MIRTAZAPINE TEVA-RATIO 45 mg FILM-COATED TABLETS

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

Do not take Mirtazapine Teva-ratio

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking mirtazapine.
• if you are taking or have taken in the last two weeks medicines 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 TAKINGmirtazapine:

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

Children and adolescents

Mirtazapine should not normally be used for the treatment of children and adolescents under 18 years. Also, you should know that patients under 18 are at an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (mainly aggression, confrontation and anger) when they take this class of medicines. However, your doctor may prescribe mirtazapine for patients under 18 when he decides that it is the best for the patient. If your doctor has prescribed mirtazapine to a patient under 18 and you want to discuss this, 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 who are taking mirtazapine. Furthermore, the long-term safety effects on growth, maturation, and cognitive and behavioral development in this age group have not yet been established. Additionally, a 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 or killing yourself. These thoughts may be worse when you first start taking antidepressants, as these medicines take a few weeks to start working, usually around two weeks or sometimes longer.

You may be more likely to think this way if:

• you have previously had thoughts about killing or harming yourself.
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

It might be helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Also, be extra careful with mirtazapine

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

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

• 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 overexcitement/hyperactivity and periods of depression). If you start to feel overexcited or manic, stop taking mirtazapine and contact your doctor immediately;
• diabetes (you may need to adjust your insulin or other antidiabetic medicines 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 diseases that may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm.

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

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 occur within 4-6 weeks of treatment.

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

Severe skin reactions, including 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. Stop taking mirtazapine 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, you should never take mirtazapine again.

Other medicines and Mirtazapine Teva-ratio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not takemirtazapine with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after you stop 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).

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 herbal remedy for depression. In rare cases, mirtazapine alone or with these medicines may cause a condition called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivers, exaggerated reflexes, restlessness, mood changes and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine or increase it again when you stop taking nefazodone.
• medicines for anxiety or insomniasuch as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine. In combination 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) and medicines for stomach ulcers (such as cimetidine). If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your 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 you stop taking these medicines.

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

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

• medicines to prevent blood clottingsuch as warfarin. Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor performs blood tests.
• medicines that may affect your heart rhythm, such as certain antibiotics and some antipsychotics.

TakingMirtazapine Teva-ratio with foodand alcohol

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

You can take mirtazapine with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Make sure your midwife and/or doctor know that you are taking mirtazapine. When similar medicines (SSRIs) are taken during pregnancy, they can increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

Breast-feeding

Ask your doctor whether you can breast-feed 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, make sure that concentration and alertness are not affected before cycling (for example).

Mirtazapine Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Mirtazapine Teva-ratio contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Mirtazapine Teva-ratio

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose is 15 or 30 mg per day. Your doctor may recommend that you increase the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages. However, if you are an elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapine Teva-ratio

Take mirtazapine at the same time each day. It is best to take the dose of mirtazapine once before going to bed. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before going to bed. The highest dose should be taken before going to bed. The tablets are taken orally. Take the prescribed dose of mirtazapine without chewing, with water or juice.

When you can expect to feel better

Mirtazapine will usually start to work after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.

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

→ between 2 and 4 weeks after you start taking mirtazapine, talk to your doctor about how this medicine has affected you.

If you 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.

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 medicine and the amount taken.

If you or someone else has taken too much mirtazapine, contact a doctor immediately. The most likely symptoms of a mirtazapine overdose (without other medicines 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 have 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 have to take your dose twice a day

• if you have forgotten the morning dose, simply take it together 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 up for them. Skip both doses and the next day continue with your normal dose in the morning and evening.

If you stop taking Mirtazapine Teva-ratio

Only stop taking mirtazapine if you have talked to your doctor.

If you stop taking it too soon, your depression may come back. When you are feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if your 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 reduce the dose gradually.

If you have any further questions on the use of this medicine, 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):

• exaggerated feeling of euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function alterations (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 may cause alterations 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 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 may 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 rashes 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 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
• sleepiness
• headache
• dry mouth

Common (may affect up to 1 in 10 patients):

• lethargy
• dizziness
• tremor
• 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, pinching, 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)
• generalized swelling (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 frequently observed in clinical trials: significant weight gain, urticaria, 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: 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 shown on the box and blister pack 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 45 mg film-coated tablets EFG contain 45 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.

Appearance of the product and package contents

Mirtazapine Teva-ratio are film-coated tablets.

White, oval, biconvex film-coated tablets, 14.5 x 7.5 mm in diameter. Marked with "I" on one face.

Package sizes:

20, 30, 50, and 100 tablets in blister packs.

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

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 45 mg Filmtabletten

Germany Mirtazapin-ratiopharm 45 mg Filmtabletten

Denmark Mirtazapin Teva B.V.

Spain Mirtazapina Teva-ratio 45 mg film-coated tablets EFG

Finland Mirtazapin ratiopharm 45 mg kalvopäällysteiset tabletit

Luxembourg Mirtazapin-ratiopharm 45 mg Filmtabletten

Portugal Mirtazapina ratiopharm

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/88860/P_88860.html