Leaflet:information for the user

Mirtazapina Teva-ratio 30 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for youonlyand should not be given to others even if they have the same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor, pharmacist or nurse,even if they are not listed in this leaflet. See section 4.

1.What is Mirtazapina Teva-ratio and what it is used for

2.What you need to knowbeforestarting totake Mirtazapina Teva-ratio

3.How to take Mirtazapina Teva-ratio

4.Possible side effects

5Storage of Mirtazapina Teva-ratio

6.Contents of the pack and additional information

Mirtazapina Teva-ratio contains the active ingredient mirtazapine and belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It may take 1 to 2 weeks for mirtazapine to start working. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you get worse or do not improve after 2 to 4 weeks.

For more information, see section 3 “When you can expect to feel better”.

Do not take Mirtazapina Teva-ratio

• if you are allergic to mirtazapina or any of the other ingredients of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking mirtazapina.
• if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take mirtazapina.

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 mouth sores after taking mirtazapina or other medications.after taking mirtazapina or other medications.

Children and adolescents

Mirtazapina should not be used in the treatment of children and adolescents under 18 years oldbecause its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years old there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and anger) when taking this type of medication. Despite this, the doctor may prescribe mirtazapina to patients under 18 years old when they decide it is the best option for the patient. If the doctor has prescribed mirtazapina to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old who are taking mirtazapina. In addition, the long-term safety effects related to growth, maturation, and cognitive and behavioral development in patients of this age group taking mirtazapina are still unknown.Furthermore, a significant weight gain has been observed in this age group more frequently when treated with mirtazapina compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have a normal effect.

You may be more prone to thinking this way if:

• you have previously had suicidal thoughts or self-harm.
• you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults under 25 years old with psychiatric disorders and taking an antidepressant.

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

It may be helpful to tell a close relative or friend that you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.

Be especially careful with mirtazapina

If you have or have had any of the following conditions.

Inform your doctor about these situations before taking Mirtazapina Teva, if you have not already:

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapina and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice appears, stop taking mirtazapina and contact your doctor immediately;
• kidney diseases;
• heart diseaseorlow blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately;
• bipolar depression(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
• eye diseases, such as increased eye pressure (glaucoma);
• difficulty urinating, which could be due to an enlarged prostate;
• certain types of heart disease that can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.

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

Stop taking mirtazapina and contact your doctor immediately to perform a blood test.

In rare cases, these symptoms can be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms appear at 4-6 weeks of treatment.

• if you are an older person. You may be more sensitive to the adverse effects of antidepressant medications.

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Discontinue use 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, do not restart treatment with mirtazapina.

Other medications and Mirtazapina Teva-ratio

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

Do not takemirtazapina with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapina during the two weeks after stopping MAOIs. Ifyou stop taking mirtazapina, do not take MAOIs during the following two weeks.

Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take mirtazapina with:

• other antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders),methylene blue (used to treat high levels of methemoglobin in the blood), andSt. John's Wort –Hypericum perforatum(a medicinal plant for depression). In very rare cases, mirtazapina alone or with these medications, may cause the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of mirtazapina, or increase it again when stopping nefazodone.
• anxiety or insomnia medicationssuch as benzodiazepines;schizophrenia medicationssuch as olanzapina;allergy medicationssuch as cetirizina;intense pain medicationssuch as morphine. In combination with these medications, mirtazapina may increase the drowsiness caused by these medications.

• infection medications:infection medications (such as erythromycin), fungal infection medications (such as ketoconazole), and HIV/AIDS medications (HIV protease inhibitors) and stomach ulcer medications (such as cimetidine). If taken with mirtazapina, these medications may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking these medications. You may need to reduce the dose of mirtazapina, or increase it again when stopping these medications.

• epilepsy medicationssuch as carbamazepine and phenytoin;
• tuberculosis medicationssuch as rifampicin.

If taken with mirtazapina, these medications may reduce the amount of mirtazapina in the blood. Inform your doctor if you are taking these medications. You may need to increase the dose of mirtazapina, or reduce it again when stopping these medications.

• blood thinnerssuch as warfarin. Mirtazapina may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that your doctor perform blood tests.
• medications that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Teva-ratio with food and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapina. It is recommended not to drink any alcohol.

You can take mirtazapina with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The limited experience of administering mirtazapna to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy. 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 taking mirtazapina. When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious disease 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's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Breastfeeding

Consult your doctor if you can breastfeed while taking mirtazapina.

Driving and using machines

Mirtazapina may affect your concentration or alertness. Make sure your faculties are not impaired before driving or using machinery. If your doctor has prescribed mirtazapina to a patient under 18 years old, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Mirtazapina Teva-ratio contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.

The recommended initial 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). Normally, the dose is the same for all ages. However, if you are an older person or if you have a kidney or liver disease, your doctor may change the dose.

