Leaflet: information for the user

Mirtazapina Flas Kern Pharma 30 mg buccal dispersible tablets EFG

Read this leaflet carefully before you start taking the medicine.

• 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Mirtazapina Flas Kern Pharma is and for what it is used

2. Before taking Mirtazapina Flas Kern Pharma

3. How to take Mirtazapina Flas Kern Pharma

4. Possible side effects

5. Storage of Mirtazapina Flas Kern Pharma

6. Additional information

Mirtazapina belongs to a group of medicines called antidepressants.

Mirtazapina is used in the treatment of depression.

Do not take Mirtazapina Flas Kern Pharma

• If you are allergic (hypersensitive) to mirtazapine or any of the other components of Mirtazapina Flas Kern Pharma (see section 6 “Additional information”). Consult your doctor as soon as possible before taking Mirtazapina Flas.

• If you are taking or have taken recently (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

• If you have ever had a severe skin rash or peeling of the skin, blisters or mouth sores after taking mirtazapine or other medications.

Be especially careful with Mirtazapina Flas Kern Pharma

Inform your doctor if you have or have had any other condition or disease such as:

• Epilepsy (seizures or convulsions). If seizures occur or your seizures become more frequent, stop taking Mirtazapina Flas and contact your doctor immediately.
• Liver diseases, including jaundice (yellowing of the skin or mucous membranes). If jaundice appears, stop taking Mirtazapina Flas and contact your doctor immediately.

• Kidney diseases.
• Heart diseases or low blood pressure.
• Eyes diseases, such as glaucoma (increased intraocular pressure).
• Difficulty urinating, which may be due to an enlarged prostate.
• Diabetes (may need to adjust insulin or other antidiabetic medication doses).
• Schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately.
• Bipolar disorder (alternation of periods of excitement/hyperactivity and periods of depression). If you start feeling excited or overexcited, stop taking Mirtazapina Flas and contact your doctor immediately.

If signs of infection, such as high fever, sore throat, and mouth sores, appear, stop taking Mirtazapina Flas and contact your doctor immediately to perform a blood test.

In rare cases, these symptoms may be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms appear 4-6 weeks after treatment.

Older patients are often more sensitive, especially to adverse effects.

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), 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 had severe skin reactions, do not restart treatment with mirtazapine.

Use in children and adolescents under 18 years

Mirtazapina Flas should not be used normally in the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe Mirtazapina Flas to patients under 18 years when they decide what is best for the patient. If your doctor has prescribed Mirtazapina Flas to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the following symptoms appear or worsen in patients under 18 years taking Mirtazapina Flas. Additionally, the long-term effects on safety related to growth, maturation, and development of Mirtazapina Flas 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 yourself or committing suicide.

This may worsen when you first start taking antidepressants, as these medications take time to become effective, usually two weeks or more.

You may be more prone to thinking this way if:

• You have previously had suicidal thoughts or self-harm.
• 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 taking an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful to tell a close relative or friendthat you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.

Use of other medications

Inform your doctor or pharmacist if you are using (or will use) any of the medications on the following list.

Also inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Do not take Mirtazapina Flas with:

• Monamine oxidase inhibitors (MAOIs)(MAOIs). Also, do not take Mirtazapina Flas during the two weeks after stopping MAOIs. If you stop taking Mirtazapina Flas, do not take MAOIs for the next two weeks. Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful if you take Mirtazapina Flas with:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders)and St. John's Wort – Hypericum perforatum(medicinal plant for depression). In rare cases, Mirtazapina Flas alone or with these medications may cause the so-called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately.
• The antidepressantnefazodone. It may increase the amount of Mirtazapina Flas in the blood.

Inform your doctor if you are taking this medication. You may need to reduce the dose of Mirtazapina Flas, or increase it again when stopping nefazodone.

• Anxiety medications or insomnia medications, such as benzodiazepines.

Schizophrenia medications, such as olanzapine.

Allergy medications, such as cetirizine.

Pain medications, such as morphine.

Mirtazapina Flas may increase the drowsiness caused by these medications when taken together.

• Infection medications:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), and HIV/AIDS medications (protease inhibitors).

When taken with Mirtazapina Flas, these medications may increase the amount of mirtazapine in the blood. Inform your doctor if you are using these medications. You may need to reduce the dose of Mirtazapina Flas or, when stopping these medications, increase the dose of Mirtazapina Flas again.

• Epilepsy medications, such as carbamazepine and phenytoin.
• Tuberculosis medications, such as rifampicin.

When taken with Mirtazapina Flas, these medications may reduce the amount of mirtazapine in the blood. Inform your doctor if you are using these medications. You may need to increase the dose of Mirtazapina Flas or, when stopping these medications, reduce the dose of Mirtazapina Flas again.

• Blood thinners, such as warfarin.

Mirtazapine may increase the effects of warfarin in the blood. Inform your doctor if you are using this medication. In the case of combination, it is recommended that a doctor closely monitor your blood.

Taking Mirtazapina Flas Kern Pharma with food and drinks

You may feel drowsy or sleepy if you take alcohol while taking Mirtazapina Flas. Therefore, it is recommended not to drinkany alcohol during treatment with Mirtazapina Flas.

Mirtazapina Flas can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The limited experience of administering Mirtazapina Flas to pregnant women does not indicate an increased risk. However, you should be cautious if used during pregnancy.

If you are taking Mirtazapina Flas and become pregnant or want to become pregnant, consult your doctor if you can continue taking Mirtazapina Flas. If you use Mirtazapina Flas until, or shortly before, delivery, your baby will be examined to detect possible adverse effects.

