MIRTAZAPINE FLAS NORMOGEN 45 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Mirtazapine Flas Normogen 45 mg Orodispersible Tablets EFG

Mirtazapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 and other information

1. What is Mirtazapine Flas Normogen and what is it used for
2. What you need to know before you take Mirtazapine Flas Normogen
3. How to take Mirtazapine Flas Normogen
4. Possible side effects
5. Storing Mirtazapine Flas Normogen

1. Contents of the pack and further information

1. What is Mirtazapine Flas Normogen and what is it used for

Mirtazapine Flas Normogen belongs to a group of medicines called antidepressants.

Mirtazapine Flas Normogen is used to treat depression in adults.

It may take between 1 and 2 weeks before Mirtazapine Flas Normogen starts to work and after 2 to 4 weeks you may start to feel better. You should consult your doctor if you feel worse or if you do not improve 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 Mirtazapine Flas Normogen

Do not take or consult your doctor before starting to take Mirtazapine Flas Normogen

• If you are allergicto 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 Mirtazapine Flas Normogen.
• If you are taking or have taken recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• If you have ever suffered from a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapine or other medicines.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapine Flas Normogen.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years because it has not been shown to be effective. At the same time, you should know that in patients under 18 years there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to a patient under 18 years when he decides it is most convenient for the patient. If your doctor has prescribed mirtazapine 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 symptoms listed above appear or worsen in patients under 18 years who are taking mirtazapine. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known. It has also been observed more frequently in this age group that there is 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 yourself or of suicide. This could get worse when you first start taking antidepressants, as these medicines usually take two weeks or sometimes more to work.

You may be more likely to think this way:

• If you have previously had suicidal thoughts or thoughts of harming yourself.
• If 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 being treated with an antidepressant.
• If you have thoughts of harming yourself or suicide at any time, consult 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 especially careful with Mirtazapine Flas Normogen:

• If you have or have ever had any of the following disorders;

→ Inform your doctor about these situations before taking Mirtazapine Flas Normogen, if you have not already:

• seizures (epilepsy). If seizures appear or your seizures are more frequent, stop taking Mirtazapine Flas Normogen and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, stop taking Mirtazapine Flas Normogen and contact your doctor immediately;
• kidney disease;
• 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 excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking Mirtazapine Flas Normogen 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 disease that can change the rhythm of your heart, a recent heart attack, heart failure, or taking certain medications that can affect the rhythm of your heart.
  • If signs of infection appear, such as unexplained high fever, sore throat, and mouth sores;

• Stop taking Mirtazapine Flas Normogen 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 usually appear 4-6 weeks after 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). 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 suffered from severe skin reactions, you should not restart treatment with mirtazapine.

Other medicines and Mirtazapine Flas Normogen

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

Do not take Mirtazapine Flas Normogenwith:

• monoamine oxidase inhibitors (MAOIs). Also, do not take Mirtazapine Flas Normogen during the two weeks after you have stopped taking MAOIs. If you stop taking Mirtazapine Flas Normogen, 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 Mirtazapine Flas Normogen with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for 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 very rare cases, Mirtazapine Flas Normogen alone or with these medicines may cause a condition called serotonin syndrome. Some of the 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, consult your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of Mirtazapine Flas Normogen in your blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of Mirtazapine Flas Normogen 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, Mirtazapine Flas Normogen 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 Flas Normogen, these medicines may increase the amount of Mirtazapine Flas Normogen in your blood. Inform your doctor if you are taking these medicines. It may be necessary to decrease the dose of Mirtazapine Flas Normogen 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 Flas Normogen, these medicines may decrease the amount of Mirtazapine Flas Normogen in your blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Flas Normogen or decrease it again when you stop taking these medicines.

• medicines to prevent blood clottingsuch as warfarin.

Mirtazapine Flas Normogen may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform blood tests.

• medicines that can affect the rhythm of your heart, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Flas Normogen with food and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapine Flas Normogen. It is recommended not to drink any alcohol. You can take Mirtazapine Flas Normogen 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 Flas Normogen until or shortly before delivery, your baby will be examined for possible adverse effects.

When taken during pregnancy, similar medicines (SSRIs) may increase the risk in babies of a serious disease 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 consult your midwife and/or doctor immediately.

Consult your doctor if you can breastfeed while taking Mirtazapine Flas Normogen.

Driving and using machines

During treatment with Mirtazapine Flas Normogen, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Mirtazapine Flas Normogen affects you.

Mirtazapine Flas Normogen contains glucose and aspartame

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

This medicine contains 6 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Mirtazapine Flas Normogen

Follow exactly the administration instructions of this medicine indicated 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 mg 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 mg 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 Mirtazapine Flas Normogen at the same time every day.

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

Take the orodispersible tablet as follows

1. The tablets are taken orally. To avoid crushing the orodispersible tablet, carefully press the tablet through the blister pack.
2. Take the orodispersible tablet with dry hands and place it on your tongue.

The orodispersible tablet will dissolve quickly and can be swallowed without water.

When can you expect to feel better

Normally, Mirtazapine Flas Normogen will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is important that during the first few weeks of treatment, you talk to your doctor about the effects of Mirtazapine Flas Normogen:

→ between 2 and 4 weeks after starting to take Mirtazapine Flas Normogen, 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 this case, talk to your doctor again after another 2-4 weeks.

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

If you take more Mirtazapine Flas Normogen than you should

→ In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

The most likely symptoms of an overdose of Mirtazapine Flas Normogen (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 disease known as Torsade de pointes.

If you forget to take Mirtazapine Flas Normogen

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 have forgotten the morning dose, simply take it with the evening dose.
• If you have forgotten the evening dose, do not take it the next morning; skip it and continue with your normal doses in the morning and evening.
• If you have forgotten both doses, do not try to make them up. Skip both doses and the next day continue with your normal dose in the morning and evening.

If you stop taking Mirtazapine Flas Normogen

Stop taking Mirtazapine Flas Normogen only if you consult your doctor.

If you stop taking 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 Mirtazapine Flas Normogen abruptly, even if depression has disappeared. If you stop taking Mirtazapine Flas Normogen abruptly, you may feel unwell, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually decrease 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):

• 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 alterations (jaundice).

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

• signs of infection such as unexplained high fever and sudden pain in the throat and sores in the mouth (agranulocytosis). In rare cases, mirtazapine may cause alterations 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, 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 disorder called "serotonin syndrome",
• thoughts of self-harm or suicide,
• severe skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis).
• red patches on the trunk, 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 may 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,
• drowsiness,
• headache,
• dry mouth.

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

• lethargy,
• dizziness,
• tremors,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• urticaria 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 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 levels of creatine kinase in the blood,
• difficulty urinating (urinary retention),
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis).

Other Adverse Effects in Children and Adolescents

In patients 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 Mirtazapine Flas Normogen

Keep This Medicine Out of Sight and Reach of Children

Do not use this medicine after the expiration date shown on the box and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofMirtazapine Flas Normogen

• The active ingredient is mirtazapine.
• Each orodispersible tablet contains 45 mg of mirtazapine (as mirtazapine hemihydrate).
• The other ingredients are: mannitol, cornstarch, microcrystalline cellulose, crospovidone, aspartame, orange flavor (contains glucose in maltodextrin from corn) and vegetable magnesium stearate.

Appearance of the Product and Package Contents

White, round, flat, beveled orodispersible tablet marked with "45" on one side.

Package size: 30 tablets in precut unit-dose blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of Last Revision of This Prospectus: September 2020

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84117/P_84117.html