MIRTAZAPINE ALMUS 15 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine Almus 15 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Contents of the pack:

1. What is Mirtazapine Almus and what is it used for
2. Before taking Mirtazapine Almus
3. How to take Mirtazapine Almus
4. Possible side effects

5 Conservation of Mirtazapine Almus

1. Additional information

1. What is Mirtazapine Almus and what is it 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 any of the other ingredients of Mirtazapine Almus. If so, contact your doctor immediately before taking Mirtazapine Almus.
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).
• if you have ever suffered from severe skin rash, skin peeling, or mouth sores after taking mirtazapine or other medicines.

Be careful with Mirtazapine Almus

Use in children and adolescents under 18 years

Mirtazapine Almus should not be used in children and adolescents under 18 years because its efficacy has not been demonstrated. Moreover, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Mirtazapine Almus to patients under 18 years when he decides it is most convenient for the patient. If your doctor has prescribed Mirtazapine Almus to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above-mentioned symptoms appear or worsen in patients under 18 years taking Mirtazapine Almus. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known.

Furthermore, significant weight gain has been observed in this age range more frequently than in adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to work.

You may be more likely to think this way if:

• you have previously had thoughts of killing or harming yourself.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Also, be careful with Mirtazapine Almus

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

? Inform your doctor about these situations before taking Mirtazapine Almus, if you have not already:

• 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 diseaseor 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 excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking mirtazapine and contact your doctor immediately;
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose);
• eye diseases, 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 high unexplained fever, sore throat, and mouth sores

? Stop taking Mirtazapine Almus and contact your doctor immediately to have a blood test. In rare cases, these symptoms can be signs of changes in blood cell production in the bone marrow. Although rare, these symptoms usually appear 4-6 weeks after treatment.

• if you are an elderly person, 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.

Severe 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 medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.

If you have ever suffered from severe skin reactions, do not restart treatment with mirtazapine.

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 other medicines, including those obtained without a prescription.

Do not take Mirtazapine Almuswith:

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

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

Be careful ifyou take Mirtazapine Almus with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraine), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), and St. John's Wort – Hypericum perforatum(a medicinal plant for depression). In rare cases, mirtazapine alone or with these medicines may cause a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.

• the antidepressant nefazodone. It may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking this medicine. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking nefazodone.

• medicines for anxiety or insomniasuch as benzodiazepines.

medicines for schizophreniasuch as olanzapine.

medicines for allergiessuch as cetirizine.

medicines for severe painsuch as morphine.

In combination with these medicines, mirtazapine may increase the drowsiness caused by these medicines.

• 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). If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking these medicines. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking these medicines.

• medicines for epilepsysuch as carbamazepine and phenytoin; medicines for tuberculosissuch as rifampicin. If taken with mirtazapine, these medicines may decrease the amount of mirtazapine in your blood. Inform your doctor if you are taking these medicines. Your doctor may need to increase the dose of mirtazapine or decrease it again when you stop taking these medicines.
• medicines to prevent blood clottingsuch as warfarin. Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend that you have blood tests.

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 can take mirtazapine with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Limited experience with the 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 plan to become pregnant, consult your doctor if you can continue taking mirtazapine. If you use mirtazapine until or shortly before delivery, your baby will be examined for possible adverse effects.

Consult your doctor if you can breastfeed while taking Mirtazapine Almus.

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

Driving and using machines

Mirtazapine Almus may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery.

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

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

3. How to take Mirtazapine Almus

Follow exactly the administration instructions of Mirtazapine Almus given 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 that you increase the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages. However, if you are an elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take it

? Take Mirtazapine Almus at the same time every day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and before bedtime. The highest dose should be taken before bedtime.

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

When you can expect to feel better

Normally, Mirtazapine Almus will start to work 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 mirtazapine:

? Between 2 and 4 weeks after starting to take mirtazapine, talk to your doctor about how this medicine has affected you.

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

Normally, you will need to take mirtazapine until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapine Almus than you should

? If you or someone else takes too much Mirtazapine Almus, contact a doctor immediately. You can also call the Toxicology Information Service. Telephone 91 562 04 20.

The most likely symptoms of a mirtazapine overdose (without other medicines or alcohol) are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapine Almus

If you have to take your dose once a day

• if you forget to take your dose of mirtazapine, do not take the missed dose. Skip it and take your usual dose the next day.

If you have to take your dose twice a day

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

If you stop taking Mirtazapine Almus

? Stop taking mirtazapine only if you consult your doctor.

If you stop too soon, depression may recur. 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 abruptly, you may feel unwell, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

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

4. Possible Adverse Effects

Like all medicines, Mirtazapina Almus can cause adverse effects, although not all people suffer from them.

Some adverse effects are more likely to occur than others. The possible adverse effects of mirtazapine are indicated below and can be divided into:

• 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 less than 1 in 10,000 patients
• Unknown:cannot be estimated from the available information

Very Common:

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

Common:

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• constipation
• hives or skin rashes (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 (edema)
• fatigue
• vivid dreams
• confusion
• anxiety
• difficulty sleeping
• sleep problems
• 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 triglycerides in the blood.

Uncommon:

• feeling of exaggerated euphoria (mania).

?Stop taking mirtazapine and consult your doctor immediately.

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• involuntary movements of agitation of the legs during sleep
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

Rare:

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

?Stop taking mirtazapine and consult your doctor immediately.

• twitching or muscle contractions (myoclonus)
• pancreatitis.

Unknown:

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (agranulocytosis).

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

In rare cases, mirtazapine may cause alterations in the production of blood cells (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine can 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).

?Stop taking mirtazapine and consult your doctor immediately.

• 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 can be signs of a disorder called "serotonin syndrome".

?Stop taking mirtazapine and consult your doctor immediately.

• thoughts of self-harm or suicide

?Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• inadequate secretion of antidiuretic hormone
• urinary retention
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• increased blood levels of creatine kinase; difficulty urinating; pain, stiffness, and/or muscle weakness and darkening or discoloration of the urine.
• red patches on the trunk, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized erythema, elevated body temperature, and increased lymph node size (DRESS or drug hypersensitivity syndrome).

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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5. Storage of Mirtazapina Almus

Keep out of the reach and sight of children.

Do not use Mirtazapina Almus after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

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6. Additional Information

Composition of Mirtazapina Almus

• The active ingredient is mirtazapine.

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

• The other components are:

Tablet core: Lactose monohydrate, pregelatinized corn starch, and magnesium stearate.

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

Appearance of the Product and Packaging Content

Mirtazapina Almus are film-coated tablets.

The tablets are yellow, oblong, biconvex, and have a score line on one side. The score line is only to facilitate breaking and swallowing, but not to divide into equal doses.

Mirtazapina Almus 15 mg film-coated tablets are packaged in blisters.

The following package 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

Phone: 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 leaflet was approved in August 2020

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