Mirtazapine Krka: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine Krka 30 mg tablets

Generic medicine
Read this leaflet carefully before you start taking this medicine

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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Mirtazapine Krka is and what it is used for
Before you take Mirtazapine Krka
How to take Mirtazapine Krka
Possible side effects
How to store Mirtazapine Krka
Further information

1. WHAT MIRTAZAPINE KRKA IS AND WHAT IT IS USED FOR

Mirtazapine Krka belongs to a group of medicines called antidepressants.
Mirtazapine Krka is used to treat depressive disorders.

2. BEFORE TAKING MIRTAZAPINE KRKA

Do not take Mirtazapine Krka

if you are allergic (hypersensitive) to mirtazapine or to any of the excipients of Mirtazapine Krka. In this case, you must discuss it with your doctor as soon as possible before taking Mirtazapine Krka.
if you are currently taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

Take special care with Mirtazapine Krka

Use in children and adolescents under 18 years of age
Mirtazapine Krka should generally not be used in children and adolescents under 18 years of age because efficacy has not been demonstrated. It is important to know that in patients under 18 years of age, taking this class of medicines is associated with a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, hostile behavior, and anger). Nevertheless, a doctor may decide to prescribe Mirtazapine Krka to patients under 18 years of age if he or she considers it to be in their best interest. If your doctor has prescribed Mirtazapine Krka to a patient under 18 years of age and you would like 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 Krka treatment.
It should also be noted that the long-term safety effects of Mirtazapine Krka in this age group with regard to growth, maturation, and cognitive and behavioral development have not yet been established. In addition, 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 ending your life. These thoughts may increase shortly after starting treatment with antidepressants, as these medicines need 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 ending your life or harming yourself.
you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants. → If at any time you find yourself thinking about ending your life or harming yourself, contact your doctor or go to hospital immediately. It may be helpful to tell a relative or friend who suffers from depression 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.

Take special care with Mirtazapine Krka also

if you suffer or have previously suffered from any of the following conditions. → If you have not already done so, inform your doctor about these conditions before taking Mirtazapine Krka.
seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking Mirtazapine Krka and contact your doctor immediately.
liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Krka 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 Krka 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 urinating, which may be caused by an enlarged prostate.
if you develop signs of infection, such as unexplained high fever, sore throat, and mouth ulcers. → Stop taking Mirtazapine Krka and contact your doctor immediately for a blood test. In rare cases, these symptoms may indicate a disorder in blood cell production in the bone marrow. Although rare, these symptoms occur more commonly after 4–6 weeks of treatment.
if you are elderly. You may be more sensitive to the adverse effects of antidepressants.

Taking Mirtazapine Krka with other medicines
Inform your doctor or pharmacist if you are taking (or intend to take) any of the following medicines.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Do not take Mirtazapine Krka in combination with:

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

Be cautious when taking Mirtazapine Krka 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), and St. John’s wort preparations (a herbal remedy for depression). Very rarely, Mirtazapine Krka alone or in combination with these medicines may lead to a condition known as serotonin syndrome.
Some of the symptoms of this syndrome include: unexplained fever, sweating, increased heart rate, diarrhea, uncontrolled muscle contractions, tremor, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. If a combination of these symptoms occurs, speak to your doctor immediately.
the antidepressant nefazodone, which may increase the amount of Mirtazapine Krka in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Krka or, when nefazodone use is discontinued, an increase in the dose of Mirtazapine Krka.
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 administered in combination with these medicines, Mirtazapine Krka may increase the drowsiness caused by these substances.
medicines to treat infections; medicines for bacterial infections (such as erythromycin), medicines to treat fungal infections (such as ketoconazole), medicines to treat HIV/AIDS (such as HIV protease inhibitors), and medicines for gastrointestinal disorders (such as cimetidine). In combination with Mirtazapine Krka, these medicines may increase the amount of Mirtazapine Krka in your blood. Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Mirtazapine Krka, or if the use of the medicine is discontinued, to increase the dose of Mirtazapine Krka again.
medicines for epilepsy, such as carbamazepine and phenytoin; medicines for tuberculosis, such as rifampicin. These medicines, when taken with Mirtazapine Krka, may decrease the amount of Mirtazapine Krka in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Krka, or when use of these medicines is discontinued, to reduce the dose of Mirtazapine Krka again.
medicines that prevent blood clotting, such as warfarin. Mirtazapine Krka may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If warfarin is taken concomitantly, your doctor must closely monitor your blood.

