MIRTAZAPINE TEVA-RATIO 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Mirtazapine Teva-ratio 30 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

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

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Mirtazapine Teva-ratio and what is it used for
2. What you need to know before taking Mirtazapine Teva-ratio
3. How to take Mirtazapine Teva-ratio
4. Possible side effects

5 Storage of Mirtazapine Teva-ratio

1. Contents of the pack and further information

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

Mirtazapine Teva-ratio contains the active substance mirtazapine and belongs to the group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

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

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

2. What you need to know before taking Mirtazapine Teva-ratio

Do not take Mirtazapine Teva-ratio

• if you are allergic to mirtazapine 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 mirtazapine.
• If you are taking or have recently taken (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

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

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING TO TAKEmirtazapine:

If you have ever suffered from a severe skin rash or skin peeling, blisters, or ulcers in the mouthafter taking mirtazapine or other medications.

Children and adolescents

Generally, mirtazapine should not 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 a higher risk of side effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and anger) when taking this class of medications. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age who are taking mirtazapine. Additionally, the long-term safety effects related to growth, maturity, and cognitive and behavioral development in this age group taking mirtazapine are still unknown. Additionally, significant weight gain has been observed in this age group more frequently when treated with mirtazapine 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 sometimes more to work.

You may be more likely to think this way if:

• you have previously had suicidal thoughts or thoughts of harming yourself.
• you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and who were being treated with an antidepressant.

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

It may be helpful to tell a relative or close friend that you are depressed and ask them to read this package 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.

Also, be especially careful with mirtazapine

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

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

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
• kidney diseases;
• heart disease or low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become 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 mirtazapine and contact your doctor immediately;
• 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;
• 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 signs of infection appear, such as unexplained high fever, sore throat, and mouth ulcers.

Stop taking mirtazapine and contact your doctor immediately to have a blood test.

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

Severe skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapine. 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 suffered from severe skin reactions, do not restart treatment with mirtazapine.

Other medications and Mirtazapine Teva-ratio

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not takemirtazapine 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, tranilcipromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take mirtazapine with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraine), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), methylene blue (used to treat high levels of methemoglobin in the blood), and St. John's Wort –Hypericum perforatum(a medicinal plant for depression). In rare cases, mirtazapine alone or with these medications may cause a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), 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 mirtazapine in your blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of mirtazapine or increase it again when you stop taking nefazodone.
• medications for anxiety or insomniasuch as benzodiazepines; medications for schizophrenia such as olanzapine; medications for allergies such as cetirizine; medications for severe pain such as morphine. In combination with these medications, mirtazapine may increase the drowsiness caused by these medications.

• medications for infections:medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole), and medications for HIV/AIDS (HIV protease inhibitors) and medications for stomach ulcers (such as cimetidine). If taken with mirtazapine, these medications may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of mirtazapine or increase it again when you stop taking these medications.

• medications for epilepsysuch as carbamazepine and phenytoin;
• medications for tuberculosissuch as rifampicin.

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

• medications to prevent blood clottingsuch as warfarin. Mirtazapine may increase the effects of warfarin on your 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 your heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Teva-ratio with food and alcohol

You may feel drowsy if you drink alcohol while being treated with mirtazapine. It is recommended not to drink any alcohol.

You can take mirtazapine with or without food.

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 using this medication.

Pregnancy

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy. If you use mirtazapine until or shortly before delivery, your baby will be examined for possible adverse effects.

Make sure your midwife and/or doctor know that you are taking mirtazapine. 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 turn blue. These symptoms usually start during the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

Breastfeeding

Consult your doctor if you can breastfeed while taking mirtazapine.

Driving and using machines

Mirtazapine may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, make sure that concentration and alertness are not affected before circulating (e.g., by bicycle).

Mirtazapine Teva-ratio contains lactose

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

Mirtazapine Teva-ratio contains sodium

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

3. How to take Mirtazapine Teva-ratio

Follow the exact instructions for administering this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 elderly person or have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapine Teva-ratio

Take mirtazapine at the same time every 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 prescribed dose of mirtazapine without chewing, with water or juice.

The tablet can be divided into equal doses.

When can you 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 to discuss the effects of mirtazapine with your doctor during the first weeks of treatment:

→ between 2 and 4 weeks after starting to take mirtazapine, discuss with your doctor how this medication has affected you.

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

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

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

If you forget to take Mirtazapine Teva-ratio

If you need to take your dose once a day

• Do not take a double dose to make up for forgotten doses. Take your usual dose the next day

If you need to take your dose twice a day

If you stop taking Mirtazapine Teva-ratio

Stop taking mirtazapine only if you consult your doctor.

If you stop too soon, depression may recur. When you feel better, discuss with 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 medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

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

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

Uncommon(may affect up to 1 in 100 patients):

• feeling of exaggerated euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function disorders (jaundice)

Frequency not known(cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (agranulocytosis). In rare cases, mirtazapine can cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine can also cause a decrease 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).
• epileptic seizure (convulsions).
• 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 can be signs of a disorder called "serotonin syndrome".
• thoughts of self-harm or suicide.
• red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin erythemas can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible adverse 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
• tremors
• nausea
• diarrhea
• vomiting
• constipation
• urticaria or skin rashes (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 patients):

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

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

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

Frequency not known(cannot be estimated from available data):

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• low sodium levels that can cause headache, fatigue, convulsions, and coma (hyponatremia)
• inadequate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech problems
• increased creatine kinase levels in the blood,
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased prolactin hormone levels in the blood (hyperprolactinemia, including symptoms of breast enlargement and/or milky discharge from the nipple).
• Painful and prolonged erection of the penis

Additional adverse effects in children and adolescents

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

Reporting of 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine Teva-ratio

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the box and on the blister or bottle after EXP or CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Mirtazapine Teva-ratio

• The active ingredient is mirtazapine.

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

• The other components are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, anhydrous colloidal silica (E551), sodium croscarmellose (E468), magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), macrogol 8000 (E1521), titanium dioxide (E171), talc.

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

Appearance of the product and package contents

Mirtazapine Teva-ratio are film-coated tablets.

Film-coated tablets of brown color, 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

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

Actavis Ltd

BLB 015, BLB 016,

Bulebel Industrial Estate

ZTN3000 Zejtun

Malta

or

Actavis Group PTC ehf

Dalshraun 1, 220

Hafnarfjörður

Iceland

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

You can request more information about this medicine 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 medicine is authorized in the member states of the European Economic Areawith the following names:

Austria Mirtabene-ratiopharm GmbH 30 mg Filmtabletten

Germany Mirtazapin-ratiopharm 30 mg Filmtabletten

Denmark Mirtazapin Teva B.V.

Spain Mirtazapina Teva-ratio 30 mg film-coated tablets EFG

Finland Mirtazapin Teva 30 mg tablet, kalvopäällysteinen

Luxembourg Mirtazapin-ratiopharm 30 mg Filmtabletten

Portugal Mirtazapina Refta

Date of the last revision of thisprospectus:March 2023

Other sources of information

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

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