Remirta Oro

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Remirta ORO (Mirtazapine Actavis)

30 mg, orally disintegrating tablets

Mirtazapine
Remirta ORO and Mirtazapine Actavis are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Remirta ORO and what is it 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 packaging and other information

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

Remirta ORO is one of a group of antidepressantmedicines.
Remirta ORO is used to treat depression in adults.
Remirta ORO starts working only after 1 to 2 weeks. After 2 - 4 weeks, the patient may feel better. If after 2 - 4 weeks there is no improvement or the patient feels worse, they should consult a doctor. More information can be found in section 3 under the heading "When can improvement in well-being be expected".

2. Important information before taking Remirta ORO

When not to take Remirta ORO

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

Warnings and precautions

Before starting to take Remirta ORO, the patient should discuss it with their doctor, pharmacist, or nurse.
THE PATIENT SHOULD NOT TAKE REMIRTA ORO OR SHOULD CONSULT THEIR DOCTOR BEFORE TAKING REMIRTA ORO IF:
EVERafter taking mirtazapine or other medicines THE PATIENT HAS EXPERIENCED
SEVERE SKIN RASH OR SKIN PEELING, BLISTERING, OR MOUTH SORES.
Page 1 10

Children and adolescents

Remirta ORO should not be used to treat children and adolescents under 18 years of age, as its efficacy has not been established in this age group. It should also be noted that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Remirta ORO to patients under 18 years of age, considering that it is in their best interest. If there are any doubts because the doctor has prescribed Remirta ORO to a patient under 18 years of age, please consult the doctor again. In the event of the development or worsening of the above symptoms in patients under 18 years of age taking Remirta ORO, the doctor should be informed. Additionally, as of now, there is a lack of data on the long-term safety of Remirta ORO in this age group regarding growth, maturation, and cognitive and behavioral development. Furthermore, in this age group, after taking mirtazapine, significant weight gain has been observed more frequently compared to adults.

Suicidal thoughts and worsening depression

People with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after about two weeks, sometimes later.
These symptoms are more likely in:

• patients who have had suicidal thoughts or self-harm before
• young adult patients. Clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders treated with antidepressant medicines. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask to be informed if they notice that the depression has worsened or if there are worrying changes in their behavior.

The patient should also be cautious

• if they have or have ever had any of the following conditions: → If not done before, the patient should inform their doctor about these conditions before taking Remirta ORO
• seizures(epilepsy). If seizures occur or their frequency increases, the patient should stop taking Remirta ORO and contact their doctor immediately
• liver disease(including jaundice). If jaundice occurs, the patient should stop taking Remirta ORO and contact their doctor immediately
• kidney disease
• heart diseaseor low blood pressure
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or worsen, the patient should contact their doctor immediately
• manic depression(alternating periods of elevated mood/excitement and depression). If the patient experiences excessive excitement or agitation, they should stop taking Remirta ORO and contact their doctor immediately
• diabetes(may require adjustment of insulin or other antidiabetic medicines)
• eye disease, such as increased intraocular pressure (glaucoma)
• difficulty urinating, which may be caused by an enlarged prostate
• certain heart conditionsthat can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that can cause disturbances in heart rhythm.
• if they experience infection symptoms, such as high fever of unknown origin, sore throat, and mouth sores. →The patient should stop taking Remirta ORO and contact their doctor immediately for a blood test. In rare cases, these symptoms may be a sign of blood cell production disorders in the bone marrow. Although rare, these symptoms usually occur within 4-6 weeks of treatment.

It is also known that mirtazapine can cause serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The patient should stop taking the medicine and seek medical help immediately if they experience any of the serious skin reactions listed in section 4.
If the patient has ever experienced a serious skin reaction, they should not restart treatment with Remirta ORO.

Remirta ORO with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including the following medicines.
THE PATIENT SHOULD NOT TAKE REMIRTA OROat the same time as:

• monoamine oxidase inhibitors (MAOIs). The patient should also not take Remirta ORO within 2 weeks of stopping MAOIs. If the patient stops taking Remirta ORO, they should not start taking MAOIs for the next 2 weeks. MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

THE PATIENT SHOULD BE CAUTIOUSwhen taking Remirta ORO in combination with:

• other antidepressant medicines, such as SSRIs, venlafaxine, and L-tryptophan or triptans(used to treat migraines), tramadol(a pain reliever), linezolid(an antibiotic), lithium salts(used to treat certain psychiatric disorders), methylene blue(used to treat high methemoglobin levels in the blood), and preparations containing St. John's Wort (Hypericum perforatum)(herbal preparations used to treat depression). Although rare, patients taking only mirtazapine or in combination with these medicines may experience serotonin syndrome. Some symptoms of this syndrome include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, loss of consciousness. The patient should contact their doctor immediately if they experience several of these symptoms together.
• the antidepressant nefazodone. It may increase the level of mirtazapine in the blood. The patient should inform their doctor about taking these medicines. It may be necessary to reduce the dose of mirtazapine, and after stopping nefazodone, the dose of mirtazapine 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 in combination with these medicines may increase the sedation caused by these medicines.
• medicines used to treat infections, such as antibacterial medicines (erythromycin), antifungal medicines (such as ketoconazole), and medicines used to treat HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers(such as cimetidine). If the patient starts taking these medicines with mirtazapine, the level of mirtazapine in the blood may increase. The patient should inform their doctor about taking these medicines. It may be necessary to reduce the dose of mirtazapine, and after stopping these medicines, the dose of mirtazapine 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 decrease the level of mirtazapine in the blood. The patient should inform their doctor about taking these medicines. It may be necessary to increase the dose of mirtazapine, and after stopping these medicines, the dose of mirtazapine may need to be decreased again.

Page 3 10
The patient should also inform their doctor if they are taking:

• anticoagulant medicines, such as warfarin. Mirtazapine may enhance the effect of warfarin. The patient should inform their doctor about taking these medicines. In the case of combination therapy with mirtazapine and warfarin, it is recommended to closely monitor blood tests.
• 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 they consume 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy:
Limited experience with mirtazapine in pregnant women does not indicate an increased risk. However, caution should be exercised when taking mirtazapine during pregnancy.
If mirtazapine is taken during pregnancy or shortly before delivery, it is recommended to monitor the newborn for possible side effects.
The patient should ensure that the midwife and/or doctor know that they are taking Remirta ORO.
Taking medicines like Remirta ORO or other similar medicines, especially in the last three months of pregnancy, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the patient should contact their doctor and/or midwife immediately.
Breastfeeding:
The patient should ask their doctor if they can breastfeed while taking Remirta ORO.

Driving and using machines

Remirta ORO may reduce alertness or concentration. The patient should make sure that 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, before participating in traffic (e.g., cycling), the patient should check if the medicine affects their alertness and concentration.

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 its improper excretion.

• Remirta ORO contains glucose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The glucose in the medicine may have a harmful effect on the teeth.

Remirta ORO contains sulfites

The medicine can rarely cause severe allergic reactions and bronchospasm.

Remirta ORO contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means the medicine is considered "sodium-free".
Page 4 10

3. How to take Remirta ORO

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Remirta ORO is available in the following doses: 30 mg, 45 mg.

Dosage

The recommended initial dose is 15 mg or 30 mg per day.

After a few days of treatment, the doctor may recommend increasing the dose to the most suitable for the patient (from 15 mg to 45 mg per day). This dose is usually the same for patients of different ages. However, in elderly patients or patients with impaired renal or hepatic function, the doctor may adjust the dose.

When to take Remirta ORO

→ Remirta ORO should be taken at the same time every day.
It is best to take Remirta ORO in a single dose before bedtime.
However, the doctor may recommend taking the medicine in two divided doses per day - one dose in the morning and one dose in the evening, before bedtime. The larger dose should be taken in the evening, before bedtime.

How to take Remirta ORO

The medicine should be taken orally.

• 1. To avoid crushing the orally disintegrating tablet, the patient should not push the tablet out of the blister (Figure 1).

Figure 1

• 2. The patient should separate one blister cell from the rest of the strip (Figure 2).

Figure 2

• 3. The patient should carefully peel off the foil, starting from the corner marked with an arrow (Figure 3 and 4).

Page 5 10

Figure 3

Figure 4

• 4. The patient should remove the tablet from the blister with dry hands and place it on their tongue (Figure 5). The tablet will quickly disintegrate and can be swallowed without water.

Figure 5

When can improvement in well-being be expected

Usually, the first signs of improvement can be expected after 1-2 weeks of treatment, and after 2-4 weeks, an improvement in well-being may occur.
It is essential to discuss the effects of Remirta ORO with the doctor during the first few weeks of treatment:
→ After 2 to 4 weeks of taking Remirta ORO, the patient should discuss the treatment effects with their doctor.
If there is no adequate clinical response, the doctor may increase the dose. After another 2 to 4 weeks, the patient should discuss the treatment effects with their doctor again. Usually, the patient will need to take Remirta ORO until the depressive symptoms have completely disappeared, which usually takes 4 to 6 months.

