Mirtazapine EG: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine EG 15 mg film-coated tablets, 30 mg film-coated tablets, 45 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Mirtazapine EG is and what it is used for
What you need to know before taking Mirtazapine EG
How to take Mirtazapine EG
Possible side effects
How to store Mirtazapine EG
Contents of the pack and other information

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

The name of the medicine is Mirtazapine EG 15, 30 or 45 mg film-coated tablets (hereinafter
Mirtazapine EG throughout this leaflet)

Mirtazapine EG is a medicine belonging to the group of so-called antidepressants. It is used to treat depressive illness.

2. What you need to know before taking Mirtazapine EG

DO NOT TAKE Mirtazapine EG:

if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, speak with your doctor as soon as possible before taking Mirtazapine EG.
if you are currently taking or have recently taken (within the previous two weeks) so-called monoamine oxidase inhibitors (MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mirtazapine EG.

Children and adolescents
Mirtazapine EG should not normally be used to treat children and adolescents under 18 years of age, as its efficacy has not been demonstrated. You should be aware that, when taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behavior, and anger). Nevertheless, your doctor may prescribe Mirtazapine EG to patients under 18 years of age if they consider it appropriate in the best interest of the patient. If your doctor has prescribed Mirtazapine EG to a patient under 18 years of age and you wish to obtain further information, please consult them again. You should inform the doctor if any of the above symptoms appear or worsen during treatment with Mirtazapine EG in a patient under 18 years of age. Furthermore, the long-term safety effects of Mirtazapine EG on growth, maturation, and cognitive and behavioral development in this patient group have not yet been established. In this age group, a significant weight gain during treatment with mirtazapine has also been observed more frequently than in adults.

Suicidal thoughts and worsening of your depression
If you are depressed, you may sometimes have thoughts about harming yourself or committing suicide. These effects may worsen when you first start taking antidepressants, because all medicines of this type take time to work, usually about two weeks but sometimes longer.

You are more likely to have such thoughts:

if you have previously had suicidal or self-harming thoughts.
if you are a young adult. Data from clinical trials 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 experience thoughts of self-harm or suicide, contact your doctor immediately or go to the hospital. It may be helpful to inform a family member or close friend that you are depressed and ask them to read this leaflet. You may ask them to observe whether your depression is worsening or whether they notice any concerning changes in your behavior.

Be especially careful with Mirtazapine EG

If you suffer or have suffered from any of the following conditions: Inform your doctor about the following conditions before taking Mirtazapine EG, if you have not already done so. Seizures (epilepsy). If seizures develop or occur more frequently, stop taking Mirtazapine EG and contact your doctor immediately; liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine EG and contact your doctor immediately; kidney disease; heart disease or low blood pressure; schizophrenia. If psychotic symptoms, such as paranoid thoughts, occur more frequently or worsen, contact your doctor immediately; manic depression (periods of euphoria/hyperactivity alternating with periods of depression). If you start feeling elated or overexcited, stop taking Mirtazapine EG and contact your doctor immediately; diabetes mellitus (your dose of insulin or other antidiabetic medicines may need adjustment); eye disorders, such as increased intraocular pressure (glaucoma); difficulty urinating, possibly due to an enlarged prostate.
if you develop signs of infection such as unexplained high fever, sore throat, and mouth ulcers. Stop taking Mirtazapine EG and contact your doctor immediately for a blood test. In rare cases, these symptoms may indicate disorders in blood cell production in the bone marrow. Although rare, these symptoms mostly occur after 4-6 weeks of treatment.
if you are an elderly person. You may be more sensitive to the adverse effects of antidepressants.

Other medicines and Mirtazapine EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Mirtazapine EG in combination with:

Monoamine oxidase inhibitors (MAO inhibitors). In addition, do not use Mirtazapine EG within two weeks after stopping treatment with MAO inhibitors. If you stop treatment with Mirtazapine EG, do not take MAO inhibitors within the following two weeks. Some MAO inhibitors are

moclobemide, tranylcypromine (both for depression), and selegiline (for Parkinson’s disease).

Caution is required when Mirtazapine EG is administered concomitantly with:

Antidepressants such as SSRIs, venlafaxine and L-tryptophan, or triptans (for migraine treatment), tramadol (a painkiller), linezolid (an antibiotic), lithium (for the treatment of certain psychiatric conditions), and St. John’s wort (Hypericum perforatum) preparations (herbal remedy for depression). In very rare cases, Mirtazapine EG alone or in combination with these medicines may cause the so-called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (involuntary), chills, overactive 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 EG in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapine EG or increase it again when nefazodone is discontinued.
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.

Concomitant administration of Mirtazapine EG and these medicines may increase the drowsiness already caused by these medicines.

Medicines for the treatment of infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and anti-HIV/AIDS medicines (such as HIV protease inhibitors).

