Mirtazapine Viatris Pharmaceuticals 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mirtazapine Viatris Pharmaceuticals 30 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Mirtazapine Viatris Pharmaceuticals is and what it is used for

2. What you need to know before taking Mirtazapine Viatris Pharmaceuticals

3. How to take Mirtazapine Viatris Pharmaceuticals

4. Possible side effects

5. How to store Mirtazapine Viatris Pharmaceuticals

6. Contents of the pack and other information

1. What Mirtazapina Viatris Pharmaceuticals is and what it is used for

Mirtazapina Viatris Pharmaceuticals belongs to a group of medicines called antidepressants.

Mirtazapina Viatris Pharmaceuticals is used to treat depression.

2. What you need to know before taking Mirtazapine Viatris Pharmaceuticals

Do not take Mirtazapine Viatris Pharmaceuticals if

• You are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6).
• You are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Do not take mirtazapine or consult your doctor before taking it:

If you have ever developed a severe skin rash or peeling of the skin, or if you have developed blisters or mouth ulcers after taking mirtazapine or other medicines. Serious skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking the medicine and seek immediate medical advice if you experience any of the symptoms described in section 4 related to these serious skin reactions. If you have ever had a serious skin reaction, you should not restart treatment with mirtazapine.

Children and adolescents under 18 years of age

Mirtazapine should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontation behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they decide it is best for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. Inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking mirtazapine. In addition, the long-term safety effects on growth, maturation, and cognitive and behavioral development of mirtazapine in this age group are still unknown. Furthermore, a considerable weight gain has been observed more frequently in this age group when treated with mirtazapine compared to adults.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This may worsen when you first start taking antidepressants, as these medicines take time to work—usually two weeks or sometimes longer.

You may be more likely to think this way:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Consult your doctor or pharmacist before taking mirtazapine if you have or have ever had any of the following conditions:

Inform your doctor about these conditions before taking mirtazapine, if you have not already done so:

• Seizures (epilepsy).
• Liver diseases, such as jaundice.
• Kidney diseases.
• Heart diseases or certain heart conditions that may alter your heart rhythm, recent heart attack, heart failure, or if you are taking certain medicines that may affect your heart rhythm.
• Low blood pressure.
• Schizophrenia.
• Bipolar disorders (alternating periods of elevated mood/hyperactivity and periods of depression).
• Diabetes (you may need to adjust your insulin dose or other antidiabetic medicines).
• Eye diseases, such as increased eye pressure (glaucoma).
• Difficulty urinating, which may be due to an enlarged prostate.

During treatment

• If signs of infection appear, such as unexplained high fever, sore throat, or mouth ulcers. Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms mostly occur 4–6 weeks after starting treatment.
• If you are elderly, you may be more sensitive to the adverse effects of antidepressant medicines.

Other medicines and Mirtazapine Viatris Pharmaceuticals

Do not take Mirtazapine Viatris Pharmaceuticals together with:

Monoamine oxidase inhibitors (MAO inhibitors). Also, do not take mirtazapine during the two weeks following discontinuation of MAO inhibitors. If you stop taking mirtazapine, do not take MAO inhibitors for the next two weeks. Examples of MAO inhibitors are moclobemide, tranilcypramine (both antidepressants), and selegiline (used for Parkinson's disease).

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription, especially any of the following:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs), for example citalopram**, venlafaxine, and L-tryptophan or triptans**, for example sumatriptan (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat certain types of blood poisoning), and St. John's wort – Hypericum perforatum (herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• The antidepressant nefazodone, which may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping nefazodone.
• Medicines for anxiety or insomnia, such as benzodiazepines, for example diazepam or chlordiazepoxide.
• Medicines for schizophrenia, such as olanzapine.
• Medicines for allergies, such as cetirizine.
• Medicines for severe pain, such as morphine.

When taken together with these medicines, mirtazapine may increase the drowsiness caused by them.

• Medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors, for example ritonavir, nelfinavir).
• Cimetidine, a medicine for stomach ulcers.

When taken together with mirtazapine, these medicines may increase mirtazapine levels in the blood. Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping these medicines.

• Carbamazepine and phenytoin, medicines for epilepsy.
• Medicines for tuberculosis, such as rifampicin.

