Mirtazapine Flas Stada 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine Flas STADA 15 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Mirtazapine Flas STADA is and what it is used for

2. What you need to know before taking Mirtazapine Flas STADA

3. How to take Mirtazapine Flas STADA

4. Possible side effects

5. How to store Mirtazapine Flas STADA

6. Contents of the pack and other information

1. What Mirtazapine Flas STADA is and what it is used for

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

Mirtazapine Flas STADA is used to treat depression.

2. What you need to know before taking Mirtazapina Flas STADA

DO NOT take Mirtazapina Flas STADA

• If you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Flas STADA.

• If you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

DO NOT TAKE – OR – CONSULT YOUR DOCTOR BEFORE STARTING MIRTAZAPINA FLAS STADA:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Mirtazapina Flas STADA.

Children and adolescents

Mirtazapina Flas STADA is not normally used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts/ideas, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapina Flas STADA to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed Mirtazapina Flas STADA to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking Mirtazapina Flas STADA. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development of Mirtazapina Flas STADA in this age group have not yet been established.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to take effect.

You may be more likely to have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.

• If 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 of 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 believe your depression is worsening or if they are concerned about changes in your behavior.

Also, take special care with Mirtazapina Flas STADA

• If you have or have ever had any of the following disorders.

• Inform your doctor about these conditions before taking Mirtazapina Flas STADA, if you have not already done so.

• Seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapina Flas STADA and contact your doctor immediately;

• Liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapina Flas STADA 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 elevated mood/hyperactivity and periods of depression). If you start feeling elated or overexcited, stop taking Mirtazapina Flas STADA and contact your doctor immediately;

• Diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• Eye disorders, such as increased pressure in the eye (glaucoma);

• Difficulty urinating, which could be due to an enlarged prostate;

• If signs of infection such as unexplained high fever, sore throat, or mouth sores appear

• Stop taking Mirtazapina Flas STADA and contact your doctor immediately for a blood test.

Rarely, these symptoms may be signs of 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 medicines.
• Serious 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 immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.
• Mirtazapine treatment should not be restarted in patients who have previously experienced serious skin reactions.

Other medicines and Mirtazapina Flas STADA

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Mirtazapina Flas STADA in combination with:

• Monoamine oxidase inhibitors (MAOIs). Also, do not take Mirtazapina Flas STADA during the two weeks following discontinuation of MAOIs. If you stop taking Mirtazapina Flas STADA, do not take MAOIs for the next two weeks.

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

Be cautious if taking Mirtazapina Flas STADA in combination 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 preparations containing St. John's wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, Mirtazapina Flas STADA alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, palpitations, 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 Mirtazapina Flas STADA in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapina Flas STADA, 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.

When taken in combination with these medicines, Mirtazapina Flas STADA may increase the drowsiness caused by them.

• 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 together with Mirtazapina Flas STADA, these medicines may increase the amount of Mirtazapina Flas STADA in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapina Flas STADA, or increase it again when stopping these medicines.

• Medicines for heartburn and stomach ulcers (cimetidine).

Cimetidine may increase the amount of Mirtazapina Flas STADA in the blood. Inform your doctor if you are taking cimetidine. It may be necessary to reduce the dose of Mirtazapina Flas STADA or, after stopping cimetidine, to increase the dose of Mirtazapina Flas STADA.

• Medicines for epilepsy, such as carbamazepine and phenytoin;
• Medicines for tuberculosis, such as rifampicin.

If taken together with Mirtazapina Flas STADA, these medicines may reduce the amount of Mirtazapina Flas STADA in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapina Flas STADA, or decrease it again when stopping these medicines.

• Medicines to prevent blood clotting, such as warfarin.

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

Taking Mirtazapina Flas STADA with food and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapina Flas STADA. It is recommended not to consume any alcohol. You may take Mirtazapina Flas STADA with or without food.

Pregnancy and breastfeeding

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.

Ensure that your midwife and/or doctor know that you are taking Mirtazapina Flas STADA. When administered during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish skin tone in the newborn. These

symptoms usually appear within the first 24 hours after birth. If this occurs, contact your midwife and/or doctor immediately.

If you become pregnant while taking Mirtazapina Flas STADA or plan to become pregnant, consult your doctor about whether you can continue taking Mirtazapina Flas STADA. If you take Mirtazapina Flas STADA up to or shortly before delivery, your baby will be monitored for possible adverse effects. Consult your doctor about whether you can breastfeed while taking Mirtazapina Flas STADA.

Driving and using machines

Mirtazapina Flas STADA may affect your concentration or level of alertness. Make sure these abilities are not impaired before driving or operating machinery.

Mirtazapina Flas STADA contains aspartame

This medicine contains 6 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Mirtazapine Flas STADA

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How much to take

The usual starting 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). Normally the dose is the same for all age groups. However, if you are elderly or have kidney or liver problems, your doctor may adjust the dose.

When to take Mirtazapine Flas STADA

? Take Mirtazapine Flas STADA at the same time each day.

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

How to take the orodispersible tablets

Take the tablets by mouth.

Mirtazapine Flas STADA orodispersible tablets are available in bottles or in two different types of blister packs: standard blister and peelable blister. Follow the instructions below if your tablets are in a peelable blister.

Follow the 4 steps described below to open the peelable blister and take the tablet:

1. Do not break the orodispersible tablet

To avoid breaking the orodispersible tablet, do not push on the tablet cavity (Figure 1).

Figure 1

1. Separate one tablet compartment

Each blister contains six tablet compartments, separated by perforated lines. Tear off one compartment along the perforated line (Figure 2).

