Mirtazapine Flas Viatris 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mirtazapine Flas Viatris 30 mg orodispersible tablets EFG

Read the entire 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. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Mirtazapine Flas Viatris is and what it is used for
2. What you need to know before taking Mirtazapine Flas Viatris
3. How to take Mirtazapine Flas Viatris
4. Possible side effects
5. How to store Mirtazapine Flas Viatris
6. Contents of the pack and other information

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

Mirtazapine Flas Viatris belongs to a group of medicines called antidepressants.

Mirtazapine Flas Viatris is used to treat depression in adults.

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

Do not take Mirtazapine Flas Viatris:

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

Warnings and precautions

Do not take or consult your doctor before starting mirtazapine:

If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Take special care with mirtazapine:

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 it and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have ever had serious skin reactions, restarting treatment with mirtazapine should not be considered.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated. At the same time, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide 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 of age if they decide it is the most appropriate treatment 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. The long-term effects on safety regarding growth, maturation, and cognitive and behavioral development of mirtazapine in this age group are not yet known. In addition, a significant increase in weight has been observed more frequently in this age group during treatment with mirtazapine compared to adults.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide.

This may worsen when you first start taking antidepressants, as these medicines usually take time to work—typically two weeks or sometimes longer.

You may be more likely to have such thoughts:

• 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 of suicide, consult 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 worsening or if they are concerned about changes in your behavior.

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

• Seizures (epilepsy).
• Liver diseases, including jaundice.
• Kidney diseases.
• Heart disease or family history of heart disease, including certain types of heart conditions that may alter heart rhythm, recent myocardial infarction, heart failure, or if you are taking certain medicines that may affect heart rhythm.
• Low blood pressure.
• Schizophrenia.
• Bipolar disorder (periods of euphoria/hyperactivity alternate with periods of depression).
• Diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines).
• Eye conditions, such as increased eye pressure (glaucoma).
• Difficulty urinating, which may be due to an enlarged prostate.

Elderly people

• If you are elderly. You may be more sensitive to the adverse effects of antidepressant medicines.

During treatment

Consult your doctor:

• If signs of infection appear, such as high fever, sore throat, and mouth ulcers.

Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

Other medicines and Mirtazapine Flas Viatris

Do not take Mirtazapine Flas Viatris together with:

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

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

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs) (e.g., citalopram), venlafaxine and L-tryptophan or triptans (used to treat migraine; e.g., sumatriptan), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat toxemia), and St. John's wort preparations (Hypericum perforatum) (a 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 signs of this syndrome include: fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these signs, consult your doctor immediately.
• Medicines for anxiety or insomnia such as benzodiazepines; e.g., diazepam or chlordiazepoxide.
• Medicines for schizophrenia such as olanzapine.
• Medicines for allergies such as cetirizine.
• Medicines for severe pain such as morphine.

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

The following medicines increase the amount of mirtazapine in the blood:

• Medicines for infections: antibacterial medicines (such as erythromycin); antifungal medicines (such as ketoconazole), medicines for HIV/AIDS (such as HIV protease inhibitors, e.g., ritonavir, nelfinavir); medicines for depression (such as nefazodone), and medicines for stomach ulcers (such as cimetidine). When taken together with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping these medicines.

The following medicines decrease the amount of mirtazapine in the blood:

• Carbamazepine and phenytoin, medicines for epilepsy, rifampicin, medicine for tuberculosis. When 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 decrease it again when stopping these medicines.
• Warfarin, a medicine to prevent blood clotting. Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, regular blood monitoring by your doctor is recommended.

Taking Mirtazapine Flas Viatris with alcohol

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

It is recommended not to drink any alcohol.

Pregnancy and breastfeeding

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 are taking mirtazapine and become pregnant or plan to become pregnant, consult your doctor about whether you can continue taking mirtazapine. If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

Ensure that your midwife and/or doctor know that you are being treated with 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.

Consult your doctor about whether you can breastfeed while taking mirtazapine.

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

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 Flas Viatris contains aspartame

This medicine contains 3 mg of aspartame in each 15 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic condition in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Mirtazapine Flas Viatris

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 15 or 30 mg 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 daily). The recommended dose is usually the same for all age groups. However, if you are elderly and have kidney or liver disease, your doctor may adjust the dose.

When to take it

Take Mirtazapine Flas Viatris at the same time each day.

It is best to take the mirtazapine dose as a single dose before bedtime. However, your doctor may recommend that you split your mirtazapine dose, taking part in the morning and part at night before bedtime.

The higher dose should be taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not press the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Fig. A).

Fig. A.

1. Separate one blister cavity

Each blister contains six cavities, separated by perforations. Separate one cavity by following the perforated lines (Fig. 1).

Fig. 1.

1. Open the blister cavity

Carefully peel back the foil, starting at the corner (Fig. 2).

Fig. 2.

