Leaflet: information for the user

Mirtazapina Combix 30 mg film-coated 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 Combix is and what it is used for

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

3. How to take Mirtazapina Combix

4. Possible side effects

5. Storage of Mirtazapina Combix

6. Contents of the pack and additional information

Mirtazapina Combix belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression.

Do not take Mirtazapina Combix

• if you areallergicto the active ingredient or to any of the other components of this medicine (listed in section 6).
• if you are taking or have taken in the last two weeksmonoamine oxidase inhibitors (MAOIs).
• if you have ever had a severe skin rash or peeling, blisters or sores in the mouth after taking mirtazapina or other medicines.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Combix.

Children and adolescents (under 18 years)

Mirtazapina Combix 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 suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. However, the doctor may prescribe Mirtazapina Combix to patients under 18 years when they decide it is the most suitable for the patient. If the doctor has prescribed Mirtazapina Combix 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 listed above in patients under 18 years taking Mirtazapina Combix appear or worsen. In addition, the long-term safety effects related to growth, maturity, and development of mirtazapina in this age group are not yet known.

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 start taking antidepressants for the first time, as these medicines usually take two weeks or more to have their full 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 suicide at any time, consult your doctor or go to a 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 getting worse, or if they are concerned about changes in your behavior.

Also, be particularly careful with Mirtazapina Combix

• Inform your doctor about these situations before taking Mirtazapina Combix, 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 diseasesorlow 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 to feel elated or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medicines);
• eye diseases, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which could be due to an enlarged prostate;
• • if you have or have had any of the following symptoms:

• Stop taking Mirtazapina Combix and contact your doctor immediately to have 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.

Use of Mirtazapina Combix with other medicines

Also inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Inform your doctor or pharmacist if you are taking (or are going to take) any of the medicines listed below.

Do not take Mirtazapina Combixwith:

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

Be careful ifyou take Mirtazapina Combix with:

schizophrenia medicinessuch as olanzapine.

allergy medicinessuch as cetirizine.

intense pain medicinessuch as morphine.

In combination with these medicines, mirtazapina may increase the drowsiness caused by these medicines.

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

tuberculosis medicinessuch as rifampicin.

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

Mirtazapina may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In case you are taking them together, your doctor may recommend blood tests.

Taking Mirtazapina Combix 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 medicine.

Consult your doctor or pharmacist before using any medicine.

The limited experience of administering Mirtazapina Combix to pregnant women does not indicate an increased risk. However, you should be careful 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 Combix.

If you are taking Mirtazapina Combix during pregnancy, tell your midwife and/or doctor. When taken during pregnancy, similar medicines (called selective 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 start within the first 24 hours after birth. If this happens in your case, you should contact a doctor and/or midwife immediately.

Driving and operating machines

During treatment with Mirtazapina Combix, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Mirtazapina Combix affects you.

Mirtazapina Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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). 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 Mirtazapina Combix at the same time every day.

It is better to take the mirtazapina dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapina dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed dose of Mirtazapina Combix without chewing, with water or juice.

When to expect to feel better

Normally, Mirtazapina Combix 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 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 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 mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Combix than you should

• If you or someone takes too much Mirtazapina Combix, 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 medications or alcohol) are drowsiness, disorientation, and palpitations.

If you forgot to take Mirtazapina Combix

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 Combix

• Stop taking mirtazapina only if you consult with your doctor.

If you stop 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 medication, ask your doctor or pharmacist.

Like all medicines, Mirtazapina Combix 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 listed below and can be divided into:

Very common:

Common:

Uncommon:

• Stop taking mirtazapina and consult your doctor immediately.
• • strange sensation in the skin, such as burning, prickling, tingling, or numbness (paresthesia)
  • involuntary movements of agitation during sleep
  • fainting (syncope)
  • numbness of 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 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).

• 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 (edema bucal).
  • 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 eruptions 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 this medication out of the sight and reach of children.

Do not use this medication 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.

No special storage conditions are required

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

the 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 of Mirtazapina Combix

Mirtazapina Combix 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.

Tablet core: maize starch, colloidal silicon dioxide, magnesium stearate (E470b), hydroxypropylcellulose (E463) and lactose monohydrate.

Tablet coating: titanium dioxide (E171), hydroxypropylmethylcellulose (E464), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172) and polyethylene glycol 8000.

Appearance of the product and contents of the packaging

Mirtazapina Combix are film-coated tablets.

The film-coated tablets of Mirtazapina Combix are beige in color, oval in shape, and have a notch on one face.

The tablet can be divided into two equal halves.

Mirtazapina Combix 30 mg film-coated tablets are packaged in blisters.

The following packaging sizes are available: 30 tablets.

Holder of the marketing authorization and Responsible for manufacturing:

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Combino Pharm Malta Ltd.

HF 60 HAL FAR Industrial Estate

HAL FAR BBG07-

Malta

or

ZYDUS FRANCE

Zac Les Hautes Pâtures

Parc d´Activités des Pleupliers

25 rue des Pleupliers

92000 Nanterre (France)

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: September 2020

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