MIRTAZAPINE TARBIS 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for theuser

Mirtazapine TARBIS 30mgorodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Mirtazapine Tarbis belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

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

Do not take MirtazapineTarbis

• if you are allergic (hypersensitive) to the active ingredient or any of the other ingredients of this medicine (listed in section 6). If so, contact your doctor as soon as possible before taking Mirtazapine Tarbis.
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).

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

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

Warnings and precautions

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

Use in children and adolescents under 18 years

Mirtazapine Tarbis should not normally be used in the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years there is an increased risk of side effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Mirtazapine Tarbis to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed Mirtazapine Tarbis 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 symptoms listed above appear or worsen in patients under 18 years who are taking Mirtazapine Tarbis. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are still unknown.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These can 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 are more likely to have these 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 disorders 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 relative 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 Mirtazapine Tarbis:

• if you have or have ever had any of the following disorders

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

• seizures(epilepsy). If seizures appear or are more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, stop taking mirtazapine and contact your doctor immediately;
• kidney disease;
• heart diseaseor low 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 excited or overexcited, stop taking mirtazapine and contact your doctor immediately;
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose);
• eye diseases, 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 high unexplained fever, sore throat, and sores in the mouth

? Stop taking Mirtazapine Tarbis and contact your doctor immediately to have a blood test. In rare cases, these symptoms can 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 elderly person, you may be more sensitive to the adverse effects of antidepressant medicines.
• serious 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). Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these serious skin reactions.
• If you have ever suffered from serious skin reactions, do not restart treatment with mirtazapine.

Using Mirtazapine Tarbis with other medicines

Tell your doctor or pharmacist if you are taking (or are going to take) any of the medicines on the following list.

Also, tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine.

Do not take Mirtazapine Tarbiswith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapine during the two weeks after you have stopped 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 ifyou take Mirtazapine Tarbis 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 some psychiatric disorders), and St. John's Wort –Hypericum perforatum(a medicinal plant for depression). In very rare cases, mirtazapine alone or with these medicines can cause a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, 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 can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone.
• medicines for anxiety or insomniasuch as benzodiazepines.

medicines for schizophreniasuch as olanzapine.

medicines for allergiessuch as cetirizine.

medicines for severe painsuch as morphine.

In combination with these medicines, mirtazapine can 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 with mirtazapine, these medicines can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping these medicines.

• medicines for epilepsysuch as carbamazepine and phenytoin; medicines for tuberculosissuch as rifampicin.

If taken with mirtazapine, these medicines can decrease 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 clottingsuch as warfarin.

Mirtazapine can increase the effects of warfarin 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.

Taking Mirtazapine Tarbis with food, drinks, 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, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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

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. If you use mirtazapine until or shortly before birth, your child will be examined for possible adverse effects.

If you are taking mirtazapine during pregnancy, tell your midwife and/or doctor. When similar medicines (called selective serotonin reuptake inhibitors: SSRIs) are taken during pregnancy, it may increase the risk of the baby suffering from a serious disease called persistent pulmonary hypertension of the newborn (PPHN), causing the child to breathe faster and appear blue. These symptoms usually start during the first 24 hours after birth. If this happens in your case, you should contact your doctor and/or midwife immediately.

Consult your doctor if you can breastfeed while taking Mirtazapine Tarbis.

Driving and using machines

Mirtazapine Tarbis can affect your concentration or alertness.

During treatment with Mirtazapine Tarbis, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Mirtazapine Tarbis affects you.

Mirtazapine Tarbis contains aspartame

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

3. How to take Mirtazapine Tarbis

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

How much to take

The usual initial dose is 15 or 30mg 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 dose is usually the same for all ages. However, if you are an elderly person or have kidney or liver disease, your doctor may change the dose.

When to take it

? Take Mirtazapine Tarbis at the same time every day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before bedtime. The highest dose should be taken before bedtime.

Take the orodispersible tablet as follows

The tablets are taken orally.

1. Do not press the orodispersible tablet

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

Fig. A.

1. Separate a blister

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

Fig. 1.

1. Open the blister

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

Fig. 2.

Fig. 3.

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue (Figure 4).

Fig. 4.

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Normally, Mirtazapine Tarbis will start to work 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 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 Tarbis than you should

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

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

If you forget to take Mirtazapine Tarbis

If you have to take your dose once a day

If you have to take your dose twice a day

If you stop taking Mirtazapine Tarbis

? Stop taking mirtazapine only if you consult your doctor.

If you stop 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 if 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 decrease the dose.

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

4. Possible Adverse Effects

Like all medicines, Mirtazapine Tarbis can cause adverse effects, although not all people suffer from them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are indicated 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 the available information

Very Common:

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

Common:

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• 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 were resolved when treatment was discontinued.

Uncommon:

• feeling of exaggerated euphoria (mania)

? Stop taking mirtazapine and consult your doctor immediately.

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

Rare:

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

? Stop taking mirtazapine and consult your doctor immediately.

• tics or muscle contractions (myoclonus)
• pancreatitis

Unknown Frequency:

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

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

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).

? Stop taking mirtazapine and consult your doctor immediately.

• 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 can be signs of a disorder called "serotonin syndrome".

? Stop taking mirtazapine and consult your doctor immediately.

• thoughts of self-harm or suicide

? Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• inadequate secretion of antidiuretic hormone
• increase in creatine kinase levels 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, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) ? Stop taking mirtazapine and consult your doctor immediately.
• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) ? Stop taking mirtazapine and consult your doctor immediately.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Adverse Effect Reporting:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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.

Do not store at a temperature above 25°C.

Keep in the original packaging to protect it from light and moisture.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines 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 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.

Mirtazapine Tarbis 30 mg orodispersible tablets contain 30 mg of mirtazapine per tablet.

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

Appearance of the Product and Package Contents

Mirtazapine Tarbis 30 mg orodispersible tablets are white, round, biconvex, and marked with 'M2' on one side.

The orodispersible tablets are packaged in child-resistant blisters, perforated for unitary dosage.

The following package sizes are available: 30 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona (Spain)

Manufacturer

Actavis HF

Reyjavikuvegur 78

220 Hafnarfjordur

Iceland

Or

Actavis Limited

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the Last Revision of this Prospectus:October 2020

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/