MIRTAZAPINE CINFA 30 mg FILM-COATED TABLETS

2. What you need to know before you take mirtazapine cinfa

Do not take mirtazapine cinfa

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, talk to your doctor before taking mirtazapine.
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before taking mirtazapine cinfa

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE TAKING MIRTAZAPINE:If you have ever had a severe skin rash or blistering of the skin, mouth, eyes, or genitals after 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, oppositional behavior, and anger) when they take this type of medicine. Nevertheless, your doctor may prescribe mirtazapine for patients under 18 when it is decided that it is the best treatment 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 above symptoms occur or worsen in patients under 18 who are taking mirtazapine. Additionally, the long-term effects of mirtazapine on growth, maturation, and cognitive and behavioral development in this age group have not yet been established. Weight gain has also been observed more frequently 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 or killing yourself. These thoughts may be worse when you first start taking antidepressants, as these medicines take some time to start working, usually about 2 weeks, or sometimes longer.

You may be more likely to think this way:

• if you have previously had thoughts about killing or harming yourself.
• if 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 killing or harming yourself at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close friendthat 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 behavior.

Also, be careful with mirtazapine:

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

• Tell your doctor about these conditions before taking mirtazapine, if you have not already done so:
• • seizures(epilepsy). If seizures occur or become 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 diseaseor 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 overactivity/mania and periods of depression). If you start to feel overactive or excited, 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 diseasethat can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.
• if you notice signs of infection such as high unexplained fever, sore throat, and mouth ulcers

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

Rarely, these symptoms can be a sign 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 side effects of antidepressant medicines.
• serious skin reactions have been reported with the use of mirtazapine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking mirtazapine and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have ever had a serious skin reaction, do not restart treatment with mirtazapine.

Other medicines and mirtazapine cinfa

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

Do not take mirtazapinewith:

• 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 to treat migraine), 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), 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 symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, 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. Tell your doctor if you are taking this medicine. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking nefazodone.
• medicines for anxiety or insomniasuch as benzodiazepines.

medicines for schizophreniasuch as olanzapine.

medicines for allergiessuch as cetirizine.

medicines for severe painsuch as morphine.

When taken 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. Tell your doctor if you are taking these medicines. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking these medicines.
• medicines for epilepsy:such as carbamazepine and phenytoin.
• medicines for tuberculosissuch as rifampicin.

If taken with mirtazapine, these medicines may decrease the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. Your doctor may need to increase the dose of mirtazapine or decrease 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. Tell your doctor if you are taking this medicine. If taken together, your doctor may recommend that you have blood tests.
• medicines that can affect your 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.

If you use mirtazapine up to or shortly before birth, your baby will be checked for possible adverse effects.

Taken during pregnancy, medicines like SSRIs may 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 or doctor immediately.

Driving and using machines

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

mirtazapine cinfa contains lactose

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

3. How to take mirtazapine cinfa

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

How much to take

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

Take mirtazapine at the same time every 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

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 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 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.

The tablet can be divided into equal doses.

If you take more mirtazapine cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the leaflet and the packaging to the healthcare professional.

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 Torsades de pointes.

If you forget to take mirtazapine cinfa

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 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 them up. Skip both doses and the next day continue with your normal dose in the morning and evening.

If you stop taking mirtazapine cinfa

Only stop taking mirtazapine after talking to your doctor.

If you stop taking it too soon, your depression may come back. When you feel 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 suddenly, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

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 alterations (jaundice).

Frequency Not Known(cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and mouth ulcers (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).
• 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.
• severe skin reactions:
• 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 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 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
• tremor
• nausea
• diarrhea
• vomiting
• constipation
• urticaria or skin rash (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)
• involuntary leg movements during sleep
• 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
• 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

Other Adverse Effects in Children and Adolescents

In patients 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. 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 Cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Cinfa

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

• Tablet core: lactose monohydrate, hydroxypropylcellulose (E-463), corn starch, colloidal anhydrous silica, low-substituted 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 Package Contents

Brown-red, biconvex, capsule-shaped, film-coated tablets, scored on one side and marked with the code "30" on the other side.

Available 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 Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of Last Revision of this Leaflet:November 2021.

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (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 to: https://cima.aemps.es/cima/dochtml/p/67068/P_67068.html