Leaflet: information for the user

Mirtazapina Tevagen 15 mg buccal tablets EFG

Read this 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 Mirtazapina Tevagen is and what it is used for

2. What you need to know before you start taking Mirtazapina Tevagen

3. How to take Mirtazapina Tevagen

4. Possible side effects

5. Storage of Mirtazapina Tevagen

6. Contents of the pack and additional information

Mirtazapina Tevagen belongs to a group of medicines calledantidepressants.

Mirtazapina Tevagen is used to treat depression in adults

It takes 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 Mirtazapina Tevagen:

• if you areallergicto mirtazapina 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 Mirtazapina Tevagen.
• if you are taking or have taken in the last two weeksmonoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapina.

Inform your doctor before taking Mirtazapina Tevagen:

If you have ever had a severe skin rash or peeling of the skin, blisters or sores in the mouthafter taking mirtazapina.

Children and adolescents

Mirtazapina Tevagen 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, there is a higher risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Mirtazapina Tevagen to patients under 18 years when they decide it is the most suitable for the patient. If your doctor has prescribed Mirtazapina Tevagen to a patient under 18 years and wants to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms mentionedearlier in patients under 18 years taking Mirtazapina Tevagen appear or worsen.

Additionally, the long-term safety effects related to growth, maturation, and development of mirtazapina in this age group are not yet known. It has also been observed more frequently that there is a significant weight gain in this age group when treated with mirtazapina, 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:

• You have previously had suicidal thoughts or self-harm.
• 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 taking an antidepressant.

• If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the 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 worsening, or if they are concerned about changes in your behavior.

Also, be especially careful with Mirtazapina Tevagen:

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

• Inform your doctor about these situations before taking Mirtazapina Tevagen, if you have not already:

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapina and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice appears, stop taking mirtazapina 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 euphoria/hyperactivity and periods of depression). If you start feeling euphoric or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
• eye diseases, such as increased eye pressure (glaucoma);
• difficulty urinating, which could 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 Mirtazapina Tevagen and contact your doctor immediately to perform a blood test. In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms appear 4-6 weeks after treatment.

• if you are an older person, you may be more sensitive to the adverse effects of antidepressant medications.
• 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 mirtazapina. 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 mirtazapina.

Other medications and Mirtazapina Tevagen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Mirtazapina Tevagenwith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapina during the two weeks after stopping MAOIs. If you stop taking mirtazapina, 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 careful ifyou take Mirtazapina Tevagen with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders), andSt. John's Wortpreparations.

• antidepressants such as nefazodone. It may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of mirtazapina, or increase it again when stopping 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, mirtazapina 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) and medications for stomach ulcers (such as cimetidine).

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

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

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

• blood thinnerssuch as warfarin.

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

• medications that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Tevagen with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapina.

It is recommended not to drink any alcohol.

You can take mirtazapina with or without food.

Pregnancy, breastfeeding, and fertility

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 Mirtazapina Tevagen to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy.

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

If you use mirtazapina 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 develop 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.

Consult your doctor if you can breastfeed while taking Mirtazapina Tevagen.

Driving and using machines

Mirtazapina Tevagen may affect your concentration or alertness. Make sure your faculties are not affected before driving or using machinery. If your doctor has prescribed mirtazapina to a patient under 18 years, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Tevagen contains aspartame

This medicationcontains 6 mg of aspartame in each buccal dispersible 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.

Mirtazapina Tevagen contains sulfites, bisulfites, and metabisulfites

This medication may produce severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfur dioxide (E-220) and potassium sulfite acid (E-228) residues.

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

How much to take

The usual 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). The usual dose is the same for all ages. However, if you are an older person or have a kidney or liver disease, your doctor may change the dose.

When to take it

• Take Mirtazapina Tevagen 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.

Take the buccal tablet in the following way:

The tablets are taken orally.

1. Do not press the buccal tablet

To avoid crushing the buccal tablet, do not press the blister (Figure A).

Fig. A.

2. Separate a blister

Each blister contains six blisters, separated by perforations. Separate a blister by following the perforated lines (Figure 1).

Fig. 1.

3. Open the blister

Remove the foil carefully, starting from the corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.

4. Remove the buccal tablet

Remove the buccal tablet with dry hands and place it on the tongue (Figure 4).

Fig. 4.

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Mirtazapina Tevagen usually starts 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 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 Mirtazapina Tevagen than you should

If you or someone takes too much mirtazapine, consult a doctor immediately.

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 may be symptoms of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take Mirtazapina Tevagen

If you have to take your doseonce a day:

• if you forget to take your mirtazapine dose, do not take the missed dose. Skip it and take the usual dose the next day.

If you have to take your dosetwice 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 usual doses in the morning and evening.
• if you have forgotten 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 Tevagen

• Stop taking mirtazapine only if you consult your doctor.

If you stop taking 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.

Some side effects are more likely to occur than others. The possible side effects of mirtazapina are listed below and can be divided into:

Very common:can affectmore than 1 in 10 patients.

Common:can affectup to 1 in 100 patients.

Uncommon:can affectup to 1 in 100 patients.

Rare:can affectup to 1 in 1000 patients.

Very rare:can affect up to 1 in10,000 patients.

Unknown:cannot be estimated from the available information.

Very common:

• increased appetite and weight gain
• drowsiness
• headache
• dry mouth

Common:

• 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:

• exaggerated feeling of euphoria (mania)

• Stop taking mirtazapina and consult your doctor immediately.

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

Rare:

• yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice).

• Stop taking mirtazapina and consult your doctor immediately.

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

Unknown frequency:

• signs of infection, such as sudden and unexplained high fever and sore throat, and mouth sores (agranulocytosis).

• Stop taking mirtazapina and consult your doctor immediately to have a blood test.

In rare cases, mirtazapina may cause changes in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina 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).

• Stop taking mirtazapina and consult your doctor immediately.

• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome."

• Stop taking mirtazapina and consult your doctor immediately.

• thoughts of self-harm or suicide

• Stop taking mirtazapina and consult your doctor immediately.

• severe skin reactions:
• • red patches on the trunk, often with circular or oval shapes, and blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. 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).

?Stop taking mirtazapina and consult your doctor immediately

• abnormal sensations in the mouth (paresthesia oral)
• swelling in the mouth (edema bucal)
• swelling throughout the body (edema generalizado)
• localized swelling
• low sodium levels
• inadequate secretion of antidiuretic hormone
• severe skin reactions (dermatitis bullosa, erythema multiforme)
• sleepwalking (somnambulismo)
• 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)
• painful and prolonged erection of the penis

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: a significant increase in weight, urticaria, and an increase in 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 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 out of 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.

Store in the original packaging to protect it from light and moisture.

Store at a temperature below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mirtazapina Tevagen

• The active ingredient is mirtazapine.Mirtazapina Tevagen 15 mg buccal tablets contain 15 mg of mirtazapine per tablet.
• The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, L-methionine, purified water, avicel, aspartame (E-951), orange silesia aroma (potato starch maltodextrin, gum arabic E414, triacetin E1518, flavor preparations, identical natural flavorings, and natural flavorings, contains traces of sulfur dioxide (E-220) and potassium acid sulfite (E-228)) and magnesium stearate.

Appearance of the product and contents of the packaging

Mirtazapina Tevagen are buccal tablets. The tablets are white, biconvex, and marked with ‘M1’ on one face.

The following packaging sizes are available: 30 buccal tablets

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid
Spain

Responsible manufacturer

Actavis, Ltd

BLB016 Bulebel Industrial Estate (Zejtun)

ZTN3000 Malta

Last review date of this leaflet:August 2024

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