MIRTAZAPINE TEVAGEN 15 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Mirtazapine Tevagen

Do not take Mirtazapine Tevagen:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Tell your doctor before taking Mirtazapine Tevagen:

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

Children and adolescents

Mirtazapine Tevagen should not normally be used in the treatment of children and adolescents under 18 years of age because it has not been shown to be effective. At the same time, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Tevagen to patients under 18 years of age when they decide it is the most convenient for the patient. If your doctor has prescribed Mirtazapine Tevagen to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years of age who are taking Mirtazapine Tevagen. Additionally, the long-term safety effects on 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 or killing yourself. This may 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 killing or harming yourself.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

• If you have thoughts of harming or killing yourself at any time, consult 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 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 especially careful with Mirtazapine Tevagen:

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

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

• 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 overactive, 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 signs of infection appear, such as unexplained high fever, sore throat, and sores in the mouth:

• Stop taking Mirtazapine Tevagen and contact your doctor immediately for 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.

• if you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medicines.
• serious skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use 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 Tevagen

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

Do not take Mirtazapine Tevagenwith:

• 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 Tevagen with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraine), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), and St. John's Wort (Hypericum perforatum)(a herbal remedy for depression). In very 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. It may be necessary 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. It may be necessary 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. It may be necessary 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 on the blood. Inform your doctor if you are taking this medicine. If taken 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 Tevagen with food, drinks, 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, breastfeeding, and fertility

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 Tevagen to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.

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 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.

Ask your doctor if you can breastfeed while taking Mirtazapine Tevagen.

Driving and using machines

Mirtazapine Tevagen may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, make sure their concentration and alertness are not affected before cycling (for example).

Mirtazapine Tevagen contains aspartame

This medicine contains 6 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Mirtazapine Tevagen contains sulfites, bisulfites, and metabisulfites

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains traces of sulfur dioxide (E-220) and potassium sulfite (E-228).

3. How to take Mirtazapina Tevagen

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

How much to take

The normal 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 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 it

• Take Mirtazapina Tevagen at the same time every day.

It is best to take the dose of mirtazapina once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapina in the morning and at night before bedtime. The highest dose should be taken before bedtime.

Take the buccal dispersible tablet as follows:

The tablets are taken orally.

1. Do not press the buccal dispersible tablet

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

Fig. A.

1. Separate a blister

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

Fig. 1.

1. Open the blister

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

Fig. 2.

Fig. 3.

1. Remove the buccal dispersible tablet

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

Fig. 4.

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Normally, Mirtazapina Tevagen 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 few weeks of treatment, you discuss the effects of mirtazapina with your doctor:

• between 2 and 4 weeks after starting to take mirtazapina, discuss with your doctor how this medication has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, discuss again with your doctor after another 2-4 weeks.

Normally, you will need to take mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Tevagen than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in your heart rate (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 Mirtazapina Tevagen

If you have to take your dose once a day:

If you have to take your dose twice a day:

If you stop treatment with Mirtazapina Tevagen

• Stop taking mirtazapina only if you consult your doctor.

If you stop too soon, depression may reappear. When you feel better, discuss with your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapina abruptly, even if depression has disappeared. If you stop taking mirtazapina 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Very common:may affect more than 1 in 10 patients.

Common:may affect up to 1 in 100 patients.

Uncommon:may affect up to 1 in 100 patients.

Rare:may affect up to 1 in 1,000 patients.

Very rare:may affect up to 1 in 10,000 patients.

Not known:cannot be estimated from the available data.

Very common:

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

Common:

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• constipation
• hives or skin rashes (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain

• dizziness or fainting when standing up quickly (orthostatic hypotension)
• swelling (usually in the 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:

• feeling of exaggerated euphoria (mania)

• Stop taking mirtazapina and consult your doctor immediately.

• strange sensation on the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

Rare:

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

• Stop taking mirtazapina and consult your doctor immediately.

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

Frequency not known:

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

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

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

• Stop taking mirtazapina and consult your doctor immediately.

• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, involuntary muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms can 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 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • generalized erythema, elevated body temperature, and lymph node enlargement (DRESS or drug hypersensitivity syndrome).

Stop taking mirtazapina and consult your doctor immediately.

• 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, which includes symptoms of breast enlargement and/or milky discharge from the nipple)
• painful and prolonged erection of the penis

Other side effects in children and adolescents

In individuals under 18 years of age, the following side effects were frequently observed in clinical trials: significant weight gain, hives, and increased triglycerides in the blood.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mirtazapina Tevagen

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister 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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Mirtazapina Tevagen

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

Appearance of the product and package contents

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

The following package sizes are available: 30 buccal dispersible tablets

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid, Spain

Manufacturer

Actavis, Ltd

BLB016 Bulebel Industrial Estate (Zejtun)

ZTN3000 Malta

Date of the last revision of this leaflet:August 2024

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