Leaflet: information for the user

mirtazapina cinfa 30 mg film-coated tablets

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

1.What is mirtazapina cinfa and what it is used for

2.What you need to know before you start taking mirtazapina cinfa

3.How to take mirtazapina cinfa

4.Possible side effects

5.Storage of mirtazapina cinfa

6.Contents of the pack and additional information

mirtazapina cinfa belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression in adults.

It may take 1 to 2 weeks for mirtazapina 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 mirtazapine cinfa

• if you are allergic to mirtazapine or any of the other ingredients in this medicine (listed in section 6). Consult your doctor as soon as possible before taking mirtazapine.
• if you are taking or have taken in the last two weeks any medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine cinfa.

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING TO TAKE mirtazapine: If you have ever had a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking mirtazapine or other medicines.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, it should be noted that in patients under 18 years there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour and irritability) when taking this class of medicines. However, the doctor may prescribe mirtazapine to patients under 18 years when they decide that it is the most appropriate for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years and wishes to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above in patients under 18 years taking mirtazapine appear or worsen. Furthermore, the long-term safety effects related to growth, maturation and development of mirtazapine in this age group are not yet known. It has also been observed that there is a considerable increase in weight in this age group 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 of suicide. This could worsen when you first start taking antidepressants, as these medicines take time to work normally two weeks or sometimes more.

You may be more prone to thinking this way:

• if you have previously had suicidal thoughts or self-harm.
• 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 suicide at any time, consult 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 concerned about changes in your behaviour.

Also, be especially careful with mirtazapine:

• if you have or have had any of the following conditions

• Inform your doctor about these situations before taking mirtazapine, if you have not already:
• • seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapine and contact your doctor immediately;
  • liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
  • kidney disease;
  • 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 elated or overexcited, stop taking mirtazapine and contact your doctor immediately;
  • diabetes(you may need to adjust your insulin dose or other diabetes medicines);
  • 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 may change your heart rhythm, a recent heart attack, heart failure, or taking certain medicines that may affect your heart rhythm.
• if you have or have had any of the following symptoms

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

These symptoms may be signs of changes 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 side effects of antidepressant medicines.
• 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 mirtazapine. Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 in relation to these severe skin reactions.

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

Other medicines and mirtazapine cinfa

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

Do not take mirtazapinewith:

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

• other antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans(used to treat migraine),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders),methylene blue(used to treat high levels of methaemoglobin in the blood),St. John's Wort–Hypericum perforatum(a medicinal plant for depression). In rare cases, mirtazapine alone or with these medicines, may cause the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhoea, 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 mirtazapine in the blood. Inform your doctor if you are taking this medicine. You may need to reduce the dose of mirtazapine, or increase it again when you stop taking nefazodone.
• anxiety or insomnia medicinessuch as benzodiazepines.

schizophrenia medicinessuch as olanzapine.

allergy medicinessuch as cetirizine.

pain medicinessuch as morphine.

In combination with these medicines, mirtazapine may increase the drowsiness caused by these medicines.

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

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

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

Taking mirtazapine cinfa with food and alcohol

You may feel drowsy if you drink alcohol while taking 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, or think you may be pregnant, or are planning to become pregnant, consultyour doctor or pharmacist before using this medicine.

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

If you use mirtazapine until, or shortly before delivery, your baby will be examined to detect any possible adverse effects.

Antidepressants like these (SSRIs) taken during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) in the baby, causing the baby to breathe faster and develop a bluish tone. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should consult your midwife or doctor immediately.

Driving and operating machines

During treatment with mirtazapine you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how mirtazapine affects you.

mirtazapine cinfa contains lactose.

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

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

How much to take

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 mirtazapine

Take mirtazapine at the same time every day.

It is better to take the mirtazapine dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapine 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 mirtazapine dose without chewing, with water or juice.

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 essential that during the first weeks of treatment, you speak with your doctor about the effects of mirtazapine: between 2 and 4 weeks after starting to take mirtazapine, speak with 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, speak with 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.

The tablet can be split into equal doses.

What to do if you take more mirtazapine cinfa 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. It is recommended to bring the leaflet and packaging to the healthcare professional.

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.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 fatal condition known as Torsades de pointes.

What to do if you forget to take mirtazapine cinfa

If you have to take your doseonce 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 dosetwice 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.

What to do if you interrupt the treatment with mirtazapine cinfa

Stop taking mirtazapine only if you consult with your doctor.

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

Do not stop taking mirtazapine abruptly, even when depression has disappeared. If you stop taking mirtazapine 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 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 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 white blood cells in the blood (eosinophilia).
• seizure (convulsions).
• 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.
• severe skin reactions:
• red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, nasal sores, genital sores, and eye sores. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized erythema, high 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 1,000 patients)

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

Unknown frequency(cannot be estimated from available data)

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

Other side effects in children and adolescents

In patients under 18 years, the following side effects were frequently observed in clinical trials: 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: 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 this medication after the expiration date that appears on the packaging and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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.

Mirtazapine cinfa composition

• The active ingredient is mirtazapine. Each film-coated tablet contains 30 mg of mirtazapine.
• The other components are:

• Tablet core: lactose monohydrate, hydroxypropylcellulose (E-463), cornstarch, anhydrous colloidal silica, low-substitution hydroxypropylcellulose (E-463), and magnesium stearate.
• Tablet coating: Opadry Brown 20A56788 (hydroxypropylcellulose (E-463), hypromellose (E-464), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172)).

Appearance of the product and contents of the packaging

Brown-red, biconvex, capsule-shaped, coated, scored on one face, and marked with the code “30” on the other face.

Presented in PVC-PVDC/ALU blisters.

Each package contains 30 or 500 (clinical package) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2021.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67068/P_67068.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/67068/P_67068.html