Mirtazapine Normon 15 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Mirtazapine NORMON 15 mg Film-coated Tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it 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.

Leaflet Contents

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

1. What Mirtazapine NORMON is and what it is used for

Mirtazapine NORMON belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. What you need to know before starting to take Mirtazapine NORMON

Do not take – or – consult your doctor before starting to take Mirtazapine NORMON

• if you are allergic to mirtazapine or to any of the other components of this medicine (listed in section 6).
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Warnings and precautions

Talk to your doctor before starting to take Mirtazapine NORMON.

Children and adolescents

Mirtazapine NORMON should not normally be used to treat children and adolescents under 18 years of age. You should also be aware 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 medicine.

Nevertheless, your doctor may prescribe Mirtazapine NORMON to patients under 18 years of age if they consider it the most appropriate treatment for the patient. If Mirtazapine NORMON has been prescribed for a patient under 18 years of age and you wish to discuss this decision, please speak to 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 NORMON. In addition, the long-term effects on growth, maturation, and cognitive and behavioral development with mirtazapine in this age group are not yet known.

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 become effective.

You may be more likely to have such thoughts:

• if you have previously had suicidal or self-harming thoughts.

• if 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 tell a close relative 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 getting worse or if they are concerned about changes in your behavior.

Also, take special care with Mirtazapine NORMON:

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

• Inform your doctor about these conditions before taking Mirtazapine NORMON, 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 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, or mouth ulcers.

• Stop taking Mirtazapine NORMON 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 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 mirtazapine treatment should not be attempted.

Taking Mirtazapine NORMON with other medicines

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

Do not take Mirtazapine NORMON 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 at least the next two weeks.

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

Be cautious if you take Mirtazapine NORMON 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), and 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, 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. 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.

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).

If 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.

If 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 both are taken together, your doctor is advised to perform regular blood tests.

Taking Mirtazapine NORMON with food, drinks, and alcohol

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

It is recommended not to drink any alcohol.

You may take mirtazapine with or without food.

Pregnancy and breastfeeding

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

Limited experience with the use of Mirtazapine NORMON in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

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

Consult your doctor about whether you can breastfeed while taking Mirtazapine NORMON.

Driving and using machines

Mirtazapine NORMON may affect your concentration or level of alertness. During treatment with Mirtazapine NORMON, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

3. How to take Mirtazapine NORMON

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much to take

The usual starting 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 elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

• Take Mirtazapine NORMON at the same time each day.

It is best to take the mirtazapine dose as a single dose before going to bed. However, your doctor may recommend dividing your mirtazapine dose, taking part in the morning and part in the evening before bedtime. The higher dose should be taken before going to bed.

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

When you can expect to feel better

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

• Between 2 and 4 weeks after starting mirtazapine, talk to your doctor about how the 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 continue taking mirtazapine until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine NORMON than you should

• If you or someone else takes too much Mirtazapine NORMON, consult a doctor immediately.

You may also call the Toxicology Information Service. Telephone: 91 562 04 20.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations.

If you forget to take Mirtazapine NORMON

If you are supposed to take your dose once daily:

• If you forget to take your dose of mirtazapine, do not take a double dose to make up for the missed dose. Skip it and take your usual dose the next day.

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 Mirtazapine NORMON

• Stop taking mirtazapine only if advised by your doctor.

Stopping too early may cause depression to return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has resolved. If you stop mirtazapine 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 gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Mirtazapine NORMON can produce adverse effects, although not everyone experiences them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are listed below and can be categorized as follows:

• Very common: affect more than 1 in 10 patients.
• Common: affect between 1 and 10 in every 100 patients.
• Uncommon: affect between 1 and 10 in every 1,000 patients.
• Rare: affect between 1 and 10 in every 10,000 patients.
• Very rare: affect fewer than 1 in every 10,000 patients.
• Not known: cannot be estimated from the available data.

Very common:

• increased appetite and weight gain.
• drowsiness.
• headache.
• dry mouth.

Common:

• lethargy.
• dizziness.
• tremor.
• nausea.
• diarrhea.
• vomiting.
• 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 (edema).
• fatigue.
• vivid dreams.
• confusion.
• anxiety.
• difficulty sleeping.
• Memory problems, which in most cases resolved when treatment was discontinued.

In children under 18 years of age, the following adverse reactions were frequently observed in clinical trials: considerable weight gain, hives, and increased blood triglycerides.

Uncommon:

• feeling of exaggerated euphoria (mania).

• Stop taking mirtazapine and consult your doctor immediately.

• unusual skin sensations such as burning, prickling, tingling, or numbness (paresthesia).

• involuntary restless leg movements during sleep.

• fainting (syncope).

• numbness of the mouth (oral hypoesthesia).

• low blood pressure.

• nightmares.

• restlessness.

• hallucinations.

• inability to remain still.

Rare:

• yellowing of the eyes or skin; may indicate liver dysfunction (jaundice).

• Stop taking mirtazapine and consult your doctor immediately.

• muscle tics or contractions (myoclonus).

• Pancreatitis.

Not known:

• signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis).

• Stop taking mirtazapine and consult your doctor immediately to have a blood test.

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 blood cells, 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).

• Stop taking mirtazapine and consult your doctor immediately.

• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome."

• Stop taking mirtazapine and consult your doctor immediately.

• thoughts of harming yourself or of suicide.

• Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia).

• swelling in the mouth (oral edema).

• hyponatremia.

• inappropriate secretion of antidiuretic hormone.

• severe skin reactions (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis).

• red patches on the trunk, appearing as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. 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).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Mirtazapine NORMON

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

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.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the Sigre Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine NORMON

• The active substance is mirtazapine.

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

• The other components (excipients) are:

Tablet core: microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance of the medicine and contents of the pack

Mirtazapine NORMON are film-coated tablets.

The tablets are white or almost white, round, biconvex, scored, and printed with the code M15.

The tablet cannot be divided into equal doses. The score is intended to facilitate breaking the tablet for ease of swallowing.

Mirtazapine NORMON 15 mg film-coated tablets are packaged in blisters.

The following pack sizes are available: 30 and 60 tablets.

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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69308/P_69308.html