MIRTAZAPINE NORMON 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mirtazapine NORMON 15 mg film-coated tablets EFG

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

• If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is Mirtazapine NORMON and what is it 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 you take Mirtazapine NORMON

Do not take - or consult your doctor before taking Mirtazapine NORMON

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken 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

Talk to your doctor before taking Mirtazapine NORMON.

Children and adolescents

Mirtazapine NORMON should not normally be used for the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years there is an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritation) when taking this type of medicine.

However, your doctor may prescribe Mirtazapine NORMON to patients under 18 years when they decide it is best for the patient. If your doctor has prescribed Mirtazapine NORMON 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 above symptoms appear or worsen in patients under 18 years who are taking Mirtazapine NORMON. Additionally, the long-term safety effects on growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known.

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 can take two weeks or sometimes longer to work.

You may be more likely to think this way:

• if you have previously had thoughts of suicide or self-harm.
• 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 are being treated with an antidepressant.

• If you have thoughts of self-harm or suicide at any time, talk to 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 NORMON:

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

• Tell your doctor about these situations before taking Mirtazapine NORMON, if you have not already:

• 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 diseaseor 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;

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

• Stop taking Mirtazapine NORMON 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 treatment.

• if you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medicines.
• Severe 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 the use of mirtazapine. 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, do not restart treatment with mirtazapine.

Taking Mirtazapine NORMON with other medicines

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

Do not take MirtazapineNORMON with:

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

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

Be careful ifyou take Mirtazapine NORMON 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), and St. John's Wort – Hypericum perforatum(a medicinal plant for depression). In very rare cases, mirtazapine 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, talk to your doctor immediately.
• the antidepressant nefazodone. It may increase the amount of mirtazapine in the blood. Tell your doctor if you are taking this medicine. Your doctor may need to decrease 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.

In combination 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).

If taken with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Tell your doctor if you are taking these medicines. Your doctor may need to decrease 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 decrease the amount of mirtazapine in the blood. Tell your doctor if you are taking these medicines. Your doctor may need to increase the dose of mirtazapine or decrease 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. Tell your doctor if you are taking this medicine. If you take them together, your doctor may recommend that you have blood tests.

Taking Mirtazapine NORMON with food, drinks, 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

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

If you use mirtazapine until or shortly before birth, your baby will be examined for possible adverse effects.

Taking similar medicines (SSRIs) during pregnancy may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), 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.

Ask your doctor if you can breastfeed while taking Mirtazapine NORMON.

Driving and using machines

Mirtazapine NORMON may affect your concentration or alertness. During treatment with Mirtazapine NORMON, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how the treatment with Mirtazapine NORMON affects you.

3. How to take Mirtazapine NORMON

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, 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 that you increase the 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 Mirtazapine NORMON at the same time every day.

It is best to take the dose of mirtazapine once before going to bed. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before going to bed. The highest 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 can you expect to feel better

Normally, Mirtazapine NORMON 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:

• between 2 and 4 weeks after starting to take mirtazapine, 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 mirtazapine until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapine NORMON than you should

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

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

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

If you forget to take Mirtazapine NORMON

If you have to take your dose once a day

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

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 NORMON

• Stop taking mirtazapine only if you consult your doctor.

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

Do not stop taking mirtazapine abruptly, even if depression has disappeared. If you stop taking mirtazapine 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 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, Mirtazapine NORMON can produce adverse effects, although not all people suffer from them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are indicated below and can be divided into:

• Very Frequent:affect more than 1 in 10 patients.
• Frequent:affect between 1 and 10 in 100 patients.
• Uncommon:affect between 1 and 10 in 1,000 patients.
• Rare:affect between 1 and 10 in 10,000 patients.
• Very Rare:affect less than 1 in 10,000 patients.
• Unknown:cannot be estimated from the available data.

Very Frequent:

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

Frequent:

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

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

Uncommon:

• feeling of exaggerated euphoria (mania).

• Stop taking mirtazapine and consult your doctor immediately.

• 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:

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

• Stop taking mirtazapine and consult your doctor immediately.

• twitching or muscle contractions (myoclonus).
• Pancreatitis.

Unknown:

• signs of infection such as unexplained high fever and sudden throat pain and sores in the mouth (agranulocytosis).

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

In rare cases, mirtazapine may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine can 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).

• 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 can be signs of a disorder called "serotonin syndrome".

• Stop taking mirtazapine and consult your doctor immediately.

• thoughts of self-harm or suicide.

• Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia).
• swelling in the mouth (oral edema).
• hyponatremia.
• inadequate secretion of antidiuretic hormone.
• severe skin reactions (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, 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 eruptions 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 or drug hypersensitivity syndrome).

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

5. Conservation of Mirtazapine NORMON

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Keep in the original packaging to protect it from light and moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines at the Sigre Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine NORMON

• The active ingredient is mirtazapine.

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

• The other components (excipients) are:

Core of the tablet: microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance of the Product and Package Contents

Mirtazapine NORMON are film-coated tablets.

The tablets are white or almost white, round, biconvex, scored, and serigraphed with M15.

The tablet cannot be divided into equal doses. The score line is to facilitate breaking and swallowing.

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

The following package 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 Last Revision of this Leaflet: September 2020

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

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