MIRTAZAPINE VIATRIS PHARMACEUTICALS 30 mg FILM-COATED TABLETS

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

Do not take Mirtazapine Viatris Pharmaceuticals

• If you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken in 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 skin peeling, or if you have developed blisters or ulcers in your mouth after taking mirtazapine or other medicines. With the use of mirtazapine, serious skin reactions have been reported, 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 medical advice immediately if you experience any of the symptoms described in section 4 related to these serious skin reactions. If you have ever developed a serious skin reaction, you should not restart treatment with mirtazapine.

Children and adolescents under 18 years

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years when he decides it is the most convenient for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years taking mirtazapine. Additionally, the long-term safety effects on growth, maturation, and development of knowledge and behavior of mirtazapine in this age group are not yet known. Also, a significant increase in weight has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. This may worsen when you first start taking antidepressants, as these medicines take time to work, usually 2 weeks or sometimes longer.

You may be more likely to think this way:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried 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:

Tell your doctor about these situations before taking mirtazapine, if you have not already:

• Seizures(epilepsy).
• Liver disease, such as jaundice.
• Kidney disease.
• Heart diseaseor certain heart diseasesthat may change your heart rhythm, a 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 excitement/hyperactivity and periods of depression).
• Diabetes(you may need to adjust your insulin or other antidiabetic medication dose).
• Eye diseases, such as increased pressure in the eye (glaucoma).
• Difficulty urinating, which may be due to an enlarged prostate.

During treatment

• If signs of infection appear, such as high unexplained fever, sore throat, and mouth ulcers. In rare cases, these symptoms can be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms usually appear within 4-6 weeks of treatment.
• If you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medicines.

Other medicines and Mirtazapine Viatris Pharmaceuticals

Do not take Mirtazapine Viatris Pharmaceuticals with:

Monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after you have stopped taking MAOIs. If you stop taking mirtazapine, do not take MAOIs during the following two weeks. Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

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

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs)such as, for example, citalopram, venlafaxine, and L-tryptophan or triptanssuch as, for example, sumatriptan (used for migraines), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), methylene blue(used to treat some types of blood poisoning), and St. John's Wort preparations – Hypericum perforatum(a medicinal plant for depression). In very rare cases, mirtazapine alone or with these medicines may lead to a condition called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately.
• The antidepressant nefazodonemay increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone.
• Medicines for anxiety or insomniasuch as benzodiazepines, for example, diazepam or chlordiazepoxide.
• Medicines for schizophreniasuch as olanzapine.
• Medicines for allergiessuch as cetirizine.
• Medicines for severe painsuch as morphine.

When combined with these medicines, mirtazapine may increase the drowsiness caused by these medicines.

• 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, such as ritonavir, nelfinavir).
• Cimetidine, a medicine for stomach ulcers.

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

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

If taken 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 decrease 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. When taking them together, it is recommended that your doctor performs blood tests.

• Medicines that may affect heart rhythmsuch as some antibiotics and some antipsychotics.

Mirtazapine Viatris Pharmaceuticals with alcohol

You may feel drowsy if you drink alcohol while being treated with 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 the administration of mirtazapine to pregnant women does not indicate an increased risk of congenital malformations. However, caution should be exercised if used during pregnancy. If you take mirtazapine until just before delivery, your baby should be monitored for possible adverse effects.

Make sure your midwife and/or doctor know that you are being treated with mirtazapine. Similar medicines (SSRIs), taken during pregnancy, may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens, you should contact your midwife and/or doctor immediately.

Breastfeeding

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

Driving and using machines

Mirtazapine may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery.

Mirtazapine Viatris Pharmaceuticals contains lactose

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

3. How to take Mirtazapine Viatris Pharmaceuticals

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

How much to take

Adults:

The recommended initial dose is 15 mg or 30 mg once a day. 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). The recommended dose is usually the same for all ages. However, if you are an elderly person or have kidney or liver disease, your doctor may change the dose.

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

When you can expect to feel better

Normally, mirtazapine will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential that during the first weeks of treatment, you talk to your doctor about the effects of mirtazapine:

Between 2 and 4 weeks after starting to take 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, talk to your doctor again after another 2-4 weeks.

Normally, you will need to take mirtazapine until the symptoms of depression have disappeared for 4-6 months.

Use in children and adolescents under 18 years:

Mirtazapine should not be used in children and adolescents under 18 years (see section 2, "Children and adolescents under 18 years").

When to take it

Take mirtazapine at the same time each day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before bedtime. The highest 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 can also call the Toxicology Information Service. Telephone 91 562 04 20.

The most likely symptoms of a mirtazapine overdose (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rhythm (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 have to take your dose once a day

• 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 have to take your dose twice a day

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

If you stop taking Mirtazapine Viatris Pharmaceuticals

Stop taking mirtazapine after consulting your doctor.

If you stop taking it too soon, depression may recur. 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 disappeared. If you stop taking mirtazapine abruptly, you may feel unwell, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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)

• Pancreatitis. This can cause moderate or severe stomach pain, which spreads to the back.
• Yellowing of the skin or eyes, this may suggest liver function changes (jaundice).

Frequency Not Known(cannot be estimated from the available data)

• Severe allergic reactions such as rash, itching or skin eruptions, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing.
• Signs of infection such as sudden high fever, sore throat and mouth ulcers (agranulocytosis). Mirtazapine may cause changes 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 and platelets in the blood (aplastic anemia), a decrease in platelets with easier bruising and bleeding than usual (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).
• Low sodium levels in the blood, which can 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, reducing the amount of sodium.
• Thoughts of self-harm or suicide (see section 2 "Suicidal Thoughts and Worsening of Depression").
• Seizures (convulsions).
• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. These may be symptoms of "serotonin syndrome".
• Signs of severe skin reaction or disease 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, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Muscle tissue breakdown, which causes muscle pain, sensitivity, stiffness, and/or weakness, and darkening or color change 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.
• Somnolence.
• Headache.
• Dry mouth.

Common(may affect up to 1 in 10 patients)

• Lethargy.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhea.
• Vomiting.
• Constipation.
• Hives or skin eruptions (exanthema).
• Joint pain (arthralgia) or muscle pain (myalgia).
• Back pain.
• Dizziness or fainting when standing up quickly (orthostatic hypotension).
• Swelling (usually in ankles or feet) due to fluid retention (edema).
• Fatigue.
• Vivid dreams.
• Confusion.
• Anxiety.
• Sleep disturbances.
• Memory problems that resolve when the medication 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 sensation in the skin, such as burning, stabbing, tingling, or numbness (paresthesia).
• Involuntary leg movements during sleep.
• Fainting (syncope).
• Numbness of the mouth (oral hypoesthesia).
• Low blood pressure.
• Nightmares.
• Agitation.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Inability to remain still.

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

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

Frequency Not Known(cannot be estimated from the available data)

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

Other Adverse Effects in Children and Adolescents

In clinical trials with children under 18 years of age, the following adverse effects have been frequently observed: significant weight gain, hives, and increased triglycerides in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that are no longer needed at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Viatris Pharmaceuticals

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

The other components (excipients) are: anhydrous lactose (see section 2 "Mirtazapine Viatris Pharmaceuticals contains lactose"), cornstarch, colloidal anhydrous silica, low-substituted hydroxypropyl cellulose, and magnesium stearate. The coating includes: titanium dioxide (E-171), macrogol 4000, lactose monohydrate (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 Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Netherlands

Or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized 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 comprimidos recubiertos con película 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 Last Revision of this Prospectus:March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/