Mirtazapine Flas Kern Pharma 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Flas Kern Pharma 15 mg orodispersible tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used in the treatment of depression.

2. BEFORE TAKING MIRTAZAPINE FLAS KERN PHARMA

Do not take Mirtazapine Flas Kern Pharma

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

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

• If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Take special care with Mirtazapine Flas Kern Pharma

Inform your doctor if you have or have had any other disorder or illness 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 diseases, including jaundice (yellowing of the skin or mucous membranes). If jaundice occurs, stop taking Mirtazapine 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 dose or other antidiabetic medicines).

• Schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately.

• Bipolar disorder (alternating periods of elevated mood/hyperactivity and depression). If you start feeling overly elated or overexcited, stop taking Mirtazapine Flas and contact your doctor immediately.

If signs of infection appear, such as unexplained high fever, sore throat, or mouth ulcers, stop taking Mirtazapine Flas and contact your doctor immediately for a blood test.

In rare cases, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

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

Severe skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these severe skin reactions.

Mirtazapine treatment should not be restarted in patients who have previously experienced severe skin reactions.

Use in children and adolescents under 18 years of age

Mirtazapine Flas is not normally used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Flas to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Mirtazapine Flas to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed below appear or worsen in patients under 18 years of age who are taking Mirtazapine Flas. In addition, the long-term effects on growth, maturation, and cognitive and behavioral development with 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 of suicide.

This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to become effective.

You may be more likely to have such thoughts if:

• You have previously had suicidal or self-harming thoughts.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

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

Use of other medicines

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

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

Do not take Mirtazapine Flas with:

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

Be cautious if taking Mirtazapine Flas with:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan or triptans (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), and preparations containing St. John’s wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, Mirtazapine Flas alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhea, uncontrollable muscle contractions, 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 may increase the amount of Mirtazapine Flas in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapine Flas, or increase it again when stopping nefazodone.
  • Medicines for anxiety or inability to sleep (insomnia), such as benzodiazepines.

Medicines for schizophrenia, such as olanzapine.

Medicines for allergies, such as cetirizine.

Medicines for severe pain, such as morphine.

When used in combination with these medicines, Mirtazapine Flas may increase the drowsiness caused by them.

• 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).

When used in combination with Mirtazapine Flas, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. You may need to reduce the dose of Mirtazapine Flas, or when stopping treatment with these medicines, increase the dose of Mirtazapine Flas again.

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

When used in combination with Mirtazapine Flas, these medicines may reduce the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. You may need to increase the dose of Mirtazapine Flas, or when stopping treatment with these medicines, reduce the dose of Mirtazapine Flas.

• Medicines to prevent blood clotting, such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In case of combination, it is advisable for a doctor to closely 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 using 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 become pregnant or plan to become pregnant while taking Mirtazapine Flas, consult your doctor whether you can continue taking Mirtazapine Flas. If you take Mirtazapine Flas up to or shortly before delivery, your baby will be monitored for possible adverse effects.

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

Driving and using machines

Mirtazapine may reduce alertness and concentration. Therefore, during treatment with Mirtazapine Flas, make sure your abilities are not impaired before driving or operating machinery.

Important information about some of the components 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 exactly the administration instructions for Mirtazapine Flas provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

How much to take

The usual starting 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 age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

Take Mirtazapine Flas at the same time each day.

It is best to take the dose of Mirtazapine Flas as a single dose before going to bed. However, your doctor may recommend dividing your dose, taking part in the morning and part at night before going to bed.

The higher dose should be taken before going to bed.

Instructions for use

• To remove the tablets from the blister pack, depending on the type of blister:

• gently press the tablet through the foil, or

• carefully peel back the foil.

• Take the tablet with dry hands and place it on your tongue.

• The tablet will dissolve. After it has dissolved, it is recommended to swallow with a small amount of water.

When can you expect to feel better

Mirtazapine Flas usually starts to take effect after 1 to 2 weeks, and after 2 to 4 weeks you may begin to feel better. It is important that during the first weeks of treatment you discuss the effects of Mirtazapine Flas with your doctor.

Two to four weeks after starting Mirtazapine Flas, inform your doctor about the effect the treatment has had. If you still do not feel better, your doctor may prescribe a higher dose. In this case, speak with your doctor again after another 2 to 4 weeks.

You will usually need to continue taking Mirtazapine Flas until depressive symptoms have

disappeared for 4 to 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 medication and the amount taken.

The most likely signs of 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 missed doses. Follow the instructions below:

If you are taking one dose per day:

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

If you are taking two doses per day:

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

If you stop taking Mirtazapine Flas Kern Pharma

Stop taking Mirtazapine Flas only if advised by your doctor.

If you stop treatment too early, depression may return. When you start feeling 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 suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to gradually reduce the dose.

If you have any further 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 everyone experiences them.

Stop using mirtazapine and contact your doctor or seek immediate medical attention if you experience any of the following serious 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
• diarrhoea
• 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 (oedema)
• 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):

• feeling of exaggerated euphoria (mania). Stop taking Mirtazapine Flas and consult your doctor immediately
• unusual skin sensations such as burning, prickling, tingling or pins and needles (paraesthesia)
• involuntary restless leg movements during sleep
• fainting (syncope)
• numbness or reduced sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• restlessness
• hallucinations
• inability to remain still

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

• yellowing of the skin or eyes; may indicate liver dysfunction (jaundice). Stop taking Mirtazapine Flas and consult your doctor immediately
• tics or muscle twitching (myoclonus)
• pancreatitis

Frequency not known (cannot be estimated from available data):

• signs of infection such as sudden unexplained 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 disturbances in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapine Flas may 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 anaemia), 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 Flas and consult your doctor immediately
• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, restlessness, mood changes and loss of consciousness. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome". Stop taking Mirtazapine Flas and consult your doctor immediately
• thoughts of harming yourself or suicide. Stop taking Mirtazapine Flas and consult your doctor immediately
• abnormal sensations in the mouth (oral paraesthesia)
• swelling of the mouth (oral oedema)
• hyponatraemia
• inappropriate secretion of antidiuretic hormone
• red patches on the trunk, appearing as well-defined or circular macules, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Generalised erythema, elevated body temperature and enlarged lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, please consult your doctor or pharmacist.

5. Storage of MIRTAZAPINE FLAS KERN PHARMA

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original container to protect from light and moisture.

Do not use Mirtazapine Flas Kern Pharma after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Mirtazapine Flas Kern Pharma

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

Appearance of the product and contents of the pack

Mirtazapine Flas Kern Pharma is presented as white, round, biconvex tablets marked with 'M1' on one side.

Each pack contains 30 orodispersible tablets.

Other Pack Sizes

Mirtazapine Flas Kern Pharma 30 mg orodispersible tablets EFG

Marketing Authorization Holder

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

Actavis Limited

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This leaflet was approved in January 2010

Date of most recent review of this leaflet: July 2020

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