Package Leaflet: Information for the Patient

mirtazapina cinfa 15 mg film-coated tablets EFG

Read this leaflet carefully before you start to take 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.

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 certain medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Inform your doctor before taking mirtazapine:

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

Children and adolescents

Mirtazapine should not be used normally in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years there is a higher risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years when he decides that it is the most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years 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 who are taking mirtazapine. In addition, the long-term safety effects related to growth, maturity, and development of mirtazapine in this age group are still unknown. It has also been observed with greater frequency a considerable weight gain 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 behavior 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 themto 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 behavior.

Also, be particularly 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 done so

• • seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapine and contact your doctor immediately;
  • liver diseases, including jaundice. If jaundice appears, stop taking mirtazapine 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 animation/hyperactivity and periods of depression). If you start to feel animated 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 eye pressure (glaucoma);
  • difficulty urinating, which may be due to an enlarged prostate;
  • certain types of heart diseasethat 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 perform a blood test. In rare cases, these symptoms may 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 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 related to these severe skin reactions.

If you have ever had severe skin reactions, do 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 takemirtazapine with:

• 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, L-tryptophan or triptans(used to treat 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 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, 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 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.
• intense pain medicinessuch as morphine.

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) andulcer 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 medicinessuch 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 performs blood tests.

• 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 plan to become pregnant, consult your 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. Taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) in babies, which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should consult your midwife and/or doctor immediately.

Driving and using 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 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 your 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 it

→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 the morning and evening before going to bed. The highest dose should be taken before going to bed.

Mirtazapine tablets are taken orally. Take the prescribed mirtazapine dose without chewing, with water or juice.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

When to expect to feel better

Normally, mirtazapine 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 mirtazapine:

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

If you take more mirtazapine cinfa than you should

→If you or someone 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.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 Torsades de pointes.

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 forgot to take mirtazapina cinfa

If you have to take your doseonce a day

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

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.

If you interrupt the treatment with mirtazapina cinfa

→Stop taking mirtazapine only if you consult 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 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 high fever and sudden onset, sore throat, and 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 (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• 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 movements of leg agitation 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 inflammation of the pancreas

Other side effects in children and adolescents

In patients under 18 years, the following side effects were frequently observed in clinical trials: a significant weight gain, urticaria, and an increase in 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 the 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 this medication after the expiration date that appears on the packaging after CAD. 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 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 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 15 mg of mirtazapine.
• The other components are:

Tablet core:monohydrate lactose, hydroxypropylcellulose, cornstarch, anhydrous colloidal silica, and magnesium stearate.

Tablet coating:hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172).

Product appearance and packaging contents

mirtazapine cinfa are brownish-red film-coated tablets, cylindrical, biconvex, with a notch on one face and marked with “M” on the other face. Each tablet is approximately 7 mm in diameter.

mirtazapine cinfa is packaged in white single-dose PVC-PVDC/ALU blister packs in packaging of 30 and 60 film-coated tablets.

Marketing authorization holder and responsible manufacturer

Cinfa, S.A Laboratories

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:April 2022

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

You can access detailed and updated information about this medication 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/86890/P_86890.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86890/P_86890.html