PATIENT INFORMATION LEAFLET

Mirtazapina TecniGen 15 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this 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 their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

2.Before taking Mirtazapina TecniGen

3.How to take Mirtazapina TecniGen

4.Possible side effects

5.Storage of Mirtazapina TecniGen

6.Further information

Mirtazapina TecniGen belongs to a group of medicines calledantidepressants. Mirtazapina is used to treat depression.

Do not take Mirtazapina TecniGen

• if you areallergic(hypersensitive) to the active ingredient or any of the other components of Mirtazapina TecniGen. In this case, consult your doctor as soon as possible before taking Mirtazapina TecniGen.
• 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 of the skin, blisters, or mouth sores after taking mirtazapina or other medications.

Be especially careful with Mirtazapina TecniGen

Use in children and adolescents under 18 years

Mirtazapina TecniGen 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 (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication.

However, your doctor may prescribe Mirtazapina TecniGen to patients under 18 years when they decide it is the best option for the patient. If your doctor has prescribed Mirtazapina TecniGen 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 TecniGen 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 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 previously had suicidal thoughts or self-harm.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and taking 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 friendthat you are depressed, and ask them to read this leaflet. Youmay ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.

Also, be especially careful with Mirtazapina TecniGen

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

?Inform your doctor about these situations before taking Mirtazapina TecniGen, 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 disease, including jaundice. If jaundice appears, stop taking mirtazapina and contact your doctor immediately;
  • kidney disease;
  • 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 animation/hyperactivity and periods of depression). If you start feeling animated 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);
  • urination difficulties, which could be due to an enlarged prostate;
• if you have or have had any of the following symptoms: fever, high unexplained fever, throat pain, and mouth sores

?Stop taking Mirtazapina TecniGen and contact your doctor immediately to perform 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.

• if you are an older person, you may be more sensitive to the adverse effects of antidepressant medications.

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

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 recently used other medications, even those purchased without a prescription.

Do not take Mirtazapina TecniGenwith:

• 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 include moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take Mirtazapina TecniGen with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, and L-triptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders), andSt. John's Wortpreparations.

In rare cases, mirtazapina alone or in combination with these medications may cause a condition called serotonin syndrome. Some 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 medication. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking nefazodone.
• anxiety or insomnia medicationssuch as benzodiazepines.

schizophrenia medicationssuch as olanzapina.

allergy medicationssuch as cetirizina.

intense pain medicationssuch as morphine.

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

• infection medications:infection medications (such as erythromycin), fungal infection medications (such as ketoconazol), and HIV/AIDS medications (HIV protease inhibitors).

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.

• epilepsy medicationssuch as carbamazepina and fenitoína;

tuberculosis medicationssuch as rifampicina.

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.

• blood clotting medicationssuch as warfarina.

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

Taking Mirtazapina TecniGen 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 TecniGen 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 child will be examined to detect any possible adverse effects.

Make sure your doctor knows that you are taking Mirtazapina TecniGen. When taking similar medications (SSRIs) during pregnancy, there may be an increased risk of a severe condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. Symptoms usually appear within the first 24 hours of the baby's life. If this occurs, you should contact your doctor immediately.

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

Driving and using machines

Mirtazapina TecniGen may affect your concentration or alertness. Make sure your faculties are not affected before driving or using machinery.

Important information about some of the components of Mirtazapina TecniGen coated tablets

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

Follow exactly the administration instructions of Mirtazapina TecniGen indicated by your doctor. Consult your doctor or pharmacist if you have 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). 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 TecniGen 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.

Tablets are taken orally. Take the prescribed dose of Mirtazapina TecniGen without chewing, with water or juice.

When to expect to feel better

Normally, Mirtazapina TecniGen 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 mirtazapine:

?between 2 and 4 weeks after 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 more Mirtazapina TecniGen than you should

?If you or someone takes too much Mirtazapina TecniGen, 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 forgot to take Mirtazapina TecniGen

If you have to take your doseonce 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 forgot the morning dose, simply take it with the evening dose.
• If you forgot 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 forgot 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.

If you interrupt the treatment with Mirtazapina TecniGen

?Stop taking mirtazapine 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 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 TecniGen 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
• Rare: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 available information

Very common:

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

Common:

• Lethargy
• Dizziness
• Tremor
• Nausea
• Diarrhea
• Vomiting
• Urticaria or skin rash (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
• In children under 18 years, the following adverse reactions were frequently observed in clinical trials: weight gain, rashes, and increases in blood triglycerides.
• Memory problems, which in most cases resolved when treatment was discontinued.

Rare:

• Exaggerated feeling of euphoria (mania).

?Stop taking mirtazapina and consult your doctor immediately.

• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• Restless leg movements during sleep
• Fainting (syncope)
• Loss of sensation in the mouth (hypoaesthesia oral)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Inability to remain still

Rare:

• Yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice).

?Stop taking mirtazapina and consult your doctor immediately.

• Tics or muscle contractions (myoclonus)
• Pancreatitis

Unknown:

• Symptoms of infection, such as sudden and unexplained high fever, 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 changes in blood cell production (bone marrow depression). Some people may 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 (involuntary), chills, exaggerated reflexes, agitation, changes in urine, 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, often with blisters in the center, skin peeling, mouth sores, throat sores, genital sores, and eye sores. 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).

An increased risk of bone fractures has been observed in patients treated with this type of medication.

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

Keep out of reach and sight of children.

Do not use Mirtazapina TecniGen 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.

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

Medicines should not be thrown down the drains or in the trash.

Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Mirtazapina TecniGen Composition

• The active ingredient is mirtazapine.

Mirtazapina TecniGen 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.

• The other components are:

Tablet core: Lactose, Maize pregelatinized starch, Magnesium stearate. Tablet coating: Hydroxypropylmethylcellulose, Titanium dioxide (E171), Polyethylene glycol 8000, Iron oxide yellow (E172).

Product Appearance and Packaging Contents

Mirtazapina TecniGen are film-coated tablets.

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

Mirtazapina TecniGen 15 mg film-coated tablets are packaged in blisters. The following packaging sizes are available: 30 and 60 tablets

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Phone: 91 3835166

Fax: 91 3835167

Email:[email protected]

Responsible Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra (Portugal)

or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

This leaflet was approved in July 2020

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