When to take Mirtazapina Teva-ratio

Take mirtazapina at the same time every day. It is better to take the mirtazapina dose once a day before going to bed. However, your doctor may recommend that you divide your mirtazapina dose into morning and evening before going to bed. The highest dose should be taken before going to bed. The tablets are taken orally. Take the prescribed mirtazapina dose without chewing, with water or juice.

The tablet can be divided into equal doses.

When to expect to feel better

Normally, mirtazapina will start to take effect 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 mirtazapina:

→ between 2 and 4 weeks after starting to take mirtazapina, 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 until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Teva-ratio than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you or someone takes too much mirtazapina, consult a doctor immediately. The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations..The symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes.

If you forgot to take Mirtazapina Teva-ratio

If you have to take your dose once a day

• Do not take a double dose to compensate for the missed doses. Take the usual dose the next day.

If you have to take your dose twice a day

• If you forgot the morning dose, simply take it with the evening dose.
• If you forgot 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 forgot 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 Teva-ratio

Stop taking mirtazapina only if you consult your doctor.

If you stop 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 abruptly, even when depression has disappeared. If you stop taking mirtazapina 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, pharmacist, or nurse.

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

If you experience any of the following serious side effects, stop taking mirtazapine and immediately inform your doctor.

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

• exaggerated feeling of euphoria (mania).

Unknown frequency(cannot be estimated from available data):

• signs of infection such as sudden and unexplained high fever and sore throat, mouth sores (agranulocytosis). In rare cases, 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). In rare cases, mirtazapine 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).
• seizure (convulsion).
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome."
• thoughts of self-harm or 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects with mirtazapine are:

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
• diarrhea
• vomiting
• constipation
• urticaria or skin rash (exanthema)
• joint or muscle pain (arthralgia or 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 100 patients):

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• restless legs syndrome
• syncope (fainting)
• numbness of the mouth (hypoaesthesia oral)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

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

• tics or muscle contractions (myoclonus)
• aggression
• abdominal pain, nausea; this may indicate pancreatitis

Unknown frequency(cannot be estimated from available data):

• abnormal sensations in the mouth (paresthesia oral)
• swelling in the mouth (buccal edema)
• generalized edema
• localized edema
• low sodium levels that may cause headache, fatigue, convulsions, and coma (hyponatremia)
• inadequate secretion of antidiuretic hormone
• severe skin reactions (dermatitis bullous, erythema multiforme)
• sleepwalking (somnambulism)
• speech problems
• increased levels of creatine kinase in the blood,
• urinary retention
• muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge).
• painful and prolonged erection of the penis

Additional side effects in children and adolescents

In clinical trials, the following side effects were observed in children under 18 years of age: significant weight gain, 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.

Keepthis medicationout of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears onthe box and in the blister pack or bottleafter EXP or CAD. The expiration date is the last day of the month indicated.

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

Mirtazapina Teva-ratio Composition

• The active ingredient is mirtazapine.

Mirtazapina Teva-ratio 30 mg film-coated tablets contain 30 mg of mirtazapine per film-coated tablet.

• The other components are:

Tablet core: lactose monohydrate, maize starch pregelatinised, anhydrous colloidal silica (E551), sodium croscarmellose (E468), magnesium stearate (E470b).

Film coating: hypromellose (E464), macrogol 8000 (E1521), titanium dioxide (E171), talc.

The film coating of Mirtazapina Teva-ratio 30 mg film-coated tablets also contains iron oxide yellow (E172) and iron oxide red (E172).

Appearance of the product and contents of the package

Mirtazapina Teva-ratio are film-coated tablets.

Yellowish-brown film-coated tablets, scored on both sides, oval, biconvex, 12.7 x 6.5 mm in diameter. Marked with “I” on one side. The tablet can be divided into equal doses.

Package sizes:

20, 30, 50, 60 and 100 tablets in blisters.

100 tablets in HDPE bottles with PE caps.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer responsible:

Actavis Ltd

BLB 015, BLB 016,

Bulebel Industrial Estate

ZTN3000 Zejtun

Malta

or

Actavis Group PTC ehf

Dalshraun 1, 220

Hafnarfjörður

Islandia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

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

AustriaMirtabene-ratiopharm GmbH 30 mg Filmtabletten

GermanyMirtazapin-ratiopharm 30 mg Filmtabletten

DenmarkMirtazapin Teva B.V.

SpainMirtazapina Teva-ratio 30 mg film-coated tablets EFG

FinlandMirtazapin Teva 30 mg tabletti, kalvopäällysteinen

LuxembourgMirtazapin-ratiopharm 30 mg Filmtabletten

PortugalMirtazapina Refta

Last revision date of thisleaflet:March 2023

Other sources of information

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

You can access detailed and updated information about this medicinal product by scanning with your smartphone the QR code included in the packaging. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/88859/P_88859.html