Mirtazapine Teva Italia

Package Leaflet: Information for the User

Mirtazapine Teva Italia 30 mg orodispersible tablets

Generic medicine
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, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Mirtazapina Teva Italia is and what it is used for

Mirtazapina Teva Italia belongs to a group of medicines called antidepressants.
Mirtazapina Teva Italia is used to treat depressive disorders in adults.
It will take 1 to 2 weeks before Mirtazapina Teva Italia starts to work. You may start to feel better after a period of 2 to 4 weeks. 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 start feeling better”.

2. What you should know before taking Mirtazapine Teva Italia MIRTAZAPINE TEVA

Do not take Mirtazapine Teva Italia

• if you are allergic to mirtazapine or to any of the excipients of this medicine (listed in section 6). In this case, you must contact your doctor as soon as possible before taking Mirtazapine Teva Italia
• if you are currently taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAOIs)

Warnings and precautions
Talk to your doctor or pharmacist before using Mirtazapine Teva Italia
Children and adolescents Mirtazapine Teva Italia should normally not be used in children and
adolescents under 18 years of age, as its 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 Teva Italia to patients under 18 years of age if considered in their best interest. If your doctor has prescribed Mirtazapine Teva Italia to a patient under 18 years of age and you wish to obtain clarification on this, please consult your doctor directly. Inform your doctor immediately if any of the above-mentioned symptoms appear or worsen in patients under 18 years of age receiving treatment with Mirtazapine Teva Italia. It should also be noted that the long-term safety effects of Mirtazapine Teva Italia in this age group in terms of growth, maturation, and cognitive and behavioral development have not yet been established. In addition, in this age group, a significant weight gain has been observed more frequently than in adults when treated with mirtazapine.

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 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.

Be especially careful with Mirtazapine Teva Italia also

• if you currently 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 Teva Italia.
• seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking Mirtazapine Teva Italia and contact your doctor immediately.
• liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Teva Italia 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 Teva Italia 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.
• certain types of heart conditions that may alter heart rhythm, recent heart attack, heart failure, or taking certain medicines that may affect heart rhythm. If you experience signs of infection, such as unexplained high fever, sore throat, or mouth ulcers. → Stop taking Mirtazapine Teva Italia 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.

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

• monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take Mirtazapine Teva Italia within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Teva Italia, do not take MAO inhibitors within two weeks after stopping Mirtazapine Teva Italia. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson’s disease). Be cautious when taking Mirtazapine Teva Italia 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 high levels of methemoglobin in the blood), and St. John’s wort preparations (Hypericum perforatum) (a herbal remedy for depression). Very rarely, Mirtazapine Teva Italia, 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 called nefazodone, which may increase the amount of Mirtazapine Teva Italia in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Teva Italia or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Teva Italia.
  • 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 Teva Italia 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 gastric ulcers (such as cimetidine). These medicines, when combined with Mirtazapine Teva Italia, may increase the amount of Mirtazapine Teva Italia in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Teva Italia or, when use of these medicines is stopped, to increase the dose of Mirtazapine Teva Italia again.
  • epilepsy medicines, such as carbamazepine and phenytoin; tuberculosis medicines, such as rifampicin. These medicines, in combination with Mirtazapine Teva Italia, may decrease the amount of Mirtazapine Teva Italia in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Teva Italia or, when use of these medicines is stopped, to reduce the dose of Mirtazapine Teva Italia again.
  • medicines that prevent blood clotting, such as warfarin. Mirtazapine Teva Italia may increase 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 certain antipsychotics.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Limited experience with the administration of Mirtazapine Teva Italia to pregnant women does not indicate an increased risk. However, caution is required when administering Mirtazapine Teva Italia during pregnancy.
If you use Mirtazapine Teva Italia up to or immediately before delivery, the newborn must be carefully 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), causing the baby to breathe faster and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

Mirtazapine Teva Italia orodispersible tablets contain aspartame, a source of
phenylalanine.
Mirtazapine Teva Italia orodispersible tablets contain aspartame, a source of phenylalanine. It may be harmful to individuals with phenylketonuria.

3. How to take Mirtazapine Teva Italia

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
How much Mirtazapine Teva Italia 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, up to the appropriate amount (between 15 and 45 mg daily).
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 Teva Italia
→ Take Mirtazapine Teva Italia every day at the same time.
It is best to take Mirtazapine Teva Italia as a single dose before going to bed. However, your doctor may suggest dividing 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.
How to take the orodispersible tablet as described below:
Take the tablets by oral route.

1. Do not break the orodispersible tablet

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

Fig. A.

2. Detach a tablet imprint

Each blister contains 6 tablets (imprints), separated by perforated lines. Detach one portion 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).

