PROSPECT: INFORMATION FOR THE USER

Mirtazapina Qualigen 30 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, 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 should not be given to others who 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 prospect.

Mirtazapina Qualigen belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression.

Do not take Mirtazapina Qualigen

• if you are allergic (hypersensitive) to mirtazapina or any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Qualigen.
• if you are taking or have taken recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• If you have ever had a severe skin rash or skin peeling, blisters or mouth sores after taking Mirtazapina Qualigen or other medicines.

Warnings and precautions

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

Use in children and adolescents under 18 years

Mirtazapina Qualigen 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 type of medication. However, the doctor may prescribe Mirtazapina Qualigen to patients under 18 years when they decide what is best for the patient. If the doctor has prescribed Mirtazapina Qualigen 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 listed above in patients under 18 years taking Mirtazapina Qualigen appear or worsen.

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 medicines 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 thoughts.
• 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.

It may be helpful to 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 getting worse, or if they are concerned about changes in your behavior.

Also, be particularly careful with Mirtazapina Qualigen:

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

Inform your doctor about these situations before taking Mirtazapina Qualigen, if you have not already done so:

• seizures (epilepsy). If seizures occur or your seizures become 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 disease or 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 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 eye pressure (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate; If signs of infection such as high fever, sore throat, and mouth sores appear.
• 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 Qualigen. Stop using it 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 Qualigen

Stop taking Mirtazapina Qualigen 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.

• You may be more sensitive to the adverse effects of antidepressant medicines as a person over 65 years old.

Use of Mirtazapina Qualigen with other medicines

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

Inform your doctor or pharmacist if you are taking (or will take) any of the following medicines:

Do not take Mirtazapina Qualigen with

• 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 either.

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

Be careful if you take Mirtazapina Qualigen with

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans (used for migraines), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat some psychiatric disorders), and St. John's Wort preparations (Hypericum perforatum plant-based medicine for depression). In rare cases, mirtazapina alone or with these medicines may cause a condition called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, 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 mirtazapina in the blood. Inform your doctor if you are taking this medicine. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking nefazodone.
• anxiety or insomnia medicines such as benzodiazepines.
• schizophrenia medicines such as olanzapine.
• allergy medicines such as cetirizine.
• intense pain medicines such as morphine.

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

• infection medicines: antibiotics for bacterial infections (such as erythromycin), antifungals for fungal infections (such as ketoconazole), and HIV/AIDS medicines (protease inhibitors).
  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.
• epilepsy medicines such as carbamazepine and phenytoin.
• tuberculosis medicines such 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.
• blood clotting medicines such as warfarin.
  Mirtazapina may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In the case of taking them together, it is recommended that your doctor perform blood tests.

Taking Mirtazapina Qualigen 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.

The limited experience of administering Mirtazapina Qualigen 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.

If you are taking Mirtazapina Qualigen during pregnancy, inform your midwife and/or doctor. When taking during pregnancy similar medicines (called selective serotonin reuptake inhibitors, SSRIs), there may be an increased risk that the baby will develop 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.

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

Driving and using machines

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

Mirtazapina Qualigen contains lactose

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

Follow exactly the administration instructions of Mirtazapina Qualigen as 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 45mg 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 Qualigen 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.

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

When to expect to feel better

Normally, Mirtazapina Qualigen will start to take effect after 1 or 2 weeks and after2 to4 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:

Even after 2 to 4 weeks of 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 moreMirtazapina Qualigen than you should

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

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

If you forget to takeMirtazapina Qualigen

If you have to take yourdoseonce 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.

Do not take double doses to compensate for the missed doses.

If you interrupt the treatment with Mirtazapina Qualigen

Stop taking mirtazapine only if you consult 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 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 product, ask your doctor or pharmacist.

Like all medicines, Mirtazapina Qualigen 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:affect more than 1 in 10 patients
• Common:affect between 1 and 10 in 100 patients
• Uncommon:affect between 1 and 10 of every 1,000 patients
• Rare:affect between 1 and 10 in 10,000 patients
• Very rare:affect less than 1 in 10,000 patients
• Unknown:cannot be estimated from available information

Very common:

• Increased appetite and weight gain,
• Drowsiness,
• Headache,
• Dry mouth.

Common:

• Lethargy,
• Dizziness,
• Tremor,
• Nausea,
• Diarrhea,
• Vomiting,
• Hives or skin rashes (exanthema),
• Pain in the joints (arthralgia) or muscles (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:

• Exaggerated feeling of euphoria (mania),

Stop taking mirtazapina and consult your doctor immediately.

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

Rare:

• Yellow discoloration of the eyes or skin; may indicate liver function abnormalities (jaundice).

Stop taking mirtazapina and consult your doctor immediately.

• Tics or muscle contractions (myoclonus).
• Pancreatitis.

Unknown:

• 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 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).

• Seizure (convulsions).

Stop taking mirtazapina and consult your doctor immediately.

• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (incontrollable), 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.

Discontinue the use of mirtazapina and contact your doctor or seek medical attention immediately if you experience any of the following severe side effects:

Unknown frequency:

• Red patches on the trunk, such as circumscribed or circular macules, often with blisters 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).

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed 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 adverse reactions, 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 Qualigen 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..

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 unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help to protect the environment.

Composition of Mirtazapina Qualigen

- The active ingredient is mirtazapine. Mirtazapina Qualigen 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.

• The other components are:

Tablet core: lactose, pregelatinized cornstarch, magnesium stearate (E-572).
Film coating: hydroxypropylmethylcellulose (E-464), titanium dioxide (E-171), polyethylene glycol 8000 (E-1521), iron oxide yellow and red (E-172).

Appearance of the product and contents of the package

Mirtazapina Qualigen 30 mg are film-coated tablets.

The tablets are salmon-colored, oblong, biconvex, and have a notch on one side. The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Mirtazapina Qualigen 30 mg tablets are packaged in blisters.

The following package sizes are available: 30 or 56 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira,

24710-189 Sintra

Portugal

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares, Rua Outeiro Da Armada, 5,

Condeixa-a-Nova, 3150-194 Sebal

Portugal

Last review date of this leaflet:May 2021

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/