REXER 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rexer 30mg film-coated tablets

mirtazapine

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Rexer and what is it used for

Rexer belongs to a group of medicines called antidepressants.

Rexer is used to treat depression in adults.

It may take 1 to 2 weeks before Rexer starts to work. After 2 to 4 weeks you may start to feel better. You should see your doctor if you feel no better or if you feel worse 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 you take Rexer

Do not take Rexer

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, talk to your doctor 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 you start taking Rexer.

Tell your doctor before taking Rexer:

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

Children and adolescents

Rexer should not normally be used for the treatment of children and adolescents under 18 years. This is because the safety and effectiveness of Rexer in this age group have not been established. Moreover, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontation, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Rexer to patients under 18 years when he decides that it is the best for the patient. If your doctor has prescribed Rexer to a patient under 18 years and you want 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 who are taking Rexer. Additionally, the long-term safety effects on growth, maturation, and development of cognition and behavior of Rexer in this age group are not yet known. It has also been observed that this age group, when treated with Rexer, experiences a significant increase in weight more frequently than adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These thoughts may worsen when you first start taking antidepressants, as these medicines take some time (usually 2 weeks or more) to start working.

You may be more likely to think this way if:

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

→ If you have thoughts of killing or harming yourself at any time, contact 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 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 very careful with Rexer

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

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

• seizures(epilepsy). If seizures occur or 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 heart rhythm.

• 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 for 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.
• Rare but serious skin reactions have been reported with Rexer, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking Rexer 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 herbal remedy for depression. In 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), shivers, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of Rexer in your blood. Tell your doctor if you are taking this medicine. Your doctor may need to decrease the dose of Rexer or increase it again when you stop taking 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 taken 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. Tell your doctor if you are taking these medicines. Your doctor may need to decrease the dose of Rexer or increase it again when you stop taking 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. Tell your doctor if you are taking these medicines. Your doctor may need to increase the dose of Rexer or decrease it again when you stop taking these medicines.

• medicines to prevent blood clottingsuch as warfarin.

Rexer may increase the effects of warfarin on the blood. Tell your doctor if you are taking this medicine. If taken together, your doctor may recommend that you have regular blood tests.

• medicines that can affect the 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you use Rexer up to or shortly before birth, your baby will be checked 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 contact your midwife and/or doctor immediately.

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, make sure that concentration and alertness are not affected before cycling (for example).

Rexer tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Rexer

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

How much to take

The recommended initial dose is 15 or 30mg per day.Your doctor may recommend that you increase 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 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 going to bed. However, your doctor may recommend that you divide your dose of Rexer into morning and evening doses 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 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 that during the first few weeks of treatment, you talk to your doctor 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 has taken too much Rexer, contact 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. Telephone 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

→ Only stop taking Rexer if you have talked to your doctor.

If you stop too soon, the 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 the 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 the treatment. Your doctor will tell you how to gradually decrease the dose.

If you have any further questions on the use of this product, 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 disorders (jaundice).

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

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (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
• hives 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 were 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 agitation of the legs during sleep
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

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

• twitches 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 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 (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 individuals under 18 years of age, the following adverse effects were frequently observed in clinical trials: significant weight gain, hives, 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 does not appear 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

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.

Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through drains or 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

• The active ingredient is mirtazapine.

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

• The other components are:

Core of the tablet: cornstarch, hypromellose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

Coating of the tablet: hypromellose, Macrogol 8000, titanium dioxide (E-171).

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

Appearance of the Product and Package Contents

Rexer is a film-coated tablet.

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

The tablet can be divided into two equal halves.

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

The following packages of Rexer 30 mg film-coated tablets are available in blister packs: 10, 20, 30, 50, 60, 90, 100, 200, and 500 tablets; 14, 28, 56, and 70 tablets; a package of 250 Rexer 30 mg film-coated tablets is available in a bottle (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:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

or

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

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

Cyprus, Greece, Netherlands, Norway Remeron

France Norset

Ireland Zispin

Spain Rexer

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/)