Mirtazapine Tecnigen 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine TecniGen 15 mg film-coated tablets EFG

Read the entire 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Mirtazapine TecniGen is and what it is used for
2. Before taking Mirtazapine TecniGen
3. How to take Mirtazapine TecniGen
4. Possible side effects
5. How to store 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 taking Mirtazapine TecniGen

Do not take Mirtazapine TecniGen

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Mirtazapine TecniGen. In this case, consult your doctor as soon as possible before taking Mirtazapine TecniGen.
• if you are 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 skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Take special care 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 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 ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine.

Nevertheless, your doctor may prescribe Mirtazapine TecniGen to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Mirtazapine TecniGen to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. 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 TecniGen. In addition, the long-term effects on growth, maturation, and cognitive and behavioral development with mirtazapine in this age group are still not fully 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 about 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 adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

? If at any time you have thoughts of harming yourself or of suicide, consult 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 notice your depression worsening or if they are concerned about changes in your behavior.

Also, take special care with Mirtazapine TecniGen

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

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

• • 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 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 periods of depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;
  • diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);
  • eye disorders, such as increased pressure in the eye (glaucoma);
  • difficulty urinating, which may be due to an enlarged prostate;
• if signs of infection appear, such as unexplained high fever, sore throat, and mouth ulcers

? Stop taking Mirtazapine TecniGen 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 appear around 4–6 weeks after starting treatment.

• if you are elderly, you may be more sensitive to the adverse 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 immediate medical attention if you notice any of the symptoms described in section 4 related to these severe skin reactions.

If you have ever experienced severe skin reactions, treatment with mirtazapine should not be restarted.

Use of other medicines

Inform 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 any other medicines, including those obtained without a prescription.

Do not take Mirtazapine TecniGen together with:

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

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

Be careful if you take Mirtazapine TecniGen together 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 certain psychiatric disorders), and preparations containing St. John's wort – Hypericum perforatum (a 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 of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, 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. This may increase the amount of mirtazapine in the 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.

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 together 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 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.

If taken together 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 clotting such as warfarin.

Mirtazapine may enhance the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, it is recommended that your doctor performs regular blood tests.

Taking Mirtazapine TecniGen with food and drink

You may feel drowsy if you drink alcohol while being treated with mirtazapine. It is recommended not to consume any alcohol.

You may 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 wish to become pregnant, consult your doctor 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.

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

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

Driving and using machines

Mirtazapine TecniGen may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery.

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

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Mirtazapine TecniGen

Follow exactly the instructions for the administration of Mirtazapine TecniGen 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 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 elderly or have a kidney or liver disease, your doctor may adjust the dose.

When to take it

? Take Mirtazapine TecniGen at the same time each day.

It is best to take the dose of mirtazapine as a single dose before going to bed. However, your doctor may recommend that you divide your dose, taking part in the morning and the remainder before going to bed. The higher 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

Mirtazapine TecniGen 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 speak with your doctor about the effects of mirtazapine:

? Between 2 and 4 weeks after starting 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, speak again with your doctor after another 2–4 weeks.

You will usually need to take mirtazapine until depressive symptoms 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 may also call the Toxicology Information Service. Telephone: 91 562 04 20.

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

If you forget to take Mirtazapine TecniGen

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 following day continue with your normal morning and evening doses.

If you stop taking Mirtazapine TecniGen

? Stop taking mirtazapine only after consulting your doctor.

If you stop too early, depression may return. When you are feeling 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 gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, Mirtazapine TecniGen 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
• In children under 18 years of age, the following adverse reactions have been frequently observed in clinical trials: weight gain, skin rashes, and increased blood triglycerides.
• Memory problems, which in most cases resolved when treatment was discontinued.

Uncommon:

• feeling of exaggerated well-being or euphoria (mania).

? Stop taking mirtazapine and consult your doctor immediately.

• unusual skin sensations such as burning, prickling, tingling, or numbness (paresthesia)
• involuntary leg movements during sleep (restless legs)
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• restlessness
• hallucinations
• inability to remain still

Rare:

• yellowing of the skin or eyes; may indicate liver dysfunction (jaundice).

? Stop taking mirtazapine and consult your doctor immediately.

• muscle tics or jerks (myoclonus)
• pancreatitis

Not known:

• signs of infection such as sudden unexplained 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 temporarily reduce white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a reduction 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).

• epileptic 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 indicate a disorder known as "serotonin syndrome."

? Stop taking mirtazapine and consult your doctor immediately.

• thoughts of harming oneself or of 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
• red patches on the trunk, appearing as circumscribed or circular macules, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome).

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

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.

5. Storage of Mirtazapine Tecnigen

Keep out of the reach and sight of children.

Do not use Mirtazapine Tecnigen after the expiry date stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

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 packaging at the SIGRE collection point at your pharmacy. If you are in any doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Information provided

Composition of Mirtazapine TecniGen

• The active substance is mirtazapine.

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

• The other components are:

Tablet core: Lactose, pregelatinized corn starch, magnesium stearate.
Tablet coating: Hypromellose, titanium dioxide (E171), polyethylene glycol 8000, yellow iron oxide (E172).

Appearance of the product and contents of the container

Mirtazapine TecniGen 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, and is not intended for dividing the tablet into equal doses.

Mirtazapine TecniGen 15 mg film-coated tablets are packaged in blisters. The following pack 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 patient information leaflet was approved in July 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es