MIRTAZAPINE ALTER 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mirtazapine Flas Alter 30 mg orodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 Flas Alter and what is it used for
2. Before taking Mirtazapine Flas Alter
3. How to take Mirtazapine Flas Alter
4. Possible side effects
5. Storage of Mirtazapine Flas Alter
6. Further information

1. What is MIRTAZAPINA FLAS ALTER and what is it used for

Mirtazapine Flas Alter belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. Before taking MIRTAZAPINA FLAS ALTER

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING TO TAKE mirtazapine:

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.

Be particularly cautious with mirtazapine:

Severe skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of mirtazapine. 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 suffered from severe skin reactions, do not restart treatment with mirtazapine.

Do not take Mirtazapine Flas Alter

• if you are allergic(hypersensitive) to the active substance or any of the other ingredients of Mirtazapine Flas Alter. In this case, consult your doctor as soon as possible before taking Mirtazapine Flas Alter.
• if you are taking or have recently taken (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Be particularly cautious with Mirtazapine Flas Alter

Use in children and adolescents under 18 years

Mirtazapine Flas Alter should not normally be used in the treatment of children and adolescents under 18 years. However, you should be aware that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Mirtazapine Flas Alter to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed Mirtazapine Flas Alter to a patient under 18 years and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years who are taking Mirtazapine Flas Alter. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known.

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 medicines usually take two weeks or sometimes more to take effect.

You may be more likely to think this way if:

• you have previously had suicidal thoughts or thoughts of harming yourself.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.

• If you have thoughts of harming yourself or of suicide at any time, consult 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 can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Also, be particularly cautious with Mirtazapine Flas Alter

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

• Tell your doctor about these situations before taking Mirtazapine Flas Alter, if you have not already done so:

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
• kidney diseases;
• 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 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 signs of infection appear, such as high unexplained fever, sore throat, and mouth ulcers

• Stop taking Mirtazapine Flas Alter 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 usually appear 4-6 weeks after treatment.

Use of 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 if you are using or have recently used other medicines, including those obtained without a prescription.

Do not take Mirtazapine Flas Alterwith:

• 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 cautious ifyou take Mirtazapine Flas Alter 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 herbal remedy for depression). In very rare cases, mirtazapine alone or with these medicines may 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 may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine or increase it again when you stop taking 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 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).

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 decrease the dose of mirtazapine or increase it again when you stop taking these medicines.

• medicines for epilepsysuch as carbamazepine and phenytoin; medicines for tuberculosissuch 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 clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin on 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.

Taking Mirtazapine Flas Alter with food and drinks

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

Consult your doctor or pharmacist before using any medicine.

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

If you are taking mirtazapine and become pregnant or plan to become pregnant, consult your doctor if you can continue taking mirtazapine. If you use mirtazapine until or shortly before delivery, your baby will be examined for possible adverse effects.

Consult your doctor if you can breastfeed while taking Mirtazapine Flas Alter.

If you are taking Mirtazapine Alter 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 baby to breathe more rapidly and appear blue. These symptoms usually start during the first 24 hours after birth. If this occurs in your case, you must contact a doctor and/or midwife immediately.

Driving and using machines

Mirtazapine Flas Alter may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery.

Important information about some of the ingredients of Mirtazapine Flas Alter

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

3. How to TAKE MIRTAZAPINA FLAS ALTER

Follow the instructions for administration of Mirtazapine Flas Alter indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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 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 Flas Alter at the same time every day.

It is best to take the dose of Mirtazapine before bedtime. However, your doctor may recommend that you divide your dose of Mirtazapine Flas Alter 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 by 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 can you expect to feel better

Normally, Mirtazapine Flas Alter 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 few 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 this 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 Flas Alter than you should

• If you or someone else takes too much Mirtazapine Flas Alter, consult a doctor immediately. You can also call the Toxicology Information Service, telephone 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 Flas Alter

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 Flas Alter

• Stop taking Mirtazapine Flas Alter 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 unwell, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

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

4. Possible Adverse Effects

Like all medicines, Mirtazapine Flas Alter 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.
• hives or skin rashes (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 on 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:

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

• Stop taking mirtazapine and consult your doctor immediately.
• • twitching or muscle contractions (myoclonus).
  • pancreatitis.

Unknown:

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

• Stop taking mirtazapine and consult your doctor immediately for 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.
  • 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 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 or drug hypersensitivity syndrome).

Reporting of 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of MIRTAZAPINA ALTER

Keep out of the reach and sight of children.

Do not use Mirtazapine Flas Alter 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.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that are no longer needed in the SIGRE Point (or any other pharmaceutical waste collection system) at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Mirtazapina Alter

• The active ingredient is mirtazapine.

Mirtazapina Flas Alter 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 (E-951), orange silesia flavor, magnesium stearate.

Appearance of the Product and Packaging Content

Mirtazapina Flas Alter 30 mg orodispersible tablets are white, biconvex, and marked with 'M2' on one side.

Each package contains 30 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS ALTER S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

ACTAVIS LIMITED

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This prospectus was revised in 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/