Prospecto: information for thepatient

Mirtazapina Flas Viatris 30 mg buccal tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult yourdoctor or pharmacist,even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Mirtazapina Flas Viatris

3.How to take Mirtazapina Flas Viatris

4.Possible adverse effects

5.Storage of Mirtazapina Flas Viatris

6.Contents of the package and additional information

Mirtazapina Flas Viatris belongs to a group of medicines calledantidepressants.

Mirtazapina Flas Viatris is used to treat depression in adult individuals.

Do not takeMirtazapina Flas Viatris:

• if you are allergic to mirtazapina or any of the other ingredients in this medicine (listed in section6).
• if you are taking or have taken in the last two weeks any medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Do not take or consult your doctor before starting to take mirtazapina:

If you have ever had a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking mirtazapina or other medicines.

Be especially careful with mirtazapina:

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Stop using it and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.

If you have ever had severe skin reactions, you should not restart treatment with mirtazapina.

Children and adolescents

Mirtazapina Flas Viatris should not be used normally in the treatment of children and adolescents under 18 yearssince its efficacy has not been demonstrated. At the same time, you should be aware that in patients under 18 years there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. Although, your doctor may prescribe Mirtazapina Flas Viatris to patients under 18 years when they decide what is best for the patient. If your doctor has prescribed Mirtazapina Flas Viatris to a patient under 18 years and wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned earlier in patients under 18 years taking Mirtazapina Flas Viatris appear or worsen. The long-term safety effects related to growth, maturation, and development of Mirtazapina Flas Viatris in this age group are still unknown.Furthermore, a significant weight gain has been observed in this age category more frequently during treatment with mirtazapina compared to adults.

Suicidal thoughts and worsening of depression

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

This may be worse when you first start taking antidepressants, as it may take two weeks or more for them to start working.

You may be more likely to have these thoughts:

• if you have had thoughts of harming yourself or of suicide before.
• if you are a young adult. The information from clinical trials has shown an increased risk of suicidal behaviour in young adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.

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

It may be helpful to tell a close relative or 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 behaviour.

Consult your doctor or pharmacist before taking Mirtazapina Flas Viatris if you experience or have ever experienced any of the following conditions:

Older patients

• If you are an older person. You may be more sensitive to the side effects of antidepressant medicines.

During treatment

Consult your doctor:

• if you develop signs of infection such as high fever, sore throat, and mouth sores.

In rare cases, these symptoms may be signs of bone marrow problems. Although rare, these symptoms appear at 4-6 weeks of treatment.

Other medicines and Mirtazapina Flas Viatris

Do not take Mirtazapina Flas Viatriswith:

• MAOIs(monoamine oxidase inhibitors). Also, do not take Mirtazapina Flas Viatris during the two weeks after stopping MAOIs. If you stop taking Mirtazapina Flas Viatris, do not take MAOIs during the two weeks that follow. Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants) and selegiline (for Parkinson's disease).

Inform your doctor or pharmacist if you are taking, have taken recently, or might need to take any other medicine, including those bought 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 migraines; e.g. sumatriptan),tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders),methylene blue(used to treat toxemia), and St. John's Wort(Hypericum perforatum) (herbal remedy fordepression). In rare cases, Mirtazapina Flas Viatris alone or with these medicines, may cause a condition known as serotonin syndrome. Some of the signs of this condition are:fever, sweating, palpitations, diarrhoea, muscle contractions(uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss ofconsciousness. If you experience a combination of these symptoms, contact your doctorimmediately.
• Anxiety or insomnia medicinessuch as benzodiazepines;for example, diazepam or clordiazepoxide.
• Schizophrenia medicinessuch as olanzapine.
• Allergy medicinessuch as cetirizine.
• Pain medicinessuch as morphine.

Mirtazapina Flas Viatris may increase the drowsiness caused by these medicines.

