MIRTAZAPINE TARBIS 30 mg FILM-COATED TABLETS

2. What you need to know before you take Mirtazapine Tarbis

Do not take Mirtazapine Tarbis

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

Warnings and precautions

Consult your doctor or pharmacist before taking mirtazapine.

Tell your doctor before taking Mirtazapine Tarbis:

If you have ever suffered from a severe skin rash or peeling of the skin, blisters or sores in the mouth after taking mirtazapine.

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). Stop taking mirtazapine and seek immediate medical attention if you notice any of the symptoms described in section 4 in relation to these severe skin reactions.

If you have ever suffered from severe skin reactions, you should not restart treatment with mirtazapine.

Suicidal thoughts and worsening of depression

If you are depressed you may sometimes have thoughts of harming or killing yourself. These thoughts may be more frequent when you first start taking antidepressants, as these medicines take 2 weeks or sometimes longer to start working.

You may be more likely to think this way if:

• you have previously had thoughts of killing or harming yourself.
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

→ If you have thoughts of harming or killing yourself at any time, contact 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 might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Also, be careful with Mirtazapine Tarbis

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

• Tell 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 (alternating periods of overactivity/manic behaviour and periods of depression). If you start to feel overactive or manic, stop taking mirtazapine and contact your doctor immediately;
• diabetes (you may need to adjust your insulin or other antidiabetic medicines);
• eye diseases, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain types of heart disease that can change the rhythm of your heart, a recent heart attack, heart failure, or taking certain medicines that can affect the rhythm of your heart.
• • if you experience signs of infection such as unexplained high fever, sore throat and mouth ulcers.

• Stop taking mirtazapine and contact your doctor immediately to have a blood test. Although rare, these symptoms can be signs of changes in blood cell production in the bone marrow. Although rare, these symptoms usually occur within 4-6 weeks of treatment.
• • if you are an elderly person. You may be more sensitive to the side effects of antidepressant medicines.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years because it has not been shown to be effective. At the same time, you should know 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 behaviour and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years when they decide it is the best for the patient. If your doctor has prescribed mirtazapine 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 above symptoms occur or worsen in patients under 18 years who are taking mirtazapine. Furthermore, the long-term safety effects on growth, maturation and development of cognition and behaviour of mirtazapine in this age group have not yet been established. It has also been observed more frequently in this age group that there is a considerable increase in weight 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 take any other medicines.

Do not take Mirtazapine Tarbis with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after you stop taking 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 if you take 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 some psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin in the blood) and St. John's Wort (Hypericum perforatum) (a herbal remedy for depression). In rare cases, mirtazapine alone or with these medicines may lead to a condition called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhoea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, mood changes and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, or increase it again when you stop taking 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) and medicines for stomach ulcers (such as cimetidine).

If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when you stop taking these medicines.

• medicines for epilepsy such as carbamazepine and phenytoin;
• medicines for tuberculosis such as rifampicin

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

• medicines to prevent blood clotting such as warfarin.

Mirtazapine may increase the effects of warfarin in the blood. Tell your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor performs blood tests.

• medicines that can affect the 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 can take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.

If you use mirtazapine up to or shortly before birth, your baby will be checked for possible adverse effects. Taken during pregnancy, medicines similar to SSRIs may increase the risk in babies of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years, make sure that concentration and alertness are not affected before cycling (for example).

Mirtazapine Tarbis contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Mirtazapine Tarbis

Follow exactly the administration instructions of this medicine given 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 that you increase 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 at the same time each day. It is best to take the dose of mirtazapine once before going to bed. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before going to bed. The highest dose should be taken before going to bed.

Method of administration

Mirtazapine is for oral use.

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

You can take mirtazapine with or without food.

When can you expect to feel better

Normally mirtazapine will start to work after 1 or 2 weeks and after 2 to 4 weeks you may start to feel better.

It is important that during the first few weeks of treatment you talk to your doctor about the effects of mirtazapine:

→ between 2 and 4 weeks after you have started taking 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 than you should

→ If you or someone else has taken too much mirtazapine, contact a doctor immediately.

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

If you forget to take mirtazapine

If you have to take your dose once a day

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

If you have to take your dose twice a day

If you stop taking mirtazapine

→ Only stop taking mirtazapine if you have discussed it with your doctor.

If you stop taking it too soon, your depression may come back. 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 your 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 tell you how to reduce the dose gradually.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

• exaggerated feeling of euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

Frequency Not Known(cannot be estimated from the available data):

• • signs of infection such as high, unexplained, and sudden fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine can cause alterations in blood cell production (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).
  • 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 can be signs of a disorder called "serotonin syndrome".
  • thoughts of self-harm or suicide.
  • severe skin reactions:
• red patches on the torso, 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 eruptions 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).

Other Possible Adverse Effects with Mirtazapine Are:

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

• increased appetite and weight gain
• somnolence
• headache
• dry mouth

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

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• constipation
• urticaria or skin eruptions (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):

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• involuntary leg movements during sleep
• fainting (syncope)
• numbness 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):

• twitching or muscle contractions (myoclonus)
• aggression
• abdominal pain, nausea; this may indicate pancreas inflammation (pancreatitis)

Frequency Not Known(cannot be estimated from the available data):

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

Other Adverse Effects

In children and adolescents, the following adverse effects were frequently observed in clinical trials in patients under 18 years: significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine 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.

This medicine does not require special storage conditions.

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. Package Contents and Additional Information

Composition of Mirtazapine Tarbis

The active ingredient is mirtazapine.

Each film-coated tablet contains 30 mg of mirtazapine.

The other components are:

Tablet core:

Lactose monohydrate, cornstarch, hypromellose, anhydrous colloidal silica, magnesium stearate.

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

Product Appearance and Package Contents

Mirtazapine Tarbis 30 mg film-coated tablets EFG

Film-coated tablets, biconvex, oval-shaped, reddish-brown in color, engraved with "MH" on one side and "3" and "0" separated by a score line on the other side.

The tablet can be divided into equal doses.

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

HDPE bottle containing 250 film-coated tablets.

Only some package 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

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Mirtazapin Amarox 30 mg Filmtabletten

Italy: Mirtazapina Amarox 30 mg compresse rivestite con film

Netherlands: Mirtazapine Amarox 30 mg filmomhulde tabletten

Spain: Mirtazapina Tarbis 30 mg comprimidos recubiertos con película EFG

Date of the Last Revision of this Prospectus: November 2023

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