Rexer Flas 15 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rexer Flas 15mg orodispersible tablets

Rexer Flas 30mg orodispersible tablets

mirtazapine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Rexer Flas is and what it is used for
2. What you need to know before taking Rexer Flas
3. How to take Rexer Flas
4. Possible adverse effects
5. How to store Rexer Flas
6. Contents of the pack and other information

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

Rexer belongs to a group of medicines called antidepressants.

Rexer is used to treat depression in adults.

It takes 1 to 2 weeks before Rexer starts to take effect. After 2 to 4 weeks, you may begin 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 start feeling 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 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 recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rexer.

Tell your doctor before taking Rexer:

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

Children and adolescents

Rexer is not normally used to treat children and adolescents under 18 years of age because its effectiveness has not been demonstrated. At the same time, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, 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 if they decide it is the most appropriate treatment 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 speak to your doctor again. You must inform your doctor if any of the symptoms described above appear or worsen in patients under 18 years of age who are taking Rexer. In addition, the long-term safety effects on growth, maturation, and cognitive and behavioral development with Rexer in this age group are still unknown. A considerable weight gain has also been observed more frequently in this age group when treated with Rexer, compared to adults.

Suicidal thoughts and worsening depression

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

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform 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 conditions:

→ Inform your doctor about these conditions 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 disease or low blood pressure;

• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately;

• bipolar depression (periods of elevated mood/hyperactivity alternate with 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 medicines);

• eye disorders, such as increased pressure in the eye (glaucoma);

• difficulty urinating, which could be due to an enlarged prostate;

• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medicines that may affect heart rhythm.

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

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

Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

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

If you have previously experienced severe skin reactions, treatment with Rexer should not be restarted.

Taking Rexer with other medicines

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

Do not take Rexer together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take Rexer within two weeks after stopping MAOIs. If you stop taking Rexer, do not take MAOIs for at least the next two weeks.

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

Be cautious if you take Rexer together 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 certain psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin in the blood), and St. John's wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, Rexer alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, 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. This may increase the amount of Rexer in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Rexer, or increase it again when stopping nefazodone.
  • medicines for anxiety or insomnia, such as benzodiazepines.
  • medicines for schizophrenia, such as olanzapine.
  • medicines for allergies, such as cetirizine.
  • medicines for severe pain, such as morphine.

When taken together with these medicines, Rexer may increase the drowsiness caused by them.

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

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

• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin.

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

• medicines to prevent blood clotting, such as warfarin.

Rexer may enhance the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor should monitor your blood regularly.

• medicines that may 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 taking Rexer.

It is recommended not to drink any alcohol.

You may 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 use of Rexer in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

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

Medicines similar to Rexer (SSRIs) taken during pregnancy may increase the risk in newborns of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, consult your midwife and/or doctor immediately.

Driving and using machines

Rexer may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed Rexer to a patient under 18 years of age, ensure that concentration and alertness are not affected before engaging in activities such as cycling.

Rexer orally disintegrating tablets contain sugar spheres, which contain sucrose

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

Rexer orally disintegrating tablets contain aspartame, a source of phenylalanine

This medicine contains aspartame, a source of phenylalanine. Each 15 mg orally disintegrating tablet contains 4.65 mg of aspartame. Each 30 mg orally disintegrating tablet contains 9.3 mg of aspartame. Aspartame contains phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Rexer orally disintegrating tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per orally disintegrating tablet, which is essentially “sodium-free”.

3. How to take Rexer Flas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting dose is 15 or 30 mg per day. Your doctor may recommend increasing your 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 elderly or have kidney or liver disease, your doctor may adjust your dose.

When to take it

→ Take Rexer at the same time each day.

It is best to take the Rexer dose as a single dose before bedtime. However, your doctor may recommend that you split your Rexer dose, taking part in the morning and part before bedtime. The higher dose should be taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not press the orodispersible tablet

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

Fig. A.

1. Separate one blister

Each blister contains six blisters separated by perforations. Separate one blister along the perforated lines (Figure 1).

Fig. 1.

1. Open the blister

Carefully peel back the foil, starting at 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 you can expect to feel better

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

It is important that during the first weeks of treatment you talk to your doctor about how Rexer is affecting you:

→ Between 2 and 4 weeks after starting Rexer, speak with 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, speak to your doctor again after another 2–4 weeks.

You will usually need to take Rexer until your depressive symptoms have been gone 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 an overdose of Rexer (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de pointes.

You may also contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Rexer

If you are supposed to take your dose once daily

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

If you are supposed to take your dose twice daily

• If you forget the morning dose, simply take it together with your evening dose.

• If you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.

• If you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Rexer

→ Only stop taking Rexer after consulting with your doctor.

If you stop too early, depression may return. 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 your depression has gone away. If you stop taking Rexer suddenly, you may feel unwell, dizzy, agitated, or anxious, and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will tell you how to reduce your dose gradually.

If you have any further 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 everyone will experience 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; this may indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances 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 very rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• • epileptic seizure (convulsions).
  • combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, 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 harming yourself or of suicide.

• serious skin reactions:

  • red patches on the trunk, often as circumscribed or circular spots, frequently with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• widespread redness, elevated body temperature, and enlarged lymph nodes (DRESS syndrome 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
• drowsiness
• headache
• dry mouth

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

• lethargy

• dizziness

• tremor

  • nausea
  • diarrhoea
  • vomiting
  • constipation
  • hives or skin rash (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 (oedema)
  • 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):

• unusual skin sensations such as burning, pricking, tingling, or numbness (paraesthesia)
  • involuntary restless leg movements during sleep
  • fainting (syncope)
  • numbness sensation in the mouth (oral hypoesthesia)
  • low blood pressure
  • nightmares
  • agitation
  • hallucinations
  • inability to stay still

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

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

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

• abnormal sensations in the mouth (oral paraesthesia)

• swelling in the mouth (oral oedema)

• swelling throughout the body (generalised oedema)

• localized swelling

• hyponatraemia

• inappropriate secretion of antidiuretic hormone

• serious skin reactions (bullous dermatitis, erythema multiforme)

• sleepwalking

• speech disorder

• increased levels of creatine kinase in the blood

• difficulty urinating (urinary retention)

• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)

• increased levels of prolactin hormone in the blood (hyperprolactinaemia, which includes symptoms such as enlarged breasts and/or milky discharge from the nipples)

• painful and prolonged erection of the penis

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were commonly observed in patients under 18 years of age: considerable weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rexer Flas Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rexer Flas

• The active substance 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, butyl methacrylate basic copolymer, aspartame (E-951), anhydrous citric acid, crospovidone (type A), mannitol (E-421), microcrystalline cellulose, natural and artificial orange flavour (no. SN027512), and sodium hydrogen carbonate.

Appearance of the product and contents of the pack

Rexer Flas are orodispersible tablets.

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

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

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

The following pack sizes of Rexer Flas 15 mg and 30 mg orodispersible tablets in blisters are available: 6, 18, 30, 48, 90, 96 and 180 orodispersible tablets (not all pack sizes 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,
P.O. Box 20
5340 BH Oss
The Netherlands

This medicinal product is authorised in the European Economic Area member states 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 most recent review of this leaflet: 03/2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)