Figure 2

1. Separate the foil from the blister

Carefully peel off the foil starting at the corner indicated by the arrows (Figures 3).

Figure 3

1. Remove the orodispersible tablet

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

Figure 4

It will rapidly disintegrate and can be swallowed without water.

When you can expect to feel better

Mirtazapine Flas STADA usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better.

It is important that during the first weeks of treatment you talk to your doctor about the effects of Mirtazapine Flas STADA:

• Between 2 and 4 weeks after starting Mirtazapine Flas STADA, discuss with your doctor how the 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 continue taking Mirtazapine Flas STADA until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine Flas STADA than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount taken.

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

If you forget to take Mirtazapine Flas STADA

Do not take a double dose to make up for missed doses.

If you are supposed to take your dose once daily

• If you forget to take your dose of Mirtazapine Flas STADA, do not take the missed dose. Skip it and take your usual dose the next 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 normal 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 STADA

? Stop taking Mirtazapine Flas STADA only after consulting your doctor.

If you stop too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Mirtazapine Flas STADA abruptly, even if your depression has resolved. If you stop Mirtazapine Flas STADA 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 step by step.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience one or more of the following side effects, stop taking Mirtazapine Flas STADA and inform your doctor immediately!

Not known (frequency cannot be estimated from available data):

• thoughts of harming yourself or taking your own life (please go to the nearest hospital)

• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these may be signs of serotonin syndrome.

• epileptic seizure (convulsions).

• signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, Mirtazapine Flas STADA may cause disturbances in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapine Flas STADA may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapine Flas STADA may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• red patches on the trunk, such as well-defined or circular macules, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• widespread erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

• feeling euphoric or emotionally "high" (mania).

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

• yellowing of the eyes or skin, which may suggest liver function abnormalities (jaundice).

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

Very common (may affect more than 1 in 10 people):

• increased appetite and weight gain

• drowsiness

• headache

• dry mouth

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

• sluggish, slow, or indifferent behaviour (lethargy)

• dizziness

• tremors or shivering

• memory problems, which in most cases resolved when treatment was discontinued.

• nausea

• diarrhoea

• 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 (oedema)

• fatigue

• vivid dreams

• confusion

• anxiety

• difficulty sleeping

• constipation

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

• unusual skin sensations, e.g. burning, prickling, tingling, or pins and needles (paraesthesia)

• restless legs

• fainting (syncope)

• numbness sensation in the mouth (oral hypoesthesia)

• low blood pressure

• nightmares

• restlessness

• hallucinations

• inability to remain still

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

• tics or muscle contractions (myoclonus)

• aggressiveness

• severe stomach pain, which may radiate to the back. This could be a sign of pancreatitis.

Not known (frequency cannot be estimated from available data):

• abnormal sensations in the mouth (oral paraesthesia)

• swelling in the mouth (oral oedema)

• increased salivation

• difficulty speaking (dysarthria)

• sleepwalking (somnambulism)

• low blood sodium levels, which may cause fatigue and confusion, muscle spasms, seizures, and coma (hyponatraemia)

• production of excessive levels of antidiuretic hormone (hormones that help the kidneys and body retain the correct amount of water). This syndrome causes the body to retain water and certain electrolyte levels in the blood (such as sodium) [inappropriate antidiuretic hormone secretion].

In children under 18 years of age, the following adverse reactions were commonly observed in clinical trials: significant weight gain, urticaria, and increased blood triglyceride levels.

Other possible adverse effects of mirtazapine include:

Increased levels of creatine kinase in the blood, difficulty urinating, muscle pain, stiffness and/or weakness, and darkening or discoloration of urine.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Flas STADA

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

Do not use this medicine 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.

Storage conditions (blister): Store in the original packaging to protect from light and moisture.

Storage conditions (bottle): Store in the original container and keep tightly closed to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Flas STADA

The active substance is mirtazapine.

Mirtazapine Flas STADA 15 mg orodispersible tablets contain 15 mg of mirtazapine per orodispersible tablet.

The other components are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, L-methionine, microcrystalline cellulose and guar gum, aspartame (E951), orange flavour, and magnesium stearate.

Nature of the product and pack contents

Mirtazapine Flas STADA are orodispersible tablets.

15 mg tablets: white or almost white, round, 8 mm in diameter, biconvex, uncoated tablets with the mark "M1".

Blister packs containing 6, 10, 18, 30, 48, 60, 84, 90, 96, 100 and 180 (clinical packs of 18x10) tablets.

Single-dose perforated peelable blister packs containing 6, 10, 18, 30, 48, 60, 84, 90, 96, 100 and 180 (clinical packs of 18x10) tablets.

Bottle: 50, 100 tablets (desiccant included)

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer:

Coripharma ehf.

Reykjavíkurvegur 78

P.O Box 420

IS-220 Hafnarfjördur

Iceland

or

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

STADA Arzneimittel AG

Stadastr. 2-18,

D-61118 Bad Vilbel

Germany

or

Lamp S. Prospero S.p.A.

Via della Pace, 25/A

41030 – San Prospero (Modena)

Italy

or

SANICO NV

Veedijk 58 – 59

BE – 2300 Turnhout

Belgium

or

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

BE: Mirtazapine EG Instant 15mg

DE: Mirtazapin AL 15mg Schmelztabletten

DK: Mirtazapin STADA

ES: Mirtazapina Flas STADA 15 mg comprimidos bucodispersables EFG

PT: Mirtazapina Ciclum 15 mg comprimidos orodispersivel

Date of the most recent revision of this leaflet: October 2020

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