MIRTAZAPINE SANDOZ 45 mg FILM-COATED TABLETS

2. What you need to know before taking Mirtazapine Sandoz Pharmaceutical

Do not take or consult your doctor before taking Mirtazapine Sandoz Pharmaceutical

• if you are allergic to mirtazapine or any of the other components of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking mirtazapine.
• if you are taking or have recently taken (in the last two weeks) medications 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 medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years of age because its efficacy has not been demonstrated. At the same time, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years of age when they decide what is most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age 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 still unknown. It has also been observed that this age group experiences 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 committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications 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 of age with psychiatric disorders and who are being treated with an antidepressant.

If you have thoughts of harming yourself or committing 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 package leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Also, be especially careful with mirtazapine

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

If you inform your doctor about these situations before taking mirtazapine, if you have not already done so

• seizures(epilepsy). If seizures appear or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver disease, including jaundice. If you develop jaundice, 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;
• certain types of heart diseasethat can change the rhythm of your heart, a recent heart attack, heart failure, or taking certain medications that can affect heart rhythm.

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

If you stop taking mirtazapine 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 between 4 and 6 weeks of treatment.

• If you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medications,
• 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.

Other medications and Mirtazapine Sandoz Pharmaceutical

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

Do not takeMirtazapine Sandoz Pharmaceuticalwith:

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

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

Be careful ifyou take mirtazapine with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans(used to treat migraines), buprenorphine (used to treat pain or opioid dependence), 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 medicinal plant for depression). In very rare cases, mirtazapine alone or with these medications can lead to a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), 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 can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone,
• medications for anxiety or insomniasuch as benzodiazepines,
• medications for schizophreniasuch as olanzapine,
• medications for allergiessuch as cetirizine,
• medications for severe painsuch as morphine.

When combined with these medications, mirtazapine can increase the drowsiness caused by these medications,

• medications for infections: medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole), and medications for HIV/AIDS (HIV protease inhibitors) and medications for stomach ulcers(such as cimetidine).

If taken with mirtazapine, these medications can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping these medications,

• medications for epilepsysuch as carbamazepine and phenytoin,
• medications for tuberculosissuch as rifampicin.

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

• medications to prevent blood clottingsuch as warfarin.

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

• medications that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Sandoz Pharmaceutical with food 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 until or shortly before delivery, your child will be examined for possible adverse effects.

Taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) in babies, 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 child, you should immediately consult your midwife and/or doctor.

Driving and using machines

Mirtazapine can affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, make sure that concentration and alertness are not affected before circulating (e.g., by bicycle).

Mirtazapine Sandoz Pharmaceutical contains lactose

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

3. How to take Mirtazapine Sandoz Pharmaceutical

Follow the administration instructions of this medication exactly as 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 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 have kidney or liver disease, your doctor may change the dose.

When to take it

Take mirtazapine at the same time every day.

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

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

When can you expect to feel better

Normally, mirtazapine 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:

If you do not feel better after 2 to 4 weeks, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 or 4 weeks.

Normally, you will need to take mirtazapine until the symptoms of depression have disappeared for 4 or 6 months.

If you take more Mirtazapine Sandoz Pharmaceutical than you should

If you or someone else takes too much mirtazapine, consult a doctor immediately.

The most likely symptoms of a mirtazapine overdose (without other medications 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 condition known as Torsades de pointes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount taken.

If you forget to take Mirtazapine Sandoz Pharmaceutical

If you need to take your dose once a day

• do not take a dose to make up for the forgotten doses. Take the next dose at the usual time.

If you need to take your dose twice a day

If you stop taking Mirtazapine Sandoz Pharmaceutical

Only stop taking mirtazapine if you consult your doctor.

If you stop too soon, depression may recur. 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 medication, 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 throat pain and mouth ulcers (agranulocytosis). 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),
• 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 can 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 torso, 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 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,
• sleepiness,
• headache,
• dry mouth.

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

• lethargy,
• dizziness,
• tremors,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• urticaria or skin eruptions (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 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 tension,
• 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),
• generalized swelling (generalized edema),
• localized swelling,
• hyponatremia,
• inadequate secretion of antidiuretic hormone,
• severe skin reactions (bullous dermatitis, erythema multiforme),
• sleepwalking (somnambulism),
• speech problems,
• increased creatine kinase levels in the blood,
• difficulty urinating (urinary retention),
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis),
• increased prolactin hormone levels in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or milky discharge from the nipple).

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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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 Sandoz Pharmaceutical

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Sandoz Pharmaceutical 45 mg Film-Coated Tablets

• The active ingredient is mirtazapine. Each film-coated tablet contains 45 mg of mirtazapine.
• The other components are:

Core: lactose, cornstarch, hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate.

Coating: hypromellose, macrogol 8000, titanium dioxide (E-171).

Appearance of the Product and Package Contents

Mirtazapine Sandoz Pharmaceutical 45 mg are film-coated tablets.

The tablets are white, round, and biconvex

They are presented in blisters, in packages with 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

COMBINO PHARM MALTA LTD

60 Hal Far Industrial Estate

Hal Far BBG 07 Malta

Date of the Last Revision of this Prospectus:November 2023

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