Remirta oro

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Remirta ORO (Mirtazapin Actavis)
30 mg, orodispersible tablets
Mirtazapinum
Remirta ORO and Mirtazapin Actavis are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Remirta ORO is and what it is used for
2. Important information before taking Remirta ORO
3. How to take Remirta ORO
4. Possible side effects
5. How to store Remirta ORO
6. Contents of the pack and other information

1. What Remirta ORO is and what it is used for

Remirta ORO belongs to a group of medicines called antidepressants.
Remirta ORO is used to treat depression in adults.
The effect of Remirta ORO begins only after 1 to 2 weeks. After 2–4 weeks, the patient may start to feel better. If there is no improvement after 2–4 weeks, or if the patient feels worse, medical advice should be sought. More information can be found in section 3 under the heading "When can improvement in well-being be expected?"

2. Important information before using Remirta ORO

When not to use Remirta ORO

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In such a case, the patient must contact their doctor as soon as possible before taking Remirta ORO.
• if the patient is currently taking or has recently taken (within the last 2 weeks) medicines from the group of monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
Before starting treatment with Remirta ORO, discuss this with your doctor, pharmacist, or nurse.
DO NOT TAKE REMIRTA ORO OR CONSULT YOUR DOCTOR BEFORE TAKING REMIRTA ORO IF:
The patient has ever experienced severe skin rash, skin peeling, blistering, or changes in the mouth after taking mirtazapine or other medicinal products.

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Children and adolescents
Remirta ORO should not be used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated in this age group. It should also be emphasized that patients under 18 years of age taking medicines of this class are at increased risk of experiencing adverse effects such as suicidal attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviors, and manifestations of anger). Nevertheless, the doctor may prescribe Remirta ORO to patients under 18 years of age if they determine it is in their best interest. If you have any doubts because the doctor has prescribed Remirta ORO to a patient under 18 years of age, please consult your doctor again. In case of development or worsening of the above-mentioned symptoms in patients under 18 years of age taking Remirta ORO, inform your doctor immediately.
Moreover, there are currently no data on the long-term safety of Remirta ORO in this age group regarding growth, puberty, cognitive development, and behavioral development. Additionally, in this age group, significant weight gain has been observed more frequently after mirtazapine administration compared to adults.

Suicidal thoughts and worsening of depression
People suffering from depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work only after about two weeks, sometimes later.
These symptoms are more likely in:

• patients who previously had suicidal thoughts or self-harm behaviors
• young adult patients. Clinical trial data show an increased risk of suicidal behaviors in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor immediately or go to a hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or concerning changes in behavior.

Special caution is also required

• if the patient has or has ever had any of the following conditions: → If not already done, inform the doctor about these conditions before taking Remirta ORO
  • seizures (epilepsy). If seizures occur or their frequency increases, stop taking Remirta ORO and contact the doctor immediately
  • liver disease (including jaundice). If jaundice occurs, stop taking Remirta ORO and contact the doctor immediately
  • kidney disease
  • heart disease or low blood pressure
  • schizophrenia. If psychotic symptoms such as paranoid thoughts become more frequent or worsen, contact the doctor immediately
  • manic depression (alternating periods of elevated mood/excitement and depression). If feelings of excessive excitement or stimulation occur, stop taking Remirta ORO and contact the doctor without delay
  • diabetes (adjustment of insulin or other antidiabetic medication dosage may be necessary)
  • eye disease, such as increased intraocular pressure (glaucoma)
  • difficulty urinating, which may be caused by an enlarged prostate gland
  • certain heart conditions that may cause changes in heart rhythm, recent heart attack, heart failure, or use of certain medicines that may cause heart rhythm disturbances.
• if signs of infection occur, such as: high fever of unknown cause, sore throat, and mouth inflammation. → Stop taking Remirta ORO and contact the doctor immediately for a blood test. In rare cases, these symptoms may be Page 2 of 10

indicative of disorders in blood cell formation in the bone marrow. Although rare, these symptoms most commonly occur after 4-6 weeks of treatment.

