Remirta Oro

Leaflet attached to the packaging: patient information

Remirta ORO, 30 mg, orally disintegrating tablets

Remirta ORO, 45 mg, orally disintegrating tablets

mirtazapine

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 you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 medicines called antidepressants.
Remirta ORO is used to treat depression in adults.
Remirta ORO starts working only after 1 to 2 weeks. After 2 to 4 weeks, the patient may
feel better. If after 2 to 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 you expect to feel better".

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 two 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 THEY HAVE EVER EXPERIENCED:
severe skin rash or peeling of the skin, blistering, or mouth sores.

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. Additionally, in the case of this class of medicines, patients under 18 are at increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Nevertheless, the doctor may prescribe Remirta ORO to patients under 18 if it is in their best interest. If you have any doubts because the doctor has prescribed Remirta ORO to a patient under 18, please consult your doctor again. If symptoms such as those mentioned above worsen in patients under 18 taking Remirta ORO, the doctor should be informed.
Furthermore, as of now, there is a lack of long-term safety data on the use of Remirta ORO in this age group regarding growth, maturation, and cognitive and behavioral development. Additionally, in this age group, significant weight gain has been observed more frequently after taking mirtazapine compared to adults.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or
behavior may worsen at the beginning of treatment with antidepressant medicines, as they 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 show an increased risk of suicidal behavior in people under 25 with mental disorders who are being treated with antidepressants. 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 careful

• if they have or have ever had any of the following conditions: → If this has not been 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 may cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that may cause changes in heart rhythm.
• if the patient experiences 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 after 4-6 weeks of treatment.
• if the patient is elderly. The patient may be more sensitive to the side 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 the use of mirtazapine. The patient should stop taking the medicine and seek medical attention immediately if they experience any of the symptoms listed in section 4 related to these serious skin reactions.
If the patient has ever experienced a serious skin reaction, they should not restart treatment with Remirta ORO.

Remirta ORO and 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 those listed below.
Remirta ORO should not be takenat the same time as:

• monoamine oxidase inhibitors (MAOIs). Remirta ORO should not be taken until two weeks after stopping MAOIs. If the patient stops taking Remirta ORO, they should not start taking MAOIs until two weeks later. MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

The patient should be carefulwhen taking Remirta ORO in combination with:

• other antidepressant medicines, such as SSRIs, venlafaxine, and L-tryptophan or triptans(used to treat migraines) , tramadol(pain reliever) , linezolid(antibiotic) , lithium salts(used to treat certain psychiatric disorders), methylene blue(used to treat high methemoglobin levels in the blood) , and products containing St. John's wort (Hypericum perforatum)(herbal products used to treat depression) .Very rarely, patients taking only mirtazapine or in combination with these medicines may experience serotonin syndrome. Some symptoms of this syndrome include sudden fever, sweating, rapid heartbeat, diarrhea, (uncontrolled) muscle contractions, chills, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. 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 if they are taking these medicines. It may be necessary to reduce the dose of mirtazapine and, after stopping nefazodone, increase the dose of mirtazapine 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 if they are taking these

• antiepileptic medicines, such as carbamazepine and phenytoin medicines used to treat tuberculosis, such as rifampicin. When taken with mirtazapine, these medicines may decrease the level of mirtazapine in the blood. The patient should inform their doctor if they are taking these medicines. It may be necessary to increase the dose of mirtazapine and, after stopping these medicines, decrease the dose of mirtazapine again.
• anticoagulant medicines, such as warfarin. Mirtazapine may increase the effect of warfarin. The patient should inform their doctor if they are 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 the use of mirtazapine 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, it is recommended to monitor the newborn for possible side effects.
The patient should ensure that the midwife and/or doctor are aware 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, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish discoloration. 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 patient under 18, before participating in traffic (e.g., cycling), the patient should check if the medicine affects their alertness and concentration.

Remirta ORO contains aspartame

Remirta ORO, 30 mg, orally disintegrating tablets, contain 12 mg of aspartame per tablet.
Remirta ORO, 45 mg, orally disintegrating tablets, contain 18 mg of aspartame per tablet.
Aspartame 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 elimination.

Remirta ORO contains glucose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
The glucose in the medicine may harm the patient's teeth.

Remirta ORO contains sulfites

The medicine may 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 it is considered "sodium-free".

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.

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 kidney or liver dysfunction, the doctor may adjust the dose.

When to take Remirta ORO

→ Remirta ORO should be taken at the same time every day.
The best time to take Remirta ORO is 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).

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

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

When can you expect to feel better

Usually, the first signs of improvement can be expected after 1-2 weeks of treatment, and after 2-4
weeks, the patient's mood may improve.
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 their depressive symptoms have completely disappeared, which usually takes 4 to 6 months.

What to do if you take more Remirta ORO than you should

→ 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 heartbeat. Overdose symptoms may include changes in heart rhythm (rapid heartbeat, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "Torsade de pointes".

What to do if you forget to take 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.
• if the patient forgets to take the evening dose, they should not take it with the morning dose; they should skip it and continue with the usual morning and evening doses.
• if the patient forgets to take both doses, they should not take them. They should skip them and continue with the usual doses the next day.

What to do if you stop taking Remirta ORO

→ The patient should only stop taking Remirta ORO after consulting their doctor.
If the patient stops taking Remirta ORO too early, their depression may return. If they feel better, they should discuss it with their doctor. The doctor will decide when to stop the treatment.
The patient should not suddenly stop taking Remirta ORO, even if their depressive symptoms 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.
If the patient has any further doubts about taking this medicine, they 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 more susceptible to infections because mirtazapine may 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 fever, sweating, rapid heartbeat, diarrhea, (uncontrolled) muscle contractions, 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, peeling of the skin, mouth sores, and genital sores. The occurrence of such serious 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 or drug hypersensitivity syndrome).

Other side effects associated with mirtazapine are:

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

• increased appetite and weight gain
• calmness 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 body position quickly (orthostatic hypotension)
• swelling (of the ankles or feet) due to fluid accumulation (edema)
• fatigue
• intense dreams
• 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 prickling (paresthesia)
• restless legs syndrome (unpleasant sensations in the legs)
• fainting
• unusual sensations in the mouth (oral hypoesthesia)
• generalized edema
• localized edema
• low blood pressure
• nightmares
• agitation
• hallucinations
• urge to move

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

• muscle twitching or contractions (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)
• mouth edema
• generalized edema
• low sodium levels in the blood
• inappropriate antidiuretic hormone secretion
• serious skin reactions (blistering skin rash, erythema multiforme)
• sleepwalking (somnambulism)
• speech disturbances
• increased creatine kinase levels in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, dark urine, or pale skin (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia with symptoms such as breast enlargement and/or milk secretion 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: 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 the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 . By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Remirta ORO

Keep out of the 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.
Storage conditions (blister):
Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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. Remirta ORO, 45 mg, orally disintegrating tablets, contain 45 mg of mirtazapine per tablet.
• The 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 (E414), triacetin (E1518), glucose, sodium sulfite (E221), and flavoring agents), 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.
Remirta ORO, 45 mg: white or almost white, round, 12 mm in diameter, biconvex, uncoated tablets with the marking M4.

Pack sizes

Blister pack (Aluminum/Aluminum) - pack sizes: 30 or 90 tablets.
Perforated blister pack divisible into single doses (Aluminum/Aluminum) - pack sizes: 30 or 90 tablets.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
IS-220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

For more information, please contact the marketing authorization holder's representative:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product 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 last revision of the leaflet: October 2023