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

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Limited experience with the administration of Mirtazapine Krka to pregnant women does not indicate an increased risk. However, caution is advised when administering Mirtazapine Krka during pregnancy.
If you are taking Mirtazapine Krka and become pregnant or plan a pregnancy, ask your doctor whether you can continue taking Mirtazapine Krka. If you use Mirtazapine Krka up to or immediately before delivery, the newborn must be carefully monitored for possible adverse effects.
Ensure that your midwife and/or doctor knows that you are taking Mirtazapine Krka. Medicines similar to Mirtazapine Krka (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Ask your doctor whether you can breastfeed while taking Mirtazapine Krka.

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

Important information about some excipients in Mirtazapine Krka
Mirtazapine Krka tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE MIRTAZAPINE KRKA

Always take Mirtazapine Krka exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much Mirtazapine Krka to take
The usual starting dose is 15 or 30 mg per day. Your doctor may advise increasing the dose after a few days to reach the amount appropriate for you (between 15 and 45 mg per day).
Normally, 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 Krka
→ Take Mirtazapine Krka at the same time every day.
It is best to take Mirtazapine Krka as a single dose before going to bed. However, your doctor may suggest splitting the dose, taking one part in the morning and the other in the evening before bedtime. The higher dose should be taken at bedtime.

Take the tablets orally.
Swallow the prescribed dose of Mirtazapine Krka without chewing, with some water or fruit juice.

When you can expect to feel better
Normally, Mirtazapine Krka takes 1–2 weeks to start working, and after 2–4 weeks you may begin to feel better.
It is important that, during the first weeks of treatment, you inform your doctor about the effects of Mirtazapine Krka:

2–4 weeks after starting Mirtazapine Krka, 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 with your doctor again after another 2–4 weeks. Normally, it is necessary to continue taking Mirtazapine Krka for 4–6 months after the symptoms of depression have disappeared.

If you take more Mirtazapine Krka than you should
If you or someone else takes too much Mirtazapine Krka, contact your doctor immediately. The most common signs of an overdose of Mirtazapine Krka (without other medicines or alcohol) are drowsiness, disorientation, and increased heart rate.

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

if you forget to take your dose of Mirtazapine Krka, do not take the missed dose. Skip the dose and take the next one 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 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 Krka
You should only stop taking Mirtazapine Krka 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 Krka suddenly, even if your depression has disappeared. If you stop Mirtazapine Krka abruptly, you may feel unwell, experience dizziness, agitation or anxiety, and have headaches. These symptoms can be avoided by gradually discontinuing the treatment. Your doctor will tell you how to reduce the dose gradually.
If you have any questions about the use of Mirtazapine Krka, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Mirtazapine Krka can cause side effects, although not everybody gets them.
Some side effects are more likely than others. The possible side effects of Mirtazapine Krka are listed below and can be categorized as:

Very common: occurring in more than 1 user in 10
Common: occurring in 1 to 10 users in 100
Uncommon: occurring in 1 to 10 users in 1,000
Rare: occurring in 1 to 10 users in 10,000
Very rare: occurring in less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data

Very common:

increased appetite and body weight gain
drowsiness or confusion
headache
dry mouth

Common:

lethargy
dizziness
tremors or loss of balance
nausea
diarrhoea
vomiting
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 ankles and feet) due to fluid retention (oedema)
fatigue
vivid dreams
confusion
anxiety
sleep problems
In children under 18 years of age, the following adverse events are commonly observed in clinical studies: weight gain, urticaria, and increased blood triglycerides.

