MIRTAZAPINE NORMON 30 mg FILM-COATED TABLETS

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 peeling of the skin, blisters or sores in the mouth after taking mirtazapine or other medicines.

Warnings and precautions

Consult your doctor before taking Mirtazapine NORMON.

Children and adolescents

Mirtazapine NORMON should not normally be used in the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years there is an increased risk of side effects such as suicidal attempts, suicidal ideation, 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 when he decides it is the most convenient 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 start taking antidepressants for the first time, as these medicines usually take two weeks or sometimes more to take effect.

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. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.
• Severe skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS). Stop taking it 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.

• If you have thoughts of harming or killing yourself 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 NORMON:

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

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

• seizures(epilepsy). If seizures appear or your seizures become more frequent, stop taking Mirtazapine and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, 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 you notice signs of infection such as high unexplained fever, sore throat, and sores in the mouth

• Stop taking Mirtazapine NORMON 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.

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 have stopped 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 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 present a combination of these symptoms, consult 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. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping 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. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping 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. It may be necessary to increase the dose of mirtazapine or decrease it again when stopping these medicines.

• medicines to prevent blood clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin in the blood. Tell your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform 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 if used during pregnancy.

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

Medicines like mirtazapine (SSRIs) taken during pregnancy 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 acquire a bluish tone. 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.

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 operate tools or machines until you know how the treatment with Mirtazapine NORMON affects you.

3. How to take Mirtazapine NORMON

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 usual initial 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). 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 taking your dose of mirtazapine divided into morning and night 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 take effect after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better. It is essential 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, consult a doctor immediately.

You can also call the Toxicology Information Service. Phone 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 have to take your dose twice a day

If you stop taking Mirtazapine NORMON

• Stop taking mirtazapine only if you consult your doctor.

If you stop 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 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 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 medications, 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 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 high, unexplained, and sudden fever, sore throat, and sores in the mouth (agranulocytosis).

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

In rare cases, mirtazapine can 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 prospectus.

5. Conservation of Mirtazapine NORMON

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine NORMON

• The active ingredient is mirtazapine.

Mirtazapine NORMON 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.

• The other components (excipients) are:

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

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

Appearance of the Product and Package Contents

Mirtazapine NORMON is a film-coated tablet.

The tablets are white or almost white, round, biconvex, with serigraphy M30 and scored.

The tablet can be divided into two equal halves.

Mirtazapine NORMON 30 mg film-coated tablets are packaged in blisters.

The following package sizes are available: 30 and 56 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 Prospectus: September 2020

Detailed and updated information on this medication 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 medication 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/67015/P_67015.html