In combination with Mirtazapine EG, 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 EG or increase it again when these medicines are discontinued.

Medicines for epilepsy, such as carbamazepine and phenytoin;
Medicines for treating tuberculosis, such as rifampicin.

In combination with Mirtazapine EG, 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 EG or reduce it again when these medicines are discontinued.

Medicines that prevent blood clotting such as warfarin. Mirtazapine EG may enhance the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. Careful monitoring of blood parameters by your doctor is advisable when used in combination.

Mirtazapine EG with food, drinks, and alcohol
After taking alcohol together with Mirtazapine EG, you may feel drowsy.
You should avoid drinking any alcoholic beverages.
Mirtazapine EG can be taken regardless of food intake.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Make sure to inform your midwife and/or doctor that you are taking Mirtazapine EG. Similar medicines (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns known as persistent pulmonary hypertension in the newborn (PPHN), which manifests as rapid breathing and bluish skin coloration in the baby. These symptoms usually appear within the first 24 hours after birth. If your baby shows these symptoms, contact your midwife and/or doctor immediately.
If you become pregnant while taking Mirtazapine EG or are planning a pregnancy, ask your doctor whether you can continue taking Mirtazapine EG. If you use Mirtazapine EG until delivery or shortly before delivery, the baby should be monitored for possible adverse effects.
Ask your doctor whether you can breastfeed while being treated with Mirtazapine EG.

Driving and using machines
Mirtazapine EG may affect your concentration or alertness. Make sure these abilities are not impaired before driving or operating machinery.

Mirtazapine EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Only Mirtazapine EG 15 mg film-coated tablets:
Mirtazapine EG 15 mg contains sunset yellow FCF (E110).
The colouring agent sunset yellow FCF (E110) may cause allergic reactions.

3. How to take Mirtazapine EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much Mirtazapine EG to take
The recommended starting dose is 15 or 30 mg daily. After a few days, your doctor may advise you to increase the dose to the most appropriate level for you (between 15 and 45 mg daily). The dose is usually the same for all age groups. However, if you are elderly or suffer from renal or hepatic disease, your doctor may adjust the dose accordingly.

When to take Mirtazapine EG
Take Mirtazapine EG every day at the same time. It is generally best to take Mirtazapine EG as a single dose before bedtime. However, your doctor may suggest splitting the dose into two daily administrations – one in the morning and one in the evening before bedtime. The higher dose should be taken before bedtime.

Take the tablets orally. Swallow the tablets corresponding to the prescribed dose of Mirtazapine EG with water or juice, without chewing them.

When to expect to start feeling better
Mirtazapine EG usually starts to take effect after 1–2 weeks, and you may start to feel better after 2–4 weeks.

It is important that during the first weeks of treatment you discuss the effects of Mirtazapine EG with your doctor:

2–4 weeks after starting treatment with Mirtazapine EG, talk to your doctor about the effects you have noticed. If you still do not feel better, your doctor may prescribe a higher dosage. In this case, inform your doctor about your condition after another 2–4 weeks. Normally, you should continue taking Mirtazapine EG until depression symptoms have resolved, for a period of 4 to 6 months.

If you take more Mirtazapine EG than you should
If you or someone else has taken too much Mirtazapine EG, seek medical help immediately.
The most likely signs of an overdose with Mirtazapine EG (regardless of other medicines or alcohol) are drowsiness, confusion, and rapid heartbeat.

If you forget to take Mirtazapine EG
Do not take a double dose to make up for a missed dose.

If you have been prescribed to take the dose once daily:

If you forget to take your dose of Mirtazapine EG, skip it and take the next dose at your usual time.

If you have been prescribed to take the 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 the missed dose together with the morning dose; skip it and continue with your regular morning and evening doses.
If you forget both doses, do not try to compensate. Skip both doses and continue with your normal dosing schedule the following day.

If you stop taking Mirtazapine EG
Stop taking Mirtazapine EG only after consulting your doctor.
If you stop treatment too early, depression may return. Contact your doctor as soon as you start feeling better. Your doctor will decide whether treatment should be discontinued.
Do not stop taking Mirtazapine EG suddenly, even if your depression has improved. Abruptly stopping Mirtazapine EG may make you feel unwell and cause symptoms such as dizziness, agitation or anxiety, and headache. These symptoms can be avoided by gradually reducing the dose. Your doctor will explain how to taper off the medicine gradually.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some side effects are more likely than others. The possible side effects of Mirtazapine EG are listed below and can be classified as follows:

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

increased appetite and weight gain
drowsiness or somnolence
headache
dry mouth

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

lethargy
dizziness
agitation or tremors
nausea
diarrhoea
vomiting
difficult, incomplete or infrequent bowel movements (constipation)
rash or skin eruptions (exanthema)
joint pain (arthralgia) or muscle pain (myalgia)
back pain
dizziness or feeling faint when standing up quickly (orthostatic hypotension)
swelling (usually of ankles or feet) due to fluid retention (oedema)
fatigue
vivid dreams
confusion
anxiety
sleep problems

The following side effects have been commonly observed in clinical studies in children under 18 years of age: significant weight gain, urticaria, and increased blood triglyceride levels.

