Prospect: information for the patient

Rexer Flas 15mg buccodispersible tablets

Rexer Flas 30mgbuccodispersible tablets

mirtazapine

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

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

2.What you need to know before starting to take Rexer Flas

3.How to take Rexer Flas

4.Possible adverse effects

5.Storage of Rexer Flas

6.Contents of the package and additional information

Rexer belongs to a group of medications calledantidepressants.

Rexer is used to treat depression in adults.

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

For more information, see the section3 "When you can expect to feel better".

Do not take Rexer

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In that 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.

Inform your doctor before taking Rexer:

If you have ever had a severe skin rash or skin peeling, blisters or mouth sores after taking Rexer.

Children and adolescents

Rexer should not be used normally in the treatment of children and adolescents under 18 years old because its efficacy has not been demonstrated. At the same time, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor may prescribe Rexer to patients under 18 years old when they decide it is the most suitable for the patient. If the doctor has prescribed Rexer to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms mentioned above in patients under 18 years old taking Rexer appear or worsen.

Suicidal thoughts and worsening of depression

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

You may be more prone to thinking this way if:

• if you have previously had suicidal thoughts or self-harm.
• if you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric disorders and who are being treated with an antidepressant.

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

It may be helpful to tell a close relative or friend that you are depressed, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Also, be particularly careful with Rexer

• if you have or have 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 diseases, including jaundice. If jaundice appears, stop taking Rexer and contact your doctor immediately;
• kidney diseases;
• heart diseaseorlow 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 feeling elated or overexcited, stop taking Rexer and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
• eye diseases, such as increased eye pressure (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 you have signs of infection such as high feverunexplained, sore throat, and mouth sores

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

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

• if you are an older person. You may be more sensitive to the adverse effects of antidepressant medications.
• serious skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rexer. 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 had serious skin reactions, do not restart treatment with Rexer.

Taking Rexer with other medicines

Informyour doctor or pharmacist if you are taking, have taken recently, 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 for the next two weeks either.

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 rare cases, Rexer alone or with these medications, may cause the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, 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 the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of Rexer, or increase it again when you stop taking nefazodone.
• • anxiety or insomnia medicationssuch as benzodiazepines.
  • schizophrenia medicationssuch as olanzapine.
  • allergy medicationssuch as cetirizine.
  • intense pain medicationssuch as morphine.

In combination with these medications, Rexer may increase the drowsiness caused by these medications.

If taken with Rexer, these medications may increase the amount of Rexer in the blood. Inform your doctor if you are taking these medications. You may need to reduce the dose of Rexer, or increase it again when you stop taking these medications.

If taken with Rexer, these medications may reduce the amount of Rexer in the blood. Inform your doctor if you are taking these medications. You may need to increase the dose of Rexer, or reduce it again when you stop taking these medications.

Rexer may increase the effects of warfarin in the 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.

Taking Rexer with food and alcohol

You may feel drowsy if you drink alcohol while taking 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The limited experience of administering Rexer to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy.

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

Antidepressants similar to Rexer (SSRIs) taken during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) in the baby, which causes the baby to breathe faster and become blue. 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 may affect your concentration or alertness. Make sure your faculties are not affected before driving or using machinery. If your doctor has prescribed Rexer to a patient under 18 years old, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Rexer buccal tablets contain sugar spheres, which contain sucrose

This medicationcontains 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 buccal tablets contain aspartame, a source of phenylalanine

This medicationcontains aspartame, a source of phenylalanine.Each 15 mg buccal tablet contains 4.65 mg of aspartame. Each 30 mg buccal tablet contains 9.3 mg of aspartame. Aspartame contains a source of phenylalanine thatmay be harmful if you have phenylketonuria(PKU),a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Rexer buccal tablets contain sodium

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

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

How much to take

The initial recommended 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 45mg per day). Normally, the dose is the same for all ages. However, if you are an older person or if you have a kidney or liver disease, your doctor may change the dose.

When to take it

→ Take Rexer at the same time every day.

It is better to take the Rexer dose all at once before going to bed. However, your doctor may recommend that you divide your Rexer dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.

Take the buccal dispersible tablet in the following way

The tablets are taken orally.

1. Do not press the buccal dispersible tablet

To avoid the buccal dispersible tablet from being crushed, do not press the alveolus (FigureA).

Fig. A.

1. Separate an alveolus

Each blister contains six alveoli, which are separated by perforations. Separate an alveolus following the perforated lines (Figure 1).

Fig. 1.

1. Open the alveolus

Remove the sheet carefully, starting from the corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.

1. Remove the buccal dispersible tablet

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

Fig. 4.

It will disintegrate quickly and can be swallowed without water.

When you can expect to feel better

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

It is essential that during the first weeks of treatment, you speak with your doctor about the effects of Rexer:

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

If you are not feeling better yet, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2‑4weeks.

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

If you take more Rexer than you should

→ If you or someone 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.Other symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

You can also consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Rexer

If you have to take your doseonce a day

If you have to take your dosetwice a day

• If you have forgotten both doses, do not try to recover them. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt the treatment with Rexer

→ Stop taking Rexer only if you consult your doctor.

If you stop taking Rexer too soon, depression may reappear. When you feel better, speak with your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Rexer abruptly, even when 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 reduce the dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• exaggerated feeling of euphoria (mania).

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

• yellow discoloration of the eyes or skin; may indicate liver function abnormalities (jaundice).

Frequency not known(cannot be estimated from available data):

• signs of infection such as sudden and unexplained high fever and sore throat, mouth sores (agranulocytosis). In rare cases, mirtazapine may cause abnormalities 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).
• • seizure (convulsions).
  • a 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 condition called "serotonin syndrome."

  • thoughts of self-harm or suicide.

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

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

Other possible side effects with mirtazapine are:

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

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

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

• lethargy
• dizziness
• tremor
• • nausea
  • diarrhea
  • vomiting
  • constipation
  • urticaria or skin rash (exanthema)
  • joint or muscle pain (arthralgia or myalgia)
  • back pain
  • dizziness or fainting when standing up quickly (orthostatic hypotension)
  • swelling (usually in the 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 movements of leg agitation during sleep
  • fainting (syncope)
  • numbness of the mouth (hypoaesthesia oral)
  • low blood pressure
  • nightmares
  • agitation
  • hallucinations
  • inability to remain still

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

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

Frequency not known(cannot be estimated from available data):

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

• muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge)

• painful and prolonged erection of the penis

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: a significant weight gain, urticaria, and an increase in triglycerides in the blood.

Reporting of side effects:

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on theboxand on the 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rexer Flas

• The active ingredient is mirtazapine.

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

Rexer Flas 30mg buccal tablets contain 30mg 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.

Appearance of the product and contents of the package

Rexer Flas are buccal tablets.

The Rexer Flas 15mg buccal tablets are round, white, with a standard beveled edge and marked with “TZ1” on one side.

The Rexer Flas 30mg buccal tablets are round, white,with a standard beveled edgeand marked with “TZ2” on one side.

The buccal tablets are packaged in child-resistant blisters, perforated for unit dose.

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

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Manufacturer responsible:

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, RomaniaRemeron SolTab

Belgium, LuxembourgRemergon SolTab

GermanyRemergil SolTab

Hungary, ItalyRemeron

Ireland, United KingdomZispin SolTab

Norway, SwedenRemeron-S

Slovak RepublicRemeron Soltab

SpainRexer Flas

Last review date of this leaflet:03/2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)