If taken together with mirtazapine, these medicines may reduce the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of mirtazapine, or reduce it again when stopping these medicines.

• Warfarin, medicines to prevent blood clotting.

Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend regular blood tests.

• Medicines that may affect heart rhythm, such as certain antibiotics and certain antipsychotics.

Mirtazapine Viatris Pharmaceuticals and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapine.

It is recommended not to drink any alcohol.

Pregnancy and breastfeeding

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

Pregnancy

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk of congenital malformations. However, caution should be exercised if used during pregnancy. If you take mirtazapine up to shortly before delivery, your baby should be monitored for possible adverse effects.

Ensure that your midwife and/or doctor know that you are taking mirtazapine. Similar medicines (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs, contact your midwife and/or doctor immediately.

Breastfeeding

Mirtazapine passes into breast milk in small amounts. There is a potential risk of effects on the baby. Therefore, you should consult your doctor, who will decide whether to discontinue breastfeeding or discontinue treatment with mirtazapine.

Driving and using machines

Mirtazapine may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery.

Mirtazapine Viatris Pharmaceuticals contains lactose

If your doctor has told you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take Mirtazapine Viatris Pharmaceuticals

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

How much to take

Adults:

The recommended starting dose is 15 mg or 30 mg once daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). Normally, the recommended dose is the same for all age groups. However, if you are elderly or if you have kidney or liver disease, your doctor may adjust the dose.

The score line is intended only for breaking the tablet if you find it difficult to swallow it whole.

When to expect to feel better

Mirtazapine usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better.

It is important that during the first weeks of treatment you discuss the effects of mirtazapine with your doctor:

Between 2 and 4 weeks after starting mirtazapine, talk to your doctor about how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2–4 weeks.

You will usually need to take mirtazapine until depressive symptoms have disappeared for 4–6 months.

Use in children and adolescents under 18 years of age:

Mirtazapine must not be used in children and adolescents under 18 years of age (see section 2, “Children and adolescents under 18 years of age”).

When to take it

Take mirtazapine at the same time each day.

It is best to take the dose of mirtazapine as a single dose before going to bed. However, your doctor may recommend dividing your dose, taking part in the morning and part at night before going to bed. The higher dose should be taken before bedtime. The tablets are taken orally.

Take the tablet without chewing, with water or juice.

If you take more Mirtazapine Viatris Pharmaceuticals than you should

If you or someone else takes too much mirtazapine, consult a doctor immediately.

You may also call the Toxicology Information Service. Telephone 91 562 04 20.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rate (fast and irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take Mirtazapine Viatris Pharmaceuticals

If you are supposed to take your dose once daily

• If you forget to take your dose of mirtazapine, do not take the missed dose. Skip it and take your usual dose the next day.

Do not take a double dose to make up for missed doses.

If you are supposed to take your dose twice daily

• If you forget the morning dose, simply take it together with the evening dose.
• If you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• If you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Viatris Pharmaceuticals

Stop taking mirtazapine only after consulting your doctor.

If you stop too early, depression may return. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, agitated or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose gradually.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In some cases, adverse effects are not caused by the medicine, but are symptoms of the illness.

If you experience any of the following adverse effects, stop taking mirtazapine and consult your doctor or go to the nearest hospital:

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the pancreas. This may cause moderate or severe stomach pain spreading to the back.
• Yellowing of the skin or eyes, which may indicate liver function problems (jaundice).

Frequency unknown (cannot be estimated from available data)

• Severe allergic reactions such as rash, itching or skin eruptions, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing.
• Signs of infection such as sudden high fever, sore throat and mouth ulcers (agranulocytosis). Mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). Mirtazapine may also cause a decrease in red and white blood cells in the blood, which may lead to pale skin, feeling tired and short of breath, dark-colored urine, and a decrease in platelets (aplastic anemia), a decrease in platelets causing bleeding and bruising more easily than usual (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).
• Lower than normal levels of sodium in the blood, which may make you feel weak and confused with muscle pain. This may be due to inappropriate secretion of ADH, a hormone that causes the body to retain water and dilute the blood, thereby reducing sodium levels.
• Thoughts of harming yourself or of suicide (see section 2 “Suicidal thoughts and worsening of depression”).
• Epileptic seizures (convulsions).
• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes and loss of consciousness. These may be symptoms of “serotonin syndrome”.
• Signs of a serious skin reaction or illness that may include rash, skin redness, fever, sore throat and fatigue, which may be followed by ulcers, skin peeling and other lesions, usually around the mouth and lips (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis or erythema multiforme).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Breakdown of muscle tissue, causing muscle pain, tenderness, stiffness and/or weakness, and darkening or change in color of the urine (rhabdomyolysis).
• Difficulty urinating or emptying the bladder.

