REMIRTA 30 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Remirta ORO, 30 mg, Orally Disintegrating Tablets
3. Remirta ORO, 45 mg, Orally Disintegrating Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What Remirta ORO is and what it is used for
5. Important information before taking Remirta ORO
   1. When not to take Remirta ORO
   2. Warnings and precautions
   3. Children and adolescents
   4. Suicidal thoughts and worsening depression
   5. Remirta ORO and other medicines
   6. Remirta ORO with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Remirta ORO contains aspartame
   10. Remirta ORO contains glucose
   11. Remirta ORO contains sulfites
   12. Remirta ORO contains sodium
6. How to take Remirta ORO
   1. Dosage
   2. The recommended initial dose is 15 mg or 30 mg per day.
   3. When to take Remirta ORO
   4. How to take Remirta ORO
   5. When can improvement in mood be expected
   6. Taking a higher dose of Remirta ORO than recommended
   7. Missing a dose of Remirta ORO
   8. Stopping treatment with Remirta ORO
7. Possible side effects
   1. The patient should stop taking Remirta ORO and contact their doctor immediately if they experience any of the following serious side effects:
   2. Other side effects associated with mirtazapine are:
   3. Additional side effects in children and adolescents
   4. Reporting side effects
8. How to store Remirta ORO
9. Contents of the pack and other information
   1. What Remirta ORO contains
   2. What Remirta ORO looks like and contents of the pack
   3. Pack sizes
   4. Marketing authorization holder
   5. Manufacturer
   6. For more information, please contact the marketing authorization holder:
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: October 2023

Package Leaflet: Information for the Patient

Remirta ORO, 30 mg, Orally Disintegrating Tablets

Remirta ORO, 45 mg, Orally Disintegrating Tablets

mirtazapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell 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 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 their doctor. More information can be found in section 3 under the heading "When can improvement in mood 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 two weeks medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting to take Remirta ORO, the patient should discuss it with their doctor, pharmacist, or nurse.
DO NOT TAKE REMIRTA ORO OR CONSULT YOUR DOCTOR BEFORE TAKING REMIRTA ORO IF:
YOU HAVE EVERexperienced severe skin rash or peeling of the skin, blistering, or mouth sores after taking mirtazapine or other medicines.
SEVERE SKIN RASH, 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. Furthermore, 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, rebelliousness, and anger). However, the doctor may prescribe Remirta ORO to patients under 18 if it is in their best interest. If you have any doubts because your doctor has prescribed Remirta ORO to a patient under 18, please consult your doctor again. In the event of development or worsening of the above symptoms in patients under 18 taking Remirta ORO, the doctor should be informed.
Additionally, as yet, there is no 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. These symptoms or behaviors may worsen at the start of treatment with antidepressant medicines, as these medicines usually start working after about two weeks, sometimes later.
The above 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 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.

Also, be particularly careful

• if the patient has or has 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 may cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that may cause disturbances in heart rhythm.
• if the patient experiences infection symptoms, such as unexplained high fever, sore throat, and mouth ulcers. → 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 disturbances in blood cell production in the bone marrow. Although rare, these symptoms most often 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.

With the use of mirtazapine, serious skin reactions have been reported, 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 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 taking or have recently taken, including those listed below.
DO NOT TAKE REMIRTA OROat the same time as:

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

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(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) .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, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, 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, to 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 medicines. It may be necessary to reduce the dose of mirtazapine and, after stopping these medicines, to increase the dose of mirtazapine again.

medicines. It may be necessary to reduce the dose of mirtazapine and, after stopping these medicines, to increase the dose of mirtazapine 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 if they are taking these medicines. It may be necessary to increase the dose of mirtazapine and, after stopping these medicines, to 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 drink alcohol while taking Remirta ORO.
The patient is advised not to drink 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 baby, they should ask their doctor or pharmacist for advice 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 birth, it is recommended to monitor the newborn for possible side effects.
The patient should ensure that their 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 the baby experiencing severe complications, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish skin. These symptoms usually appear in the first day after birth. 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, 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 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 the medicine is considered "sodium-free".

3. How to take Remirta ORO

This medicine should always be taken as directed by the doctor. In case of doubt, 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 always 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 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, do not push it out of the blister (Figure 1).

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

• 3. Carefully peel off the covering foil, starting from the corner marked with an arrow (Figure 3 and 4).

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

When can improvement in mood be expected

Usually, the first signs of improvement can be expected after 1-2 weeks of treatment, and after 2-4 weeks, there may be an improvement in mood.
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 symptoms of depression 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. Overdose symptoms may include changes in heart rhythm (rapid heart rate, irregular heartbeat) 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 misses the morning dose, they should take it together with the evening dose.
• if the patient misses the evening dose, they should not take it together with the morning dose; they should skip it and continue treatment, taking the usual morning and evening doses.
• if the patient misses both doses, they should not take them. They should skip them and continue treatment the next day, taking the usual morning and evening doses.

Stopping treatment with Remirta ORO

→ The patient should only stop taking Remirta ORO after consulting their doctor.
If the patient stops taking Remirta ORO too early, 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 further doubts about the use of 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 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 ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production in the bone marrow. Although rare, these symptoms most often occur after 4-6 weeks of treatment.
• seizures (convulsions)
• a combination of symptoms such as fever of unknown origin, sweating, rapid heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, 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 patches on the torso in a target shape or round, often with blisters in the center, peeling of the skin, mouth ulcers, genital ulcers, and eye ulcers. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

extensive rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• 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):

• 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
• 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):

• abnormal skin sensations, e.g., burning, tingling, or prickling (paresthesia)
• restless legs syndrome (unpleasant sensations in the legs)
• fainting
• abnormal 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):

• abnormal sensations in the mouth (oral paresthesia)
• mouth edema
• generalized edema
• low sodium levels in the blood
• inappropriate antidiuretic hormone secretion
• severe skin reactions (blistering skin disease, erythema multiforme)
• sleepwalking (somnambulism)
• speech disturbances
• increased creatine kinase levels in the blood
• urination difficulties (urinary retention)
• muscle pain, stiffness, and/or weakness, dark urine, or pale urine (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 those 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, 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

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 pack 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.
• 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 (Aluminum/Aluminum) - pack sizes: 30 or 90 tablets.
Perforated blister 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:

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