Mirtazapine Zentiva: detailed information

Package leaflet: Information for the user

Mirtazapine Zentiva 30 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Mirtazapine Zentiva belongs to a group of medicines called antidepressants.
Mirtazapine Zentiva is used to treat depressive disorders in adults.
Mirtazapine Zentiva will take 1 to 2 weeks before it starts to work. After 2 to 4 weeks, you may begin to feel better. You should contact your doctor if you do not feel better, or if you feel worse, after 2 to 4 weeks. More information is provided in section 3, under the heading “When to expect to feel better”.

2. What you need to know before taking Mirtazapine Zentiva

Do not take Mirtazapine Zentiva

if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6);
if you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

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

Children and adolescents
Mirtazapine Zentiva should normally not be used in children and adolescents under 18 years of age, as efficacy has not been demonstrated. Furthermore, it should be noted that in patients under 18 years of age, this class of medicines is associated with a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, hostile behaviour, and rage). Nevertheless, a doctor may decide to prescribe Mirtazapine Zentiva to patients under 18 years of age if considered to be in their best interest. If your doctor has prescribed Mirtazapine Zentiva for a patient under 18 years of age and you would like further clarification, please consult your doctor directly. Inform your doctor immediately if any of the symptoms described above appear or worsen in patients under 18 years of age receiving Mirtazapine Zentiva. In addition, the long-term safety effects of Mirtazapine Zentiva in this age group with regard to growth, maturation, and cognitive and behavioural development have not yet been established. Moreover, a significant weight gain has 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 think about harming yourself or taking your own life. These thoughts may increase shortly after starting treatment with antidepressants, as these medicines require time to take effect, usually about two weeks but sometimes longer.

You are more likely to have such thoughts:

if you have previously thought about taking your own life or harming yourself;
if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants. If at any time you find yourself thinking about taking your own life or harming yourself, contact your doctor or go to hospital immediately. It may be helpful to tell a relative or friend that you are depressed and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression is worsening, or if they are concerned about changes in your behaviour. Pay particular attention when taking Mirtazapine Zentiva also
if you suffer or have previously suffered from any of the following conditions. Discuss these conditions with your doctor before taking Mirtazapine Zentiva, if you have not already done so:
- seizures (epilepsy). If you begin to have seizures or if your seizures become more frequent, stop taking Mirtazapine Zentiva and contact your doctor immediately;
- liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Zentiva 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;
- manic depression (alternating periods of euphoria/hyperactivity and depressed mood). If you start feeling euphoric or overexcited, stop taking Mirtazapine Zentiva and contact your doctor immediately;
- diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines);
- eye disorders, such as increased eye pressure (glaucoma);
- difficulty in urination, which may be caused by an enlarged prostate;
- certain types of heart conditions that may alter heart rhythm, a recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.
if you develop signs of infection, such as unexplained high fever, sore throat, and mouth ulcers. → Stop taking Mirtazapine Zentiva and contact your doctor immediately for a blood test. In rare cases, these symptoms may indicate a disorder affecting blood cell production in the bone marrow. Although rare, these symptoms most commonly occur after 4–6 weeks of treatment.
if you are elderly. You may be more sensitive to the side effects of antidepressants.

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

Do not take Mirtazapine Zentiva in combination with:

monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take Mirtazapine Zentiva within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Zentiva, do not take MAO inhibitors within the following two weeks. Examples of MAO inhibitors include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson’s disease).

Be cautious when taking Mirtazapine Zentiva in combination with:

