Mirtazapine Flas Cinfamed 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

mirtazapine flas cinfamed 15 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What mirtazapine flas cinfamed is and what it is used for
2. What you need to know before taking mirtazapine flas cinfamed
3. How to take mirtazapine flas cinfamed
4. Possible adverse effects
5. How to store mirtazapine flas cinfamed

Contents of the pack and other information

1. What mirtazapine flas cinfamed is and what it is used for

Mirtazapine flas cinfamed belongs to a group of medicines called antidepressants. Mirtazapine flas cinfamed is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if you get worse or do not improve after 2 to 4 weeks.

For more information, see section 3 "When can you expect to start feeling better".

2. What you need to know before starting to take mirtazapine flas cinfamed

DO NOT TAKE – OR – CONSULT YOUR DOCTOR BEFORE STARTING mirtazapine:

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

Take special care with mirtazapine:

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 serious skin reactions.

If you have ever had severe skin reactions, treatment with mirtazapine should not be restarted.

Do not take mirtazapine flas cinfamed

• if you are allergic to mirtazapine or to any of the other ingredients of this medicine (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 (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take mirtazapine flas cinfamed.

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 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 medication. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking mirtazapine. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development with mirtazapine in this age group are still unknown.

A more pronounced weight gain has also been observed more frequently in this age group 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 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 these thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm.
• 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 you have thoughts of harming yourself or of suicide at any time, consult your doctor or go to a hospital immediately.

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

Also, take special care with mirtazapine:

• if you have or have ever had any of the following conditions:

→ Inform your doctor about these conditions before taking mirtazapine, if you have not already done so

• • seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately;
  • liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
  • kidney disease;
  • heart disease or 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 elevated mood/hyperactivity and periods of depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;
  • diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);
  • eye diseases, such as increased eye pressure (glaucoma);
  • difficulty urinating, which could be due to an enlarged prostate;
  • certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.
• if signs of infection such as unexplained fever, sore throat, and mouth ulcers appear

→ Stop taking mirtazapine and contact your doctor immediately for a blood test. Rarely, 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.

• if you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medicines.

Other medicines and mirtazapine flas cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Do not take mirtazapine together with:

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

Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson's disease).

Be cautious if you take mirtazapine together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans (used to treat migraine), 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 herbal remedy for depression). In very rare cases, mirtazapine 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. This may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping 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 may increase the drowsiness caused by them.

• medicines for infections: antibacterial medicines (such as erythromycin), antifungal medicines (such as ketoconazole), medicines for HIV/AIDS (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).

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

• medicines for epilepsy such as carbamazepine and phenytoin;
• medicines for tuberculosis such as rifampicin.

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

• 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. If taken together, it is recommended that your doctor performs regular blood tests.

• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking mirtazapine flas cinfamed with food and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapine. It is recommended not to drink any alcohol.

You may take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you use mirtazapine up to or shortly before delivery, your baby will be examined for possible adverse effects. Medicines similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk in newborns of developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and develop a bluish skin tone. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

Driving and using machines

During treatment with mirtazapine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how mirtazapine affects you.

Mirtazapine flas cinfamed contains aspartame.

This medicine contains 2 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take mirtazapine flas cinfamed

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended 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). Usually, the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust your dose.

When to take it

→ Take mirtazapine at the same time each day.

It is best to take the mirtazapine dose as a single dose before bedtime. However, your doctor may recommend that you split your mirtazapine dose, taking part in the morning and part at night before bedtime. The higher dose should be taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. To avoid crushing the orodispersible tablet, carefully push the tablet through the blister foil.
2. Take the orodispersible tablet with dry hands and place it on your tongue.

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Mirtazapine usually starts to take effect after 1 or 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 talk to your doctor about how mirtazapine is affecting you:

→ 2 to 4 weeks after starting mirtazapine, discuss with your doctor how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2–4 weeks.

You will usually need to take mirtazapine until depressive symptoms have disappeared for 4–6 months.

If you take more mirtazapine flas cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsade de pointes.

If you forget to take mirtazapine flas cinfamed

If you are supposed to take your dose once daily

• Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you are supposed to take your dose twice daily

• if you forget the morning dose, simply take it together with the evening dose.
• if you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• if you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking mirtazapine flas cinfamed

→ Stop taking mirtazapine only if advised by your doctor.

If you stop too early, depression may return. 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 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 reduce the dose gradually.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and contact 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 skin or eyes; may indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may temporarily reduce white blood cells (granulocytopenia). In very rare cases, mirtazapine may also cause a reduction in red blood cells, white blood cells, and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
• epileptic seizure (convulsions).
• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome".
• thoughts of self-harm or suicide.
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• red spots on the trunk, appearing as well-defined or circular patches, often with blisters in the center, skin peeling, and 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 rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects with mirtazapine include:

Very common (may affect more than 1 in 10 patients):

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

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

• lethargy
• dizziness
• tremor
• nausea
• diarrhoea
• vomiting
• constipation
• hives or skin rash (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• dizziness or fainting upon standing 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 (may affect up to 1 in 100 patients):

• unusual skin sensations such as burning, prickling, tingling, or numbness (paraesthesia)
• involuntary restless leg movements during sleep
• fainting (syncope)
• numbness sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• restlessness
• hallucinations
• inability to stay still

Rare (may affect up to 1 in 1,000 patients):

• tics or muscle jerks (myoclonus)
• aggression
• abdominal pain, nausea; this may indicate inflammation of the pancreas (pancreatitis)

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

• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (oral oedema)
• swelling throughout the body (generalised oedema)
• localized swelling
• hyponatraemia
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorder
• increased blood creatine kinase levels
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased levels of prolactin in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky nipple discharge)

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were commonly observed in patients under 18 years of age: marked weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of mirtazapine flas cinfamed

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of mirtazapine flas cinfamed

• The active substance is mirtazapine. Each tablet contains 15 mg of mirtazapine (as mirtazapine hemihydrate).
• The other components are mannitol, corn starch, microcrystalline cellulose, crospovidone, aspartame (E-951), orange flavour (containing glucose in maltodextrin derived from corn, flavouring components and alpha-tocopherol (E-307)), anhydrous colloidal silica and vegetable magnesium stearate.

Appearance of the product and contents of the pack

Mirtazapine flas cinfamed 15 mg tablets are white, cylindrical, flat, bevelled orodispersible tablets marked with "15" on one side.

The orodispersible tablets are packed in aluminium/polyamide-aluminium-PVC blisters. Each pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Date of the most recent revision of this leaflet: November 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84103/P_84103.html

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