• if the patient is elderly. The patient may be more sensitive to the adverse effects of antidepressant medicines.

Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with mirtazapine use. Discontinue the medicine and seek immediate medical help if any of the symptoms listed in section 4 occur due to these serious skin reactions.
Do not restart treatment with Remirta ORO if the patient has ever experienced a serious skin reaction.

Remirta ORO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use, including those listed below.
Do not take Remirta ORO simultaneously with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take Remirta ORO within two weeks after stopping MAOI treatment. If the patient stops taking Remirta ORO, they should not start MAOIs for at least two weeks. MAO inhibitors include moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease).

Exercise caution when using Remirta ORO in combination with:

• other antidepressants, such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium salts (used to treat certain psychiatric disorders), methylene blue (used to treat high methemoglobin levels in blood), and preparations containing St. John's wort ( Hypericum perforatum ) (herbal remedies used to treat depression). Very rarely, patients taking only mirtazapine or mirtazapine in combination with these medicines may develop serotonin syndrome. Some symptoms of this syndrome include sudden fever, sweating, increased heart rate, diarrhea, uncontrolled muscle contractions, chills, exaggerated reflexes, restlessness, mood changes, and loss of consciousness. Contact the doctor immediately if several of these symptoms occur together.
• the antidepressant nefazodone. It may increase the blood concentration of mirtazapine. Inform the doctor about taking these medicines. A reduction in mirtazapine dosage may be necessary, and after stopping nefazodone treatment, the mirtazapine dose may need to be increased again.
• medicines used to treat anxiety and insomnia, such as benzodiazepines; medicines used to treat schizophrenia, such as olanzapine; medicines used to treat allergies, such as cetirizine; medicines used to treat severe pain, such as morphine. Mirtazapine, when used in combination with these medicines, may intensify the drowsiness caused by them.
• medicines used to treat infections, such as antibacterial agents (erythromycin), antifungal agents (such as ketoconazole), medicines used in the treatment of HIV/AIDS (such as HIV protease inhibitors), and medicines used in peptic ulcer disease (such as cimetidine). When starting concomitant administration of these medicines with mirtazapine, the blood concentration of mirtazapine may increase. Inform the doctor about taking these medicines. A reduction in mirtazapine dosage may be necessary, and after stopping treatment with these medicines, the mirtazapine dose may need to be increased again.
• antiepileptic medicines, such as carbamazepine and phenytoin; medicines used to treat tuberculosis, such as rifampicin. In combination with mirtazapine, these medicines may reduce the blood concentration of mirtazapine. Inform the doctor about taking these medicines. An increase in mirtazapine dosage may be necessary, and after stopping treatment with these medicines, the mirtazapine dose may need to be reduced again.

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• anticoagulant medicines, such as warfarin. Mirtazapine may enhance the effect of warfarin. Inform the doctor about taking these medicines. Close monitoring of blood parameters is recommended during combined treatment with mirtazapine.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Remirta ORO with food, drink, and alcohol
The patient may feel drowsy if consuming alcohol while taking Remirta ORO. The patient is advised not to consume alcohol while taking Remirta ORO.
Remirta ORO can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy:
Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised when using mirtazapine during pregnancy.
If mirtazapine is taken during pregnancy or shortly before delivery, newborns should be monitored for possible adverse effects.
Ensure that the midwife and/or doctor are aware that the patient is taking Remirta ORO.
Taking medicines such as Remirta ORO or similar ones during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It manifests as rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Breastfeeding:
Ask the doctor whether breastfeeding is allowed while taking Remirta ORO.

Driving and operating machinery
Remirta ORO may reduce alertness or the ability to concentrate. The patient should ensure these abilities are not impaired before driving or operating machinery. If the doctor has prescribed Remirta ORO to a person under 18 years of age, check whether the medicine affects alertness and concentration before participating in road traffic (e.g., cycling).

