Rexer 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rexer 30mg film-coated 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 is and what it is used for
2. What you need to know before taking Rexer
3. How to take Rexer
4. Possible side effects
5. How to store Rexer
6. Contents of the pack and other information

1. What Rexer 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 work. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if your condition worsens or does not improve after 2 to 4 weeks.

For more information, see section 3 "When you can expect to start feeling better".

2. What you need to know before taking Rexer

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 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 or peeling skin, 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 contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking Rexer. In addition, the long-term effects on safety related to 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 time to work—typically two weeks or sometimes longer.

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, contact your doctor or go to a hospital immediately.

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

Also, take special care 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 dose of insulin or other antidiabetic medicines);

• eye disorders, 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 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 occur, 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.
• 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). Discontinue use and seek immediate medical attention 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, 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 (MAO inhibitors). Also, do not take Rexer within two weeks after stopping MAO inhibitors. If you stop taking Rexer, do not take MAO inhibitors for the following two weeks.

Examples of MAO inhibitors 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, rapid heartbeat, diarrhea, uncontrollable muscle twitching, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. This may increase the amount of Rexer in your 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 used in combination with these medicines, Rexer may increase the drowsiness caused by them.

• medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), medicines for HIV/AIDS (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 your 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 your 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 in 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 being treated with 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 are planning 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 it is used during pregnancy.

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

Antidepressants similar to Rexer (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns 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, contact 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 impaired before engaging in activities such as cycling.

Rexer tablets contain lactose

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

3. How to take Rexer

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If you are unsure, 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 best suited for you (between 15 and 45 mg per day). Usually, the dose is 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 dose of Rexer as a single dose before going to bed. However, your doctor may recommend splitting your dose, taking part in the morning and part at night before going to bed. The higher 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 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 discuss the effects of Rexer with your doctor:

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

You will usually need to take Rexer until depressive symptoms have been absent 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 a day

• 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 a day

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

If you stop too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Rexer abruptly, even if depression has resolved. 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 advise you how to reduce the 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 experiences them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and contact 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 skin or eyes; may indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained high 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 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 the number of white blood cells in the blood (eosinophilia).

• epileptic seizure (convulsions).

• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, 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 suicide.

• serious skin reactions:

• red patches on the trunk, often as well-defined or circular spots, frequently with blisters in the center, 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, high 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

• diarrhea

• 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 (edema)

• fatigue

• vivid dreams

• confusion

• anxiety

• difficulty sleeping

  • memory problems, which in most cases resolved when treatment was stopped

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

• unusual skin sensations such as burning, prickling, tingling, or numbness (paresthesia)

• involuntary leg movements during sleep

• fainting (syncope)

• numbness sensation in the mouth (oral hypoesthesia)

• low blood pressure

• nightmares

• restlessness

• hallucinations

• inability to stay still

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

• muscle tics or 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 paresthesia)

• swelling in the mouth (oral edema)

• swelling throughout the body (generalized edema)

• localized swelling

• hyponatremia

• 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 (hyperprolactinemia, including symptoms such as breast enlargement and/or milky nipple discharge)

  • prolonged and painful 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: considerable weight gain, hives, and increased blood triglyceride levels.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Storage Instructions

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.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rexer

• The active substance is mirtazapine.

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

• The other components are:

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

Film coating: hypromellose, Macrogol 8000, titanium dioxide (E-171).

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

Nature and contents of the container

Rexer is film-coated tablets.

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

The tablet may be divided into equal halves.

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

The following pack sizes of Rexer 30 mg film-coated tablets in blisters are available: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets. A pack of 250 tablets of Rexer 30 mg film-coated tablets in a bottle is also available (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:

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

or

N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Cyprus, Greece, The Netherlands, Norway: Remeron
France: Norset
Ireland: Zispin
Spain: Rexer

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/)