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on the tongue (Fig. 3).

Fig. 3.

It will dissolve rapidly and can be swallowed without water.

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 start to feel better. It is important that during the first weeks of treatment you talk to your doctor about the effects of mirtazapine:

• Between 2 and 4 weeks after starting mirtazapine, discuss with your doctor 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 been absent 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”).

If you take more Mirtazapine Flas Viatris than you should

If you or someone else takes too much mirtazapine, consult a doctor immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, changes in heart rate (irregular, rapid heartbeat), or fainting, which may be symptoms of a potentially life-threatening condition known as torsade de pointes.

If you forget to take Mirtazapine Flas Viatris

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 Flas Viatris

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 taking mirtazapine suddenly, you may feel unwell, dizzy, restless, or anxious and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to gradually reduce the dose.

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 will experience them.

If you experience any of the following, stop taking mirtazapine and contact your doctor immediately or go to the nearest hospital emergency department:

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

• Inflammation of the pancreas. This causes moderate to severe stomach pain that spreads to the back.

Frequency not known (cannot be estimated from available data)

• Seizure (convulsions).
• Yellowing of the eyes or skin; may indicate liver problems (jaundice).
• Combination of symptoms such as fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome."
• Thoughts of suicide or self-harm, or suicide attempt.
• Red patches on the trunk, appearing as well-defined or circular spots, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized redness, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Symptoms 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 more susceptible to infections because mirtazapine may temporarily reduce white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a reduction in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).
• Breakdown of muscle tissue, causing muscle pain, tenderness, stiffness, or weakness, and darkening or discoloration of urine (rhabdomyolysis).
• Difficulty urinating or emptying the bladder.
• Lower than normal sodium levels in the blood, which may make you feel weak or confused, accompanied by muscle pain. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, thereby reducing sodium levels.

Other possible adverse effects

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

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

Common (may affect up to 1 in 10 people)

• Lethargy.
• Dizziness.
• Tremor.
• Feeling unwell (nausea).
• Diarrhea.
• Discomfort (vomiting).
• Constipation.
• Hives or skin rash (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.
• Difficulty sleeping.
• Memory problems, which in most cases resolved when treatment was discontinued.

Uncommon (may affect up to 1 in 100 people)

• Feeling of euphoria or emotional elation (mania).
• Strange sensations in the skin, such as burning, prickling, tingling, or numbness (paresthesia).
• Involuntary restless leg movements during sleep.
• Fainting (syncope).
• Numbness of the mouth (oral hypoesthesia).
• Low blood pressure.
• Nightmares.
• Agitation.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Inability to remain still.

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

• Tics or muscle contractions (myoclonus).
• Aggressive behavior.
• Increased liver enzymes (detected by blood tests).

Frequency not known (cannot be estimated from available data)

• Abnormal sensations in the mouth, such as burning, stinging, tingling, or numbness (oral paresthesia).
• Swelling in the mouth (oral edema).
• Low sodium levels in blood (hyponatremia) (detected by blood tests).
• Increased levels of creatine kinase in blood (detected by blood tests).
• Increased salivation.
• Sleepwalking.
• Difficulty speaking.
• Increased blood concentration of the hormone prolactin (hyperprolactinemia, including symptoms such as breast enlargement or milky discharge from the nipples).
• Prolonged and painful erection of the penis.

Other adverse effects in children and adolescents

The following adverse events have been observed in children under 18 years of age in clinical trials: hives and increased blood triglycerides.

Reporting of adverse effects

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

5. Storage of Mirtazapine Flas Viatris

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Mirtazapine Flas Viatris

The active substance is mirtazapine.

Each orodispersible tablet contains 30 mg of mirtazapine.

The other components are: crospovidone, mannitol (E-421), microcrystalline cellulose, aspartame (E-951) (see section 2 “Mirtazapine Flas Viatris contains aspartame”), strawberry and guarana flavour, mint flavour, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

Mirtazapine Flas Viatris tablets are white, round, and marked with “A” on one side and the code “36” on the other.

Mirtazapine Flas Viatris is available in blisters containing: 6, 12, 18, 30, 48, 60, 90, 96 and 100 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Ltd T/A Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
H-2900 Komárom,
Mylan utca 1,
Hungary

Further information on this medicinal product is available from 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 European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Denmark Mirtazapin Viatris 30 mg smeltetabletter
Spain Mirtazapina Flas Viatris 30 mg orodispersible tablets EFG
Netherlands Mirtazapine SmeltTab Mylan 30 mg, orodispergeerbare tablet
Italy Mirtazapina Mylan Generic Italia
Poland Mirtagen
Portugal Mirtazapina Mylan 30 mg comprimido orodispersivel
United Kingdom (Northern Ireland) Mirtazapine 30 mg Orodispersible Tablets
Czech Republic Mirtazapina Viatris

Date of the most recent review of this leaflet: November 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/.