Leaflet: information for theuser

Mirtazapina TARBIS 30mgfilm-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What isMirtazapina Tarbisand what it is used for

2. What you need to know before you start takingMirtazapina Tarbis

3. How to takeMirtazapina Tarbis

4. Possible side effects

5. Storage ofMirtazapina Tarbis

6. Contents of the pack and additional information

Mirtazapina Tarbis belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression.

Do not take MirtazapinaTarbis

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Tarbis.
• If you are taking or have taken in the last two weeks certain medicines called monoamine oxidase inhibitors (MAOIs).

DO NOT TAKE - OR - CONSULT YOUR DOCTOR BEFORE STARTING TO TAKE MIRTAZAPINA TARBIS:

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 medicines.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Tarbis.

Use in children and adolescents under 18 years

Mirtazapina Tarbis should not be used normally 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 higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, the doctor may prescribe Mirtazapina Tarbis to patients under 18 years when they decide it is best for the patient. If the doctor has prescribed Mirtazapina Tarbis 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 listed above appear or worsen in patients under 18 years who are taking Mirtazapina Tarbis. In addition, the long-term effects on safety related to growth, maturity, and development of knowledge and behavior of mirtazapina in this age group are still unknown.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as these medicines require time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these types of thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric illnesses and who were treated with an antidepressant.

?If at any time you have thoughts of self-harm or suicide, consult your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friendthat you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Also, be especially careful with Mirtazapina Tarbis:

• If you have or have had any of the following conditions

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

• 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 appears, stop taking mirtazapina and contact your doctor immediately;
• kidney diseases;
• heart diseaseorlow 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 animated or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medicines);
• eye diseases, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;

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

?Stop taking Mirtazapina Tarbis and contact your doctor immediately to perform 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 4-6 weeks after treatment.

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

Use of Mirtazapina Tarbis with other medicines

Inform 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 that you are using, have used recently, or may need to use any other medicine.

Do not take Mirtazapina Tarbiswith:

• 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 for the next two weeks either.

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

Be careful ifyou take Mirtazapina Tarbis with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders), and herbal preparations based on St. John's Wort –Hypericum perforatum(medicinal plant for depression). In rare cases, mirtazapina alone or with these medicines, 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 nefazodona. It may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking this medicine. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking nefazodona.
• anxiety or insomnia medicinessuch as benzodiazepines.

schizophrenia medicinessuch as olanzapina.

allergy medicinessuch as cetirizina.

pain medicinessuch as morphine.

In combination with these medicines, mirtazapina may increase the drowsiness caused by these medicines.

• infection medicines:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazol), and HIV/AIDS medicines (protease inhibitors).

If taken with mirtazapina, these medicines may increase the amount of mirtazapina in the blood. Inform your doctor if you are taking these medicines. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking these medicines.

• epilepsy medicinessuch as carbamazepina and fenitoína;
  tuberculosis medicinessuch as rifampicina.

If taken with mirtazapina, these medicines may reduce the amount of mirtazapina in the blood. Inform your doctor if you are taking these medicines. You may need to increase the dose of mirtazapina, or reduce it again when you stop taking these medicines.

• blood thinnerssuch as warfarina.

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

Administration of Mirtazapina Tarbiswith food, drinks, 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.

Mirtazapina Tarbis contains aspartamo

This medicine may be harmful to people with phenylketonuria because it contains aspartamo, which is a source of phenylalanine.

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

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 usual dose is the same for all ages. However, if you are an older person or have a kidney or liver disease, your doctor may change the dose.

When to take it

?Take Mirtazapina Tarbis at the same time every day.

It is better to take the mirtazapina dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapina dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.

Take the buccal tablet in the following way

The tablets are taken orally.

1.Do not press the buccal tablet

To avoid crushing the buccal tablet, do not press the blister (Figure A).

Fig. A.

2.Separate a blister

Each blister contains six blisters, separated by perforations. Separate a blister by following the perforated lines (Figure 1).

Fig. 1.

3.Open the blister

Remove the foil carefully, starting from the corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.

4.Take the buccal tablet

Take the buccal tablet with dry hands and place it on the tongue (Figure 4).

