Leaflet: information for the user

Mirtazapina Flas Kern Pharma 15 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 effect 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 medications known as antidepressants.

Mirtazapina is used in the treatment of depression.

Do not take Mirtazapina Flas Kern Pharma

• If you are allergic (hypersensitive) to mirtazapine or to 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 sores in the mouth 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 disorder 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.
• 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 or other antidiabetic medication dose).
• Schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately.

If you experience any of the following symptoms, contact your doctor immediately:

• Trastorno bipolar (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 you experience signs of infection, such as high fever, sore throat, and mouth sores, stop taking Mirtazapina Flas and contact your doctor immediately to have a blood test.

In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms occur 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 (NET), 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. At the same time, 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 class of medications. However, 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.

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 are going to use) any of the medications on the following list.

Also inform your doctor or pharmacist if you are using or have used recently 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 are 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 of the 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 you stop taking nefazodone.
• • Medications for anxiety (anxiety) or insomnia (insomnia), such as benzodiazepines.

Medications for schizophrenia, such as olanzapine.

Medications for allergies, such as cetirizine.

Medications for intense pain, such as morphine.

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

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

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

Mirtazapina Flas 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 drink any 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 careful if you use it 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 any possible adverse effects.

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

Driving and using machines

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

Important information about some of the 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 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 Mirtazapina Flas dose 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 should, depending on the type of blister:

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

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

When to expect to feel better

Mirtazapina Flas usually starts 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.

You will usually 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 Toxicological 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:

In the case of takingtwo doses per day:

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):

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

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

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

Unknown(cannot be estimated from available information):

• Red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, genital sores, and eye sores. 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 at a temperature 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 packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

Composition of Mirtazapina Flas Kern Pharma

• The active ingredient is mirtazapine. Each buccal dispersible tablet contains 15 mg of mirtazapine.
• The other components (excipients) are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, L-methionine, microcrystalline cellulose, and guar gum (Avicel CE-15), aspartame (E-951), orange peel 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 ‘M1’ on one side.

Each package contains 30 buccal dispersible tablets.

Other Presentations

Mirtazapina Flas Kern Pharma 30 mg buccal dispersible tablets EFG

Holder of the marketing authorization

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

Actavis Limited

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This prospectus was approved in January 2010

Last reviewed date of this prospectus: 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/