Mirtazapine Stada 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Mirtazapine STADA 30 mg film-coated 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.

Leaflet contents

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

2. What you need to know before taking Mirtazapine STADA

3. How to take Mirtazapine STADA

4. Possible adverse effects

5. How to store Mirtazapine STADA

6. Contents of the pack and other information

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

Mirtazapine STADA belongs to a group of medicines called antidepressants.

Mirtazapine STADA is used to treat depression.

2. What you need to know before taking Mirtazapine STADA

DO NOT take Mirtazapine STADA

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

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Mirtazapine STADA.

Children and adolescents

Mirtazapine STADA should not normally be used to treat children and adolescents under 18 years of age, as its effectiveness 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 STADA to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Mirtazapine STADA to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. 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 STADA. In addition, the long-term safety effects related to growth, maturation, and cognitive and behavioral development of Mirtazapine STADA in this age group are still unknown. Furthermore, significant weight gain has been observed more frequently in patients in this age group treated with Mirtazapine STADA compared to treated 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 time to work—typically two weeks or sometimes longer. 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, 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 believe your depression is worsening or if they are concerned about changes in your behavior.

Also, be especially careful with Mirtazapine STADA

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

Inform your doctor about these conditions before taking Mirtazapine STADA, if you have not already done so.

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapine STADA and contact your doctor immediately;

• liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine STADA 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 STADA 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, or mouth ulcers

→ Stop taking Mirtazapine STADA 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 such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with mirtazapine use. Stop taking it 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 should not be restarted.

Other medicines and Mirtazapine STADA

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

DO NOT take Mirtazapine STADA together with:

• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapine STADA during the two weeks following discontinuation of MAO inhibitors. If you stop taking Mirtazapine STADA, do not take MAO inhibitors for the next two weeks. Examples of MAO inhibitors include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson’s disease).

Be careful if you take Mirtazapine STADA 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 St. John’s wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, Mirtazapine STADA 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, as treatment must be stopped and symptomatic supportive treatment initiated.

• the antidepressant nefazodone. This may increase the amount of Mirtazapine STADA in your blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapine STADA, 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 STADA 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 (protease inhibitors).

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

• medicines to prevent blood clotting, such as warfarin. Mirtazapine STADA may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor should monitor your blood regularly.

Taking Mirtazapine STADA with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapine STADA.

It is recommended not to drink any alcohol.

You may take Mirtazapine STADA with or without food.

Pregnancy and breastfeeding

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

Ensure that your midwife and/or doctor know that you are taking Mirtazapine STADA. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish skin tone in the newborn. These symptoms usually appear within the first 24 hours after birth. If this occurs, contact your midwife and/or doctor immediately.

If you are taking Mirtazapine STADA and become pregnant or wish to become pregnant, consult your doctor about whether you can continue taking Mirtazapine STADA. If you use Mirtazapine STADA up to or shortly before delivery, your baby will be examined for possible adverse effects.

Ask your doctor whether you can breastfeed while taking Mirtazapine STADA.

Driving and using machines

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

Mirtazapine STADA contains lactose

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

3. How to take Mirtazapine STADA

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 best suited for you (between 15 and 45 mg daily). Normally, the dose is the same for all age groups. However, if you are elderly or suffer from kidney or liver disease, your doctor may adjust the dose.

When to take Mirtazapine STADA

Take Mirtazapine STADA at the same time each day. It is best to take the dose as a single dose before bedtime. However, your doctor may recommend splitting your dose, taking part in the morning and part before bedtime. The higher dose should be taken before going to bed.

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

When you can expect to feel better

Mirtazapine STADA 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 the effects of Mirtazapine STADA:

• 2 to 4 weeks after starting Mirtazapine STADA, 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, speak to your doctor again after another 2–4 weeks.

You will usually need to take Mirtazapine STADA until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine STADA than you should

If you or someone else takes too much Mirtazapine STADA, consult a doctor immediately. You may also call the Toxicology Information Service at: 91 562 04 20.

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

If you forget to take Mirtazapine STADA

Do not take a double dose to make up for missed doses.

If you are supposed to take your dose once daily

• If you forget to take your dose of Mirtazapine STADA, 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 Mirtazapine STADA

Stop taking Mirtazapine STADA only after consulting your doctor.

