Mirtazapine Flas Teva-Ratiopharm 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Flas Teva-ratiopharm 30 mg orodispersible tablets EFG

mirtazapine

Read the entire 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 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 may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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 Mirtazapine Flas Teva-ratiopharm is and what it is used for

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

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

It takes 1 to 2 weeks before Mirtazapine Flas Teva-ratiopharm starts to take effect. 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 you can expect to start feeling 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 experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medications.

Children and adolescents

Mirtazapine Flas Teva-ratiopharm should not normally be used to treat children and adolescents under 18 years of age, as efficacy has not been demonstrated. Additionally, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational 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 decide it is 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 who are taking Mirtazapine Flas Teva-ratiopharm. Furthermore, 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 known. In addition, 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 of harming yourself or committing suicide.

This may worsen when you first start taking antidepressants, as these medicines usually take time to work—typically two weeks or sometimes longer.

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 relative 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 (periods of elevated mood/hyperactivity alternate with periods of depression). If you begin to feel elated or overexcited, stop taking Mirtazapine Flas Teva-ratiopharm and contact your doctor immediately;

• diabetes (you may need to adjust your dose of insulin 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, a 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, or 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 appear 4–6 weeks after starting 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, 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, treatment with mirtazapine should not be restarted.

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 medicine.

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 thereafter. Examples of MAO inhibitors include moclobemide, tranilcipromine (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, and 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 methemoglobin in the blood), and St. John’s wort (Hypericum perforatum) preparations (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, diarrhea, uncontrollable 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 together with these medicines, mirtazapine may increase the drowsiness caused by them.

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

If 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.

If 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 reduce 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 both medicines are 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 taking Mirtazapine Flas Teva-ratiopharm.

It is recommended not to drink any alcohol.

You may take mirtazapine with or without food.

Pregnancy and breastfeeding

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 in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

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

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 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 Machinery

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

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

Mirtazapina Flas Teva-ratiopharm 30 mg orodispersible tablets EFG contain 6 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful if you suffer from 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 30 mg orodispersible tablets EFG contain 0.48 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; hence, 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 that is best 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 Mirtazapine Flas Teva-ratiopharm dose as a single dose before going to bed. However, your doctor may recommend that you divide your dose, taking part in the morning and part at night before going to bed.

The higher dose should be taken at night 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 strip is divided by perforations. Separate one blister by following the perforated lines (Figure 1)

Fig. 1

1. Open the blister

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

With dry hands, remove the orodispersible tablet and place it on your tongue (Figure 4).

Fig. 4

It will dissolve rapidly and can be swallowed without water.

When you can expect to start feeling 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.

Normally, 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 takes too much Mirtazapine Flas Teva-ratiopharm, consult a doctor or pharmacist immediately. You can also call the Toxicology Information Service at telephone number: 91 562 04 20.

The most likely symptoms of an overdose of Mirtazapine Flas Teva-ratiopharm (without other medicines or alcohol) are drowsiness, confusion, 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 are supposed 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 are supposed to take your dose twice a day:

• if you forget the morning dose, simply take it together with the 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 recover them. Skip both doses and the next day continue with your normal morning and evening doses.

If you interrupt 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 depression has resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, restless, 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 may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and contact 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 skin or eyes; may indicate liver problems (jaundice)

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

• Signs of infection such as sudden unexplained 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 reduction 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).

• Seizure (convulsions)
• Combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, involuntary muscle contractions, chills, exaggerated reflexes, 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 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)
• Widespread redness (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 when standing up quickly (orthostatic hypotension)
• Swelling (usually in ankles or feet) due to fluid retention (oedema)
• 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):

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

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

• Tics or muscle jerks (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 of the mouth (oral oedema)
• Swelling throughout the body (generalised oedema)
• Localised swelling
• Hyponatraemia
• 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 (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• Painful and prolonged erection of the penis

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were commonly observed in patients 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 can also report them directly via 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 medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This way, you 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 30 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, propylene glycol, sodium and benzyl alcohol) and mint flavour (artificial flavours, corn starch).

Appearance of the product and content of the pack

Orodispersible tablets.

Round, white tablets, marked with “37” on one side and “A” on the other side, with a raised circular edge.

Mirtazapine Flas Teva-ratiopharm 30 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 marketed.

Marketing Authorization Holder and Manufacturing Responsibility

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

31-546 Kraków

Poland

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

Member State Name	Medicinal Product Name
Germany	Mirtazapin-ratiopharm 30 mg orodispersible tablets
Italy	Mirtazapina Teva Italia 30 mg orodispersible tablets
Netherlands	Mirtazapine ratiopharm 30 mg dispersible tablets, orodispersible tablets
Portugal	Mirtazapina ratiopharm
Spain	Mirtazapina Flas Teva-ratiopharm 15 mg orodispersible tablets EFG Mirtazapina 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 about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and current 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 web address: https://cima.aemps.es/cima/dochtml/p/69704/P_69704.html