Mirtazapine Flas Teva-Ratiopharm 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Flas Teva-ratiopharm 15 mg orodispersible tablets EFG

mirtazapine

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

Contents of the leaflet:

1. What Mirtazapine Flas Teva-ratiopharm is and what it is used for
2. What you need to know before taking Mirtazapine Flas Teva-ratiopharm
3. How to take Mirtazapine Flas Teva-ratiopharm
4. Possible side effects
5. How to store Mirtazapine Flas Teva-ratiopharm
6. Contents of the pack and other information

1. What Mirtazapina Flas Teva-ratiopharm is and what it is used for

Mirtazapina Flas Teva-ratiopharm belongs to a group of medicines called antidepressants.

Mirtazapina Flas Teva-ratiopharm is used to treat depression in adults.

It takes 1 to 2 weeks before Mirtazapina Flas Teva-ratiopharm starts to work. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if you worsen or do not improve after 2 to 4 weeks.

For more information, see section 3, "When can you expect to feel better?"

2. What you need to know before starting to take Mirtazapine Flas Teva-ratiopharm

Do not take Mirtazapine Flas Teva-ratiopharm:

• If you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). In that case, consult your doctor as soon as possible before taking Mirtazapine Flas Teva-ratiopharm.
• If you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapine Flas Teva-ratiopharm.

DO NOT TAKE – OR – CONSULT YOUR DOCTOR BEFORE STARTING MIRTAZAPINE:

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

Children and adolescents

Mirtazapine Flas Teva-ratiopharm is not normally recommended for use in children and adolescents under 18 years of age, as efficacy has not been demonstrated. Additionally, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontation behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe Mirtazapine Flas Teva-ratiopharm to patients under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed mirtazapine 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 taking Mirtazapine Flas Teva-ratiopharm. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development with Mirtazapine Flas Teva-ratiopharm in this age group are not yet fully known. Furthermore, a significant weight gain has been observed more frequently in patients in this age group treated with mirtazapine compared to treated adults.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts about harming yourself or committing suicide.

This may worsen when you first start taking antidepressants, as these medicines usually take about two weeks or sometimes longer to become effective.

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm, or
• 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 inform a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to let you know 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 Teva-ratiopharm

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

? Inform your doctor about these conditions before taking Mirtazapine Flas Teva-ratiopharm, if you have not already done so:

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapine Flas Teva-ratiopharm and contact your doctor immediately;

• liver disease, including jaundice. If jaundice develops, stop taking Mirtazapine Flas Teva-ratiopharm 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 depression). If you start feeling elated or overexcited, stop taking Mirtazapine Flas Teva-ratiopharm and contact your doctor immediately;

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

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

• difficulty urinating, which may be due to an enlarged prostate;

• certain types of heart disease that may alter your heart rhythm, recent heart attack, heart failure, or use of certain medications that may affect heart rhythm.

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

? Stop taking Mirtazapine Flas Teva-ratiopharm and contact your doctor immediately for a blood test.

Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically occur 4–6 weeks after starting treatment.

• If you are elderly. You may be more sensitive to the adverse effects of antidepressant medications.

Serious skin reactions have been reported with the use of mirtazapine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use 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 experienced serious skin reactions, re-initiation of mirtazapine treatment is not recommended.

Taking Mirtazapine Flas Teva-ratiopharm with other medicines

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

Do not take Mirtazapine Flas Teva-ratiopharm together with:

• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapine Flas Teva-ratiopharm within two weeks after stopping MAO inhibitors. If you stop taking mirtazapine, do not take MAO inhibitors for at least two weeks afterwards. Examples of MAO inhibitors include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson's disease).

Be cautious if taking Mirtazapine Flas Teva-ratiopharm together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin in the blood), and St. John's Wort (Hypericum perforatum) preparations (a herbal remedy for depression). In very rare cases, Mirtazapine Flas Teva-ratiopharm alone or in combination with these medicines may lead to a condition known as serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, rapid heartbeat, diarrhoea, uncontrolled muscle contractions, shivering, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact 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 after 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, mirtazapine may increase drowsiness caused by them.

• medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), medicines for HIV/AIDS (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).

When taken together with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of mirtazapine or increase it again after stopping these medicines.

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

When taken together with mirtazapine, these medicines may reduce the amount of mirtazapine in the blood. Inform your doctor if you are taking any of these medicines. It may be necessary to increase the dose of mirtazapine, or decrease it again after stopping these medicines.

• medicines used 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.

• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Flas Teva-ratiopharm with food and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapine Flas Teva-ratiopharm.

It is recommended not to drink any alcohol.

You can take mirtazapine with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

If you take mirtazapine up to or shortly before delivery, your baby will be examined for possible adverse effects.

When similar medicines (known as serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your case, you should contact your midwife and/or doctor immediately.

Breastfeeding

Consult your doctor whether you can breastfeed while taking Mirtazapina Flas Teva-ratiopharm.

Driving and use of machines

Mirtazapina Flas Teva-ratiopharm may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed Mirtazapina Flas Teva-ratiopharm to a patient under 18 years of age, ensure that concentration and alertness are not affected before cycling or engaging in similar activities.

Mirtazapina Flas Teva-ratiopharm orodispersible tablets contain aspartame (E951)

Mirtazapina Flas Teva-ratiopharm 15 mg orodispersible tablets EFG contain 3 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Mirtazapina Flas Teva-ratiopharm orodispersible tablets contain benzyl alcohol

Mirtazapina Flas Teva-ratiopharm 15 mg orodispersible tablets EFG contain 0.24 micrograms of benzyl alcohol per tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Mirtazapina Flas Teva-ratiopharm orodispersible tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; therefore, it is essentially "sodium-free".

