Mirtazapine Almus 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine Almus 15 mg film-coated tablets EFG

Read the entire 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 must not be given to other people, even if they have

the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects

not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Mirtazapine Almus is and what it is used for

Mirtazapine Almus belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. Before taking Mirtazapine Almus

Do not take Mirtazapine Almus

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Mirtazapine Almus. In this case, consult your doctor as soon as possible before taking Mirtazapine Almus.
• if you are 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, peeling of the skin, blisters, or mouth sores after taking mirtazapine or other medicines.

Take special care with Mirtazapine Almus

Use in children and adolescents under 18 years of age

Mirtazapine Almus must not be used in children and adolescents under 18 years of age because 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 medicine. Nevertheless, your doctor may prescribe Mirtazapine Almus to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Mirtazapine Almus 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 above appear or worsen in patients under 18 years of age who are taking Mirtazapine Almus. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development of mirtazapine in this age group are still unknown.

Furthermore, significant weight gain has been observed more frequently in this age group than in 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 up to two weeks or sometimes longer to take effect.

You may be more likely to have such 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 at any time you have thoughts of harming yourself or of suicide, contact 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 getting worse, or if they are concerned about changes in your behavior.

Also, take special care with Mirtazapine Almus

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

? Inform your doctor about these conditions before taking Mirtazapine Almus, 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 (periods of elevated mood/hyperactivity alternate with 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 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;

• if signs of infection appear, such as unexplained high fever, sore throat, and mouth sores

? Stop taking Mirtazapine Almus and contact your doctor immediately for a blood test. Rarely, these symptoms may be signs of 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.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Serious 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 immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have ever experienced serious skin reactions, treatment with mirtazapine must not be restarted.

Use of other medicines

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

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

Do not take Mirtazapine Almus together with:

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

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

Be careful if you take Mirtazapine Almus together 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 alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, palpitations, diarrhea, 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: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors). 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, regular blood monitoring by your doctor is recommended.

Taking Mirtazapine Almus with food and drinks

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

Consult your doctor or pharmacist before using any medicine.

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

If you are taking mirtazapine and become pregnant or wish to become pregnant, consult your doctor whether you can continue taking mirtazapine. If you use mirtazapine 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 Almus.

Ensure that your doctor or midwife knows that you are taking Mirtazapine Almus. When taken during pregnancy, particularly during the last 3 months of pregnancy, medicines such as Mirtazapine Almus may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, inform your doctor or midwife immediately.

Driving and using machines

Mirtazapine Almus may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery.

Important information about some of the components of Mirtazapine Almus film-coated tablets

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

3. How to take Mirtazapine Almus

Follow exactly the instructions for using Mirtazapine Almus provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much to take

The usual starting dose is 15 or 30 mg per day. Your doctor may recommend increasing your 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 your dose.

When to take it

? Take Mirtazepine Almus at the same time each day.

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

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

When you can expect to feel better

Mirtazepine Almus usually starts to take effect after 1 to 2 weeks, and you may start to feel better after 2 to 4 weeks. It is important that during the first weeks of treatment you talk to your doctor about how mirtazepine is affecting you:

? 2 to 4 weeks after starting mirtazepine, 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 to your doctor again after another 2–4 weeks.

Usually, you will need to take mirtazepine until depression symptoms have been gone for 4–6 months.

If you take more Mirtazepine Almus than you should

? If you or someone else takes too much Mirtazepine Almus, consult a doctor immediately. You may also call the Toxicology Information Service. Telephone: 91 562 04 20.

The most likely symptoms of an overdose of mirtazepine (without other medicines or alcohol) are drowsiness, confusion, and palpitations.

If you forget to take Mirtazepine Almus

If you are supposed to take your dose once daily

• if you forget to take your dose of mirtazepine, do not take the missed dose. Skip it and 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 Mirtazepine Almus

? Stop taking mirtazepine only if advised by 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 mirtazepine abruptly, even if depression has disappeared. If you stop taking mirtazepine suddenly, you may feel unwell, dizzy, agitated, or anxious, and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will tell you 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, Mirtazapine Almus may produce adverse effects, although not everyone experiences them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are listed below and can be categorized as follows:

• Very common: affect more than 1 in 10 patients
• Common: affect between 1 and 10 in 100 patients
• Uncommon: affect between 1 and 10 in 1,000 patients
• Rare: affect between 1 and 10 in 10,000 patients
• Very rare: affect fewer than 1 in 10,000 patients
• Not known: cannot be estimated from the available information

Very common:

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

Common:

• 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 quickly (orthostatic hypotension)
• swelling (usually in ankles or feet) due to fluid retention (edema)
• fatigue
• vivid dreams
• confusion
• anxiety
• difficulty sleeping
• sleep disturbances
• memory problems, which in most cases resolved when treatment was discontinued

In clinical trials with children under 18 years of age, the following adverse effects were frequently observed: significant weight gain, hives, and increased blood triglyceride levels.

Uncommon:

• feeling of exaggerated euphoria (mania).

? Stop taking mirtazapine and consult your doctor immediately.

• unusual sensations in the skin such as burning, prickling, tingling, or numbness (paresthesia)
• 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:

• yellowing of the eyes or skin; may indicate liver dysfunction (jaundice).

? Stop taking mirtazapine and consult your doctor immediately.

• muscle twitches or contractions (myoclonus)
• pancreatitis.

Not known:

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis).

? Stop taking mirtazapine and consult your doctor immediately for a blood test.

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 rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a reduction in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• epileptic seizure (convulsions).

? Stop taking mirtazapine and consult your doctor immediately.

• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, restlessness, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome."

? Stop taking mirtazapine and consult your doctor immediately.

• thoughts of harming yourself or suicide

? Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• urinary retention
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• increased blood levels of creatine kinase; difficulty urinating; muscle pain, stiffness and/or weakness; and darkening or discoloration of urine.
• 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).
• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Almus

Keep out of the reach and sight of children.

Do not use Mirtazapine Almus 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.

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

No special storage conditions are required.

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

6. Additional information

Composition of Mirtazapine Almus

• The active substance is mirtazapine.

Mirtazapine Almus 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.

• The other components are:

Tablet core: Monohydrate lactose, pregelatinized corn starch and magnesium stearate.

Tablet coating: Hydroxypropylmethylcellulose, titanium dioxide (E171), polyethylene glycol 8000, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Mirtazapine Almus are film-coated tablets.

The tablets are yellow, oblong, biconvex, and have a score line on one side. The score line is intended only to facilitate breaking the tablet and swallowing, but not for dividing it into equal doses.

Mirtazapine Almus 15 mg film-coated tablets are packed in blisters.

The following pack sizes are available: 30 and 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

ATLANTIC PHARMA - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira

24710-189, Sintra (Portugal)

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194, Sebal (Portugal)

This patient information leaflet was approved in August 2020

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