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

Driving and using machines

Mirtazapine may reduce alertness and concentration. Therefore, during treatment with Mirtazapina Flas, ensure that your faculties are not affected before driving or using machinery.

Important information about some components of Mirtazapina Flas Kern Pharma

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions for Mirtazapina Flas Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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). Normally, the dose is the same for all ages. However, if you are an older person or if you have a kidney or liver disease, your doctor may change the dose.

When to take it

Take Mirtazapina Flas at the same time every day.

It is better to take the dose of Mirtazapina Flas all at once before going to bed. However, your doctor may recommend that you divide your dose of Mirtazapina Flas into the morning and evening before going to bed.

The highest dose should be taken before going to bed.

Usage instructions

• To extract the tablets from the blister, you must, depending on the type of blister:

• press the tablet carefully through the sheet or
• carefully remove the sheet.

• Take the tablet with dry hands and put it on your tongue.
• The tablet will dissolve. After dissolving, it is recommended to drink a little water.

When to expect to feel better

Normally, Mirtazapina Flas 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 weeks of treatment, you talk to your doctor about the effects of Mirtazapina Flas.

Inform your doctor about the effect of the treatment 2-4 weeks after starting to take Mirtazapina Flas. If you still do not feel better, your doctor may prescribe a higher dose. In this case, talk to your doctor after another 2-4 weeks.

Normally, you will need to take Mirtazapina Flas until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Flas Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount taken. The most likely signs of an overdose are numbness, disorientation, and palpitations.

If you forgot to take Mirtazapina Flas Kern Pharma

Do not take a double dose to compensate for the missed doses. Follow these instructions:

In the case of takingone dose per day:

• If you forgot to take your dose, do not take the missed dose. Simply skip it. Continue treatment the next day with the usual dose.

In the case of takingtwo doses per day:

• If you forgot the morning dose, take it with the evening dose.
• If you forgot the evening dose, do not take it with the morning dose the next day; skip it and continue with your usual morning and evening doses.
• If you forgot both doses, do not try to compensate for the missed doses. Skip both doses and continue the next day with your usual morning and evening doses.

If you interrupt the treatment with Mirtazapina Flas Kern Pharma

Stop taking Mirtazapina Flas only if you consult with 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 Mirtazapina Flas abruptly, even when depression has disappeared. If you stop treatment abruptly, you may feel sick, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually reduce the dose.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Mirtazapina Flas Kern Pharma may cause side effects, although not everyone will experience them.

Stop using mirtazapina and contact your doctor or seek medical attention immediately if you experience one of the following severe side effects:

Very common(affects more than 1 in 10 patients):

• Increased appetite and weight gain
• Drowsiness
• Headache
• Dry mouth

Common(affects between 1 and 10 in 100 patients):

• Lethargy
• Dizziness
• Tremor
• Nausea
• Diarrhea
• Vomiting
• Urticaria or skin rash (exanthema)
• Pain in the joints (arthralgia) or muscles (myalgia)
• Back pain
• Dizziness or fainting when standing up quickly (orthostatic hypotension)
• Swelling (usually in the 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(affects between 1 and 10 in 1,000 patients):

• Exaggerated feeling of euphoria (mania). Stop taking Mirtazapina Flas and consult your doctor immediately
• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)

• Involuntary movements of leg agitation during sleep
• Fainting (syncope)
• Feeling of numbness in the mouth (hypoaesthesia oral)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Inability to remain still

Rare(affects between 1 and 10 in 10,000 patients):

• Yellowing of the eyes or skin; may indicate liver dysfunction (jaundice). Stop taking Mirtazapina Flas and consult your doctor immediately

• Tics or muscle contractions (myoclonus)
• Pancreatitis

Unknown(cannot be estimated from available information):

• Signs of infection, such as sudden and unexplained high fever, sore throat, and mouth sores (agranulocytosis). Stop taking Mirtazapina Flas and consult your doctor immediately for a blood test
• In rare cases, Mirtazapina Flas may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapina Flas may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapina Flas may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia)
• Seizure (convulsions). Stop taking Mirtazapina Flas and consult your doctor immediately
• Combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome". Stop taking Mirtazapina Flas and consult your doctor immediately
• Thoughts of self-harm or suicide. Stop taking Mirtazapina Flas and consult your doctor immediately

• Abnormal sensations in the mouth (paresthesia oral)
• Swelling in the mouth (buccal edema)
• Hyponatremia
• Inadequate secretion of antidiuretic hormone
• Red patches on the trunk, often with circular or circumscribed lesions, and sometimes with blisters in the center, skin peeling, mouth ulcers, 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 consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, consult your doctor or pharmacist.

Keep out of reach and sight of children.

Do not store above 25°C.

Store in the original packaging to protect it from light and humidity.

Do not use Mirtazapina Flas Kern Pharma after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Mirtazapina Flas Kern Pharma

• The active ingredient is mirtazapine. Each buccal dispersible tablet contains 30 mg of mirtazapine.
• The other components (excipients) are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropyl cellulose, crospovidone, anhydrous colloidal silica, L-methionine, microcrystalline cellulose, and guar gum (Avicel CE-15), aspartame (E-951), orange silesia aroma, magnesium stearate.

Appearance of the product and contents of the package

Mirtazapina Flas Kern Pharma is presented in the form of white, round, biconvex tablets marked with ‘M2’ on one side.

Each package contains 30 buccal dispersible tablets.

Other Presentations

Mirtazapina Flas Kern Pharma 15 mg buccal dispersible tablets EFG

Marketing Authorization Holder

Kern Pharma S.L.

Poligono Ind. Colon II.Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

Actavis Limited

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This leaflet was approved in January 2010

Last reviewed date of this leaflet: July 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/