Remirta ORO contains aspartame (E 951)
Remirta ORO 30 mg orally disintegrating tablets contain 12 mg of aspartame (E 951) per tablet.
Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Remirta ORO contains glucose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Glucose contained in the medicine may have harmful effects on teeth.

Remirta ORO contains sulphites
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Remirta ORO contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, meaning the medicine is considered "sodium-free".

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3. How to use Remirta ORO

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Remirta ORO is available in the following strengths: 30 mg, 45 mg.
Dosage
The recommended starting dose is 15 mg or 30 mg once daily.
After a few days of treatment, your doctor may decide to increase the dose to the most appropriate level for the patient
(from 15 mg to 45 mg once daily). This dose is usually the same for patients of different ages.
However, in elderly patients or patients with impaired kidney or liver function, your doctor may adjust the dosage.
When to take Remirta ORO
→ Remirta ORO should always be taken at the same time each day.
It is best to take Remirta ORO as a single dose before going to bed.
However, your doctor may recommend taking the medicine in two divided doses during the day – one dose in the morning and one in the evening before sleep. The larger dose should be taken in the evening, before going to bed.
How to take Remirta ORO
The medicine should be taken orally.

1. To avoid breaking the orally disintegrating tablet, do not push the tablet out of the blister (Figure 1).

Figure 1

2. Separate one blister cell from the rest of the strip (Figure 2).

Figure 2

3. Carefully peel back the foil starting from the corner marked with an arrow (Figures 3 and 4).

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Figure 3

Figure 4

4. Remove the tablet from the blister with dry hands and place it on the tongue (Figure 5). The tablet will rapidly disintegrate and can be swallowed without water.

Figure 5
When to expect improvement in well-being
Usually, the first signs of improvement can be expected after 1–2 weeks of treatment, and improvement in well-being may occur after 2–4 weeks.
It is important to discuss the effects of Remirta ORO with your doctor during the first few weeks of treatment:
→ 2 to 4 weeks after starting Remirta ORO, you should discuss the treatment effects achieved so far with your doctor.
If there is no adequate clinical response, your doctor may increase the dose. After another 2 to 4 weeks, you should again discuss the treatment outcomes with your doctor. Usually, patients will need to continue taking Remirta ORO until symptoms of depression have completely resolved, which typically takes about 4 to 6 months.
Taking more than the recommended dose of Remirta ORO
→ If a patient or anyone else has taken too much Remirta ORO, they should contact a doctor immediately.
The most commonly observed symptoms of overdose with Remirta ORO (without other medicines and without alcohol) are drowsiness, confusion, and rapid heartbeat.
Symptoms of overdose may include changes in heart rhythm (increased heart rate, irregular heartbeat) and/or fainting. These may be signs of life-threatening ventricular arrhythmias known as "Torsade de pointes".
Missed dose of Remirta ORO
If the medicine is taken once daily

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

If the medicine is taken twice daily

• If the patient forgets to take the morning dose, take it together with the evening dose.

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• If the patient forgets to take the evening dose, do not take it together with the morning dose; skip the missed dose and continue treatment by taking the usual morning and evening doses.
• If the patient forgets to take both doses, do not make them up. Skip both doses and continue treatment the next day with the usual morning and evening doses.

Stopping treatment with Remirta ORO
→ Remirta ORO should only be discontinued after consultation with your doctor.
If treatment is stopped too early, depression may return. If improvement occurs, discuss this with your doctor. Your doctor will decide when treatment can be stopped.
Do not stop taking Remirta ORO suddenly, even if symptoms of depression have resolved.
If a patient suddenly stops taking Remirta ORO, they may experience nausea, dizziness, agitation or anxiety, and headache. These symptoms can be avoided by gradually tapering the medicine. Your doctor will advise how to gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking mirtazapine and contact your doctor immediately if
any of the following serious adverse reactions occur:
Uncommon (may affect up to 1 in 100 people):

• feeling of excitement or agitation (mania).

