Afloyan 15 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Afloyan 15 mg 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could 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.

Leaflet Contents

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

1. What Afloyan is and what it is used for

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine starts to work. After 2 to 4 weeks, you may begin 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 to expect to feel better".

2. What you need to know before taking Afloyan

Do not take Afloyan

• if you are allergic to mirtazapine or any of the other components 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 recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting mirtazapine.

Tell your doctor before taking Afloyan:

If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine.

Children and adolescents

Mirtazapine should not normally be used to treat children and adolescents under 18 years of age, as its efficacy 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 medication. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed mirtazapine 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 described above appear or worsen in patients under 18 years of age who are taking mirtazapine. In addition, the long-term safety effects on growth, maturation, and cognitive and behavioral development with mirtazapine in this age group are still unknown. A significant weight gain has also been observed more frequently in this age group when treated with mirtazapine compared to adults.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This may worsen when you first start taking antidepressants, as these medicines usually take up to two weeks or sometimes longer to take effect.

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 committing suicide, consult your doctor or go to a hospital immediately.

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

Also, take special care with mirtazapine

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

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

• seizures (epilepsy). If seizures occur or 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 elevated mood/hyperactivity and depression). If you start feeling elated or overexcited, stop taking mirtazapine 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;

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

→ Stop taking mirtazapine 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 mirtazapine, 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 experienced serious skin reactions, re-initiation of treatment with mirtazapine is not recommended.

Taking Afloyan with other medicines

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

Do not take Afloyan together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks following discontinuation of MAOIs. If you stop taking mirtazapine, do not take MAOIs for the next two weeks.

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

Be careful if you take Afloyan 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 methemoglobin in the blood), and herbal preparations containing St. John's wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, 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. This may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, 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, mirtazapine may increase the drowsiness caused by them.

• medicines for infections: antibacterial medicines (such as erythromycin), antifungal medicines (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).

When taken together with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping these medicines.

• medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.

When taken together with mirtazapine, these medicines may reduce the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of mirtazapine, or reduce it again when stopping these medicines.

• medicines to prevent blood clotting such as warfarin. Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, regular blood monitoring by your doctor is recommended.
• medicines that may 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 may take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised when using it during pregnancy.

If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects. Antidepressants similar to mirtazapine (SSRIs), when taken during pregnancy, may increase the risk of newborns developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing 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

This medicine may affect your concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, ensure that concentration and alertness are not impaired before engaging in activities such as cycling.

Afloyan 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 Afloyan

Follow exactly the instructions for using 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 that is best for you (between 15 and 45 mg per day). Normally, the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust your dose.

When to take it

→ Take Afloyan at the same time each day.

It is best to take the dose of Afloyan all at once before going to bed. However, your doctor may recommend that you split your dose of Afloyan, 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 Afloyan without chewing, with water or juice.

When you can expect to feel better

Afloyan usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better. It is important that during the first weeks of treatment you discuss the effects of Afloyan with your doctor:

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

You will usually need to continue taking Afloyan until depressive symptoms 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. 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 can also call the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Afloyan

If you are supposed to take your dose once daily

• 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 daily

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

→ Stop taking Afloyan only if advised by your doctor.

If you stop too soon, 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 Afloyan abruptly, even if your depression has resolved. If you stop taking Afloyan suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce your dose step by step.

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 eyes or skin; this may indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained 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 very rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), 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, diarrhoea, 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 of suicide.
• serious skin reactions:
  • red patches on the trunk, appearing as well-defined or circular spots, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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 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.
• diarrhoea.
• 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 (oedema).
• 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 (paraesthesia).
• involuntary restless leg movements during sleep.
• fainting (syncope).
• numbness sensation in the mouth (oral hypoesthesia).
• low blood pressure.
• nightmares.
• agitation.
• hallucinations.
• inability to stay still.

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

• tics or muscle 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 paraesthesia).
• swelling in the mouth (oral oedema).
• swelling throughout the body (generalized oedema).
• localized swelling.
• hyponatraemia.
• inappropriate secretion of antidiuretic hormone.
• serious skin reactions (bullous dermatitis, erythema multiforme).
• sleepwalking (somnambulism).
• 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 (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipple).
• painful and prolonged penile erection.

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, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Afloyan

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Store in the original container to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Afloyan:

• The active substance is mirtazapine.

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

• The other components are:

Tablet core: pregelatinized starch (from corn), hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, monohydrate lactose.

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

Appearance of the product and contents of the pack:

Afloyan 15 mg are film-coated tablets.

The tablets are round, biconvex, white in colour, with a score line on one side.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

It is supplied in blisters, pack sizes of 30 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 leaflet has been reviewed on: October 2023

Detailed 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/