MIRTAZAPINE FLAS KERN PHARMA 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mirtazapine Flas Kern Pharma 30 mg orodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the pack:

1. What Mirtazapine Flas Kern Pharma is and what it is used for
2. Before taking Mirtazapine Flas Kern Pharma
3. How to take Mirtazapine Flas Kern Pharma
4. Possible side effects
5. Storing Mirtazapine Flas Kern Pharma
6. Further information

1. What MIRTAZAPINE FLAS KERN PHARMA is and what it is used for

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. Before taking MIRTAZAPINE FLAS KERN PHARMA

Do not take Mirtazapine Flas Kern Pharma

• If you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapine Flas Kern Pharma (see section 6 "Further information"). In this case, consult your doctor as soon as possible before taking Mirtazapine Flas.

• If you are taking or have recently 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.

Be careful with Mirtazapine Flas Kern Pharma

Tell your doctor if you have or have had any other disorder or disease, such as:

• Epilepsy (seizures or fits). If seizures occur or your seizures become more frequent, stop taking Mirtazapine Flas and contact your doctor immediately.
• Liver disease, including jaundice (yellowing of the skin or mucous membranes). If jaundice occurs, stop taking Mirtazapine Flas and contact your doctor immediately.

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

If signs of infection appear, such as unexplained high fever, sore throat, and sores in the mouth, stop taking Mirtazapine Flas and contact your doctor immediately for 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 starting treatment.

Elderly patients are often more sensitive, especially to side effects.

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.

Use in children and adolescents under 18 years

Mirtazapine Flas 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 a higher risk of side effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medication. Nevertheless, your doctor may prescribe Mirtazapine Flas to patients under 18 years when they decide what is best for the patient. If your doctor has prescribed Mirtazapine Flas 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 symptoms listed below appear or worsen in patients under 18 years taking Mirtazapine Flas. Additionally, the long-term safety effects on growth, maturity, and development of knowledge and behavior of Mirtazapine 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 could get worse when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to work.

You may be more likely to think this way if:

• You have previously had suicidal thoughts or thoughts of harming yourself.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years 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 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.

Use of other medicines

Tell your doctor or pharmacist if you are taking (or are about to take) any of the medicines listed below.

Also, tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.

Do not take Mirtazapine Flas with:

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

Be careful if you take Mirtazapine 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)(a herbal remedy for depression). In very rare cases, Mirtazapine Flas 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, consult your doctor immediately.
• The antidepressant nefazodone. It may increase the amount of Mirtazapine Flas in your blood.

Tell your doctor if you are taking this medicine. Your doctor may need to decrease the dose of Mirtazapine Flas or increase it again when you stop taking 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 Flas 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).

In combination with Mirtazapine Flas, these medicines may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. You may need to decrease the dose of Mirtazapine Flas or, when you stop taking these medicines, increase the dose of Mirtazapine Flas again.

• Medicines for epilepsy, such as carbamazepine and phenytoin.
• Medicines for tuberculosis, such as rifampicin.

In combination with Mirtazapine Flas, these medicines may decrease the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of Mirtazapine Flas or, when you stop taking these medicines, decrease the dose of Mirtazapine Flas.

• Medicines to prevent blood clotting, such as warfarin.

Mirtazapine may increase the effects of warfarin on your blood. Tell your doctor if you are taking this medicine. In the case of combination, it is advisable for a doctor to carefully monitor your blood.

Taking Mirtazapine Flas Kern Pharma with food and drinks

You may feel drowsy or sleepy if you drink alcohol while taking Mirtazapine Flas. Therefore, it is advisable not to drink any alcohol during treatment with Mirtazapine Flas.

Mirtazapine Flas can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

If you are taking Mirtazapine Flas and become pregnant or plan to become pregnant, consult your doctor if you can continue taking Mirtazapine Flas. If you use Mirtazapine Flas until or shortly before delivery, your baby will be examined for possible side effects.

