Prospecto: information for the patient

Rexer 30mg film-coated tablets

mirtazapina

Read this prospect carefully before starting to take this medicine, because 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 medicine has been prescribed only for you, and you must 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 do not appear in this prospect. See section4.

1.What is Rexer and for what it is used

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

3.How to take Rexer

4.Possible adverse effects

5.Storage of Rexer

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 for Rexer to start taking effect. After 2 to 4weeks, you may start to feel better. You should consult your doctor if you worsen or do not improve after 2 to 4weeks.

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

No take Rexer

• if you are allergic to mirtazapine or any of the other ingredients of this medication (listed in section 6). Consult your doctor as soon as possible before taking Rexer.

• if you are taking or have taken in the last two weeks any medications 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 of age because its effectiveness has not been demonstrated. At the same time, it should be known that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. However, the doctor may prescribe Rexer to patients under 18 years of age when they decide it is the most appropriate for the patient. If the doctor has prescribed Rexer to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above in patients under 18 years of age taking Rexer appear or worsen.

Additionally, the long-term effects on safety related to growth, maturity, and development of Rexer in this age group are not yet known. It has also been observed more frequently a significant weight gain in this age group when treated with Rexer, 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 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 of age with psychiatric disorders and 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 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 worsening, or if they are concerned about changes in your behavior.

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

• if you have signs of infection such as unexplained fever, sore throat, and mouth sores

→ Stop taking Rexer and contact your doctor immediately to have 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 medications

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

Do not take Rexer with:

• 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.

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

Be careful if you take Rexer with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans (used to treat migraines),tramadol (for pain),linezolid (an antibiotic),lithium (used to treat certain psychiatric disorders),methylene blue (used to treat high levels of methemoglobin in the blood),and St. John's Wort (Hypericum perforatum) preparations (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 stopping nefazodone.
• anxiety or insomnia medications such as benzodiazepines.
• schizophrenia medications such as olanzapine.
• allergy medications such as cetirizine.
• intense pain medications such as morphine.

Rexer may increase the drowsiness caused by these medications when taken together.

If taken together 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 stopping these medications.

If taken together 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 stopping these medications.

Rexer may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medication. In the case of taking them together, it is recommended that the 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, or plan to become 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.

When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition called persistent neonatal pulmonary hypertension (HPPN) in newborns, which makes them 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 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 of age, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Rexer tablets contain lactose

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

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 your 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 in the morning and in the evening before going to bed. The highest dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed dose of Rexer without chewing, with water or juice.

When to expect to feel better

Normally, Rexer will start to take effect after 1 or 2weeks and after 2 to4weeks you may start to feel better.

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

→ between 2 and 4weeks after starting to take Rexer, talk to your doctor about how this medication 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 2‑4weeks.

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) aredrowsiness, disorientation, and palpitations.The 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 fatal condition known as Torsades de pointes.

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

If you forgot to take Rexer

If you have to take your doseonce a day

If you have to take your dosetwice a day

If you interrupt the treatment with Rexer

→ Stop taking Rexer only if you consult your doctor.

If you stop taking it 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 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):

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

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

• generalized erythema, elevated 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):

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

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

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

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

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

• 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 secretion)
• • 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 increased 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 through the Spanish System for the Pharmacovigilance 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 the box and on the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.C.

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 containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rexer

• The active ingredient is mirtazapine.

Rexer 30mg film-coated tablets contain 30mg of mirtazapine per tablet.

• The other components are:

Tablet core: maize starch, hypromellose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

Film coating: hypromellose, Macrogol8000, titanium dioxide(E‑171).

The film coating of Rexer 30mg film-coated tablets also contains yellow iron oxide(E‑172) and red iron oxide(E‑172).

Appearance of the product and contents of the package

Rexer are film-coated tablets.

The Rexer 30mg film-coated tablets are oval in shape, convex on both sides, reddish-brown, scored and marked with “MSD” on one face and with “TZ5” on the other face, on both sides of the score.

The tablet can be divided into two equal halves.

Rexer 30mg film-coated tablets are packaged in blisters or bottles.

The following pack sizes of Rexer 30mg film-coated tablets in blisters are available: 10, 20, 30, 50, 60, 90, 100, 200 and 500tablets; 14, 28, 56 and 70tablets; a pack size of 250tablets of Rexer 30mg film-coated tablets in a bottle (may not be marketed in all pack sizes).

Holder of the marketing authorization and responsible for manufacture

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible for manufacture:

Organon Heist bv

Industriepark30

2220Heist‑op‑den‑Berg

Belgium

or

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus, Greece, Netherlands, NorwayRemeron

FranceNorset

IrelandZispin

SpainRexer

Last date of revision of this leaflet:03/2021

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