Uncommon:

feelings of euphoria or emotional excitement (mania). → Stop taking Mirtazapine Krka and consult your doctor immediately.
abnormal sensations on the skin, e.g. burning, tingling, itching or pins and needles (paraesthesia)
restless legs syndrome
fainting (syncope)
numbness of the mouth (oral hypoaesthesia)
low blood pressure
nightmares
agitation
hallucinations
urge to move

Rare:

yellowish discoloration of the eyes and skin; this may indicate liver function disorders (jaundice). → Stop taking Mirtazapine Krka and consult your doctor immediately.
muscle twitching (myoclonus).
- Aggressive behaviour.

Not known:

signs of infection such as sudden unexplained high fever, sore throat and mouth ulcers (agranulocytosis). → Stop taking Mirtazapine Krka and contact your doctor immediately for a blood test. In rare cases, Mirtazapine Krka may cause a disorder in blood cell production (bone marrow depression). Some people become more susceptible to infections because Mirtazapine Krka may cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases, Mirtazapine Krka may also cause a deficiency of red blood cells and platelets (aplastic anaemia), a deficiency of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
Seizures (convulsions). → Stop taking Mirtazapine Krka and consult your doctor immediately.
a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, tremor, hyperactive reflexes, exhaustion, mood changes and loss of consciousness. Very rarely, these may be symptoms of serotonin syndrome. → Stop taking Mirtazapine Krka and consult your doctor immediately.
thoughts of harming yourself or taking your own life → Consult your doctor or go to hospital immediately.
- • unusual sensation in the mouth (oral paraesthesia)
  Difficulty speaking
swelling of the mouth (mouth oedema)
- Increased salivation
hyponatraemia
inappropriate secretion of antidiuretic hormone
- Sleepwalking
- Severe skin reactions (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis).

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 Krka

Keep out of the reach and sight of children.
Do not use Mirtazapine Krka after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Mirtazapina Krka contains

The active substance is mirtazapine. Each Mirtazapina Krka tablet contains 30 mg of mirtazapine (as hemihydrate).
The other ingredients in Mirtazapina Krka 30 mg film-coated tablets are monohydrate lactose, powdered cellulose, sodium starch glycolate, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate in the tablet core; and hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172), red iron oxide (E172) in the coating layer.

Description of the appearance of Mirtazapina Krka tablets and contents of the pack
Mirtazapina Krka 30 mg film-coated tablets are brown-orange, oval-shaped, slightly biconvex, with a dividing line on one side.
Mirtazapina Krka 30 mg film-coated tablets are available in packs containing 10, 14, 18, 20, 28, 30, 48, 50, 56, 60, 70, 90, 96, 100, 200, 250, 300, 500, 1x100 tablets in blister packs, and 250 and 500 tablets in HDPE plastic containers.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturing and batch release
Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Millmount Healthcare Ltd.
Units 5-7, Navan Enterprise Centre, Trim Road
Navan, Co. Meath
Ireland
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Microchem Laboratories
Clogerane, Dungarvan
Co. Waterford
Ireland
Paranova Pack
Industriparken 23-25
2750 Ballerup
Denmark
Pharmathen S.A.
6 Dervenakion Str.
15351 Pallini Attiki
Greece

This medicinal product has been authorized in the EEA Member States under the following names:
Finland: Mirtazapin Krka
Austria: Mirtazapin Alternova
Czech Republic: Mirzaten
Denmark: Mirtazapin Krka
Estonia: Mirzaten
Greece: Azapin
Sweden: Mirtazapin Krka
Slovak Republic: Mirzaten
Italy: Mirtazapina Krka
Poland: Mirzaten 30 mg/45 mg

This patient information leaflet was last approved on