Package Insert: Information for the Patient

mirtazapina flas cinfamed 45 mg buccal dispersible tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Mirtazapina flas cinfamed belongs to a group of medicines calledantidepressants. Mirtazapina flas cinfamed 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 - 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 medications.

Be especially cautious with mirtazapine:

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reactions with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapine. Stop using 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 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 components of this medication (listed in section 6). In that case, consult your doctor as soon as possible before taking mirtazapine.
• If you are taking or have taken recently (in the last two weeks) medications 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 be used normally 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 higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor may prescribe mirtazapine to patients under 18 years when they decide 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 described above appear or worsen in patients under 18 years who are taking mirtazapine. In addition, the long-term safety effects related to growth, maturation, and development of mirtazapine in this age group are still unknown.

It has also been observed more frequently 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 committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have a normal effect.

You may be more prone to thinking this way if:

• 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 adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.

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

You can tell a close relative or friend that you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.

Also, be especially cautious 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 excitement/hyperactivity and periods of depression). If you start feeling excited or overexcited, stop taking mirtazapine and contact your doctor immediately;
  • diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
  • 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 may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm.
• If you have signs of infection such as high fever, sore throat, and mouth sores

→ 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 medications.

Other medications and mirtazapine flas cinfamed

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

Do not takemirtazapinewith:

• 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 for the next two weeks either.

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, 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 Wortpreparations.
• nefazodone. It may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of mirtazapine, or increase it again when you stop taking nefazodone.
• anxiety or insomnia medicationssuch as benzodiazepines.
• schizophrenia medicationssuch as olanzapine.
• allergy medicationssuch as cetirizine.
• intense pain medicationssuch as morphine.

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

• infection medications:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), and HIV/AIDS medications (protease inhibitors) andulcer medications(such as cimetidine).

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

• epilepsy medicationssuch as carbamazepine and phenytoin;
• tuberculosis medicationssuch as rifampicin.

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

• blood thinnerssuch as warfarin.

Mirtazapine may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that your doctor perform blood tests.

• medications that may affect 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 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, consult your doctor or pharmacist before using this medication.

The limited experience of administering mirtazapine to pregnant women does not indicate an increased risk. However, you should be cautious 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 medications (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) in babies, which makes them breathe faster and acquire a bluish tone. These symptoms usually begin 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 flas cinfamed contains aspartame.

This medication contains 6 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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 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.

Take the buccal tablet in the following way

The tablets are taken orally.

1. To avoid crushing the buccal tablet, carefully press the tablet through the blister foil.

2. Take the buccal tablet with dry hands and place it on your tongue.

It will dissolve quickly and can be swallowed without water.

When you can 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 important 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 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 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.

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 Torsade de pointes.

If you forgot to take mirtazapina

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

→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.

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, which may indicate liver dysfunction (jaundice).

Frequency not known(cannot be estimated from available data):

• signs of infection such as high fever, sudden and inexplicable, 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 inexplicable 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.

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 leg agitation during sleep
• fainting (syncope)
• numbness of the mouth (hypoaesthesia oral)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

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

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

Frequency not known(cannot be estimated from available data):

• abnormal sensations in the mouth (paresthesia oral)
• swelling in the mouth (buccal edema)
• swelling throughout the body (generalized edema)
• localized swelling
• low sodium levels (hyponatremia)
• inadequate secretion of antidiuretic hormone
• severe skin reactions (dermatitis bullous, erythema multiforme)
• sleepwalking (somnambulism)
• speech problems
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge)

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: a significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting of 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 Vigilance of Medicinal Products 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 box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drain 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.

Composition ofmirtazapine flas cinfamed

• The active ingredient is mirtazapine. Each tablet contains 45 mg of mirtazapine (as mirtazapine hemihydrate).
• The other components are mannitol, cornstarch, microcrystalline cellulose, crospovidone, aspartame (E-951), orange essence (contains glucose in maltodextrin from corn, flavoring components, and alpha-tocopherol (E-307)), anhydrous colloidal silica, and vegetable magnesium stearate.

Appearance of the product and contents of the packaging

Mirtazapine flas cinfamed 45 mg tablets are buccal dispersible tablets, white, cylindrical, flat, bisected, and marked with “45” on one face.

The buccal dispersible tablets are packaged in Aluminio/poliamida-aluminio-PVC blisters, with each package containing30 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Last review date of this leaflet:November 2020

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/84105/P_84105.html

QR code to:https://cima.aemps.es/cima/dochtml/p/84105/P_84105.html