Mirtazapine Mylan Generics Italia

Package leaflet: Information for the patient

Mirtazapine Mylan Generics Italia 15 mg orodispersible tablets, 30 mg orodispersible tablets

Mirtazapine
Equivalent 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• 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 Mylan Generics Italia is and what it is used for
2. What you need to know before taking Mirtazapine Mylan Generics Italia
3. How to take Mirtazapine Mylan Generics Italia
4. Possible side effects
5. How to store Mirtazapine Mylan Generics Italia
6. Contents of the pack and other information

1. What Mirtazapine Mylan Generics Italia is and what it is used for

Mirtazapine Mylan Generics Italia belongs to a group of medicines called antidepressants.
Mirtazapine Mylan Generics Italia is used to treat depression in adults.

2. What you need to know before taking Mirtazapine Mylan Generics Italia

Do not take Mirtazapine Mylan Generics Italia:

• 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 inhibitors).

Warnings and precautions
Do not take or consult your doctor before taking Mirtazapine Mylan Generics Italia:
If you have previously experienced a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking mirtazapine or other medicines. Serious skin reactions have been reported with mirtazapine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use immediately and contact your doctor if you notice any of the symptoms described in section 4 related to these serious skin reactions. If you have previously had severe skin reactions, treatment with mirtazapine must not be restarted.

Children and adolescents
Mirtazapine Mylan Generics Italia should generally not be used in children and adolescents under 18 years of age, as efficacy has not been demonstrated. It is also 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, your doctor may prescribe Mirtazapine Mylan Generics Italia to patients under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed Mirtazapine Mylan Generics Italia for a patient under 18 years of age and you wish to discuss this, please speak directly with them. Inform your doctor immediately if any of the symptoms listed above appear or worsen in patients under 18 years of age receiving treatment with Mirtazapine Mylan Generics Italia. It should also be noted that the long-term safety effects of Mirtazapine Mylan Generics Italia in this age group, with regard to growth, maturation, and cognitive and behavioral development, have not yet been established.
In addition, a significantly greater weight gain has been observed in this age group treated with mirtazapine compared to adults.

Suicidal thoughts and worsening depression
If you are depressed, you may sometimes have thoughts of harming yourself or ending your life. These thoughts may increase shortly after starting treatment with antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.
You are more likely to have such thoughts if:

• you have previously had thoughts of ending 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 having thoughts of harming yourself or ending your life, contact your doctor or go to hospital immediately.

It may be helpful to confide in 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.

Talk to your doctor or pharmacist before taking Mirtazapine Mylan Generics Italia if you currently have or have previously had any of the following conditions:

• seizures (epilepsy)
• liver disease, including jaundice.
• kidney disease;
• heart disease or family history of heart disease, including certain heart conditions that may affect heart rhythm, recent heart attack, heart failure, or if you are taking certain medicines that may affect heart rhythm;
• low blood pressure;
• schizophrenia;
• bipolar disorder (alternating periods of euphoria/hyperactivity and depressed mood);
• diabetes (dose adjustments of insulin or other antidiabetic medicines may be needed);
• eye disorders, such as increased eye pressure (glaucoma);
• difficulty urinating, which may be caused by an enlarged prostate.

Elderly patients

• If you are elderly, you may be more sensitive to the side effects of antidepressants.

During treatment
Consult your doctor:

• if you develop signs of infection, such as high fever, sore throat, or mouth ulcers. In rare cases, these symptoms may indicate a disorder in blood cell production in the bone marrow. Although rare, these symptoms most commonly occur after 4–6 weeks of treatment.

Other medicines and Mirtazapine Mylan Generics Italia
Do not take Mirtazapine Mylan Generics Italia in combination with:
monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take Mirtazapine Mylan Generics Italia within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Mylan Generics Italia, do not take MAO inhibitors within two weeks after stopping mirtazapine.
MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson’s disease).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, especially any of the following:

• antidepressants such as SSRIs (e.g., citalopram), venlafaxine, and L-tryptophan or triptans (used to treat migraine, e.g., sumatriptan), tramadol (for pain treatment), linezolid (an antibiotic), lithium (used to treat certain psychiatric conditions), methylene blue (used to treat certain types of blood poisoning), and St. John’s wort Hypericum perforatum (a herbal remedy for depression). Very rarely, Mirtazapine Mylan Generics Italia, alone or in combination with these medicines, may lead to a condition known as serotonin syndrome. Some symptoms of this syndrome include: fever, sweating, increased heart rate, diarrhea, uncontrolled muscle contractions, tremor, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. If you experience a combination of these symptoms, speak to your doctor immediately.
• medicines for anxiety or insomnia, such as benzodiazepines, e.g., diazepam, chlordiazepoxide;
• 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 Mylan Generics Italia may increase the drowsiness caused by these substances.

