REXER FLAS 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Rexer Flas 15mg orodispersible tablets

Rexer Flas 30mgorodispersible tablets

mirtazapine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rexer Flas and what is it used for
2. What you need to know before taking Rexer Flas
3. How to take Rexer Flas
4. Possible side effects
5. Storage of Rexer Flas
6. Package Contents and Additional Information

1. What is Rexer Flas and what is it used for

Rexer belongs to the group of medications called antidepressants.

Rexer is used to treat depression in adults.

It may take 1 to 2 weeks before Rexer starts to take effect. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you worsen or do not improve after 2 to 4 weeks.

For more information, see section 3 "When can you expect to feel better".

2. What you need to know before taking Rexer Flas

Do not take Rexer

• if you are allergic to mirtazapine or any of the other components of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking Rexer.
• if you are taking or have recently taken (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rexer.

Tell your doctor before taking Rexer:

If you have ever suffered from a severe skin rash or skin peeling, blisters, or sores in the mouth after taking Rexer.

Children and Adolescents

Rexer should not normally be used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated. At the same time, you should be aware that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe Rexer to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor has prescribed Rexer to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age who are taking Rexer. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of Rexer in this age group are not yet known. It has also been observed that there is a more frequent and significant weight gain in this age group when treated with Rexer, compared to adults.

Suicidal Ideas and Worsening of Depression

If you are depressed, you may sometimes have ideas of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or sometimes more to take effect.

You may be more likely to think this way if:

• you have previously had suicidal thoughts or thoughts of harming yourself.
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

→ If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to a hospital immediately.

It may be helpful to tell a close relative or friendthat you are depressed and ask them to read this package leaflet. You can ask them to tell you if they think your depression is worsening or if they are concerned about changes in your behavior.

Also, be especially careful with Rexer

• if you have or have ever had any of the following disorders:

→ Inform your doctor about these situations before taking Rexer, if you have not already done so

• seizures(epilepsy). If seizures appear or your seizures become more frequent, stop taking Rexer and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, stop taking Rexer and contact your doctor immediately;
• kidney disease;
• heart diseaseor low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately;
• bipolar depression(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking Rexer and contact your doctor immediately;
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose);
• eye diseases, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain types of heart diseasethat can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.

• if signs of infection appear, such as unexplained high fever, sore throat, and mouth sores

→ Stop taking Rexer and contact your doctor immediately to have a blood test.

In rare cases, these symptoms can be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms usually appear 4-6 weeks after starting treatment.

• if you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medications.
• serious skin reactions have been reported with the use of Rexer, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have ever suffered from serious skin reactions, do not restart treatment with Rexer.

Taking Rexer with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not take Rexerwith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Rexer during the two weeks after stopping MAOIs. If you stop taking Rexer, do not take MAOIs during the following two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take Rexer with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used to treat migraines), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), methylene blue(used to treat high levels of methemoglobin in the blood), and St. John's Wort – Hypericum perforatum(a medicinal plant for depression). In very rare cases, Rexer alone or with these medications can lead to a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately.
• the antidepressant nefazodone. It can increase the amount of Rexer in your blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of Rexer or increase it again when stopping nefazodone.
• • medications for anxiety or insomniasuch as benzodiazepines.
  • medications for schizophreniasuch as olanzapine.
  • medications for allergiessuch as cetirizine.
  • medications for severe painsuch as morphine.

When combined with these medications, Rexer can increase the drowsiness caused by these medications.

• medications for infections:medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole), and medications for HIV/AIDS (HIV protease inhibitors) and medications for stomach ulcers(such as cimetidine).

If taken with Rexer, these medications can increase the amount of Rexer in your blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of Rexer or increase it again when stopping these medications.

• medications for epilepsysuch as carbamazepine and phenytoin;
• medications for tuberculosissuch as rifampicin.

If taken with Rexer, these medications can decrease the amount of Rexer in your blood. Inform your doctor if you are taking these medications. It may be necessary to increase the dose of Rexer or decrease it again when stopping these medications.

• medications to prevent blood clottingsuch as warfarin.

Rexer can increase the effects of warfarin on your blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that your doctor perform blood tests.

• medications that can affect your heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Rexer with Food and Alcohol

You may feel drowsy if you drink alcohol while being treated with Rexer.

It is recommended not to drink any alcohol.

You can take Rexer with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Limited experience with the administration of Rexer to pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you use Rexer until or shortly before delivery, your baby will be examined for possible adverse effects.

Medications similar to Rexer (SSRIs) taken during pregnancy may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) in babies, which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should consult your midwife and/or doctor immediately.

Driving and Using Machines

Rexer can affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed Rexer to a patient under 18 years of age, make sure that concentration and alertness are not affected before circulating (e.g., by bicycle).

Rexer orodispersible tablets contain sugar spheres, which contain sucrose

This medication contains sugar spheres, which contain sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Rexer orodispersible tablets contain aspartame, a source of phenylalanine

This medication contains aspartame, a source of phenylalanine. Each 15 mg orodispersible tablet contains 4.65 mg of aspartame. Each 30 mg orodispersible tablet contains 9.3 mg of aspartame. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

Rexer orodispersible tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; that is, it is essentially "sodium-free".

3. How to Take Rexer Flas

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How Much to Take

The recommended initial dose is 15 or 30mg per day.Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages. However, if you are an elderly person or have kidney or liver disease, your doctor may change the dose.

