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 the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions or doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• 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 of the leaflet

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 usually begins 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. Further information is provided 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 medicines from the group of monoamine oxidase inhibitors (MAOIs) are currently being taken or have been taken recently (within the last 2 weeks).

Warnings and precautions
Before starting to take 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 mouth sores after taking mirtazapine or other medicinal products.

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 population. 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: suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger). Nevertheless, a doctor may prescribe Remirta ORO to patients under 18 years of age if they determine it to be in their best interest. If you have any doubts because a 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.
Furthermore, there are currently no data on the long-term safety of Remirta ORO use in this age group regarding growth, maturation, and cognitive and behavioral development. Additionally, in this age group, mirtazapine has been observed to cause a more pronounced increase in body weight compared to adults.

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

The following symptoms are more likely in:

• patients who previously had suicidal thoughts or self-harm behavior
• young adult patients. Clinical trial data show an increased risk of suicidal behavior 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 them if they notice worsening depression or concerning changes in behavior.

Special caution is also required

• if the patient has or has previously 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 your doctor immediately
• Liver disease (including jaundice). If jaundice occurs, stop taking Remirta ORO 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 worsen, contact your 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 your doctor immediately
• Diabetes (dose adjustment of insulin or other antidiabetic medicines may be necessary)
• Eye disease, such as increased intraocular pressure (glaucoma)
• Difficulty urinating, which may be due to an enlarged prostate gland
• Certain types of 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 your doctor immediately for a blood test. In rare cases, these symptoms may indicate 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 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 the use of mirtazapine. Treatment should be discontinued and immediate medical help sought if any of the symptoms listed in section 4 occur due to these serious skin reactions.
If the patient has ever experienced a serious skin reaction, treatment with Remirta ORO should not be resumed.

Remirta ORO with other medicines
Tell 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 taking MAO inhibitors for the next 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, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact your doctor immediately if several of these symptoms occur together.

• the antidepressant nefazodone. It may increase the blood concentration of mirtazapine. Inform your doctor about taking these medicines. A reduction in the mirtazapine dose 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), and medicines used to treat HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat peptic ulcer disease (such as cimetidine). When these medicines are taken together with mirtazapine, the blood concentration of mirtazapine may increase. Inform your doctor about taking these medicines. A reduction in the mirtazapine dose 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 your doctor about taking these medicines. An increase in the mirtazapine dose may be necessary, and after stopping treatment with these medicines, the mirtazapine dose may need to be reduced again.

• anticoagulant medicines, such as warfarin. Mirtazapine may enhance the effect of warfarin. Inform your 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 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using 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, the newborn 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 of pregnancy, 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 day after birth.
If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.

Breastfeeding:
Ask your doctor whether you can breastfeed 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 a 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
Remirta ORO 30 mg orodispersible tablets contain 12 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 improper excretion.

Remirta ORO contains glucose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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 orodispersible tablet, meaning the medicine is considered "sodium-free".

3. How to take Remirta ORO

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Remirta ORO is available in 30 mg and 45 mg strengths.

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 you (from 15 mg to 45 mg once daily). This dose is generally the same for patients of all ages. However, in elderly patients or in patients with impaired kidney or liver function, your doctor may adjust the dose.

When to take Remirta ORO

• Remirta ORO should 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 in the morning and one in the evening before bedtime. 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 crushing the orally disintegrating tablet, do not push the tablet out of the blister (Figure 1).

Figure 1

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

Figure 2

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

Figure 3

Figure 4

4. Remove the tablet 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

Improvement is usually noticeable after 1–2 weeks of treatment, and well-being may improve further after 2–4 weeks.

It is important to discuss the effects of Remirta ORO with your doctor during the first few weeks of treatment:

• After 2 to 4 weeks of starting Remirta ORO, you should discuss the treatment effects 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 review the treatment outcomes with your doctor. Generally, patients will need to continue taking Remirta ORO until depressive symptoms have completely resolved, which usually takes about 4 to 6 months.

Taking more than the recommended dose of Remirta ORO

• If you or anyone else has taken too much Remirta ORO, contact a doctor immediately. The most commonly observed symptoms of overdose (without other medicines or alcohol) are drowsiness, confusion, and rapid heartbeat. Symptoms of overdose may include changes in heart rhythm (fast heartbeat, 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 you forget the morning dose, take it together with the evening dose.
• If you forget the evening dose, do not take it together with the morning dose; skip the missed dose and continue treatment with the usual morning and evening doses.
• If you forget both doses, do not make them up. Skip both doses and continue treatment the next day with your usual morning and evening doses.

Stopping Remirta ORO

• Remirta ORO should only be discontinued after consulting your doctor. If you stop taking the medicine 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 depressive symptoms have resolved. If you suddenly stop taking Remirta ORO, you may experience nausea, dizziness, agitation or anxiety, and headache. These symptoms can be avoided by gradually reducing the dose. Your doctor will advise you on how to taper the dose gradually.

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 unexplained fever, sore throat, mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine can 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 increased number of white blood cells (eosinophilia).
• seizures (fits)
• a combination of symptoms such as unexplained fever, sweating, rapid heartbeat, diarrhoea, muscle spasms (involuntary), 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 or circular rashes on the trunk, often with blisters in the centre, peeling skin, mouth, throat, nose, genital or eye ulcers. Such serious skin rashes 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):

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

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

• lethargy
• dizziness
• tremor 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 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, stinging, or tingling (paraesthesiae)
• restless legs syndrome (unpleasant sensations in the legs)
• fainting
• abnormal sensations in the mouth (oral hypoaesthesia)
• generalised body swelling (generalised oedema)
• localised swelling
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need for movement

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

• muscle tremors or spasms (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
• generalised body swelling (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)

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 adverse reactions not listed
in this leaflet, you should 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

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 stated month.
Store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package 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 (E414), triacetin (E1518), glucose, sodium sulphite (E 221) and flavouring ingredients), 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" on one side.
Pack sizes
Aluminium/Aluminium blisters – pack sizes: 30 or 90 tablets, in a cardboard box.
Aluminium/Aluminium perforated blisters – pack sizes: 30 or 90 tablets, in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Lithuania, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warszawa
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warszawa
Marketing Authorisation Number in Lithuania, country of export: LT/1/07/0799/012
Parallel Import Licence Number: 212/23
This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia Mirtazapin Actavis
Iceland Miron Smelt
Lithuania Mirtazapin Actavis
Malta Remirta
Poland Remirta ORO