These medicines increase the amount of mirtazapina in the blood:

• Infection medicines:antibiotics for bacterial infections (e.g. erythromycin);antifungal medicines (e.g. ketoconazole), HIV/AIDS medicines (e.g. HIV protease inhibitors, such as ritonavir, nelfinavir);antidepressants(e.g. nefazodone) andstomach ulcer medicines(e.g. cimetidine). If taken with Mirtazapina Flas Viatris, these medicines may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking these medicines. You may need to reduce your Mirtazapina Flas Viatris dose, or increase it again when you stop taking these medicines.

These medicines decrease the amount of mirtazapina in the blood:

• Carbamazepine and phenytoin,epilepsy medicines,rifampicin, a tuberculosis medicine.If taken with Mirtazapina Flas Viatris, these medicines may reduce the amount of mirtazapina in the blood. Inform your doctor if you are taking these medicines. You may need to increase your Mirtazapina Flas Viatris dose, or reduce it again when you stop taking these medicines.
• Warfarin, a blood thinner medicine. Mirtazapina Flas Viatris may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If you take them together, your doctor may recommend blood tests.

Taking Mirtazapina Flas Viatris with alcohol

You may feel drowsy if you drink alcohol while taking Mirtazapina Flas Viatris.

It is recommended not to drink any alcohol.

Pregnancy and breastfeeding

The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk of congenital malformations. However, you should be cautious if you use it during pregnancy.

If you are taking mirtazapina and become pregnant or want to become pregnant, consult your doctor if you can continue taking mirtazapina. If you use mirtazapina until, or shortly before, delivery, your baby will be examined to detect any possible adverse effects.

Make sure your midwife and/or doctor know that you are being treated with mirtazapina.

Similar medicines (SSRIs), taken during pregnancy, may increase the risk of a serious condition in the baby, known as 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, contact your midwife and/or doctor immediately.

Consult your doctor if you can breastfeed while taking Mirtazapina Flas Viatris.

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

Driving and operating machinery

Mirtazapina Flas Viatris may affect your concentration or alertness. Make sure your faculties are not impaired before driving or operating machinery.

Mirtazapina Flas Viatris contains aspartame

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

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Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 15 or 30 mg per 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 older person and have a kidney or liver disease, your doctor may change the dose.

When to take it

Take Mirtazapina Flas Viatris at the same time every day.

It is better to take the dose of Mirtazapina Flas Viatris all at once before going to bed. However, your doctor may recommend that you divide your dose of Mirtazapina Flas Viatris into the morning and evening before going to bed.

The highest dose should be taken before going to bed.

Take the buccal tablet in the following way

The tablets are taken orally.

1. Do not press the buccal tablet

To avoid the buccal tablet from crushing, do not press the alveolus (Figure A).

Fig. A.

1. Separate an alveolus

Each blister contains six alveoli, which are separated by perforations. Separate an alveolus following the perforated lines (Figure 1).

Fig. 1.

1. Open the alveolus

Remove the sheet carefully, starting from the corner (Figure 2).

Fig. 2.

1. Remove the buccal tablet

Remove the buccal tablet carefully with dry hands and place it on the tongue (Figure 3).

Fig. 3.

It will disintegrate quickly and can be swallowed without water.

When you can expect to feel better

Mirtazapina Flas Viatris usually starts to work after 1 or 2 weeks and after2 to4 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 Mirtazapina Flas Viatris:

• Between 2 and 4 weeks after starting to take Mirtazapina Flas Viatris, talk to your doctor about how this medication 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 Mirtazapina Flas Viatris until the symptoms of depression have disappeared for 4-6 months.

Use in children and adolescents under 18 years:

Mirtazapina Flas Viatris should not be used in children and adolescents under 18years (see section2 “Children and adolescents under 18years”).

If you take more Mirtazapina Flas Viatris than you should

If you or someone takes too much Mirtazapina Flas Viatris, consult a doctor immediately. You can also call the Toxicological Information Service, phone, 91 562 04 20.

The most likely symptoms of a Mirtazapina Flas Viatris overdose (without other medications or alcohol) are drowsiness, disorientation,changes in heart rhythm (irregular, rapid heartbeat) or fainting, which can be symptoms of a potentially fatal condition known as torsade de pointes.