When to Take It

→ Take Rexer at the same time every day.

It is best to take the dose of Rexer once before bedtime. However, your doctor may recommend dividing your dose of Rexer into morning and bedtime. The highest dose should be taken before bedtime.

Take the orodispersible tablet as follows

The tablets are taken orally.

1. Do not press the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Figure A).

Fig. A.

1. Separate a blister

Each blister pack contains six blisters, which are separated by perforations. Separate a blister by following the perforations (Figure 1).

Fig. 1.

1. Open the blister

Carefully remove the foil, starting from the corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue (Figure 4).

Fig. 4.

It will dissolve quickly and can be swallowed without water.

When Can You Expect to Feel Better

Normally, Rexer will start to take effect after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential to discuss the effects of Rexer with your doctor during the first few weeks of treatment:

→ between 2 and 4 weeks after starting to take Rexer, discuss with your doctor how this medication has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In this case, discuss with your doctor again after another 2-4 weeks.

Normally, you will need to take Rexer until the symptoms of depression have disappeared for 4-6 months.

If You Take More Rexer Than You Should

→ If you or someone else takes too much Rexer, consult a doctor immediately.

The most likely symptoms of a Rexer overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

You can also contact the Toxicology Information Service. Phone 91 562 04 20.

If You Forget to Take Rexer

If you need to take your dose once a day

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

If you need to take your dose twice a day

• if you have forgotten the morning dose, simply take it with the evening dose.
• if you have forgotten the evening dose, do not take it the next morning; skip it and continue with your normal doses in the morning and evening.

• if you have forgotten both doses, do not try to make them up. Skip both doses and the next day continue with your normal dose in the morning and evening.

If You Interrupt Treatment with Rexer

→ Stop taking Rexer only if you consult your doctor.

If you stop too soon, depression may reappear. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Rexer abruptly, even if depression has disappeared. If you stop taking Rexer abruptly, you may feel sick, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually decrease the dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and inform your doctor immediately.

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

• exaggerated feeling of euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

Frequency Not Known(cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia).
• • epileptic seizure (convulsions).
  • combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome".
  • thoughts of self-harm or suicide.

• severe skin reactions:
• • red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible adverse effects with mirtazapine are:

Very Common(may affect more than 1 in 10 patients):

• increased appetite and weight gain
• sleepiness
• headache
• dry mouth

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

• lethargy
• dizziness
• tremor
• • nausea
  • diarrhea
  • vomiting
  • constipation
  • urticaria or skin eruptions (exanthema)
  • joint pain (arthralgia) or muscle pain (myalgia)
  • back pain
  • dizziness or fainting when standing up quickly (orthostatic hypotension)
  • swelling (usually in ankles or feet) due to fluid retention (edema)
  • fatigue
  • vivid dreams
  • confusion
  • anxiety

• difficulty sleeping
• • memory problems, which in most cases resolved when treatment was discontinued

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• • involuntary leg movements during sleep
  • fainting (syncope)
  • numbness in the mouth (oral hypoesthesia)
  • low blood pressure
  • nightmares
  • agitation
  • hallucinations
  • inability to remain still

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

• twitching or muscle contractions (myoclonus)
• aggression
• abdominal pain, nausea; this may indicate pancreas inflammation (pancreatitis)

Frequency Not Known(cannot be estimated from available data):

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inadequate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech problems
• increased creatine kinase levels in the blood
• difficulty urinating (urinary retention)

• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased prolactin hormone levels in the blood (hyperprolactinemia, including symptoms of breast enlargement and/or milky discharge from the nipple)

• painful and prolonged erection of the penis

Other Adverse Effects in Children and Adolescents

In patients under 18 years of age, the following adverse effects were frequently observed in clinical trials: significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rexer Flas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister pack. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Rexer Flas Composition

• The active ingredient is mirtazapine.

Rexer Flas 15 mg orodispersible tablets contain 15 mg of mirtazapine per tablet.

Rexer Flas 30 mg orodispersible tablets contain 30 mg of mirtazapine per tablet.

• The other components are sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butyl methacrylate copolymer, aspartame (E-951), anhydrous citric acid, crospovidone (type A), mannitol (E-421), microcrystalline cellulose, natural and artificial orange flavor (SN027512), and sodium hydrogen carbonate.

Product Appearance and Package Contents

Rexer Flas are orodispersible tablets.

The Rexer Flas 15 mg orodispersible tablets are round, white, with a standard beveled edge, and marked with "TZ1" on one face.

The Rexer Flas 30 mg orodispersible tablets are round, white, with a standard beveled edge, and marked with "TZ2" on one face.

The orodispersible tablets are packaged in child-resistant blisters, perforated for unit dosage.

The following packages of Rexer Flas 15 and 30 mg orodispersible tablets in blisters are available: 6, 18, 30, 48, 90, 96, and 180 orodispersible tablets (not all packages may be marketed).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6,

PO Box 20

5340 BH Oss

Netherlands

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

Netherlands, Portugal, Romania Remeron SolTab

Belgium, Luxembourg Remergon SolTab

Germany Remergil SolTab

Hungary, Italy Remeron

Ireland, United Kingdom Zispin SolTab

Norway, Sweden Remeron-S

Slovak Republic Remeron Soltab

Spain Rexer Flas

Date of the Last Revision of this Prospectus:03/2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)