Leaflet: information for the user

Mirtazapina Flas Alter 15 mg buccal tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you think you have experienced a side effect, report it to your doctor or pharmacist.

1. What Mirtazapina Flas Alter is and what it is used for

2. Before taking Mirtazapina Flas Alter

3. How to take Mirtazapina Flas Alter

4. Possible side effects

5. Storage of Mirtazapina Flas Alter

6. Additional information

Mirtazapina Flas Alter belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression.

Do not take Mirtazapina Flas Alter or consult your doctor before starting to take mirtazapina:

If you have ever experienced a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking mirtazapina or other medications.

Be especially cautious with mirtazapina:

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 experienced severe skin reactions, do not restart treatment with mirtazapina.

Do not take Mirtazapina Flas Alter

Be especially careful with Mirtazapina Flas Alter

Use in children and adolescents under 18 years

Mirtazapina Flas Alter should not be used normally in the treatment of children and adolescents under 18 years. 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 Mirtazapina Flas Alter to patients under 18 years when they decide that it is the most convenient for the patient. If the doctor has prescribed Mirtazapina Flas Alter to a patient under 18 years and wants to discuss this decision, please go back 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 Mirtazapina Flas Alter. Additionally, the long-term effects on safety related to growth, maturity, and development of mirtazapina in this age group are still unknown.

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 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.

Be especially careful with Mirtazapina Flas Alter

• Inform your doctor about these situations before taking Mirtazapina Flas Alter, 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 excitement/hyperactivity and periods of depression).

If you start feeling elated 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;
• • if you experience signs of infection such as high fever, sore throat, and mouth sores

• Stop taking Mirtazapina Flas Alter 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 4-6 weeks after treatment.
• • if you are an older person, you may be more sensitive to the adverse effects of antidepressant medications.

Use of other medications

Inform your doctor or pharmacist if you are taking (or will be taking) any of the medications listed below.

Also inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription.

Do not take Mirtazapina Flas Alterwith:

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

Be careful ifyou take Mirtazapina Flas Alter with:

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.

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 you stop taking these medications.

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 you stop taking these medications.

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

Taking Mirtazapina Flas Alter with food and drinks

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 and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If you are taking mirtazapina and become pregnant or want to become pregnant, consult your doctor if you can continue taking mirtazapina. If you use mirtazapina until, or shortly before, delivery, your baby will be examined to detect any possible adverse effects.

Consult your doctor if you can breastfeed while taking Mirtazapina Flas Alter.

If you are taking Mirtazapina Alter during pregnancy, inform your midwife and/or doctor. When taken during pregnancy, similar medications (called serotonin reuptake inhibitors: SSRIs) may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your case, you should contact a doctor and/or midwife immediately.

Driving and using machines

Mirtazapina Flas Alter may affect your concentration or alertness. Make sure your faculties are not impaired before driving or using machinery.

Important information about some of the components of Mirtazapina Flas Alter

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions for Mirtazapina Flas Alter indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 if you have a kidney or liver disease, your doctor may change the dose.

When to take it

• Take Mirtazapina Flas Alter at the same time every day.

It is better to take the dose of Mirtazapina at one time before going to bed. However, your doctor may recommend that you divide your Mirtazapina Flas Alter 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. Do not press the buccal tablet

To avoid the buccal tablet from being crushed, do not press the blister (Figure A).

Fig. A.

1. Separate a blister

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

Fig. 1.

1. Open the blister

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

Fig. 2.

Fig. 3.

1. 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 to expect to feel better

Mirtazapina Flas Alter 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 mirtazapina:

• between 2 and 4 weeks after starting to take mirtazapina, 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 mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Flas Alter than you should

• If you or someone takes too much Mirtazapina Flas Alter, consult a doctor immediately. You can also call the Toxicological Information Service, phone 91 562 04 20.

The most likely symptoms of a mirtazapina overdose (without other medicines or alcohol) are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapina Flas Alter

If you have to take your doseonce a day

If you have to take your dosetwice a day

If you interrupt the treatment with Mirtazapina Flas Alter

• Stop taking Mirtazapina Flas Alter 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 mirtazapina abruptly, even when 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Mirtazapina Flas Alter may cause side effects, although not everyone will experience them.

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

•Frequent:occur in more than 1 in 10 patients

•Common:occur in between 1 and 10 in 100 patients

•Uncommon:occur in between 1 and 10 in 1,000 patients

•Rare:occur in between 1 and 10 in 10,000 patients

•Very rare:occur in less than 1 in 10,000 patients

•Unknown:cannot be estimated from the available information

Frequent:

Common:

Uncommon:

• Stop taking mirtazapina and consult your doctor immediately.

• Strange sensation in the skin, for example, burning, pinching, tingling, or numbness (paresthesia).
• • Involuntary movements of agitation of the legs during sleep.
  • Fainting (syncope).
  • Feeling of numbness in the mouth (hypoaesthesia oral).
  • Low blood pressure.
  • Nightmares.
  • Agitation.
  • Hallucinations.
  • Inability to remain still.

Rare:

• Stop taking mirtazapina and consult your doctor immediately.
• • Tics or muscle contractions (myoclonus).
  • Pancreatitis.

Unknown:

• Stop taking mirtazapina and consult your doctor immediately to have 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 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).

• 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.
• • Abnormal sensations in the mouth (paresthesia oral).
  • Swelling in the mouth (buccal edema).
  • Hyponatremia.
  • Inadequate secretion of antidiuretic hormone.
  • Red patches on the trunk, such as circumscribed or circular macules, often with vesicles in the center, skin peeling, mouth ulcers, throat ulcers, genital ulcers, and eye ulcers. These severe skin rashes 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).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep out of reach and sight of children.

Do not use Mirtazapina Flas Alter after the expiration date that appears on the packaging and in the blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Mirtazapina Alter Composition

Mirtazapina Flas Alter 15 mg buccal tablets contain 15 mg of mirtazapina per tablet.

The other components are mannitol, microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, L-methionine, crospovidone, microcrystalline cellulose, and guar gum (Avicel CE-15), aspartame (E-951), orange peel aroma, magnesium stearate

Product appearance and packaging contents

Mirtazapina Flas Alter 15 mg buccal tablets are white, biconvex, and marked with ‘M1’ on one side.

Each package contains 30 buccal tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

LABORATORIOS ALTER S.A

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer responsible

ACTAVIS LIMITED

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This leaflet was revised in October 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/