Mirtazapine Qualigen 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: INFORMATION FOR THE USER

Mirtazapine Qualigen 15 mg film-coated tablets EFG

Read the entire package 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet.

Leaflet contents:

1. What Mirtazapine Qualigen is and what it is used for
2. What you need to know before taking Mirtazapine Qualigen
3. How to take Mirtazapine Qualigen
4. Possible adverse effects
5. How to store Mirtazapine Qualigen
6. Package contents and additional information

1. What Mirtazapina Qualigen is and what it is used for

Mirtazapina Qualigen belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. What you need to know before taking Mirtazapine Qualigen

Do not take Mirtazapine Qualigen

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Mirtazapine Qualigen.

Use in children and adolescents under 18 years of age

Mirtazapine Qualigen should normally not be used in the treatment of children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Qualigen to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed Mirtazapine Qualigen to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking Mirtazapine Qualigen. In addition, the long-term safety effects of mirtazapine on growth, maturation, and cognitive and behavioral development in this age group are not yet known.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to become effective.

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in antidepressant-treated psychiatric patients under 25 years of age.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Also, take special care with Mirtazapine Qualigen:

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

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

• seizures (epilepsy). If seizures occur or 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 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 elevated mood/hyperactivity and depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;
• diabetes (you may need to adjust your insulin dose or other antidiabetic medications);
• eye disorders, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which could be due to an enlarged prostate; If signs of infection such as unexplained high fever, sore throat, and mouth ulcers appear.
• Serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Mirtazapine Qualigen. Discontinue use and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions. If you have ever experienced serious skin reactions, treatment with Mirtazapine Qualigen should not be restarted.

Stop taking Mirtazapine Qualigen and contact your doctor immediately for a blood test.

Rarely, these symptoms may be signs of disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

• If you are elderly, you may be more sensitive to the adverse effects of antidepressant medicines.

Taking Mirtazapine Qualigen with other medicines

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

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

Do not take Mirtazapine Qualigen together with

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks following discontinuation of MAOIs. If you stop taking mirtazapine, do not take MAOIs for the following two weeks.

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

Be careful when taking Mirtazapine Qualigen together with

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), and St. John's wort (Hypericum perforatum) herbal preparations (herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.

• the antidepressant nefazodone. This 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 stopping nefazodone.

• medicines for anxiety or insomnia such as benzodiazepines.

• medicines for schizophrenia such as olanzapine.

• medicines for allergies such as cetirizine.

• medicines for severe pain such as morphine.

When taken together with these medicines, mirtazapine may increase the drowsiness caused by them.

• medicines for infections: antibacterial medicines (such as erythromycin), antifungal medicines (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors). When taken together 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 stopping these medicines.
• medicines for epilepsy such as carbamazepine and phenytoin.
• medicines for tuberculosis such as rifampicin. When taken together 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 stopping these medicines.
• medicines to prevent blood clotting such as warfarin. Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor should monitor your blood regularly.

Taking Mirtazapine Qualigen 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 may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with the administration of Mirtazapine Qualigen to pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you are taking mirtazapine and become pregnant or wish to become pregnant, consult your doctor about whether you can continue taking mirtazapine. If you take mirtazapine up to or shortly before delivery, your baby will be examined for possible adverse effects.

If you are taking Mirtazapine Qualigen during pregnancy, inform your midwife and/or doctor. When similar medicines (called serotonin reuptake inhibitor antidepressants, SSRIs) are taken during pregnancy, there may be an increased risk of the baby developing 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, contact a doctor and/or midwife immediately.

Consult your doctor about whether you can breastfeed while taking Mirtazapine Qualigen.

Driving and using machines

During treatment with mirtazapine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Mirtazapine Qualigen affects you.

Mirtazapine 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.

3. How to take Mirtazapine Qualigen

Follow exactly the instructions for taking Mirtazapine Qualigen as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

How much to take

The usual starting dose is 15 or 30 mg once daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg daily). Normally, the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

Take Mirtazapine Qualigen at the same time each day.

It is best to take the mirtazapine dose as a single dose before going to bed. However, your doctor may recommend dividing your mirtazapine dose, taking part in the morning and part in the evening before bedtime. The higher dose should be taken before bedtime.

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

When you can expect to feel better

Mirtazapine Qualigen usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better. It is important that during the first weeks of treatment you discuss the effects of mirtazapine with your doctor:

Between 2 and 4 weeks after starting mirtazapine, talk to your doctor about how the medicine has affected you.

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

You will usually need to continue taking mirtazapine until depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapine Qualigen than you should

If you or someone else takes too much Mirtazapine Qualigen, consult a doctor immediately. You may also call the Toxicology Information Service. Telephone: 91 562 04 20.

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

If you forget to take Mirtazapine Qualigen

If you are supposed to take your dose once daily:

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

If you are supposed to take your dose twice daily:

• If you forget the morning dose, simply take it together with the evening dose.
• If you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• If you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

Do not take double doses to make up for missed doses.

If you stop taking Mirtazapine Qualigen

Stop taking mirtazapine only if advised by your doctor.

If you stop too early, depression may return. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has disappeared. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose gradually.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Mirtazapine Qualigen may cause adverse effects, although not everyone experiences them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are listed below and can be categorized as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects between 1 and 10 in 100 patients
• Uncommon: affects between 1 and 10 in 1,000 patients
• Rare: affects between 1 and 10 in 10,000 patients
• Very rare: affects fewer than 1 in 10,000 patients
• Not known: 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 rash (exanthema),
• Joint pain (arthralgia) or muscle pain (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:

• Feeling of exaggerated euphoria (mania).

Stop taking mirtazapine and consult your doctor immediately.

• Strange sensations in the skin, such as burning, prickling, tingling, or pins and needles (paresthesia),
• Involuntary restless leg movements during sleep,
• Fainting (syncope),
• Numbness of the mouth (oral hypoesthesia),
• Low blood pressure,
• Nightmares,
• Agitation,
• Hallucinations,
• Inability to remain still.

Rare:

• Yellowing of the skin or eyes; may indicate liver problems (jaundice).

Stop taking mirtazapine and consult your doctor immediately.

• Muscle tics or contractions (myoclonus),
• Pancreatitis.

Not known:

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

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

In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people become more susceptible to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in red blood cells, white blood cells, and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• Seizure (convulsions).

Stop taking mirtazapine and consult your doctor immediately.

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

Stop taking mirtazapine and consult your doctor immediately.

• Thoughts of harming yourself or suicide.

Stop taking mirtazapine and consult your doctor immediately.

• Abnormal sensations in the mouth (oral paresthesia).
• Swelling of the mouth (oral edema).
• Hyponatremia.
• Inappropriate secretion of antidiuretic hormone.

Discontinue use of mirtazapine and contact your doctor or seek immediate medical attention if you experience any of the following serious side effects:

Frequency not known:

• Red patches on the trunk, such as well-defined or circular macules, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Qualigen

Keep this medicine out of the sight and reach of children.

Do not use Mirtazapine Qualigen after the expiry date stated on the packaging and blister. After EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Qualigen

• The active substance is mirtazapine. Mirtazapine Qualigen 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.
• The other components are:

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

Appearance of the product and contents of the pack

Mirtazapine Qualigen 15 mg are film-coated tablets.

The tablets are yellow, oblong, biconvex, and have a score line on one side. The score line is intended only to facilitate breaking the tablet and swallowing, but not to divide it into equal doses.

Mirtazapine Qualigen 15 mg tablets are packed in blisters.

The following pack sizes are available: 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

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

Date of the most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/