Mirtazapina sandoz farmaceutica 45 mg comprimidos recubiertos con pelicula efg

Package Insert: Information for the Patient

Mirtazapina Sandoz Farmacéutica 45 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Mirtazapina belongs to a group of medicines called antidepressants.

Mirtazapina is used for the treatment of depression in adults.

It takes 1 to 2 weeks for mirtazapina to start taking effect. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you get worse or do not improve after 2 to 4 weeks.

For more information, see section 3 "When you can expect to feel better".

Do not take or consult your doctor before starting to take Mirtazapina Sandoz Farmacéutica

• if you are allergic to mirtazapina or to any of the other components of this medication (listed in section 6). In that case, consult your doctor as soon as possible before taking mirtazapina.
• if you are taking or have taken recently (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs),
• if you have ever had a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking mirtazapina or other medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapina.

Children and adolescents

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, you should be aware that in patients under 18 years there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor may prescribe mirtazapina to patients under 18 years when they decide what is best for the patient. If the doctor has prescribed mirtazapina 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 mentioned above in patients under 18 years taking mirtazapina appear or worsen. In addition, the long-term safety effects related to growth, maturity, and development of mirtazapina in this age group are not yet known. It has also been observed more frequently a considerable weight gain in this age group when treated with mirtazapina, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed you may sometimes have thoughts of harming yourself or of 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 you have previously had suicidal thoughts or self-harm,
• if you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults under 25 years with psychiatric disorders and being treated with an antidepressant.

?If you have thoughts of harming yourself or 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. You can ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.

Also, be particularly careful with mirtazapina

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

?Inform your doctor about these situations before taking mirtazapina, if you have not already done so

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapina and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice occurs, stop taking mirtazapina and contact your doctor immediately;
• kidney diseases;
• heart diseasesorlow 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 to feel 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 pressure in the eye(glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain types of heart diseasethat may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm.

• if you have signs of infection such as high fever, sore throat, and mouth sores

?Stop taking mirtazapina and contact your doctor immediately to have a blood test.

In rare cases, these symptoms may be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms appear between 4 and 6 weeks of 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.

Other medications and Mirtazapina Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not takeMirtazapina Sandoz Farmacéuticawith:

• 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 during the following two weeks.

Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take mirtazapina with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs),venlafaxina and L-tryptophan or triptans(used to treat migraines), buprenorphine (used to treat pain or opioid dependence),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders),methylene blue(used to treat high levels of methemoglobin in the blood)and preparations based on St. John's Wort –Hypericum perforatum(medicinal plant for depression). In rare cases, mirtazapina alone or with these medications, may cause the so-called serotonin syndrome. Some of the 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: medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole) and medications for HIV/AIDS (HIV protease inhibitors) andstomach ulcer medications(such as cimetidina).

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 carbamazepine and phenytoin,
• tuberculosis medicationssuch as rifampicin.

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 warfarin.

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

• medications that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Sandoz Farmacéutica with food and alcohol

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

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy.

If you use mirtazapina until, or shortly before delivery, your baby will be examined to detect any possible adverse effects.

Medications similar to mirtazapina (SSRIs) taken during pregnancy may increase the risk of a serious disease called persistent pulmonary hypertension in the newborn (PPHN) in the baby, which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should consult your midwife and/or doctor immediately.

Driving and using machines

Mirtazapina may affect your concentration or alertness. Make sure your faculties are not affected before driving or using machinery. If your doctor has prescribed mirtazapina to a patient under 18 years, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Sandoz Farmacéutica contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended 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 mirtazapine 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.

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

When to expect to feel better

Normally, mirtazapine 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 or 4 weeks.

Normally, you will need to take mirtazapine until the symptoms of depression have disappeared for 4 or 6 months.

If you take more Mirtazapina Sandoz Farmacéutica than you should

?If you or someone takes too much mirtazapine, consult a doctor immediately.

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) aredrowsiness,disorientationandpalpitations. Symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount taken.

If you forgot to take Mirtazapina Sandoz Farmacéutica

If you have to take your doseonce a day

• do not take a dose to compensate for the missed doses. Take the next dose at the usual time.

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 Sandoz Farmacéutica

?Stop taking mirtazapine only if you consult your doctor.

If you stop 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop taking mirtazapine and immediately inform your doctor.

Rare(may affect up to 1 in 1,000 patients):

• exaggerated feeling of euphoria (mania).

Unknown frequency(cannot be estimated from available data):

• signs of infection such as sudden and unexplained high fever and sore throat, mouth sores (agranulocytosis). In rare cases, mirtazapine may cause alterations in blood cell production (bone marrow depression).

Some people become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine 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),
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome",
• thoughts of self-harm or suicide,
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• red patches on the trunk, such as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe 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 hypersensitivity syndrome).

Other possible side effects with mirtazapine are:

Very common(may affect more than 1 in 10 patients):

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

Common(may affect up to 1 in 10 patients):

• lethargy,
• dizziness,
• tremor,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• urticaria or skin rash (exanthema),
• joint or muscle pain (arthralgia or 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 resolved when treatment was discontinued.

Rare(may affect up to 1 in 1,000 patients):

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of leg agitation during sleep,
• fainting (syncope),
• numbness of the mouth (hypoaesthesia oral),
• low blood pressure,
• nightmares,
• agitation,
• hallucinations,
• inability to remain still.

Unknown frequency(cannot be estimated from available data):

• tics or muscle contractions (myoclonus),
• aggression,
• abdominal pain, nausea; this may indicate pancreatitis.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mirtazapina Sandoz Pharmaceutical 45 mg film-coated tablets

-The active ingredient is mirtazapine. Each film-coated tablet contains 45 mg of mirtazapine.

-The other components are:

Core: lactose, cornstarch, hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose, macrogol 8000, titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Mirtazapina Sandoz Pharmaceutical 45 mg are film-coated tablets.

The tablets are white, round, and biconvex

They are presented in a blister pack, in containers with 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

COMBINO PHARM MALTA LTD

60 Hal Far Industrial Estate

Hal Far BBG 07 Malta

Date of the last review of this leaflet:November 2023

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