MIRTAZAPINE TECNIGEN 30 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine TecniGen 30 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.
• If you get 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 Mirtazapine TecniGen is and what it is used for
2. Before you take Mirtazapine TecniGen
3. How to take Mirtazapine TecniGen
4. Possible side effects
5. Storing Mirtazapine TecniGen
6. Further information

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

Mirtazapine TecniGen belongs to a group of medicines called antidepressants. Mirtazapine is used to treat depression.

2. Before you take 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 or peeling of the skin, blisters 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. At the same time, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines.

However, your doctor may prescribe Mirtazapine TecniGen to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed Mirtazapine TecniGen 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 symptoms mentioned above appear or worsen in patients under 18 years who are taking Mirtazapine TecniGen. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are still unknown.

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 sometimes more to take effect.

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 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 harming yourself or committing 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 disorders

? Inform your doctor about these situations before taking Mirtazapine TecniGen, if you have not already:

• • seizures(epilepsy). If seizures appear or your seizures are more frequent, stop taking mirtazapine and contact your doctor immediately;
  • liver disease, including jaundice. If jaundice appears, stop taking mirtazapine and contact your doctor immediately;
  • kidney disease;
  • heart diseaseor low blood pressure;
  • schizophrenia. If psychotic symptoms, such as paranoid thoughts, are 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 could be due to an enlarged prostate;
• if signs of infection appear, such as high unexplained fever, sore throat, and sores in the mouth

? 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 starts.

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

Severe skin reactions have been reported with the use of mirtazapine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). 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.

Use of other medicines

Tell your doctor or pharmacist if you are taking (or are going 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 purchased without a prescription.

Do not take Mirtazapine TecniGen with:

• 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 during the following two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (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 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, 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. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone.
• medicines for anxiety or insomniasuch as benzodiazepines.

medicines for schizophreniasuch as olanzapine.

medicines for allergiessuch as cetirizine.

medicines for severe painsuch as morphine.

In combination 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. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping 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. It may be necessary to increase the dose of mirtazapine or decrease it again when stopping 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. In case of taking them together, it is recommended that your doctor performs 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 adverse 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 certain sugars, consult them before taking this medicine.

3. How to take Mirtazapine TecniGen

Follow exactly the administration instructions of Mirtazapine 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). The dose is usually the same for all ages. However, if you are an elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take it

? Take Mirtazapine TecniGen at the same time every 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 you can expect to feel better

Normally, Mirtazapine 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 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 the 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 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 indicate how to gradually decrease 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 the legs during sleep
• fainting (syncope)
• numbness 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 mouth sores (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, muscle contractions (involuntary), 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 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 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 down the drain or into the trash.

Deposit the packaging and medicines that you no longer need at 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 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.

• The other components are:

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

Appearance of the Product and Packaging Content

Mirtazapine TecniGen are film-coated tablets.

The tablets are salmon-colored, 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.

Mirtazapine TecniGen 30 mg film-coated tablets are packaged in blisters. The following packaging sizes are available: 30 and 56 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