproductive system and breast disorders

Genital bleeding, prolonged menstruation.

Investigations

In laboratory tests performed in 1401 patients, a slight decrease in the number of leukocytes and the activity of alanine and aspartate aminotransferases was found, but this has no clinical significance.

Most of the symptoms are related to the underlying disease and usually disappear as treatment continues.

Suicidal thoughts, worsening of depression or anxiety disorders

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide.

Such symptoms or behaviors 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 are being treated with antidepressants.

If you experience suicidal thoughts or self-harm, contact your doctor or go to the hospital immediately.

It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mobemid

Store the medicine at a temperature 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 the words: Expiry date.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

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 are: lactose monohydrate, corn starch, povidone, sodium carboxymethylcellulose (type A), magnesium stearate. The coating contains: hypromellose, macrogol 6000, hydroxypropylcellulose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), simethicone.

What Mobemid looks like and contents of the pack

Mobemid is yellow-orange, round, biconvex, coated tablets.

Packaging: blisters in a cardboard box.

2 blisters of 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: jelfa@jelfa.com.pl

Bausch Health Poland sp. z o.o., ul. Przemysłowa 2, 35-959 Rzeszów, Poland

Date of last revision of the leaflet