Taking a higher dose of Remirta ORO than recommended

→ If the patient or anyone else has taken too much Remirta ORO, they should contact their doctor immediately. The most common symptoms of Remirta ORO overdose (without other medicines and without alcohol) are drowsiness, disorientation, and rapid heart rate.
The symptoms of overdose may include changes in heart rhythm (rapid heart rate, irregular heart rhythm) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "Torsade de pointes".

Missing a dose of Remirta ORO

If the medicine is taken once a day

• The patient should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time.

If the medicine is taken twice a day

• if the patient forgets to take the morning dose, they should take it with the evening dose.

Page 6 10

• if the patient forgets to take the evening dose, they should not take it with the morning dose; they should skip it and continue treatment, taking the usual morning and evening doses.
• if the patient forgets to take both doses, they should not make them up. They should skip them and continue treatment the next day, taking the usual morning and evening doses.

Stopping Remirta ORO

→ The patient should only stop taking Remirta ORO after consulting their doctor.
If the patient stops taking Remirta ORO too early, the depression may return. If there is an improvement, the patient should discuss it with their doctor. The doctor will decide when to stop treatment.
The patient should not suddenly stop taking Remirta ORO, even if the symptoms of depression have disappeared.
If the patient suddenly stops taking Remirta ORO, they may experience nausea, dizziness, agitation, or anxiety and headache. These symptoms will not occur during gradual withdrawal of the medicine. The doctor will inform the patient how to gradually reduce the dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Remirta ORO can cause side effects, although not everybody gets them.

The patient should stop taking Remirta ORO and contact their doctor immediately if they experience any of the following serious side effects:

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

• feeling of excitement or agitation (mania).

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

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

Unknown(frequency cannot be estimated from the available data):

• infection symptoms, such as unexplained high fever, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause blood cell production disorders in the bone marrow. Some patients may become less resistant to infections because mirtazapine can cause a temporary decrease in the number of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in the number of red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained high fever, sweating, rapid heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be symptoms of serotonin syndrome.
• thoughts of self-harm or suicide
• red spots on the torso in a target shape or round, often with blisters in the center, skin peeling, mouth sores, sores in the throat, nose, genital area, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects associated with mirtazapine are:

Very common(may affect more than 1 in 10 people):
Page 7 10

• increased appetite and weight gain
• sedation or drowsiness
• headache
• dry mouth.

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

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions
• joint or muscle pain
• back pain
• dizziness or fainting when changing position quickly (orthostatic hypotension)
• swelling (of the ankles or feet) due to fluid accumulation (edema)
• fatigue
• intensive dreaming
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disturbances, which in most cases disappeared after stopping treatment.

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

• unusual skin sensations, such as burning, tingling, or numbness (paresthesia)
• restless legs syndrome (unpleasant sensations in the legs)
• fainting
• unusual sensations in the mouth (oral hypoesthesia)
• swelling of the whole body (generalized edema)
• local swelling
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need to move.

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

• muscle tremors or spasms (clonic muscle spasms)
• aggressive behavior
• abdominal pain and nausea; this may indicate pancreatitis.

Unknown(frequency cannot be estimated from the available data):

• unusual sensations in the mouth (oral paresthesia)
• swelling of the mouth
• swelling of the whole body (generalized edema)
• low sodium levels in the blood
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disturbances
• increased creatine kinase levels in the blood
• urination difficulties (urinary retention)
• pain, stiffness, and/or weakness of the muscles, darkening or discoloration of the urine (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia with symptoms such as breast enlargement and/or milk discharge from the nipple - galactorrhea)
• prolonged and painful erection of the penis.

Additional side effects in children and adolescents

The following side effects were commonly observed in clinical trials with children under 18 years of age: significant weight gain, hives, and increased triglyceride levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Remirta ORO

Store 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 month.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Remirta ORO contains

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

What Remirta ORO looks like and contents of the pack

Remirta ORO is an orally disintegrating tablet.
Remirta ORO, 30 mg: white or almost white, round, 10 mm in diameter, biconvex, uncoated tablets with the marking M2.

Pack sizes

Aluminum/Aluminum blisters in a cardboard box - pack sizes: 30 or 90 tablets.
Aluminum/Aluminum blisters, perforated, in a cardboard box - pack sizes: 30 or 90 tablets.
To obtain more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Page 9 10

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Lithuanian, the country of export, marketing authorization number: LT/1/07/0799/012

Parallel import authorization number: 296/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia
Mirtazapin Actavis
Iceland
Miron Smelt
Lithuania
Mirtazapin Actavis
Poland
Remirta ORO

Date of revision of the leaflet: 23.07.2024

[Information about the trademark]
Page 10 10