Mirtazapine Tarbis 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Tarbis 15 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Mirtazapine Tarbis is and what it is used for
2. What you need to know before taking Mirtazapine Tarbis
3. How to take Mirtazapine Tarbis
4. Possible side effects
5. How to store Mirtazapine Tarbis
6. Contents of the pack and other information

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

This medicine contains the active substance mirtazapine.

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks you may begin to feel better. You should consult your doctor if you worsen or do not improve after 2 to 4 weeks.

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

2. What you need to know before taking Mirtazapine Tarbis

Do not take Mirtazapine Tarbis

• if you are allergic to mirtazapine or to any of the other components of this medicine (listed in section 6).
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting mirtazapine.

Inform your doctor before taking Mirtazapine Tarbis:

If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after taking mirtazapine.

Severe skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking it and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

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

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This may worsen when you first start taking antidepressants, as these medicines usually take 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 behaviour 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 committing suicide, contact 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 think your depression is getting worse or if they are concerned about changes in your behaviour.

Also, be especially careful with Mirtazapine Tarbis

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

• Inform your doctor about these conditions before taking mirtazapine, 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 (periods of elevated mood/hyperactivity alternate with 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 insulin dose or other antidiabetic medicines);

• eye conditions, such as increased eye pressure (glaucoma);

• difficulty urinating, which may be due to an enlarged prostate;

• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.

  • if you develop signs of infection such as unexplained high fever, sore throat, or mouth ulcers.

• Stop taking mirtazapine and contact your doctor immediately for a blood test. Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

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

Children and adolescents

Mirtazapine is not normally used to treat children and adolescents under 18 years of age because its efficacy has not been demonstrated. Also, you should know 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 behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they consider it appropriate. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please contact 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 taking mirtazapine. In addition, the long-term effects on growth, maturation, and cognitive and behavioural development with mirtazapine in this age group are still unknown. A considerable weight gain has also been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Other medicines and Mirtazapine Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Mirtazapine Tarbis with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine within two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for at least two weeks afterwards. Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson’s disease).

Be cautious if taking Mirtazapine Tarbis with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin in the blood), and St. John’s wort (Hypericum perforatum) preparations (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 symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact 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. When used in combination with these medicines, mirtazapine may increase the drowsiness caused by them.
• medicines for infections: antibacterial medicines (such as erythromycin), antifungal medicines (such as ketoconazole), medicines for HIV/AIDS (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).

When 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.

When 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 reduce it again when stopping these medicines.

• medicines used to prevent blood clotting such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If both medicines are taken together, your doctor may recommend regular blood monitoring.

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

Taking mirtazapine with food and alcohol

You may feel drowsy if you drink alcohol while being treated with mirtazapine.

It is recommended not to drink any alcohol.

You may take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects. Medicines similar to mirtazapine (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, ensure that concentration and alertness are not impaired before cycling or similar activities.

Mirtazapine Tarbis contains lactose

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

3. How to take Mirtazapine Tarbis

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting dose is 15 or 30 mg once daily. Your doctor may recommend increasing the dose after a few days to the amount best suited for you (between 15 and 45 mg daily). Normally the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

→ Take mirtazapine at the same time each day. It is best to take the dose as a single dose before going to bed. However, your doctor may recommend splitting your mirtazapine dose, taking part in the morning and part at night before going to bed. The higher dose should be taken before bedtime.

Method of administration

Mirtazapine is for oral use.

Take your tablets without chewing, with a little water or juice.

You may take mirtazapine with or without food.

When you can expect to feel better

Mirtazapine 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, discuss with your doctor how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2–4 weeks.

Normally, you will need to take mirtazapine until depressive symptoms have been absent for 4–6 months.

If you take more mirtazapine than you should

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

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast or irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de pointes. You may also contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take mirtazapine

If you are taking your dose once daily:

• Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you are taking 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

→ Only stop taking mirtazapine after consulting your doctor.

If you stop too early, 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 resolved. If you stop 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 reduce the dose gradually.

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

4. Possible adverse effects

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

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

Uncommon (may affect up to 1 in 100 patients):

• feeling of exaggerated euphoria (mania).

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

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

Frequency not known (cannot be estimated from available data):

• • signs of infection such as unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances 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 reduction 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).
  • a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome".
  • thoughts of harming yourself or of suicide.
  • severe skin reactions:
• red patches on the trunk, often as well-defined or circular spots, frequently with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. 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).

Other possible adverse effects with mirtazapine include:

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
• diarrhoea
• vomiting
• constipation
• 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
• memory problems, which in most cases resolved when treatment was discontinued

Uncommon (may affect up to 1 in 100 patients):

• unusual skin sensations such as burning, prickling, tingling, or pins and needles (paraesthesia)
• involuntary restless leg movements during sleep
• fainting (syncope)
• numbness sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

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

• tics or muscle jerks (myoclonus)
• aggression
• abdominal pain, nausea; this may indicate inflammation of the pancreas (pancreatitis)

Frequency not known (cannot be estimated from available data):

• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorder
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milky nipple discharge)
• painful and prolonged penile erection

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were frequently observed in patients under 18 years of age: considerable weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Tarbis

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

Do not use this medicine 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Tarbis

The active substance is mirtazapine.

Each film-coated tablet contains 15 mg of mirtazapine.

The other components are:

Tablet core:

Lactose monohydrate, maize starch, hypromellose, colloidal anhydrous silica, magnesium stearate.

Tablet coating: Hypromellose (E464), macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Mirtazapine Tarbis 15 mg film-coated tablets EFG

Film-coated tablets, biconvex, yellow, oval-shaped, marked with “MH” on one side and “1” and “5” separated by a score line on the other side.

The tablet can be divided into equal doses.

Blister packs containing 20, 30, 50, 60, 100 and 500 film-coated tablets.

HDPE bottle containing 250 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Mirtazapin Amarox 15 mg Filmtabletten

Italy: Mirtazapina Amarox 15 mg compresse rivestite con film

The Netherlands: Mirtazapine Amarox 15 mg filmomhulde tabletten

Spain: Mirtazapina Tarbis 15 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: November 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/