MIRTAZAPINE QUALIGEN 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet:INFORMATION FOR THE USER

MirtazapineQualigen15 mgfilm-coated tabletsEFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Mirtazapine Qualigen and what is it used for
2. What you need to know before you take Mirtazapine Qualigen
3. How to take Mirtazapine Qualigen
4. Possible side effects
5. Storage of Mirtazapine Qualigen
6. Contents of the pack and further information

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

Mirtazapine Qualigen belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

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

Do not take Mirtazapine Qualigen

• if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, contact your doctor immediately before taking Mirtazapine Qualigen.
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).
• If you have ever suffered from a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking Mirtazapine Qualigen or other medicines.

Warnings and precautions

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

Use in children and adolescents under 18 years

Mirtazapine Qualigen should not normally be used in the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years there is an increased risk of side effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Qualigen to patients under 18 years when he decides what is best for the patient. If your doctor has prescribed Mirtazapine Qualigen to a patient under 18 years 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 who are taking Mirtazapine Qualigen. 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.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. 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 suicidal thoughts or thoughts of harming yourself.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful to tell a relative or close 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 worried about changes in your behavior.

Also, be especially careful with Mirtazapine Qualigen:

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

Tell your doctor about these situations before taking Mirtazapine Qualigen, 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 diseases, including jaundice. If jaundice occurs, stop taking mirtazapine 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 excited or overexcited, 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; If signs of infection such as high unexplained fever, sore throat, and mouth sores appear.
• Severe 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 medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions. If you have ever suffered from severe skin reactions, do not restart treatment with Mirtazapine Qualigen.

Stop taking Mirtazapine Qualigen and contact your doctor immediately to have 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 starts.

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

Using Mirtazapine Qualigen with other medicines

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

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

Do not take Mirtazapine Qualigen with

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after you have stopped 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 if you take Mirtazapine Qualigen 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) preparations (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, contact your doctor immediately.

• the antidepressant nefazodone. It may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking this medicine. Your doctor may need to reduce the dose of mirtazapine or increase it again when you stop taking 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 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). If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. Your doctor may need to reduce the dose of mirtazapine or increase it again when you stop taking these medicines.
• medicines for epilepsy, such as carbamazepine and phenytoin.
• medicines for tuberculosis, such as rifampicin. If taken with mirtazapine, these medicines may reduce the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. Your doctor may need to increase the dose of mirtazapine or reduce it again when you stop taking these medicines.
• medicines to prevent blood clotting, such as warfarin. Mirtazapine may increase the effects of warfarin on the blood. Tell your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform blood tests.

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

If you are taking mirtazapine and become pregnant or want to become pregnant, consult your doctor if you can continue taking mirtazapine. If you use mirtazapine until or shortly before birth, your baby will be examined for possible side effects.

If you are taking Mirtazapine Qualigen during pregnancy, tell your midwife and/or doctor. When similar medicines (called selective serotonin reuptake inhibitors, SSRIs) are taken during pregnancy, there may be an increased risk that the baby will suffer from a serious disease 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.

Ask your doctor if 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 use tools or machines until you know how the treatment with Mirtazapine Qualigen affects you.

Mirtazapine Qualigen contains lactose

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

3. How to take Mirtazapine Qualigen

Follow exactly the administration instructions of Mirtazapine Qualigen given by your doctor. Ask your doctor or pharmacist if you have any doubts.

How much to take

The usual starting 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 have kidney or liver disease, your doctor may change the dose.

When to take it

Take Mirtazapine Qualigen at the same time every day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend taking your dose of mirtazapine divided into morning and bedtime. The highest 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

Normally, Mirtazapine Qualigen will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better. It is important that during the first few weeks of treatment, you talk to your doctor about the effects of mirtazapine:

Between 2 and 4 weeks after starting to take mirtazapine, 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 mirtazapine until the symptoms of depression 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, contact a doctor immediately. You can also call the Toxicology Information Service. Telephone 91 562 04 20.

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

If you forget to take Mirtazapine Qualigen

If you have to take your dose once a day:

If you have to take your dose twice a day:

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

If you stop taking Mirtazapine Qualigen

Stop taking mirtazapine only if you consult your doctor.

If you stop too soon, depression may recur. 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 abruptly, you may feel unwell, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually reduce the dose.

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

4. Possible Adverse Effects

Like all medicines, Mirtazapina Qualigen can cause adverse effects, although not all people suffer from them.

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

• Very frequent: affect more than 1 in 10 patients
• Frequent: affect between 1 and 10 in 100 patients
• Infrequent: affect between 1 and 10 in 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 the available information

Very frequent:

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

Frequent:

• 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 were resolved when treatment was discontinued.

Infrequent:

• feeling of exaggerated euphoria (mania),

Stop taking mirtazapina and consult your doctor immediately.

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of agitation of the legs during sleep,
• fainting (syncope),
• numbness sensation in 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.

• tics or muscle contractions (myoclonus).
• pancreatitis.

Unknown:

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (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 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 the number of 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, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms can be signs of a disorder 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 (oral paresthesia).
• swelling in the mouth (oral edema).
• hyponatremia.
• inadequate secretion of antidiuretic hormone.

Suspend the use of mirtazapina and contact your doctor or seek immediate medical attention if you suffer from one of the following serious side effects:

Unknown frequency:

• Red patches on the trunk, 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 erythemas can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

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

5. Conservation of Mirtazapina Qualigen

Keep this medicine out of sight and reach of children.

Do not use Mirtazapina Qualigen 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.

No special storage conditions are required.

Keep in the original packaging to protect it from light and moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapina Qualigen

• The active ingredient is mirtazapina. Mirtazapina Qualigen 15 mg film-coated tablets contain 15 mg of mirtazapina per tablet.
• The other components are:

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

Appearance of the Product and Package Contents

Mirtazapina 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 only to facilitate breaking and swallowing, but not to divide into equal doses.

Mirtazapina Qualigen 15 mg tablets are packaged in blisters.

The following package 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 Last Revision of this Prospectus:May 2021

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