The following medicines increase the amount of mirtazapine in the blood:

• medicines to treat 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, e.g., ritonavir, nelfinavir),
• medicines for depression (such as nefazodone) and medicines for gastric ulcer ( cimetidine). These medicines, when taken with Mirtazapine Mylan Generics Italia, 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 Mylan Generics Italia or, when these medicines are discontinued, to increase the dose of Mirtazapine Mylan Generics Italia again.

The following medicines decrease the amount of mirtazapine in the blood:

• carbamazepine and phenytoin, medicines for epilepsy,
• rifampicin, a medicine for tuberculosis.
• These medicines, when taken with Mirtazapine Mylan Generics Italia, may decrease 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 Mylan Generics Italia or, when these medicines are discontinued, to reduce the dose of Mirtazapine Mylan Generics Italia again.
• warfarin, a medicine that prevents blood clotting.
• Mirtazapine Mylan Generics Italia 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.

Mirtazapine Mylan Generics Italia and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Mylan Generics Italia.
It is best not to consume alcoholic beverages.

Pregnancy and breastfeeding
Limited experience with mirtazapine administration in pregnant women does not indicate an increased risk. However, caution is advised when administering it during pregnancy.
If you become pregnant while taking Mirtazapine Mylan Generics Italia or are planning a pregnancy, consult your doctor whether you can continue taking Mirtazapine Mylan Generics Italia. If you take Mirtazapine Mylan Generics Italia up to or immediately before delivery, the newborn must be closely monitored for possible adverse effects.
Ensure that your midwife and/or doctor know that you are taking Mirtazapine Mylan Generics Italia.
Medicines such as Mirtazapine Mylan Generics Italia (SSRIs) taken during pregnancy 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 bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Ask your doctor whether you can breastfeed while taking Mirtazapine Mylan Generics Italia.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

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

Mirtazapine Mylan Generics Italia contains aspartame
This medicine contains 3 mg or 6 mg of aspartame in 15 mg or 30 mg orodispersible tablets, respectively. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly metabolize it.

3. How to take Mirtazapine Mylan Generics Italia

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How much Mirtazapine Mylan Generics Italia to take
The recommended 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 recommended dose is
the same for all ages. However, your doctor may adjust the dose if you are elderly or if you have had
kidney or liver disease.
When to take Mirtazapine Mylan Generics Italia
Take Mirtazapine Mylan Generics Italia every day at the same time.
It is best to take Mirtazapine Mylan Generics Italia as a single dose before going to bed. However, your
doctor may suggest dividing the dose of Mirtazapine Mylan Generics Italia, taking one dose in the morning and one dose
in the evening before going to bed. The higher dose should be taken at bedtime.
Taking 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 tablets (imprints) separated by perforated lines. Detach one tablet by tearing along the perforated lines (Figure 1).

Fig. 1.

3. Lift the cover sheet

Carefully lift the cover sheet, starting from the corner (figure 2).

Fig. 2.

4. Removing the orodispersible tablet

The orodispersible tablet must be removed from its blister pack with dry hands and placed on the
tongue. (Figure 3).

Fig. 3.
It will rapidly disintegrate and can be swallowed without water.
When to expect to feel better
Normally, Mirtazapine Mylan Generics 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 Mylan Generics Italia:
2–4 weeks after starting Mirtazapine Mylan Generics 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, it is necessary to continue taking Mirtazapine Mylan Generics Italia for 4–6 months after the symptoms of depression have disappeared.
Use in children and adolescents under 18 years of age
Mirtazapine Mylan Generics Italia must not be used in children and adolescents under 18 years of age (see section 2 Children and adolescents under 18 years of age).
If you take more Mirtazapine Mylan Generics Italia than you should
If you or someone else takes too much Mirtazapine Mylan Generics Italia, contact your doctor immediately.
The most common signs of an overdose of Mirtazapine Mylan Generics Italia (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rhythm (fast or irregular heartbeat) and/or fainting, which may be symptoms of a life-threatening condition known as torsade de pointes.
If you forget to take Mirtazapine Mylan Generics Italia
If you are supposed to take the dose once a day
If you have forgotten to take your dose of Mirtazapine Mylan Generics Italia, do not take the missed dose. Skip the dose. Take the next dose at your usual time.
Do not take a double dose to make up for the forgotten dose.
If you are supposed to take the dose twice a day
If you have forgotten to take the morning dose, simply take this dose together with the evening dose.
If you have forgotten to take 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 Mylan Generics Italia
You should only stop taking Mirtazapine Mylan Generics Italia after speaking with your doctor.
If you stop taking it 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 Mylan Generics Italia suddenly, even if depression has disappeared. If you stop Mirtazapine Mylan Generics Italia suddenly, you may feel unwell, become dizzy, agitated or anxious, and may have a headache. These symptoms can be avoided by stopping treatment gradually. Your doctor will tell you 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 everybody gets them.
If you experience any of the following side effects, stop taking Mirtazapine Mylan Generics Italia and contact your doctor immediately or go to the nearest hospital Emergency Department.
Rare (may affect up to 1 in 1,000 people)

• inflammation of the pancreas. This causes mild to severe stomach pain that spreads to the back.

