MIRTAZAPINE TECNIGEN 15 mg FILM-COATED TABLETS

2. Before taking Mirtazapine TecniGen

Do not take Mirtazapine TecniGen

• if you are allergic(hypersensitive) to the active ingredient or any of the other ingredients of Mirtazapine TecniGen. If so, contact your doctor immediately before taking Mirtazapine TecniGen.
• 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, skin peeling, or sores in the mouth after taking mirtazapine or other medicines.

Be careful with Mirtazapine TecniGen

Use in children and adolescents under 18 years

Mirtazapine TecniGen should not normally be used in the treatment of children and adolescents under 18 years. However, you should be aware that in patients under 18 years there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine.

However, your doctor may prescribe Mirtazapine TecniGen to patients under 18 years when they decide it is the most suitable for the patient. If your doctor has prescribed Mirtazapine TecniGen to a patient under 18 years and you wish to discuss this decision, please contact your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years taking Mirtazapine TecniGen. 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 suicide. This may worsen when you start taking antidepressants for the first time, 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 self-harm.
• you are a young adult. Clinical trial information 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 self-harm or suicide at any time, consult your doctor or go to a hospital immediately.

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

Also, be careful with Mirtazapine TecniGen

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

?Inform your doctor about these situations before taking Mirtazapine TecniGen, 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 disease, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
  • kidney disease;
  • heart diseaseor 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 ulcers appear

?Stop taking Mirtazapine TecniGen 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.

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

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. 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.

Using other medicines

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

Also, inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Do not take Mirtazapine TecniGenwith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapine during the two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for the next two weeks.

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

Be careful ifyou take Mirtazapine TecniGen 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(a herbal remedy for depression). In 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, consult your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of mirtazapine in the blood. Inform 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 insomniasuch as benzodiazepines.

medicines for schizophreniasuch as olanzapine.

medicines for allergiessuch as cetirizine.

medicines for severe painsuch as morphine.

When combined 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 the blood. Inform 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 epilepsysuch as carbamazepine and phenytoin;

medicines for tuberculosissuch as rifampicin.

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

• medicines to prevent blood clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend that you have blood tests.

Taking Mirtazapine TecniGen with food and drinks

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 and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Limited experience with the administration of Mirtazapine TecniGen 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 plan to become pregnant, consult your doctor if you can continue taking mirtazapine. If you use mirtazapine until or shortly before delivery, your baby will be examined for possible side effects.

Make sure your doctor knows that you are being treated with Mirtazapine TecniGen. When similar medicines (SSRIs) are taken during pregnancy, it may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. The symptoms usually appear within the first 24 hours of the baby's life. If this happens, you should contact your doctor immediately.

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

Driving and using machines

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

Important information about some of the ingredients of Mirtazapine TecniGen film-coated tablets

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

3. How to take Mirtazapine TecniGen

Follow the instructions for taking Mirtazapine TecniGen exactly as indicated 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 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 TecniGen at the same time each day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before bedtime. The highest dose should be taken before bedtime.

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

When can you expect to feel better

Normally, Mirtazapine TecniGen will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better. It is essential 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 TecniGen than you should

?If you or someone else takes too much Mirtazapine TecniGen, consult 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 TecniGen

If you have to take your dose once a day

• 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 have to take your dose twice 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 make them up. Skip both doses and the next day continue with your usual dose in the morning and evening.

If you stop taking Mirtazapine TecniGen

?Stop taking mirtazapine only if you consult your doctor.

If you stop too soon, 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 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, Mirtazapine TecniGen can cause adverse effects, although not all people suffer from them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine 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
• Uncommon: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
• tremors
• nausea
• diarrhea
• vomiting
• hives or skin rashes (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
• In children under 18 years of age, the following adverse reactions have been frequently observed in clinical trials: weight gain, hives, and increased triglycerides in the blood.
• Memory problems, which in most cases were resolved when treatment was discontinued.

Uncommon:

• feeling of exaggerated euphoria (mania).

? Stop taking mirtazapine 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 mirtazapine and consult your doctor immediately.

• tics or muscle contractions (myoclonus)
• pancreatitis

Unknown:

• signs of infection such as unexplained and sudden high fever, sore throat, and sores in the mouth (agranulocytosis).

? Stop taking mirtazapine and consult your doctor immediately to have a blood test.

In rare cases, mirtazapine may cause alterations in the production of blood cells (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine 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 mirtazapine 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 mirtazapine and consult your doctor immediately.

• thoughts of self-harm or suicide

? Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• inadequate secretion of antidiuretic hormone
• 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlargement of lymph nodes (DRESS or drug hypersensitivity syndrome).

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

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.

5. Conservation of Mirtazapine Tecnigen

Keep out of the reach and sight of children.

Do not use Mirtazapine TecniGen 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.

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

Medicines should not be thrown away through the sewers or in 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. Additional Information

Composition of Mirtazapine TecniGen

• The active ingredient is mirtazapine.

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

• The other components are:

Core of the tablet: Lactose, Pregelatinized corn starch, Magnesium stearate. Tablet coating: Hydroxypropyl methylcellulose, Titanium dioxide (E171), Polyethylene glycol 8000, Yellow iron oxide (E172).

Appearance of the Product and Packaging Content

Mirtazapine TecniGen are film-coated tablets.

The tablets are yellow, oblong, biconvex, and have a score line on one side. The score line is only to allow for fractionation and to facilitate swallowing, but not to divide into equal doses.

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

Marketing Authorization Holder and 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

Tel: 91 3835166

Fax: 91 3835167

E-mail: [email protected]

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 prospectus was approved in July 2020

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