Mirtazapine Cinfa 30 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

mirtazapine cinfa 30 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What mirtazapine cinfa is and what it is used for
2. What you need to know before taking mirtazapine cinfa
3. How to take mirtazapine cinfa
4. Possible adverse effects
5. How to store mirtazapine cinfa
6. Contents of the pack and other information

1. What mirtazapina cinfa is and what it is used for

mirtazapina cinfa belongs to a group of medicines called antidepressants.

Mirtazapine 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 your condition worsens or does not improve after 2 to 4 weeks.

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

2. What you need to know before taking mirtazapine cinfa

Do not take mirtazapine cinfa

• if you are allergic to mirtazapine or to any of the other components 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 cinfa.

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING mirtazapine: If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Children and adolescents

Mirtazapine should not normally be used to treat children and adolescents under 18 years of age, as its efficacy has not been demonstrated. Also, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. Inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age who are taking mirtazapine. In addition, the long-term effects on growth, maturation, and cognitive and behavioural development with mirtazapine in this age group are still unknown. A considerable 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 about two weeks, or sometimes longer, to become effective.

You may be more likely to have such thoughts:

• if you have previously had suicidal thoughts or thoughts of self-harm.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in antidepressant-treated psychiatric patients under 25 years of age.
• if at any time you have thoughts of self-harm or suicide, consult your doctor or go to a hospital immediately.

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

Also, take special care with mirtazapine:

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

  • seizures (epilepsy). If seizures occur or 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 depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;
  • diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);
  • eye disorders, such as increased pressure in the eye (glaucoma);
  • difficulty urinating, which may be due to an enlarged prostate;
  • certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medicines that may affect heart rhythm.

• if you develop signs of infection such as unexplained high fever, sore throat, or mouth ulcers.

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 elderly, you may be more sensitive to the adverse effects of antidepressant medicines.
• serious skin reactions have been reported with mirtazapine use, 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 previously experienced serious skin reactions, restarting treatment with mirtazapine is not recommended.

Other medicines and mirtazapine cinfa

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

Do not take mirtazapine together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks following discontinuation of MAOIs. If you stop taking mirtazapine, do not take MAOIs for at least the next two weeks.

Examples of MAOIs include moclobemide, tranylcypromine (both antidepressants), and selegiline (used for Parkinson's disease).

Be careful 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 methaemoglobin 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 known as serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact 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.

When taken together with these medicines, mirtazapine may increase the drowsiness caused by them.

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

When 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 reduce it again when stopping these medicines.

• medicines to prevent blood clotting, such as warfarin. Mirtazapine may enhance the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend regular blood monitoring.
• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking mirtazapine cinfa with food and alcohol

You may feel drowsy if you drink alcohol while being treated with 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 take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

Antidepressants similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife 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 cinfa contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take mirtazapine cinfa

Follow exactly the dosing instructions for this medicine as provided 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 once daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg daily). The dose is usually 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 mirtazapine

Take mirtazapine at the same time each day.

It is best to take the daily dose as a single dose before bedtime. However, your doctor may recommend splitting your dose, taking part in the morning and part before bedtime. In this case, the larger dose should be taken at bedtime.

The tablets are taken orally. Take the prescribed dose of mirtazapine without chewing, with water or juice.

When you can expect to feel better

Mirtazapine usually starts to take effect after 1 or 2 weeks, and you may begin to feel better after 2 to 4 weeks.

It is important that during the first weeks of treatment you speak with your doctor about how mirtazapine is affecting you: between 2 and 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 continue taking mirtazapine until depressive symptoms have resolved for 4–6 months.

The tablet can be divided into equal doses.

If you take more mirtazapine cinfa 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, indicating the medication and the amount ingested. It is recommended to bring the package leaflet and container to the healthcare professional.

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 also include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take mirtazapine cinfa

If you are supposed to take your dose once daily

• Do not take a double dose to make up for a missed dose. Take your usual dose the next day.

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 cinfa

Stop taking mirtazapine only after consulting your doctor.

If you stop 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 abruptly, even if depression has resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by tapering off the 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 will experience 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 eyes or skin; may indicate liver function abnormalities (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 cause a temporary decrease in white blood cells (granulocytopenia). In very rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).
• epileptic seizure (convulsions).
• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome."
• thoughts of harming yourself or of suicide.
• serious skin reactions:
• red patches on the trunk, such as well-defined or circular spots, often with blisters in the center, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. 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).

Other possible adverse effects with mirtazapine are:

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
• diarrhea
• vomiting
• constipation
• hives or skin rash (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• dizziness or fainting upon 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 resolved when treatment was discontinued

Uncommon (may affect up to 1 in 100 patients)

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

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

• muscle tics or contractions (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 paresthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate antidiuretic hormone secretion
• serious skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorder
• increased creatine kinase levels in blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased levels of prolactin hormone in blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• painful and prolonged penile erection

Other adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 cinfa

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly 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 cinfa

• The active substance is mirtazapine. Each film-coated tablet contains 30 mg of mirtazapine.

• The other components are:

• Tablet core: lactose monohydrate, hydroxypropylcellulose (E-463), corn starch, colloidal anhydrous silica, low-substituted hydroxypropylcellulose (E-463) and magnesium stearate.

• Tablet coating: Opadry Brown 20A56788 (hydroxypropylcellulose (E-463), hypromellose (E-464), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172) and black iron oxide (E-172)).

Appearance of the product and contents of the pack

Reddish-brown, biconvex, capsule-shaped, film-coated tablets, scored on one side and marked with the code “30” on the other side.

Presented in PVC-PVDC/ALU blisters.

Each pack contains 30 or 500 tablets (hospital pack) of film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: November 2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) 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 leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67068/P_67068.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67068/P_67068.html