antidepressants such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (for pain treatment), linezolid (an antibiotic), lithium (used to treat certain psychiatric conditions), methylene blue (used to treat elevated methemoglobin levels in the blood), and St. John’s wort herbal preparations - Hypericum perforatum (a herbal remedy for depression). Very rarely, Mirtazapine Zentiva 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, increased heart rate, diarrhoea, muscle twitching (involuntary), tremor, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. If a combination of these symptoms occurs, speak to your doctor immediately.
the antidepressant called nefazodone, which may increase the amount of Mirtazapine Zentiva in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Zentiva, or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Zentiva.
medicines for anxiety or insomnia, such as benzodiazepines.
medicines for schizophrenia, such as olanzapine.
medicines for allergies, such as cetirizine.
strong painkillers, such as morphine. When administered in combination with these medicines, Mirtazapine Zentiva may increase the drowsiness caused by them.
medicines to treat infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), medicines for treating HIV/AIDS (such as HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine). These medicines, when taken with Mirtazapine Zentiva, may increase the amount of Mirtazapine Zentiva in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Zentiva, or, when these medicines are discontinued, to increase the dose of Mirtazapine Zentiva again.
epilepsy medicines, such as carbamazepine and phenytoin;
tuberculosis medicines, such as rifampicin. These medicines, when taken with Mirtazapine Zentiva, may decrease the amount of Mirtazapine Zentiva in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Zentiva, or, when these medicines are discontinued, to reduce the dose of Mirtazapine Zentiva again.
medicines that prevent blood clotting, such as warfarin. Mirtazapine Zentiva may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken concomitantly, your doctor must monitor your blood closely.
medicines that may affect heart rhythm, such as certain antibiotics and certain antipsychotics.

Taking Mirtazapine Zentiva with food, drinks and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Zentiva. It is best not to consume alcoholic drinks.
Mirtazapine Zentiva may be taken with or without food.

Pregnancy, breastfeeding and fertility
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.
Limited experience with the use of Mirtazapine Zentiva in pregnant women does not indicate an increased risk. However, caution is advised when administering Mirtazapine Zentiva during pregnancy.
If you take Mirtazapine Zentiva up to or immediately before delivery, the newborn should be closely monitored for possible adverse effects.
When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after the baby’s birth. If this occurs in your baby, you must contact your midwife and/or doctor immediately.

Driving and using machines
Mirtazapine Zentiva may affect your concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed Mirtazapine Zentiva for a patient under 18 years of age, ensure that concentration and alertness are not impaired before engaging in activities such as cycling.

Mirtazapine Zentiva contains lactose
Mirtazapine Zentiva film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Mirtazapine Zentiva

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Take the tablets orally. Swallow the prescribed dose of Mirtazapine Zentiva without chewing, with a
glass of water or fruit juice.

Dosage
The recommended starting dose is 15 mg (equivalent to half a tablet of Mirtazapine Zentiva) or 30 mg once daily.
Your doctor may advise you to increase the dose after a few days up to the appropriate amount (between 15 mg –
half a tablet – and 45 mg – one and a half tablets of Mirtazapine Zentiva – per day). Usually, the dose is the same
for all age groups. However, your doctor may adjust the dose if you are elderly or if you have had kidney or
liver disease.

When to take Mirtazapine Zentiva
→ Take Mirtazapine Zentiva every day at the same time. It is best to take Mirtazapine Zentiva as a single dose before
going to bed. However, your doctor may suggest splitting the dose, taking one part in the morning and one part in
the evening before going to bed. The higher dose should be taken at bedtime.

When to expect to feel better
Mirtazapine Zentiva usually takes 1–2 weeks to start working, and after 2–4 weeks you may begin to notice an
improvement.
It is important that during the first weeks of treatment you inform your doctor about the effects of Mirtazapine Zentiva:
→ 2–4 weeks after starting Mirtazapine Zentiva, discuss with your doctor the effects the medicine has had on you.
If you continue to notice no improvement, your doctor may prescribe a higher dose. In this case, speak to your doctor again after another 2–4 weeks.
Normally, it is necessary to continue taking Mirtazapine Zentiva for 4–6 months after depression symptoms have disappeared.

If you take more Mirtazapine Zentiva than you should
If you or someone else takes too much Mirtazapine Zentiva, contact your doctor immediately.
The most likely signs of an overdose of Mirtazapine Zentiva (without other medicines or alcohol) are drowsiness,
confusion, and increased heart rate. Symptoms of a possible overdose may include changes in your heart rhythm (fast or irregular heartbeat) and/or fainting, which could be symptoms of a life-threatening condition known as torsade de pointes.

If you forget to take Mirtazapine Zentiva
If you are supposed to take the dose once daily:

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you are supposed to take the dose twice daily:

If you forget the morning dose, simply take this dose together with the evening dose.
If you forget the evening dose, do not take it together with the next morning dose; skip the missed dose and continue normally with the morning and evening doses.
If you have forgotten to take both doses, do not try to make up for the missed doses. Skip both doses and continue normally the next day with the morning and evening doses.