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

feeling of euphoria or sensation of "extreme" well-being (mania) – Stop taking Mirtazapine EG and contact your doctor immediately.
abnormal skin sensations, such as burning, stabbing pains, tingling or prickling (paraesthesia)
restless legs syndrome
loss of consciousness (syncope)
numbness sensations around the mouth (oral hypoaesthesia)
low blood pressure
nightmares
feeling agitated
hallucinations
strong urge to move

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

yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice) – Stop taking Mirtazapine EG and contact your doctor immediately.
muscle spasms or contractions (myoclonus)
aggression
severe stomach pain that may spread to the back – this could be a sign of pancreatitis

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

signs of infection such as unexplained high fever, sore throat and mouth ulcers (agranulocytosis) – Stop taking Mirtazapine EG and consult your doctor immediately for a blood test. In rare cases, Mirtazapine EG may cause disturbances in blood cell production (bone marrow depression). Some people may become more susceptible to infections because Mirtazapine EG can cause a temporary deficiency in white blood cells (granulocytopenia). In rare cases, Mirtazapine EG may also cause a deficiency in red and white blood cells as well as platelets (aplastic anaemia), a deficiency in platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
Severe skin reactions (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis).
Seizure (convulsion) – Stop taking Mirtazapine EG and contact your doctor immediately.
A combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, chills, overactive reflexes, agitation, mood changes and loss of consciousness. In very rare cases, these may be signs of serotonin syndrome. Stop taking Mirtazapine EG and contact your doctor immediately.
Suicidal or self-harming thoughts – Contact your doctor immediately or go immediately to hospital.
abnormal sensations in the mouth (oral paraesthesia)
swelling of the mouth (oral oedema)
increased salivation
difficulty speaking (dysarthria)
sleepwalking (somnambulism)
hyponatraemia
syndrome of inappropriate antidiuretic hormone secretion
increased levels of creatine kinase in the blood
difficulty urinating
muscle stiffness and/or weakness and darkening or discolouration of the urine (rhabdomyolysis)

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirtazapine EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, or bottle.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mirtazapine EG contains
The active substance in 15 mg, 30 mg or 45 mg tablets is mirtazapine.
Mirtazapine EG 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.
Mirtazapine EG 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.
Mirtazapine EG 45 mg film-coated tablets contain 45 mg of mirtazapine per tablet.
15 mg / 30 mg: The tablet can be divided into equal doses.
Other components are: monohydrate lactose, maize starch, hydroxypropylcellulose, anhydrous colloidal silica,
magnesium stearate, hypromellose, titanium dioxide (E171) and polyethylene glycol 8000.
The 15 mg tablets also contain: yellow iron oxide (E172), quinoline yellow (E104), sunset yellow FCF (E110).
The 30 mg tablets also contain: red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Mirtazapine EG and contents of the pack
Mirtazapine EG is available as film-coated tablets.
Mirtazapine EG 15 mg tablets are yellow, oblong, biconvex, film-coated tablets with a score line on one side.
Mirtazapine EG 30 mg tablets are beige, oblong, biconvex, film-coated tablets with a score line on one side.
Mirtazapine EG 45 mg tablets are white, round, biconvex, film-coated tablets.
Mirtazapine EG is available in blister packs of 15 mg, 30 mg and 45 mg containing: 10, 14, 20, 28, 30,
40, 48, 50, 60, 90, 98, 100, 110, 150, 200, 250, 300, 350, 500, 1000 tablets, although not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy

Manufacturers responsible for batch release
STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel (Germany)
COSMO S.p.A. VIA C. Colombo, 1- 20020 Lainate – Milan, Italy
Combino Pharm SL c/ Fructuos Gelabert 6-8, 08970 Sant Joan Despí, Barcelona (Spain)
Centrafarm Service B.V., Nieuwe Donk 9, 4865 Etten Leur – Netherlands

This medicinal product is authorized in the European Economic Area Member States under the following names:
BE: Mirtazapine EG 15/30/45 mg filmomhulde tabletten
DE: Mirtazapin EG 15/30/45 mg Filmtabletten
EE: Mirtastad 15/30 mg
HU: Mirtastad 30/45 mg filmtabletta
IT: Mirtazapina EG 15/30/45 mg compresse rivestite con film
LT: Mirtastad 15/30 mg plėvele dengtos tabletės
LU: Mirtazapine EG 15/30/45 mg filmomhulde tabletten
LV: Mirtastad 15/30 mg
NL: Mirtazapine CF 15/30/45 mg, filmomhulde tabletten