Mirtazapine Sandoz GmbH

Package leaflet: Information for the patient

MIRTAZAPINE SANDOZ GMBH 15 mg orodispersible tablets, 30 mg orodispersible tablets, 45 mg orodispersible tablets

Equivalent medicinal product
Please read this leaflet carefully before 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. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, tell your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Mirtazapine Sandoz GmbH is and what it is used for
2. What you need to know before taking Mirtazapine Sandoz GmbH
3. How to take Mirtazapine Sandoz GmbH
4. Possible side effects
5. How to store Mirtazapine Sandoz GmbH
6. Contents of the pack and other information

1. What Mirtazapina Sandoz GmbH is and what it is used for

Mirtazapina Sandoz GmbH belongs to a group of medicines called antidepressants.
Mirtazapina Sandoz GmbH is used to treat depressive illness in adults.
Mirtazapina Sandoz GmbH will take 1 to 2 weeks before starting to be effective. After 2 to 4 weeks you may begin to feel better. You should speak to your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. Further information can be found in section 3 under "When to expect improvement".

2. What you should know before taking Mirtazapine Sandoz GmbH

Do not take Mirtazapine Sandoz GmbH:

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, you must speak to your doctor as soon as possible before taking Mirtazapine Sandoz GmbH.
• if you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-I).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mirtazapine Sandoz GmbH.
Children and adolescents
Mirtazapine Sandoz GmbH 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, 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 Sandoz GmbH to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Mirtazapine Sandoz GmbH for a patient under 18 years of age and you wish to obtain 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 Sandoz GmbH. It should also be noted that the long-term safety effects of Mirtazapine Sandoz GmbH in this age group with regard to growth, and cognitive and behavioral maturation and development, have not yet been established. In addition, a significant weight gain has been frequently observed in this patient group compared to adults treated with Mirtazapine Sandoz GmbH.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or taking 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 thoughts of this kind if:

• you have previously thought about taking your life or harming yourself.
• you are a young adult. Clinical trial data 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 taking your life or harming yourself, contact your doctor or go to hospital immediately.

It may be helpful to confide in a family member 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.
Pay particular attention when taking Mirtazapine Sandoz GmbH 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 Sandoz GmbH. Seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking Mirtazapine Sandoz GmbH and contact your doctor immediately. Liver diseases, including jaundice. If you develop jaundice, stop taking Mirtazapine Sandoz GmbH and contact your doctor immediately. Kidney diseases; 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 Sandoz GmbH and contact your doctor immediately. Diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines). Eye diseases, such as increased eye pressure (glaucoma).

Difficulty urinating, 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 if you are taking certain medicines that may affect heart rhythm.

• If you experience signs of infection, such as unexplained high fever, sore throat, and mouth ulcers. Stop taking Mirtazapine Sandoz GmbH and contact your doctor immediately for a blood test.

In rare cases, these symptoms may be signs of 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 adverse effects of antidepressants.

Other medicines and Mirtazapine Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Sandoz GmbH in combination with:

• monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take Mirtazapine Sandoz GmbH within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Sandoz GmbH, 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 Sandoz GmbH 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 methemoglobin levels in blood), and St. John's wort - Hypericum perforatum extracts (a herbal remedy for depression). Very rarely, Mirtazapine Sandoz GmbH, alone or in combination with these medicines, may lead to the so-called serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, increased heart rate, diarrhea, uncontrollable 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 Sandoz GmbH in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Sandoz GmbH or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Sandoz GmbH.
• 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 Sandoz GmbH may increase the drowsiness caused by these substances.
• medicines for infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and medicines for treating HIV/AIDS (such as HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine). These medicines, in combination with Mirtazapine Sandoz GmbH, may increase the amount of Mirtazapine Sandoz GmbH in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Sandoz GmbH or, when use of these medicines is discontinued, to increase the dose of Mirtazapine Sandoz GmbH again.
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin. These medicines, in combination with Mirtazapine Sandoz GmbH, may decrease the amount of Mirtazapine Sandoz GmbH in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Sandoz GmbH or, when use of these medicines is discontinued, to reduce the dose of Mirtazapine Sandoz GmbH again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapine Sandoz GmbH 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.
• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Mirtazapine Sandoz GmbH with food and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Sandoz GmbH.
It is best not to consume alcoholic beverages.
Mirtazapine Sandoz GmbH can be taken with or without food.