If you forget to take Mirtazapina Flas Viatris

If you have to take your doseonce a day

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

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

If you have to take your dosetwice 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 usual doses in the morning and evening.
• If you have forgotten both doses, do not try to recover them. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt the treatment with Mirtazapina Flas Viatris

Stop taking Mirtazapina Flas Viatris only after consulting your doctor.

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

Do not stop taking Mirtazapina Flas Viatris abruptly, even when depression has disappeared. If you stop taking Mirtazapina Flas Viatris abruptly, you may feel sick, dizzy, agitated or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually reduce the dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Mirtazapina Flas Viatris and inform your doctor immediately or go to the nearest hospital emergency service:

Rare(may affect up to 1 in 1000 people)

• Pancreatitis. This causes moderate to severe abdominal pain that radiates to the back.

Frequency not known(cannot be estimated from available data)

• Seizure (convulsions).
• Yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice).
• A combination of symptoms such as fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome."
• Thoughts of suicide or self-harm, or attempted suicide.
• Red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and lymph node enlargement (DRESS syndrome or drug hypersensitivity syndrome).
• Symptoms of infections such as sudden high fever, sore throat, and mouth ulcers (agranulocytosis).
• Mirtazapina may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia).
• Muscle rupture, which causes muscle pain, stiffness, weakness, and dark or discolored urine (rhabdomyolysis).
• Difficulty urinating or emptying the bladder.
• Low sodium levels in the blood, which may cause weakness or confusion accompanied by muscle pain. This may be due to inadequate secretion of ADH, a hormone that causes the body to retain water and dilute the blood, reducing sodium levels.

Other possible side 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.
• Unpleasant feeling (nausea).
• Diarrhea.
• Unpleasant feeling (vomiting).
• Constipation.
• Rash or skin eruptions (exanthema).
• Pain in the joints (arthralgia) or muscles (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.

Rare(may affect up to 1 in 1000 people)

• Euphoric sensation or emotional exaltation (mania).
• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia).
• Involuntary movements of leg agitation during sleep.
• Fainting (syncope).
• Sensation of numbness in the mouth (hypoaesthesia oral).
• Low blood pressure.
• Nightmares.
• Agitation.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Inability to remain still.

Frequency not known: cannot be estimated from available data

• Abnormal sensations in the mouth, such as burning, stinging, tingling, or numbness (paresthesia oral).
• Swelling in the mouth (buccal edema).
• Low sodium levels in the blood (hyponatremia) (observed through blood tests).
• Increased levels of creatine kinase in the blood (observed through blood tests).
• Increased salivation.
• Somnambulism.
• Difficulty speaking.
• Increased concentration of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement or nipple discharge).

Other side effects in children and adolescents

The following adverse events have been observed in children under 18 years old in clinical trials: urticaria and increased triglycerides in the blood.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use thismedicationafter the expiration date that appears on the packaging and in the blisterafter CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Mirtazapina Flas Viatris Composition

The active ingredient is mirtazapine.

Each buccal dispersible tablet contains 30 mg of mirtazapine.

The other components are: crospovidone, mannitol (E-421), microcrystalline cellulose, aspartame (E-951)(see section2 “Mirtazapina Flas Viatris contains aspartame”),raspberry and guarana flavor, peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

Mirtazapina Flas Viatris 30 mg buccal dispersible tabletsare white, round, and marked with “A” on one side and the code “36” on the other.

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

Only some package sizes may be marketed.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

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

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

DenmarkMirtazapin Mylan 30 mg smeltetabletter

SpainMirtazapina Flas Viatris 30 mg comprimidos bucodispersables EFG

NetherlandsMirtazapine SmeltTab Mylan 30 mg, orodispergeerbare tablet

IrelandZismirt orotab 30 mg Orodispersible Tablet

PolandMirtagen 30 mg

PortugalMirtazapina Mylan 30 mg comprimindo orodispersivel

United KingdomMirtazapine 30 mg Orodispersible Tablets

Last review date of this leaflet:June 2020

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.