Other possible adverse effects:

Very common (may affect more than 1 in 10 patients)

• Increased appetite and weight gain.
• Drowsiness.
• Headache.
• Dry mouth.

Common (may affect up to 1 in 10 patients)

• Lethargy.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhoea.
• Vomiting.
• Constipation.
• Hives or skin rashes (exanthema).
• Joint pain (arthralgia) or muscle pain (myalgia).
• Back pain.
• Dizziness or fainting when getting up quickly (orthostatic hypotension).
• Swelling (usually in ankles or feet) due to fluid retention (edema).
• Tiredness.
• Vivid dreams.
• Confusion.
• Anxiety.
• Difficulty sleeping.
• Memory problems that resolve when the medicine is discontinued.

Uncommon (may affect up to 1 in 100 patients)

• Feeling of exaggerated euphoria (mania).

Stop taking mirtazapine and consult your doctor immediately.

• Strange skin sensations such as burning, pricking, tingling or numbness (paraesthesia).
• Involuntary restless leg movements during sleep.
• Fainting (syncope).
• Numbness sensation in the mouth (oral hypoesthesia).
• Low blood pressure.
• Nightmares.
• Agitation.
• Seeing, feeling or hearing things that do not exist (hallucinations).
• Inability to stay still.

Rare (may affect up to 1 in 1,000 patients)

• Tics or muscle contractions (myoclonus).
• Aggressive behaviour.
• Increased liver enzymes, detected in a blood test.

Frequency not known (cannot be estimated from available data)

• Abnormal sensations in the mouth (oral paraesthesia).
• Swelling in the mouth (oral edema).
• Low levels of sodium in the blood (hyponatremia) detected in a blood test.
• Increased levels of creatine kinase in the blood detected in a blood test.
• Difficulty speaking.
• Increased salivation.
• Sleepwalking.
• Increased levels of the hormone prolactin in the blood (hyperprolactinaemia, including symptoms such as enlarged breasts or milk secretion from the nipple).
• Painful and prolonged penile erection.

Other adverse effects in children and adolescents

In clinical trials with children under 18 years of age, the following adverse effects were frequently observed: significant weight gain, urticaria and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Viatris Pharmaceuticals

The active substance is mirtazapine. Each tablet contains 30 mg of mirtazapine.

The other components (excipients) are: anhydrous lactose (see section 2 “Mirtazapine Viatris Pharmaceuticals contains lactose”), maize starch, colloidal anhydrous silica, low-substituted hydroxypropyl cellulose and magnesium stearate. The coating contains: titanium dioxide (E-171), macrogol 4000, monohydrate lactose (see section 2 “Mirtazapine Viatris Pharmaceuticals contains lactose”), red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172) and hypromellose.

Appearance of the product and contents of the pack

Mirtazapine tablets are film-coated, circular, ochre-coloured tablets marked with the code 'MR/30' on one side and 'G' on the other.

Mirtazapine is available in blisters containing 10, 14, 20, 28, 30, 50, 100, 250 and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

Or

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands

Or

Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany Mirtazapin dura 30 mg Filmtabletten
Belgium Mirtazapine Mylan 30 mg filmomhulde tabletten
Spain Mirtazapina Viatris Pharmaceuticals 30 mg film-coated tablets EFG
Greece MIRTAZAPINE/MYLAN F.C. TAB 30 mg/TAB
Netherlands Mirtazapine Mylan 30 mg filmomhulde tabletten
Ireland Zismirt 30 mg Film Coated Tablets
Italy Mirtazapina Mylan Generics 30 mg
Portugal Mirtazapina Mylan 30 mg Comprimidos Revestidos
United Kingdom Mirtazapine 30 mg Tablets

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/