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

Driving and using machines

Mirtazapine may decrease your alertness and concentration. Therefore, during treatment with Mirtazapine Flas, make sure your abilities are not affected before driving or using machinery.

Important information about some of the ingredients of Mirtazapine Flas Kern Pharma

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

3. How to TAKE MIRTAZAPINE FLAS KERN PHARMA

Follow the instructions for administration of Mirtazapine Flas Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

How much to take

The initial dose is usually 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 Flas at the same time every day.

It is best to take the dose of Mirtazapine Flas once before bedtime. However, your doctor may recommend taking your dose of Mirtazapine Flas divided into morning and night before bedtime.

The highest dose should be taken before bedtime.

Instructions for use

• To remove the tablets from the blister pack, you will need to:

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

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

When can you expect to feel better

Normally, Mirtazapine Flas will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better. It is essential to talk to your doctor during the first few weeks of treatment about the effects of Mirtazapine Flas.

At 2-4 weeks after starting to take Mirtazapine Flas, inform your doctor of the effect of the treatment. 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 Mirtazapine Flas until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapine Flas Kern Pharma than you should

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 medicine and the amount taken. The most likely signs of an overdose are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapine Flas Kern Pharma

Do not take a double dose to make up for forgotten doses. Follow these instructions:

In the case of one dose per day:

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

In the case of two doses per day:

• If you have forgotten the morning dose, take it with the night dose.
• If you have forgotten the night dose, do not take it with the next morning's dose; skip it and continue with your usual morning and night doses.
• If you have forgotten both doses, do not try to make up for the forgotten doses. Skip both doses and continue the next day with your usual morning and night doses.

If you stop taking Mirtazapine Flas Kern Pharma

Stop taking Mirtazapine Flas only 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 Flas abruptly, even if depression has disappeared. If you stop treatment 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Mirtazapine Flas Kern Pharma can cause adverse effects, although not all people suffer from them.

Suspend the use of mirtazapine and contact your doctor or seek immediate medical attention if you suffer from one of the following serious side effects:

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

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

Common (affecting between 1 and 10 out of 100 patients):

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• hives or skin rash (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

Uncommon (affecting between 1 and 10 out of 1,000 patients):

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

• involuntary movements of the legs during sleep
• fainting (syncope)
• numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

Rare (affecting between 1 and 10 out of 10,000 patients):

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice). Stop taking Mirtazapine Flas and consult your doctor immediately

• twitching or muscle contractions (myoclonus)
• pancreatitis

Unknown (cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and mouth ulcers (agranulocytosis). Stop taking Mirtazapine Flas and consult your doctor immediately for a blood test
• in rare cases, Mirtazapine Flas may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapine Flas can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapine 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)
• epileptic seizure (convulsions). Stop taking Mirtazapine Flas and consult your doctor immediately
• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome". Stop taking Mirtazapine Flas and consult your doctor immediately
• thoughts of self-harm or suicide. Stop taking Mirtazapine Flas and consult your doctor immediately

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• inadequate secretion of antidiuretic hormone
• 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 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 or drug hypersensitivity syndrome).

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, consult your doctor or pharmacist.

5. Conservation of MIRTAZAPINA FLAS KERN PHARMA

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

Store in the original package, to protect it from light and moisture.

Do not use Mirtazapine Flas Kern Pharma after the expiration date shown on the package, 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 packages 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 packages and medicines you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Mirtazapine Flas Kern Pharma

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

Appearance of the Product and Package Contents

Mirtazapine Flas Kern Pharma is presented in the form of white, round, biconvex tablets marked with 'M2' on one face.

Each package contains 30 buccodispersible tablets.

Other Presentations

Mirtazapine Flas Kern Pharma 15 mg buccodispersible tablets EFG

Marketing Authorization Holder

Kern Pharma S.L.

Poligono Ind. Colon II. Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

Actavis Limited

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This prospectus was approved in January 2010

Date of last revision of this prospectus: July 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.es/