Rare (may affect up to 1 in 1000 people):

• yellowing of the whites of the eyes or skin; this may indicate liver problems (jaundice).

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

• signs of infection such as fever of unknown origin, sore throat, mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow suppression). Some patients 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 anaemia), a low platelet count (thrombocytopenia), or an increase in white blood cells (eosinophilia).
• seizures (fits)
• a combination of symptoms such as fever of unknown origin, sweating, rapid heartbeat, diarrhoea, involuntary muscle contractions, chills, increased reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be signs of serotonin syndrome.
• thoughts of self-harm or suicide
• red, target-shaped rashes on the trunk or circular rashes, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and around the eyes. Such serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other adverse reactions associated with mirtazapine include:
Very common (may affect more than 1 in 10 people):
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• increased appetite and weight gain
• sedation or drowsiness
• headache
• dry mouth.

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

• lethargy
• dizziness
• tremors or shaking
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions
• joint pain, muscle pain
• back pain
• dizziness or fainting upon sudden change in body position (orthostatic hypotension)
• swelling of the ankles or feet due to fluid accumulation (oedema)
• fatigue
• vivid dreams
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disturbances, which in most cases resolved after discontinuation of treatment.

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

• unusual skin sensations such as burning, tingling, or pins and needles (paraesthesia)
• restless legs syndrome (unpleasant sensations in the legs)
• fainting
• abnormal sensations in the mouth (oral hypoaesthesia)
• swelling of the entire body (generalised oedema)
• localised swelling
• low blood pressure
• nightmares
• agitation
• hallucinations
• an urgent need to move.

Rare (may affect up to 1 in 1000 people):

• muscle tremors or convulsions (clonic muscle seizures)
• aggressive behaviour
• abdominal pain and nausea; this may indicate pancreatitis.

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

• abnormal sensations in the mouth (oral paraesthesia)
• swelling of the mouth
• swelling of the entire body (generalised oedema)
• low sodium levels in the blood
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorders
• increased blood creatine kinase levels
• difficulty passing urine (urinary retention)
• muscle pain, stiffness, and (or) weakness, dark or discoloured urine (rhabdomyolysis)
• increased blood prolactin levels (hyperprolactinaemia with symptoms such as breast enlargement and (or) milky discharge from the nipple – galactorrhoea)
• prolonged painful erection (priapism). Page 8 of 10

Additional adverse reactions in children and adolescents
The following adverse reactions were commonly observed in clinical trials involving
children under 18 years of age: marked weight gain, urticaria, and increased blood triglyceride
levels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Remirta ORO

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Remirta ORO contains

• The active substance is mirtazapine. Remirta ORO 30 mg orodispersible tablets contain 30 mg of mirtazapine per orodispersible tablet.
• Other ingredients are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, L-methionine, microcrystalline cellulose and guar gum (Avicel CE-15), aspartame (E 951), orange flavour (maltodextrin, gum arabic (E 414), triacetin (E 1518), glucose, sodium sulphite (E 221) and flavouring substances), magnesium stearate.

What Remirta ORO looks like and contents of the pack
Remirta ORO is an orodispersible tablet.
Remirta ORO 30 mg: white or almost white, round, biconvex, uncoated tablets, 10 mm in diameter, marked with "M2".
Pack types
Aluminium/Aluminium blisters in cardboard packaging – pack sizes: 30 or 90 tablets.
Perforated Aluminium/Aluminium blisters in cardboard packaging – pack sizes: 30 or 90 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, country of export:
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
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Manufacturer:
Actavis Ltd., BLB 015-016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/07/0799/012
Parallel import authorisation number: 296/24
This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia Mirtazapin Actavis
Iceland Miron Smelt
Lithuania Mirtazapin Actavis
Poland Remirta ORO
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