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.
Limited experience with the administration of Mirtazapine Sandoz GmbH to pregnant women does not indicate an increased risk. However, caution is advised when administering Mirtazapine Sandoz GmbH during pregnancy.
If you take Mirtazapine Sandoz GmbH until delivery or shortly before, the newborn should be monitored for possible adverse effects. 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 the baby to breathe faster and appear cyanotic. These symptoms usually begin within the first 24 hours after birth.
If this occurs in your baby, you must contact your midwife and/or doctor immediately.

Driving and using machines
Mirtazapine Sandoz GmbH may affect concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed Mirtazapine Sandoz GmbH for a patient under 18 years of age, ensure that concentration and alertness are not affected before going out (e.g., riding a bicycle).

Mirtazapine Sandoz GmbH contains aspartame:
Mirtazapine Sandoz GmbH orodispersible tablets contain aspartame, a source of phenylalanine. It may be harmful to individuals with phenylketonuria.

Mirtazapine Sandoz GmbH contains sulfites:
This medicine also contains very small amounts of sulfites. In rare cases, this may cause severe allergic reactions (hypersensitivity) and bronchospasm.

3. How to take Mirtazapine Sandoz GmbH

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
How much Mirtazapine Sandoz GmbH to take
The recommended starting dose is 15 or 30 mg daily. Your doctor may advise you to increase the
dose after a few days to reach the appropriate amount (between 15 and 45 mg daily).
The dose is usually 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 Sandoz GmbH
Take Mirtazapine Sandoz GmbH every day at the same time.
It is best to take Mirtazapine Sandoz GmbH as a single dose before going to bed. However, your
doctor may advise you to divide the dose, taking one part in the morning and one part in the evening
before going to bed. The higher dose should be taken before bedtime.
How to take the orodispersible tablet as described below:
Take the tablet orally.

1. Do not break the orodispersible tablet

To prevent breaking the orodispersible tablet, do not press on the tablet pocket
on the blister (Figure A).

2. Detach one tablet pouch from the blister

Each blister contains 6 tablet pouches, separated by perforated lines. Detach one pouch by tearing along the perforated lines (figure 1).

3. Lift the cover sheet

Carefully lift the cover sheet, starting from the corner indicated by the arrow (figures 2 and 3).

4. Remove the orodispersible tablet

The orodispersible tablet must be removed from its blister with dry hands and placed
on the tongue.
(Figure 4).

It will rapidly disintegrate and can be swallowed without water.
When can you expect to feel better?
Normally, Mirtazapine Sandoz GmbH takes 1–2 weeks to start working, and after 2–4
weeks you may notice an improvement.
It is important that during the first weeks of treatment you inform your doctor about the effects of
Mirtazapine Sandoz GmbH:
2–4 weeks after starting Mirtazapine Sandoz GmbH, discuss with your doctor the effects the medicine has had on you.
If you still do not notice any 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 Sandoz GmbH for 4–6 months after the symptoms of
depression have disappeared.
If you take more Mirtazapine Sandoz GmbH than you should
If you or someone else takes too much Mirtazapine Sandoz GmbH, contact your doctor
immediately.
The most common signs of an overdose of Mirtazapine Sandoz GmbH (without other medicines or
alcohol) are drowsiness, confusion, and increased heart rate. Symptoms of a possible overdose may include changes in heart rhythm (fast and irregular heartbeat) and/or fainting, which could be signs of a life-threatening condition known as torsade de pointes.
If you forget to take Mirtazapine Sandoz GmbH
If you are supposed to take the dose once daily

