AFLOYAN 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Afloyan 30 mg 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 Afloyan and what is it used for
2. What you need to know before you take Afloyan
3. How to take Afloyan
4. Possible side effects
5. Storing Afloyan
6. Contents of the pack and other information

1. What is Afloyan and what is it used for

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It may take 1 to 2 weeks before mirtazapine starts to work. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you feel no improvement or if your condition worsens 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 Afloyan

Do not take Afloyan

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, consult your doctor as soon as possible before taking mirtazapine.
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Tell your doctor before taking Afloyan:

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

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years of age because it has not been shown to be effective. 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 suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age when he decides that it is the most convenient for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish 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 of age who are taking mirtazapine. Additionally, the long-term safety effects on growth, maturation, and development of knowledge and behavior of mirtazapine in this age group are not yet known. It has also been observed that this age group experiences a significant increase in weight when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. This may worsen when you first start taking antidepressants, as these medicines take 2 weeks or sometimes longer 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. Clinical trial data have shown an increased risk of suicidal behavior in young adults with psychiatric disorders who were treated with an antidepressant.

→ If you have thoughts of harming or killing 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 mirtazapine

• if you have or have ever had any 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 become more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine 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(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking mirtazapine 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 your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.

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

→ Stop taking mirtazapine and contact your doctor immediately to have 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.
• Severe skin reactions have been reported with the use of mirtazapine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking mirtazapine 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 suffered from severe skin reactions, do not restart treatment with mirtazapine.

Taking Afloyan with other medicines

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

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, 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, Afloyan 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), shivering, 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 mirtazapine in your blood. Inform your doctor if you are taking this medicine. Your doctor may need to reduce the dose of mirtazapine 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 combined with these medicines, mirtazapine 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 mirtazapine, these medicines may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking these medicines. Your doctor may need to reduce the dose of mirtazapine 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 mirtazapine, these medicines may reduce the amount of mirtazapine in your blood. Inform your doctor if you are taking these medicines. Your doctor may need to increase the dose of mirtazapine or reduce it again when you stop taking these medicines.

• Medicines to prevent blood clottingsuch as warfarin. Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor performs 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 being treated with 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you use mirtazapine until or shortly before delivery, your baby will be examined for possible adverse effects. Taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) in babies, 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 immediately consult your midwife and/or doctor.

Driving and using machines

This medicine may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, make sure that concentration and alertness are not affected before cycling (for example).

Afloyan tablets contain lactose

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

3. How to take Afloyan

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended initial 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 an elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take it

→ Take Afloyan at the same time every day.

It is best to take the dose of Afloyan once before bedtime. However, your doctor may recommend that you divide your dose of Afloyan in the morning and before bedtime. The highest dose should be taken before bedtime.

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

When can you expect to feel better

Normally, Afloyan 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 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 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 Afloyan until the symptoms of depression have disappeared for 4-6 months.

If you take more Afloyan than you should

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

The most likely symptoms of an overdose of Afloyan (without other medicines or alcohol) are drowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

You can also call the Toxicological Information Service. Telephone 91 562 04 20.

If you forget to take Afloyan

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 Afloyan

→ Stop taking Afloyan only if you consult your doctor.

If you stop too soon, depression may recur. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Afloyan abruptly, even if depression has disappeared. If you stop taking Afloyan abruptly, you may feel unwell, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually reduce the dose.

If you have any other 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 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).

• exaggerated feeling of euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

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

• signs of infection such as high, unexplained, and sudden fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, Afloyan can cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Afloyan can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Afloyan 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 erythemas 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 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.
• sleepiness.
• headache.
• dry mouth.

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

• lethargy.
• dizziness.
• tremors.
• nausea.
• diarrhea.
• vomiting.
• constipation
• urticaria 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 discontinued.

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia).
• involuntary leg movements during sleep.
• fainting (syncope).
• numbness in the mouth (oral hypoesthesia).
• low blood pressure.
• nightmares.
• agitation.
• hallucinations.
• inability to remain still.

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

• twitching 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 creatine kinase levels in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased prolactin hormone levels 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, urticaria, 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 an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Afloyan

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Do not use this medicine after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Afloyan composition:

• The active ingredient is mirtazapine

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

• The other components are:

Core of the tablet: pregelatinized starch (from corn), hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

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

Appearance of the product and package contents:

Afloyan 30 mg are film-coated tablets.

The tablets are round, lenticular, white, and have a score line on one of their faces.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

They are presented in blisters, in packages of 30 or 56 tablets.

Other presentations

Afloyan 15 mg film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

This prospectus was revised in:October 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/