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

• seizure (convulsions)
• yellowing of the eyes and skin; this may indicate liver problems (jaundice)
• a combination of symptoms such as fever, sweating, increased heart rate, diarrhea, uncontrollable muscle contractions, tremor, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. Very rarely, these may be symptoms of serotonin syndrome
• thoughts of harming yourself or taking your own life, or attempting to do so
• red spots on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), signs of infection such as sudden high fever, sore throat, and mouth ulcers

(agranulocytosis).
Mirtazapine may cause disturbances in blood cell production (bone marrow suppression).
Some people may become less resistant to infections because mirtazapine may cause a temporary reduction in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a deficiency in red blood cells, white blood cells, and platelets (aplastic anaemia), a deficiency of platelets alone (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia)

• breakdown of muscle tissue causing muscle pain, tenderness, stiffness and/or weakness, and dark or discolored urine (rhabdomyolysis)
• difficulty urinating or emptying the bladder
• lower than normal sodium levels in the blood, which may cause weakness and confusion, with muscle pain. This may be due to inappropriate ADH secretion, a hormone causing fluid retention in the body and blood dilution, thereby reducing sodium levels.

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

• increased appetite or body weight
• drowsiness or somnolence
• headache
• dry mouth

Common (may affect up to 1 in 10 people)

• lethargy
• dizziness
• tremors
• nausea
• diarrhea
• 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 (edema)
• fatigue
• vivid dreams
• confusion
• anxiety
• sleep disturbances
• memory problems, which in most cases resolved after stopping treatment

Uncommon (may affect up to 1 in 100 people)

• feeling elated and emotionally excited (mania)
• abnormal sensations on the skin, e.g. burning, tingling, itching, or prickling (paresthesia)
• restless legs syndrome
• fainting (syncope)
• numbness or tingling sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• seeing, sensing, or hearing things that are not there (hallucinations)
• urge to move.

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

• muscle twitching (myoclonus)
• aggressive behaviour
• increased liver enzymes (observed in blood tests)

Not known: frequency cannot be estimated from the available data

• abnormal sensation in the mouth, such as burning, tingling, or prickling (oral paresthesia)
• swelling of the mouth (oral edema)
• low sodium levels (hyponatremia), observed in blood tests
• increased blood levels of creatine kinase, observed in blood tests
• increased salivation
• sleepwalking
• difficulty speaking
• increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milky discharge from the nipple).

Additional side effects in children and adolescents
In children under 18 years of age, the following adverse events have been commonly observed in clinical studies: urticaria and increased blood triglyceride levels.
Reporting of side effects
If you experience any side effects, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirtazapine Mylan Generics 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 after the word
EXP. 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 Mylan Generics Italia contains

• The active substance is mirtazapine. Each orodispersible tablet contains 15 mg of mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine.

The other excipients are:
crospovidone, mannitol, microcrystalline cellulose, aspartame (E951) (see section 2 “Mirtazapina Mylan
Generics Italia contains aspartame”), strawberry and guarana flavour, mint flavour, colloidal anhydrous silica, and
magnesium stearate.

Description of the appearance of Mirtazapina Mylan Generics Italia and package contents
Mirtazapina Mylan Generics Italia 15 mg orodispersible tablets are white, round tablets with “A” engraved on one side and “36” on the other side.
Mirtazapina Mylan Generics Italia 30 mg orodispersible tablets are white, round tablets with “A” engraved on one side and “37” on the other side.
Mirtazapina Mylan Generics Italia is available in blister packs containing: 6, 12, 18, 30, 48, 60, 90, 96 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer responsible for batch release:
Mc Dermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Generics UK,
Station Close, Potters Bar,
Herts, EN6 1TL
United Kingdom
Mylan Hungary Kft
H-2900 Komárom,
Mylan utca 1,
Hungary
Mylan UK Healthcare Limited
Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Mirtazapin Mylan
Denmark: Mirtazapin Mylan 15mg, 30mg & 45mg smeltetabletter
Ireland: Zismirt orotab 15mg, 30mg & 45mg Orodispersible Tablet
Italy: Mirtazapina Mylan Generics Italia 30mg & 45mg compresse orodispersibili
Netherlands: Mirtazapine SmeltTab Mylan 15mg, 30mg & 45mg orodispergeerbare tablet
Poland: Mirtagen 15mg, 30mg & 45mg
Portugal: Mirtazapina Mylan 15mg, 30mg & 45mg comprimido orodispersivel
Slovenia: Mirtazapin Mylan 30mg & 45mg orodisperzibilne tablete
Spain: Mirtazapina FLAS MYLAN 15mg & 30mg comprimidos bucodispersables EFG
United Kingdom: Mirtazapine 15mg, 30mg & 45mg orodispersible tablets