Fig. 3.

4. Removing the orodispersible tablet

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

It will disintegrate rapidly and can be swallowed without water.
When to expect to feel better
Normally, Mirtazapine Teva Italia 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 Teva
Italia:
→ 2–4 weeks after starting Mirtazapine Teva Italia, 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, Mirtazapine Teva Italia should be taken for 4–6 months after depression symptoms have disappeared.
If you take more Mirtazapine Teva Italia than you should
→ If you or someone else takes too much Mirtazapine Teva Italia, contact your doctor immediately.
The most common signs of an overdose of Mirtazapine Teva Italia (without other medicines or alcohol) are
drowsiness, confusion, and increased heart rate. Symptoms of a possible
overdose may include changes in heart rhythm (fast or 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 Teva Italia
If you are supposed to take the dose once daily

• Do not take a double dose to make up for a forgotten dose of Mirtazapine Teva. 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 Teva Italia
→ You may only stop taking Mirtazapine Teva Italia 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 Teva Italia suddenly, even if your depression has resolved. If you stop Mirtazapine Teva Italia abruptly, you may feel unwell, experience dizziness, agitation or anxiety, and have 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 doubts 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 experiences them.
If you experience any of the following serious side effects, stop taking
mirtazapine and contact your doctor immediately.

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

• euphoria or emotional excitement (mania)

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

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

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 disturbances in blood cell production (bone marrow depression). Some people may become more susceptible to infections because mirtazapine can cause a temporary deficiency in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a deficiency in red and white blood cells and platelets (aplastic anaemia), a deficiency in platelets (thrombocytopenia), or an increase in white blood cells (eosinophilia).
• epileptic seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, involuntary muscle contractions, tremor, hyperactive reflexes, agitation, mood changes, loss of consciousness, and increased salivation. Very rarely, 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 with mirtazapine include:

Very common (may occur in more than 1 in 10 people):
increased appetite and body weight
confusional state or drowsiness
headache
dry mouth

Common (may occur in up to 1 in 10 people):
lethargy
dizziness
tremor
nausea
diarrhoea
vomiting
constipation
rash or skin eruption
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)
tiredness
vivid dreams
confusion
anxiety
sleep problems

Uncommon (may occur in up to 1 in 100 people):
Mirtazapine Teva abnormal sensations on the skin, e.g. burning, tingling, itching, or pins and needles (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 occur in up to 1 in 1,000 people):
muscle twitching (myoclonus)
aggression
abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

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)
• night walking (sleepwalking)
• speech disorder
• muscle pain, stiffness and/or weakness and dark or discoloured urine (rhabdomyolysis)
• difficulty in urination (urinary retention)
• increased blood levels of creatine kinase

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
Do not dispose of medicines 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 Teva Italia contains
The active substance is mirtazapine.
Each orodispersible tablet contains 30 mg of mirtazapine.
The other ingredients are: crospovidone (type B), mannitol (E 421), microcrystalline cellulose (E 460),
aspartame (E 951), colloidal anhydrous silica, magnesium stearate (E 572), strawberry flavour [artificial flavours,
maltodextrin, triethyl citrate and propylene glycol], and peppermint flavour [artificial flavours, maize starch].

Description of the appearance of Mirtazapina Teva Italia and pack sizes
Orodispersible tablets.
Mirtazapina Teva Italia 30 mg orodispersible tablets:
White, round tablets, marked with the number “37” on one side and the letter 'A' on the other, with circular raised edges.
Mirtazapina Teva Italia orodispersible tablets are available in packs of 6, 10, 18, 20, 30, 48, 50,
60, 90, 96, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. Piazzale Luigi Cadorna, 4 20123 Milan, Italy

Responsible manufacturer for batch release
Teva Operation Poland SP.z o.o. Ul. Mogilska 80 31-546 Krakow, Poland
Merckle GmbH – Ludwig-Merckle Strasse, 3 – 89143 Blaubeuren (Germany)

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Mirtazapin-ratiopharm 30 mg Schmelztabletten
Italy: Mirtazapina Teva Italia 30 mg compresse orodispersibili
Lithuania: Mirtazapin-ratiopharm 30 mg burnoje disperguojamosios tabletės
Luxembourg: Mirtazapin-ratiopharm 30 mg Schmelztabletten
Netherlands: Mirtazapine ratiopharm dispergeerbaar 30 mg, orodispergeerbare tabletten
Portugal: Mirtazapina Teva
Spain: Mirtazapina Flas ratiopharm 30 mg comprimidos bucodispersables EFG
United Kingdom: Mirtazapine 30 mg orodispersible tablets

This patient information leaflet was last approved on.