Mirtazapine Flas Alter 15 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mirtazapine Flas Alter 15 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Leaflet contents:

1. What Mirtazapine Flas Alter is and what it is used for
2. Before you take Mirtazapine Flas Alter
3. How to take Mirtazapine Flas Alter
4. Possible side effects
5. How to store Mirtazapine Flas Alter
6. Further information

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

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

Mirtazapine is used to treat depression.

2. BEFORE TAKING MIRTAZAPINE ALTER

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING mirtazapine:

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

Take special care with 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.

Do not take Mirtazapine Flas Alter

• if you are allergic (hypersensitive) to the active substance or to any of the other components 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 (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Take special care with Mirtazapine Flas Alter

Use in children and adolescents under 18 years of age

Mirtazapine Flas Alter should not normally be used in the treatment of children and adolescents under 18 years of age. 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 (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe Mirtazapine Flas Alter to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Mirtazapine Flas Alter 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 who are taking Mirtazapine Flas Alter. In addition, the long-term safety effects on growth, maturation, and cognitive and behavioral development of mirtazapine in this age group are still unknown.

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 work.

You may be more likely to have these thoughts if:

• you have previously had suicidal or self-harming thoughts.

• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

• If at any time you have thoughts of harming yourself or committing suicide, consult 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 behavior.

Also, take special care with Mirtazapine Flas Alter

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

• Inform your doctor about these conditions before taking Mirtazapine Flas Alter, 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 mania/hyperactivity and depression).

If you start feeling manic or overexcited, stop taking mirtazapine and contact your doctor immediately;

• diabetes (you may need to adjust your insulin dose or other antidiabetic medications);

• 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 unexplained high fever, sore throat, and mouth sores

• Stop taking Mirtazapine Flas Alter and contact your doctor immediately for a blood test.

• In rare cases, 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 elderly, you may be more sensitive to the adverse effects of antidepressant medications.

Use of other medicines

Inform your doctor or pharmacist if you are taking (or plan to take) any of the medicines listed below.

Also inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Do not take Mirtazapine Flas Alter together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for the following two weeks.

Examples of MAOIs include moclobemide, tranylcypromine (both antidepressants), and selegiline (used for Parkinson's disease).

Be careful if you take Mirtazapine Flas Alter together 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 certain psychiatric disorders), and St. John's wort – Hypericum perforatum (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, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult 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.

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

• medicines for infections: antibacterial agents (such as erythromycin), antifungal agents (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors).

If 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.

If 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 to prevent blood clotting such as warfarin.

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

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 may take mirtazapine with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Limited experience with administering 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 wish to become pregnant, consult your doctor about whether you can continue taking mirtazapine. If you use mirtazapine up to or shortly before delivery, your baby will be examined for possible adverse effects.

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

If you are taking Mirtazapine Alter during pregnancy, inform your midwife and/or doctor. When similar medicines (called serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within 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 impaired before driving or operating machinery.

Important information about some of the components of Mirtazapine Flas Alter

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

3. HOW TO TAKE MIRTAZAPINE FLAS ALTER

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

How much to take

The usual starting dose is 15 or 30 mg daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg daily). The dose is usually 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 Flas Alter at the same time each day.

It is best to take the dose of Mirtazapine as a single dose before bedtime. However, your doctor may recommend that you divide your dose of Mirtazapine Flas Alter, taking part in the morning and part before bedtime. The higher dose should be taken before going to bed.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not press the orodispersible tablet

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

Fig. A.

1. Separate one blister

Each blister contains six blisters separated by perforations. Separate one blister along the perforated lines (Figure 1).

Fig. 1.

1. Open the blister

Carefully peel off the foil, starting at 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 rapidly and can be swallowed without water.

When to expect to feel better

Mirtazapine Flas Alter usually starts to take effect after 1 or 2 weeks, and you may start to feel better after 2 to 4 weeks. It is important that during the first weeks of treatment you talk to your doctor about how mirtazapine is affecting you:

• 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.

You will usually need to take mirtazapine until depressive symptoms 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 may also call the Toxicology Information Service at telephone number 91 562 04 20.

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

If you forget to take Mirtazapine Flas Alter

If you are supposed to take your dose once daily

• if you forget to take your dose of mirtazapine, do not take the missed dose. Skip it and take your next dose at the usual time the following day.

If you are supposed to take your dose twice daily

• if you forget the morning dose, simply take it together with your evening dose
• if you forget the evening dose, do not take it the next morning; skip it and continue with your usual morning and evening doses
• if you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Flas Alter

• Stop taking Mirtazapine Flas Alter only if advised by your doctor.

If you stop too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when it is appropriate to 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 using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Mirtazapine Flas Alter can cause adverse effects, although not everyone experiences them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are listed below and can be categorized as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects 1 to 10 in 100 patients
• Uncommon: affects 1 to 10 in 1,000 patients
• Rare: affects 1 to 10 in 10,000 patients
• Very rare: affects fewer than 1 in 10,000 patients
• Not known: cannot be estimated from available data

Very common:

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

Common:

• Lethargy.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhea.
• Vomiting.
• 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.
• Sleep difficulties.
• Memory problems, which in most cases resolved when treatment was discontinued.

Uncommon:

• Feeling of exaggerated euphoria (mania).

• Stop taking mirtazapine and consult your doctor immediately.

• Unusual skin sensations such as burning, prickling, itching, or tingling (paresthesia).

  • Involuntary restless leg movements during sleep.
  • Fainting (syncope).
  • Numbness sensation in the mouth (oral hypoesthesia).
  • Low blood pressure.
  • Nightmares.
  • Restlessness.
  • Hallucinations.
  • Inability to remain still.

Rare:

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

• Stop taking mirtazapine and consult your doctor immediately.

  • Muscle tics or contractions (myoclonus).
  • Pancreatitis.

Not known:

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

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

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 blood cells, 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).

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

• Stop taking mirtazapine and consult your doctor immediately.

  • Thoughts of harming yourself or suicide.

• Stop taking mirtazapine and consult your doctor immediately.

  • Abnormal sensations in the mouth (oral paresthesia).
  • Swelling of the mouth (oral edema).
  • Hyponatremia.
  • Inappropriate secretion of antidiuretic hormone.
  • Red patches on the trunk, appearing as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Generalized red rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MIRTAZAPINE ALTER

Keep out of the reach and sight of children.

Do not use Mirtazapine Flas Alter 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.

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point (or any other medicine waste collection system) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Mirtazapine Alter

• The active substance is mirtazapine.

Mirtazapine Flas Alter 15 mg orally disintegrating tablets contain 15 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), Silesia orange flavor, magnesium stearate.

Appearance of the product and contents of the pack

Mirtazapine Flas Alter 15 mg orally disintegrating tablets are white, biconvex and marked with 'M1' on one side.

Each pack contains 30 orally disintegrating 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 leaflet was last reviewed in October 2020

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