Fig. 4.

It will dissolve quickly and can be swallowed without water.

When to expect to feel better

Mirtazapina Tarbis usually starts to work after 1 or 2 weeks and after 2 to 4 weeks you may start to feel better. It is essential to talk to your doctor about the effects of mirtazapina during the first weeks of treatment:

?between 2 and 4 weeks after starting to take mirtazapina, talk to your doctor about how this medication has affected you.

If you are not feeling better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2-4 weeks.

You will usually need to take mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Tarbis than you should

?If you or someone takes too much Mirtazapina Tarbis, consult a doctor immediately. You can also call the Toxicological Information Service, phone 91 562 04 20.

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapina Tarbis

If you have to take it once a day:

• If you forget to take your mirtazapina dose, do not take the missed dose. Skip it and take the usual dose the next day.

If you have to take it twice 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 Tarbis

?Stop taking mirtazapina only if you consult your doctor.

If you stop taking 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 mirtazapina abruptly, even when depression has disappeared. If you stop taking mirtazapina 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, Mirtazapina Tarbis may cause side effects, although not everyone will experience them.

Some side effects are more likely than others. The possible side effects of mirtazapina are listed below and can be divided into:

• Very common:Affect more than 1 in 10 patients
• Common: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 available information

Very common:

• Increased appetite and weight gain
• Drowsiness
• Headache
• Dry mouth

Common:

• Lethargy
• Dizziness
• Tremor
• Nausea
• Diarhea
• Vomiting
• Constipation
• Urticaria or skin rash (exanthema)
• Muscle or joint 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 stopped.

Uncommon:

• Exaggerated feeling of euphoria (mania)

?Stop taking mirtazapina and consult your doctor immediately.

• Strange sensation in the skin, such as burning, prickling, tingling, or numbness (paresthesia)
• Restless leg movements during sleep
• Fainting (syncope)
• Reduced sensation in the mouth (hypoaesthesia oral)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Inability to remain still

Rare:

• Yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice).

?Stop taking mirtazapina and consult your doctor immediately.

• Tics or muscle contractions (myoclonus)
• Pancreatitis

Unknown frequency:

• Signs of infection, such as sudden and unexplained high fever, sore throat, and mouth sores (agranulocytosis).

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

In rare cases, mirtazapina may cause changes in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina 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).

?Stop taking mirtazapina and consult your doctor immediately.

• A 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 may be signs of a condition called "serotonin syndrome."

?Stop taking mirtazapina and consult your doctor immediately.

• Thoughts of self-harm or suicide

?Stop taking mirtazapina and consult your doctor immediately.

• Abnormal sensations in the mouth (paresthesia oral)
• Swelling in the mouth (edema bucal)
• Hyponatremia
• Inadequate secretion of antidiuretic hormone
• Increased levels of creatine kinase in the blood
• Difficulty urinating (urinary retention)
• Muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis).
• Red patches on the trunk, such as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)?Stop taking mirtazapina and consult your doctor immediately.
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)?Stop taking mirtazapina and consult your doctor immediately.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. 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 medication.

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

Do not use this medication 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.

Do not store above25ºC.

Store in the original packaging to protect it from light and humidity.

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

Composition of Mirtazapina Tarbis

• The active ingredient is mirtazapine.

Mirtazapina Tarbis 30 mg buccal tablets contain 30 mg of mirtazapine per tablet.

• The other components are: mannitol, microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, L-methionine, crospovidone, microcrystalline cellulose, and guar gum (Avicel CE-15) , aspartame (E951), orange peel aroma, and magnesium stearate.

Appearance of the product and content of the packaging

Mirtazapina Tarbis 30 mg buccal tablets are white, round, biconvex, and marked with ´M2`on one side.

The buccal tablets are packaged in child-resistant blisters, perforated for unit dose.

The following packaging sizes are available: 30 buccal tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona (Spain)

Responsible for manufacturing

Actavis HF

Reyjavikuvegur 78

220 Hafnarfjordur

Islandia

Ó

Actavis Limited

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of this leaflet: October 2020

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