Package Leaflet: Information for the Patient

Afloyan 15 mg Film-Coated Tablets

mirtazapine

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

1. What Afloyan is and what it is used for

2. What you need to know before you start taking Afloyan

3. How to take Afloyan

4. Possible side effects

5. Storage of Afloyan

6. Contents of the pack and additional information

Mirtazapina belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression in adults.

It takes 1 to 2 weeks for mirtazapina to start working. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you get worse or do not improve after 2 to 4 weeks.

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

Do not take Afloyan

• if you areallergicto 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 Afloyan.
• if you are taking or have taken recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Inform your doctor before taking Afloyan:

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

Children and adolescents

Mirtazapine should not be used normally in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years 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 class of medicines. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years when he decides that it is the most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years who are taking mirtazapine. In addition, the long-term safety effects related to growth, maturity, and development of mirtazapine in this age group are still unknown.Also, a considerable weight gain has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed you may sometimes have thoughts of harming yourself or of suicide. This could worsen when you start taking antidepressants for the first time, as these medicines usually take two weeks or more to have their full 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 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 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 concerned about changes in your behavior.

Also, be particularly careful with mirtazapine

• if you have or have had at any time one of the following conditions

→ Inform your doctor about these situations before taking mirtazapine, if you have not already done so:

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice appears, stop taking mirtazapine 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 mirtazapina 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 could be due to an enlarged prostate;

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

→ Stop taking mirtazapine and contact your doctor immediately to have a blood test. In rare cases, these symptoms can 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 medicines.
• Severe 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 mirtazapine. Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.

If you have ever had severe skin reactions, do not restart treatment with mirtazapine.

Taking Afloyan with other medicines

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

Do not take Afloyanwith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapine during the two weeks after stopping MAOIs. If you stop taking mirtazapine, 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 Afloyan 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 some psychiatric disorders),methylene blue(used to treat high levels of methemoglobin in the bloodand preparations based on St. John's Wort –Hypericum perforatum(medicinal plant for depression). In rare cases, mirtazapine alone or in combination with these medicines, 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 mirtazapine in the blood. Inform your doctor if you are taking this medicine. You may need to reduce the dose of mirtazapine, or increase it again when you stop taking nefazodone.
• anxiolytics or hypnoticssuch as benzodiazepines.

antipsychoticssuch as olanzapine.

allergiessuch as cetirizine.

intense painsuch as morphine.

In combination with these medicines, mirtazapine may increase the drowsiness caused by these medicines.

• infection medicines:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole) and HIV/AIDS medicines (protease inhibitors of HIV)andulcer medicines(such as cimetidine).

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

• epilepsy medicinessuch as carbamazepine and phenytoin;tuberculosis medicinessuch as rifampicin.

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

• blood thinnerssuch as warfarin. Mirtazapine may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In the case of taking them together, it is recommended that your doctor monitor your blood tests.
• medicines that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Afloyan with food and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapine.

It is recommended not to drink any alcohol.

You can take mirtazapine 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 medicine.

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

If you use mirtazapine until,or shortly before delivery, your baby will be examined to detect any possible adverse effects. Taken during pregnancy, similar medicines(SSRIs), may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN) in the baby, which makes the baby 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

This medicine may affect your concentration or alertness. Make sure your faculties are not impaired before driving or using machinery.If your doctor has prescribed mirtazapine to a patient under 18 years, make sure concentration and alertness are not impaired before driving (for example, on a bicycle).

Afloyan tablets contain lactose

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

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 30 mg per day.Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg 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 Afloyan at the same time every day.

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

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

When you can expect to feel better

Normally, Afloyan will start to take effect after 1 or 2 weeks and after 2 to 4 weeks 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 Afloyan:

→ between 2 and 4 weeks after starting to take Afloyan, 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 2-4 weeks.

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

If you take more Afloyan than you should

→ If you or someone takes too much Afloyan, consult a doctor immediately.

The most likely symptoms of an Afloyan overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.Symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.You can also call the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Afloyan

If you have to take your doseonce a day

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

If you have to take your dosetwice a day

• If you forgot the morning dose, simply take it with the evening dose.
• If you forgot the evening dose, do not take it the next morning; skip it and continue with your usual doses in the morning and evening.
• If you forgot 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 Afloyan

→ Stop taking Afloyan only if you consult your doctor.

If you stop 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 Afloyan abruptly, even when depression has disappeared. If you stop taking Afloyan 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):

• yellowing of the eyes or skin, which may indicate liver dysfunction (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 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 blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal 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 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.

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

• abnormal sensations in the mouth (oral paresthesia).
• swelling in the mouth (buccal edema).
• swelling throughout the body (generalized edema)
• localized swelling
• low sodium levels (hyponatremia).
• inadequate secretion of antidiuretic hormone.
• severe skin reactions (dermatitis bullous, 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 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 not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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.

No special storage conditions are required.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection 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 Afloyan:

• The active principle is mirtazapine

Afloyan 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.

• The other components are:

Tablet core: pregelatinized cornstarch, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

Coating: hypromellose, triacetin, titanium dioxide (E-171).

Appearance of the product and content of the packaging:

Afloyan 15 mg are film-coated tablets.

The tablets are round, biconvex, white in color, and have a notch on one of their faces.

The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses.

It is presented in a blister pack, in containers of 30 tablets.

Other presentations

Afloyan 15 mg film-coated tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

This leaflet has been reviewed in:October 2023

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