If you stop taking Mirtazapine Zentiva
You should only stop taking Mirtazapine Zentiva after consulting your doctor.
If you stop treatment too early, depression may return. When you start feeling better, discuss this with your
doctor. Your doctor will decide when it is appropriate to stop treatment.
Do not stop taking Mirtazapine Zentiva suddenly, even if your depression has resolved. If you stop taking Mirtazapine Zentiva 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 tell you how to reduce the dose gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking
mirtazapine and contact your doctor immediately.
Uncommon (may affect up to 1 in 100 people):

feelings of euphoria or emotional excitement (mania).

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

yellowing of the skin or eyes; this may indicate liver function disorders (jaundice).

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

signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disorders in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may cause a temporary deficiency of white blood cells (granulocytopenia). In very rare cases, mirtazapine may also cause a deficiency of red and white blood cells and platelets (aplastic anaemia), a deficiency of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
epileptic seizures (convulsions).
a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, chills, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. In very rare cases, these may be symptoms of serotonin syndrome.
thoughts of harming yourself or of suicide.
severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other possible side effects of mirtazapine are:
Very common (may affect more than 1 in 10 people):

increased appetite and body weight gain
drowsiness or somnolence
headache
dry mouth.

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

lethargy
dizziness
unsteadiness or tremors
nausea
diarrhoea
vomiting
constipation
rash or skin eruptions (exanthema)
joint pain (arthralgia) or muscle pain (myalgia)
back pain
dizziness or fainting when standing up suddenly (orthostatic hypotension)
swelling (usually in the ankles and feet) due to fluid retention (oedema)
fatigue
vivid dreams
confusion
anxiety
sleep problems.

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

abnormal sensations on the skin, e.g. burning, tingling, itching, or prickling (paraesthesia)
restless legs syndrome
fainting (syncope)
numbness or tingling sensation in the mouth (oral hypoesthesia)
low blood pressure
nightmares
feeling of restlessness
hallucinations
urge to move.

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

muscle twitching (myoclonus)
aggression
abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis).

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

abnormal sensations in the mouth (oral paraesthesia)
swelling of the mouth (mouth oedema)
swelling throughout the body (generalised oedema)
localized swelling
hyponatraemia
inappropriate secretion of antidiuretic hormone
severe skin reactions (bullous dermatitis, erythema multiforme)
nocturnal wandering (sleepwalking)
speech disorder
increased salivation
increased levels of creatine kinase in the blood
difficulty in urination
muscle pain, stiffness and/or weakness, and dark or discoloured urine.

Additional side effects in children and adolescents
In clinical studies, the following side effects were commonly observed in children under 18 years of age: significant increase in body weight, urticaria, and increased blood triglyceride levels.
Reporting of side effects
If you experience any side effect, including those 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 Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Mirtazapina Zentiva Contains
The active substance is mirtazapine.
Mirtazapina Zentiva contains 30 mg of mirtazapine per film-coated tablet.
The other components are:
Tablet core: monohydrate lactose, maize starch, hydroxypropylcellulose, anhydrous colloidal silica,
magnesium stearate (Ph. Eur.).
Tablet coating: hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172) and black iron oxide (E172).

Description of the Appearance of Mirtazapina Zentiva and Pack Contents
Mirtazapina Zentiva are film-coated tablets,
oblong, biconvex, beige in colour, with a break line on one side. The tablet can be divided into two
equal doses.
Mirtazapina Zentiva 30 mg film-coated tablets are packaged in blisters.
The following blister pack sizes are available: 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 200 and 500 film-coated tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale Bodio n. 37/b – 20158 Milano
Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Mirtazapina Zentiva
Portugal: Mirtazapina Zentiva 15 mg comprimidos
Mirtazapina Zentiva 30 mg comprimidos
Mirtazapina Zentiva 45 mg comprimidos
Spain: Mirtazapina Zentiva 15 mg comprimidos recubiertos con película EFG
Mirtazapina Zentiva 30 mg comprimidos recubiertos con película EFG