Stopping treatment too early may cause depression to return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Mirtazapine STADA abruptly, even if depression has resolved. If you stop taking Mirtazapine STADA 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 will experience them. Some adverse effects are more likely than others. The possible adverse effects of Mirtazapine STADA are listed below and can be categorized as follows:

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

• increased appetite and weight gain

• drowsiness

• headache

• dry mouth

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

• lethargy

• dizziness

• tremor

• memory problems, which in most cases resolved when treatment was discontinued

• nausea

• diarrhoea

• vomiting

• difficulty passing stools, incomplete or infrequent bowel movements (constipation)

• 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)

• tiredness

• vivid dreams

• confusion

• anxiety

• difficulty sleeping

In children under 18 years of age, the following adverse effects were commonly observed in clinical trials: significant weight gain, urticaria, and increased blood triglycerides.

Uncommon (may affect up to 1 in 100 people):

• feeling of exaggerated euphoria (mania). Stop taking Mirtazapine STADA and consult your doctor immediately.

• unusual skin sensations such as burning, prickling, tingling or numbness (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 (may affect up to 1 in 1,000 people):

• yellowing of the eyes or skin; this may indicate liver problems (jaundice). Stop taking Mirtazapine STADA and consult your doctor immediately.

• muscle tics or jerks (myoclonus)

• aggression

• severe stomach pain, which may radiate to the back. This could be a sign of pancreatitis.

Not known (frequency cannot be estimated from available data):

• signs of infection such as sudden unexplained high fever, sore throat and mouth ulcers (agranulocytosis). Stop taking Mirtazapine STADA and consult your doctor immediately for a blood test.

In rare cases, Mirtazapine STADA may cause disturbances in blood cell production (bone marrow depression). Some people may become more susceptible to infections because Mirtazapine STADA may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapine STADA 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 in the blood (eosinophilia).

• serious skin reactions (bullous dermatitis, erythema multiforme)

• red patches on the trunk, appearing as well-defined or circular spots, often with blisters in the centre, 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).

• widespread redness, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Consult your doctor immediately if you experience these symptoms.

• epileptic seizure (convulsions). Stop taking Mirtazapine STADA 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 known as "serotonin syndrome". Stop taking Mirtazapine STADA and consult your doctor immediately.

• thoughts of harming yourself or suicide. Contact your doctor or go directly to hospital.

• abnormal sensations in the mouth (oral paraesthesia)

• swelling in the mouth (oral oedema)

• increased salivation

• difficulty speaking (dysarthria)

• sleepwalking (somnambulism)

• hyponatraemia

• inappropriate secretion of antidiuretic hormone

• increased blood levels of creatine kinase

• difficulty urinating

• muscle pain with stiffness and/or weakness and darkening or discolouration of urine (rhabdomyolysis)

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 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 STADA

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. 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 STADA

The active substance is mirtazapine.

Each Mirtazapine STADA 30 mg film-coated tablet contains 30 mg of mirtazapine.

The tablet may be divided into equal doses.

The other components are: monohydrate lactose, corn starch, hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, polyethylene glycol 8000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

Mirtazapine STADA 30 mg are beige-colored, oblong, biconvex film-coated tablets, with a score on one side.

Mirtazapine STADA 30 mg is available in PVC/PVDC/Al blister packs containing 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 120, 200 and 500 tablets, and in unit-dose PVC/PVDC/Al blister packs containing 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 70x1, 90x1, 100x1, 120x1, 200x1 and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2-18 (Bad Vilbel) - D-61118

Germany

or

Clonmel Healthcare Ltd.

Waterfort Road (Clonmel, County Tipperary)

Ireland

or

Combino Pharm (Malta) Ltd

HF 60, Hal Far Industrial Estate (Hal Far)

BBG07 Malta

or

Combino Pharm, S.L.

Fructuós Gelabert, 6-8

08970 Sant Joan Despí (Barcelona)

or

STADA ARZNEIMITTEL GMBH

Muthgasse 36 (Vienna)

A-1190 – Austria

or

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Mirtazapin "Stada" 30 mg - Film Tablets

Denmark Combar

Portugal Mirtazapina Ciclum 30 mg tablets

Spain Mirtazapina STADA 30 mg film-coated tablets EFG

Date of the most recent review of this leaflet: October 2020

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