REXER FLAS 30 mg ORALLY DISINTEGRATING TABLETS

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 ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Rexer.
• if you are taking or have taken in the last two weeks medicines 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 had a severe skin rash, skin peeling, 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 established. 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 (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Rexer to patients under 18 years of age when he decides that it is the most convenient for the patient. If your doctor has prescribed Rexer to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms 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 in this age group, when treated with Rexer, there is a more frequent and significant weight gain compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This could get worse when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to work.

You may be more likely to think this way if:

• you have previously had thoughts of suicide or self-harm.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults with psychiatric disorders who are being treated with an antidepressant.

→ If you have thoughts of self-harm or suicide at any time, consult your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close 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 getting worse, or if they are worried about changes in your behavior.

Also, be especially careful with Rexer

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

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

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking Rexer and contact your doctor immediately;
• liver disease, including jaundice. If jaundice occurs, 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 the rhythm of your heart, a recent heart attack, heart failure, or taking certain medications that can affect the rhythm of your heart.

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

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

In rare cases, these symptoms can be signs of changes 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 medicines.
• 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). Stop using it 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 had a serious skin reaction, do not restart treatment with Rexer.

Taking Rexer with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 migraine), 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 medicines may cause 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 may increase the amount of Rexer in your blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of Rexer or increase it again when stopping nefazodone.
• • medicines for anxiety or insomniasuch as benzodiazepines.
  • medicines for schizophreniasuch as olanzapine.
  • medicines for allergiessuch as cetirizine.
  • medicines for severe painsuch as morphine.

When combined with these medicines, Rexer may increase the drowsiness caused by these medicines.

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

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

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

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

• medicines to prevent blood clottingsuch as warfarin.

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

• medicines that can affect 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 medicine.

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.

Medicines like Rexer (SSRIs) taken during pregnancy may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you should immediately consult your midwife and/or doctor.

Driving and using machines

Rexer may 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 cycling (for example).

Rexer orodispersible tablets contain sugar spheres, which contain sucrose

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

Rexer orodispersible tablets contain aspartame, a source of phenylalanine

This medicine 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 may be harmful in case of having 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 medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; this is essentially "sodium-free".

3. How to take Rexer Flas

Follow exactly the administration instructions of this medicine 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 that you divide 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, 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 work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential to talk to your doctor during the first weeks of treatment about the effects of Rexer:

→ between 2 and 4 weeks after starting to take Rexer, talk to your doctor about how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, talk to 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 medicines or alcohol) are drowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in the rhythm of your heart (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 have 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 have to take your dose twice a day

If you stop taking Rexer

→ Stop taking Rexer only if you consult your doctor.

If you stop too soon, depression may come back. 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 unwell, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

If you have any other questions about the use of this medicine, 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):

• feeling of exaggerated 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 can cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine can 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 can 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, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can 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
• tremors
• nausea
• diarrhea
• vomiting
• constipation
• urticaria or skin rashes (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 down the drain or into the trash. 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

Composition of Rexer Flas

• 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 side.

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

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 under 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/)