MIRTAZAPINE FLAS CINFAMED 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information: Summary of Product Characteristics

mirtazapine flas cinfamed 30 mg orodispersible tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is mirtazapine flas cinfamed and what is it used for
2. What you need to know before you take mirtazapine flas cinfamed
3. How to take mirtazapine flas cinfamed
4. Possible side effects
5. Storing mirtazapine flas cinfamed

Package contents and additional information

1. What is mirtazapine flas cinfamed and what is it used for

Mirtazapine flas cinfamed belongs to a group of medicines called antidepressants. Mirtazapine flas cinfamed is used to treat depression in adults.

It may take 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 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 you take mirtazapine flas cinfamed

DO NOT TAKE - OR CONSULT YOUR DOCTOR BEFORE TAKING mirtazapine:

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

Be particularly cautious with mirtazapine:

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. Stop taking it and seek immediate medical attention 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, you should not restart treatment with mirtazapine.

Do not take mirtazapine flas cinfamed

• 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 recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine flas cinfamed.

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, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years and you wish 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. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known.

It has also been observed more frequently in this age group that there is a significant increase in weight 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 usually take two weeks or sometimes longer to work.

You may be more likely to think this way if:

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

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

It may be useful to tell a relative or close 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 worried about changes in your behavior.

Also, be particularly cautious with mirtazapine:

• if you have or have ever 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 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 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 diseasethat can change the rhythm of your heart, a recent heart attack, heart failure, or taking certain medications that can affect heart rhythm.
• if you notice signs of infection such as unexplained high fever, sore throat, and mouth sores

→ 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 starts.

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

Other medicines and mirtazapine flas cinfamed

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

Do not takemirtazapinewith:

• 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 for the next two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be cautious 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 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 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, 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 medicine. Your doctor may need to reduce 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. Inform your doctor if you are taking these medicines. Your doctor may need 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. Your doctor may need 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 in your blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend that you have regular blood tests.

• medicines that may affect your heart rhythm, such as certain antibiotics and some antipsychotics.

Taking mirtazapine flas cinfamed 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 medicine.

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. Taken during pregnancy, similar medicines (SSRIs) may increase the risk in babies of a serious disease called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start during 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 use tools or machines until you know how the treatment with mirtazapine affects you.

Mirtazapine flas cinfamed contains aspartame.

This medicine contains 4 mg of aspartame in each tablet. Aspartame is a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take mirtazapine flas cinfamed

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in 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 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 have kidney or liver disease, your doctor may change the dose.

When to take it

→ 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.

Take the orodispersible tablet as follows

The tablets are taken orally.

1. To avoid crushing the orodispersible tablet, carefully press the tablet through the blister pack.
2. Take the orodispersible tablet with dry hands and place it on your tongue.

It will dissolve quickly and can be swallowed without water.

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 that during the first few 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 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.

If you take more mirtazapine flas cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 the rhythm of your heart (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 flas cinfamed

If you have to take your dose once a day

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

If you have to take your dose twice a day

If you stop taking mirtazapine flas cinfamed

→ Only stop taking mirtazapine if you have consulted your doctor.

If you stop too soon, depression may return. 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 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 reduce the dose.

If you have any other questions about 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 unexplained and sudden high fever, sore throat, and mouth ulcers (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 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.
• severe skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis).
• 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 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 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
• sleepiness
• headache
• dry mouth

Common(may affect up to 1 in 10 patients)

• lethargy
• dizziness
• tremors
• nausea
• diarrhea
• vomiting
• constipation
• urticaria or skin eruptions (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)
• involuntary movements of the legs 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)
• generalized swelling
• 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)

Other Adverse Effects in Children and Adolescents

In individuals 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. Conservation of Mirtazapine Flas Cinfamed

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

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 ofMirtazapine Flas Cinfamed

• The active ingredient is mirtazapine. Each tablet contains 30 mg of mirtazapine (as mirtazapine hemihydrate).
• The other components are mannitol, cornstarch, microcrystalline cellulose, crospovidone, aspartame (E-951), orange flavor (contains glucose in maltodextrin from corn, flavoring agents, and alpha-tocopherol (E-307)), colloidal anhydrous silica, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Mirtazapine Flas Cinfamed 30 mg tablets are buccal dispersible, white, cylindrical, flat, beveled, and marked with "30" on one side.

The buccal dispersible tablets are packaged in aluminum/polyamide-aluminum-PVC blisters, each package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Date of the Last Revision of this Prospectus:November 2020

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 prospectus 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/84104/P_84104.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84104/P_84104.html