• Do not take a double dose to make up for the missed dose. Take the next dose at your 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 Sandoz GmbH
You should only stop taking Mirtazapine Sandoz GmbH 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 to stop treatment.
Do not stop taking Mirtazapine Sandoz GmbH suddenly, even if your depression has disappeared. If you stop Mirtazapine Sandoz GmbH abruptly, you may feel unwell, dizzy, agitated or anxious, and may have 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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):

• feeling euphoric or being in an elevated mood (mania)

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

• yellowing of the skin or eyes; this may be a sign of liver problems (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 a disorder in blood cell production (bone marrow depression). Some people may 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 both white and red blood cells and platelets (aplastic anaemia), a deficiency of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia)
• Seizures (fits)
• A combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, muscle contractions (involuntary), chills, overactive reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be symptoms of serotonin syndrome.
• Thoughts of self-harm or suicide
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Other possible side effects with mirtazapine are:
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
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling of dizziness or fainting when getting 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, such as burning, itching, pricking, or tingling (paraesthesia)
• restless legs syndrome
• fainting (syncope)
• numbness or altered sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urge to move

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

• muscle twitching (myoclonus)
• aggression
• abdominal pain and nausea, which may be signs of inflammation of the pancreas (pancreatitis)

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

• abnormal sensation 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)
• sleepwalking (somnambulism)
• speech disorder

Other possible side effects with mirtazapine are:
Increased levels of creatine kinase in the blood, difficulty passing urine, and pain, stiffness and/or weakness in muscles, and darkening or discolouration of urine.

Additional side effects in children and adolescents:
The following side effects have been commonly observed in clinical studies in children under 18 years of age: marked weight gain, urticaria, and increased levels of triglycerides in the blood.

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 the website
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 Sandoz GmbH

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 packaging and on the
blister. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
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 SANDOZ GMBH contains

• The active substance is: mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
• The other components are: mannitol (E421), povidone K30, crospovidone, anhydrous colloidal silica, aspartame (E951), calcium stearate, orange flavour (maltodextrin, natural and artificial flavourings, dl-alpha-tocopherol), peppermint flavour (maltodextrin, natural flavourings, dextrin, sulphites).

Description of the appearance of MIRTAZAPINA SANDOZ GMBH and package contents
Orodispersible tablets: round, flat tablets, white to off-white in colour, with bevelled edges and smooth on both sides.
Aluminium/aluminium blisters containing 6, 10, 14, 18, 20, 28, 30, 30 (unit doses), 48, 50, 56, 60,
84, 90, 96, 100 or 100 (unit doses) orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Local representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Responsible manufacturers for batch release:

• LEK Pharmaceuticals d.d. - Verovškova 57 - 1526 Ljubljana - Slovenia
• Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben - Germany
• Sandoz GmbH - Biochemiestrasse 10 - 6250 Kundl - Austria
• Salutas Pharma GmbH - Dieselstrasse 5 - 70839 Gerlingen - Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Mirtazapin “1A Pharma” 15 mg - Schmelztabletten
Belgium: Mirtazapine Sandoz 15 mg orodispergeerbare tabletten
Czech Republic: Mirtazapin Sandoz 15 mg rozpustné tablety
Denmark: Arintapin Smelt
Finland: Mirtazapin Sandoz
Germany: Mirtazapin Sandoz 15 mg Schmelztabletten
Hungary: Mirtazapin Sandoz 15 mg szájban diszpergálódó tabletta
Italy: MIRTAZAPINA SANDOZ GMBH 15 mg compresse orodispersibili
Netherlands: Mirtazapine Sandoz orodispergeerbare tablet 15 mg, orodispergeerbare tabletten
Norway: Mirtazapin Sandoz
Portugal: MIRTAZAPINA SANDOZ
Slovak Republic: Mirtazapin ODT Sandoz 15 mg
Spain: MIRTAZAPINA SANDOZ 15 mg comprimidos bucodispersables EFG
Sweden: Mirtazapin Sandoz
United Kingdom: Mirtazapine 15 mg Orodispersible Tablets

This leaflet was last reviewed/approved on