Mirtazapine Flas Normogen 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mirtazapine Flas Normogen 15 mg orodispersible tablets EFG

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 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 Mirtazapine Flas Normogen is and what it is used for

2. What you need to know before taking Mirtazapine Flas Normogen

3. How to take Mirtazapine Flas Normogen

4. Possible adverse effects

5. How to store Mirtazapine Flas Normogen

6. Contents of the pack and other information

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

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

Mirtazapine Flas Normogen is used to treat depression in adults.

It takes one to two weeks before Mirtazapine Flas Normogen starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if your condition worsens or if you do not feel better 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 taking Mirtazapina Flas Normogen

Do not take or consult your doctor before starting Mirtazapina Flas Normogen

• If you are allergic to mirtazapine or to any of the other components of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Flas Normogen.
• If you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• If you have ever experienced severe skin rash or peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Warnings and precautions

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

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. Additionally, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to a patient under 18 years of age if they decide it is most appropriate 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 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 mirtazapine. Furthermore, the long-term safety effects of mirtazapine on growth, maturation, and cognitive and behavioral development in this age group are still unknown. A considerable 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 of 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.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in antidepressant-treated psychiatric patients under 25 years of age.
• If at any time you have thoughts of harming yourself or of suicide, consult your doctor or go to a hospital immediately.

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

Also, take special care with Mirtazapina Flas Normogen:

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

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

• Seizures (epilepsy). If seizures occur or become more frequent, stop taking Mirtazapina Flas Normogen and contact your doctor immediately;

• Liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapina Flas Normogen 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 periods of depression). If you start feeling elated or overexcited, stop taking Mirtazapina Flas Normogen and contact your doctor immediately;

• Diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• Eye conditions, such as increased eye pressure (glaucoma);

• Difficulty urinating, which could be due to an enlarged prostate.

• Certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.

  • If you experience signs of infection such as unexplained high fever, sore throat, and mouth ulcers;

• Stop taking Mirtazapina Flas Normogen and contact your doctor immediately for a blood test.

  • Rarely, these symptoms may indicate disorders 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, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with mirtazapine use. 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 previously experienced serious skin reactions, re-initiation of treatment with mirtazapine is not recommended.

Other medicines and Mirtazapina Flas Normogen

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

Do not take Mirtazapina Flas Normogen together with:

• Monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapina Flas Normogen within two weeks after stopping MAO inhibitors. If you stop taking Mirtazapina Flas Normogen, do not take MAO inhibitors for at least the next two weeks.

Examples of MAO inhibitors include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson’s disease).

Be cautious if you take Mirtazapina Flas Normogen together 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 certain 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, Mirtazapina Flas Normogen 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 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. It may increase the amount of Mirtazapina Flas Normogen in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapina Flas Normogen, 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, Mirtazapina Flas Normogen 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).

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

• Medicines that prevent blood clotting, such as warfarin.

Mirtazapina Flas Normogen may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor is advised to perform regular blood monitoring.

• Medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Flas Normogen with food and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapina Flas Normogen. It is recommended not to consume any alcohol. You may take Mirtazapina Flas Normogen with or without food.

Pregnancy and lactation

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 mirtazapine in pregnant women does not indicate an increased risk. However, caution should be exercised when using it during pregnancy. If you take Mirtazapina Flas Normogen until or shortly before delivery, your baby will be examined for possible adverse effects.

Similar medicines (SSRIs) taken during pregnancy may increase the risk of newborns developing a serious condition 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 occurs in your baby, you should contact your midwife and/or doctor immediately.

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

Driving and operating machinery

During treatment with Mirtazapina Flas Normogen, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Mirtazapina Flas Normogen contains glucose and aspartame

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

This medicine contains 2 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Mirtazapine Flas Normogen

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting dose is 15 mg 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 mg and 45 mg per day). The dose is usually 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 Mirtazapina Flas Normogen at the same time each day.

It is best to take the Mirtazapina Flas Normogen dose as a single dose before bedtime. However, your doctor may recommend splitting your dose, taking part in the morning and part at night before bedtime. The higher dose should be taken before bedtime.

How to take the orodispersible tablet

1. The tablets are taken by mouth. To avoid crushing the orodispersible tablet, gently press the tablet through the blister foil.
2. Take the orodispersible tablet with dry hands and place it on your tongue.

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

When you can expect to feel better

Mirtazapina Flas Normogen 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 Mirtazapina Flas Normogen with your doctor:

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

You will usually need to take Mirtazapina Flas Normogen until depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapina Flas Normogen than you should

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

The most likely symptoms of an overdose of Mirtazapina Flas Normogen (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 Torsade de pointes.

If you forget to take Mirtazapina Flas Normogen

If you are taking your dose once daily:

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

If you are taking your dose twice daily:

• 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 Mirtazapina Flas Normogen

Stop taking Mirtazapina Flas Normogen only if advised by your doctor.

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

Do not stop taking Mirtazapina Flas Normogen abruptly, even if depression has resolved. If you stop Mirtazapina Flas Normogen 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 on 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 eyes or skin; may suggest liver dysfunction (jaundice).

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

• signs of infection such as unexplained and sudden 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 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 indicate a disorder known as "serotonin syndrome",

• thoughts of harming yourself or of suicide,

• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis),

• red patches on the trunk, such as well-defined or circular macules, often with blisters in the center, skin peeling, 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, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects with mirtazapine include:

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 rash (exanthema),
• joint pain (arthralgia) or muscle pain (myalgia),
• back pain,
• dizziness or fainting upon standing 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 discontinued.

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):

• 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 paraesthesia),
• swelling in the mouth (oral oedema),
• swelling throughout the body (generalized oedema),
• localized swelling,
• hyponatraemia,
• inappropriate secretion of antidiuretic hormone,
• severe 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 discolouration of urine (rhabdomyolysis).

Other adverse effects in children and adolescents

In patients under 18 years of age, the following adverse effects were commonly observed in clinical trials: substantial weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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. Conservation of Mirtazapine Flas Normogen

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should 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 unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Flas Normogen

• The active substance is mirtazapine.
• Each orodispersible tablet contains 15 mg of mirtazapine (as mirtazapine hemihydrate).
• The other components are: mannitol, corn starch, microcrystalline cellulose, crospovidone, aspartame, orange flavour (containing glucose in maltodextrin derived from corn), and vegetable magnesium stearate.

Appearance of the medicine and contents of the pack

White, round, flat, bevelled orodispersible tablet marked with "15" on one side.

Pack sizes: 30 and 60 orodispersible tablets in unit-dose perforated blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: September 2020

Detailed and up-to-date 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84115/P_84115.html