3. How to take Mirtazapine Flas Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much to take

The recommended starting dose is 15 or 30 mg once daily. Your doctor may recommend increasing the dose after a few days to the amount best suited for you (between 15 and 45 mg daily). Normally, the dose is 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 at the same time each day.

It is best to take the dose of Mirtazapine Flas Teva-ratiopharm as a single dose before bedtime. However, your doctor may recommend dividing your dose, taking part in the morning and the remainder before bedtime.

The higher dose should be taken before bedtime.

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 cavity (Figure A)

Fig. A.

.

1. Separate one blister cavity

Each blister is separated by perforations. Separate one blister cavity by following the perforated lines (Figure 1)

Fig. 1

1. Open the blister cavity

Carefully peel off the foil, starting at the corner where the aluminum cover is not sealed (Figures 2 and 3)

Fig. 2

Fig. 3

1. Remove the orodispersible tablet

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

Fig. 4

It will dissolve rapidly and can be swallowed without water.

When you can expect to feel better

Mirtazapine Flas Teva-ratiopharm usually starts to take effect after 1 or 2 weeks, and you may begin 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.

? 2 to 4 weeks after starting mirtazapine, speak with 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, speak to your doctor again after another 2–4 weeks.

Usually, you will need to take Mirtazapine Flas Teva-ratiopharm until depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapine Flas Teva-ratiopharm than you should:

If you or someone else takes more than the prescribed amount of Mirtazapine Flas Teva-ratiopharm, consult a doctor or pharmacist immediately. You may also call the Toxicology Information Service at: 91 562 04 20.

The most likely symptoms of an overdose of Mirtazapine Flas Teva-ratiopharm (without other medicines or alcohol) are drowsiness, disorientation, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take Mirtazapine Flas Teva-ratiopharm:

If you have to take your dose once a day:

• do not take a double dose to make up for missed doses. Take the next dose at your usual time.

If you have to take your dose twice a day:

• 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 treatment with Mirtazapine Flas Teva-ratiopharm

?Stop taking Mirtazapine Flas Teva-ratiopharm 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 you can stop treatment.

Do not stop taking Mirtazapine Flas Teva-ratiopharm abruptly, even if your depression has resolved. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, agitated or anxious, and may experience headache. 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 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 any of the following serious adverse effects, stop taking mirtazapine and inform your doctor immediately.

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

• Feeling of exaggerated euphoria (mania)

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

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

Frequency not known (frequency cannot be estimated from available data):

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

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 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).

• Seizure (convulsions)
• Combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, exaggerated shivering, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome"
• Thoughts of harming yourself or of suicide
• Red patches on the trunk, appearing as well-defined or circular spots, often with blisters in the center, 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)
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

Other possible adverse effects with mirtazapine include:

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):

• Lethargy
• Dizziness
• Tremor
• Nausea
• Diarrhoea
• Vomiting
• Constipation
• Hives or skin rash (exanthema)
• Joint pain (arthralgia) or muscle pain (myalgia)
• Back pain
• Dizziness or fainting upon standing 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 discontinued

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

• Strange skin sensations such as burning, pricking, tingling, or numbness (paraesthesia)
• Involuntary restless leg movements during sleep
• Fainting (syncope)
• Numbness sensation in the mouth (oral hypoesthesia)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Inability to remain still

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

• Tics or muscle contractions (myoclonus)
• Aggression
• Abdominal pain, nausea; this may indicate inflammation of the pancreas (pancreatitis)

Frequency not known (frequency cannot be estimated from available data):

• Abnormal sensations in the mouth (oral paraesthesia)
• Swelling in the mouth (oral edema)
• Swelling throughout the body (generalized edema)
• Localized swelling
• Hyponatremia
• Inappropriate secretion of antidiuretic hormone
• Severe skin reactions (bullous dermatitis, erythema multiforme)
• Sleepwalking (somnambulism)
• Speech disorder
• Increased levels of creatine kinase in the blood
• Difficulty urinating (urinary retention)
• Muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• Increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• Painful and prolonged penile erection

Other adverse effects in children and adolescents

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

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 directly through the Spanish Pharmacovigilance System for Human Medicines: 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 Teva-ratiopharm

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 blister. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If in doubt, 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 Teva-ratiopharm

• The active substance is mirtazapine. Each orodispersible tablet contains 15 mg of mirtazapine.
• The other components are: crospovidone (type B), mannitol (E421), microcrystalline cellulose (E460), aspartame (E951), colloidal anhydrous silica, magnesium stearate (E572), strawberry flavour (artificial flavours, corn maltodextrin, triethyl citrate and propylene glycol, sodium and benzyl alcohol) and mint flavour (artificial flavours, corn starch).

Appearance of the product and contents of the pack

Orodispersible tablets.

Round, white tablets, marked with “36” on one side and “A” on the other side, with a circular raised edge.

Mirtazapine Flas Teva-ratiopharm 15 mg is available in packs containing 6, 10, 18, 20, 30, 48, 50, 60, 90, 96 and 100 orodispersible tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid) Spain

Manufacturer

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren (Germany)

Or

Teva Operations Poland SP. Z O.O.
Ul. Mogilska 80,
Krakow 31-546
Poland

This medicinal product is authorized in the EEA Member States under the following names:

Member State Name	Medicinal Product Name
Germany	Mirtazapin-ratiopharm 15 mg orodispersible tablets
Netherlands	Mirtazapine ratiopharm 15 mg dispersible tablets, orodispersible tablets
Portugal	Mirtazapine ratiopharm
Spain	Mirtazapine Flas Teva-ratiopharm 15 mg orodispersible tablets EFG Mirtazapine Flas Teva-ratiopharm 30 mg orodispersible tablets EFG

Date of the most recent review of this leaflet: December 2024

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69705/P_69705.html