Mirtazapine Aurobindo

Package leaflet: Information for the user

Mirtazapine Aurobindo 30 mg orodispersible tablets

Equivalent 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 pass it on to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Mirtazapina Aurobindo is and what it is used for

Mirtazapina Aurobindo belongs to a group of medicines called antidepressants.
Mirtazapina Aurobindo is used to treat depressive disorders in adults.
It takes 1-2 weeks before Mirtazapina Aurobindo starts to work. After 2-4 weeks you may start to feel better.
Contact your doctor if you do not feel better or if you feel worse after 2-4 weeks.
Further information is provided in section 3, titled “When can you expect to feel better”.

2. What you need to know before taking Mirtazapine Aurobindo

Do not take Mirtazapine Aurobindo

• if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). In this case, you should speak to your doctor as soon as possible before taking Mirtazapine Aurobindo.
• if you are currently 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 Aurobindo.
DO NOT TAKE - OR - INFORM YOUR DOCTOR BEFORE TAKING MIRTAZAPINE A UROBINDO:
if you have previously experienced a severe skin rash, skin peeling, blisters and/or mouth ulcers
after taking mirtazapine or other medicines.

Children and adolescents
Mirtazapine Aurobindo is generally not recommended for use 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 behaviour and rage). Nevertheless,
your doctor may prescribe Mirtazapine Aurobindo 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 Aurobindo to a patient under 18 years of age and you wish to discuss this, please speak to your doctor. You must inform your doctor if any of the symptoms described
above develop or worsen while a patient under 18 years of age is taking Mirtazapine Aurobindo.
It should also be noted that the long-term safety effects of Mirtazapine Aurobindo in this
age group in terms of growth, maturation, and cognitive and behavioural development have not yet
been established. Furthermore, a significant weight gain has been observed in this age group when treated
with Mirtazapine Aurobindo, more frequently than in 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 take time to work, usually about two weeks but sometimes longer.
You are more likely to have such thoughts if:

• you have previously thought about suicide or self-harm.
• you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders being treated with antidepressants. → If at any time you find yourself thinking about suicide or self-harm, contact your doctor or go to hospital immediately. It may be helpful to confide in a family member or friend who is aware of your 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 behaviour.

Pay particular attention when taking Mirtazapine Aurobindo 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 Aurobindo:
• seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking Mirtazapine Aurobindo and contact your doctor immediately;
• liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Aurobindo 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 begin to feel euphoric or overexcited, stop taking Mirtazapine Aurobindo 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 disease that may affect your heart rhythm, a recent heart attack, heart failure, or if you are taking 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 Aurobindo 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.
• serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Mirtazapine Aurobindo. Discontinue use and contact your doctor immediately if you notice any of the symptoms described in section 4 related to these serious skin reactions. If you have previously had serious skin reactions, treatment with mirtazapine should not be restarted.

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

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

Be cautious when taking Mirtazapine Aurobindo 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 methaemoglobin in the blood) and St. John’s wort preparations (Hypericum perforatum) (a herbal remedy for depression). Very rarely, Mirtazapine Aurobindo, 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, 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 Aurobindo in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Aurobindo or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Aurobindo.
• 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 Aurobindo 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) and medicines to treat HIV/AIDS (such as HIV protease inhibitors) and medicines for gastric ulcer (such as cimetidine). These medicines, when used in combination with Mirtazapine Aurobindo, may increase the amount of Mirtazapine Aurobindo in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Aurobindo or, when the use of these medicines is stopped, to increase the dose of Mirtazapine Aurobindo again.
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin. These medicines, when used in combination with Mirtazapine Aurobindo, may decrease the amount of Mirtazapine Aurobindo in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Aurobindo or, when the use of these medicines is stopped, to reduce the dose of Mirtazapine Aurobindo again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapine Aurobindo 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 Aurobindo with food, drinks and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Aurobindo.
It is best not to consume alcoholic beverages.
Mirtazapine Aurobindo may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you might 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 Aurobindo to pregnant women does not
indicate an increased risk. However, caution is advised when administering Mirtazapine Aurobindo during
pregnancy.
If you take Mirtazapine Aurobindo up to or immediately before delivery, the newborn must be carefully
monitored for possible adverse effects.
Ensure that your midwife and/or doctor know that you are taking Mirtazapine Aurobindo. 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 begin within the first 24 hours after the baby's birth. If this occurs with your baby, contact your midwife and/or doctor immediately.

Driving and using machines
Mirtazapine Aurobindo may affect concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed Mirtazapine Aurobindo to a patient under 18 years of age, ensure that their concentration and alertness are not affected before they engage in traffic (e.g. cycling).

Mirtazapine Aurobindo orodispersible tablets contain aspartame.
Mirtazapine Aurobindo orodispersible tablets contain aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.

3. How to take Mirtazapine Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Mirtazapine Aurobindo 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). 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
a kidney or liver disease.
When to take Mirtazapine Aurobindo
→ Take Mirtazapine Aurobindo every day at the same time.
It is best to take Mirtazapine Aurobindo as a single dose before going to bed. However, your doctor
may suggest splitting the dose of Mirtazapine Aurobindo, 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 orally.

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 one tablet imprint

Each blister contains 6 tablets (imprints), separated by perforated lines. Detach one portion by tearing along the perforated lines (Figure 1).

Fig. 1.

3. Lift the cover sheet

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

Fig. 2.

Fig. 3.

4. Removing the orodispersible tablet

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

Fig. 4.
It will rapidly disintegrate and can be swallowed without water.
When can you expect to start feeling better?
Normally, Mirtazapine Aurobindo 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
Aurobindo:
→ 2–4 weeks after starting Mirtazapine Aurobindo, 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 Aurobindo should be taken for 4–6 months after the symptoms of depression have disappeared.
If you take more Mirtazapine Aurobindo than you should
→ If you or someone else takes too much Mirtazapine Aurobindo, contact your doctor immediately.
The most common signs of an overdose of Mirtazapine Aurobindo (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 signs of a life-threatening condition known as torsades de pointes.
If you forget to take Mirtazapine Aurobindo
If your dose is to be taken once daily

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

If your dose is to be taken 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 your 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 your morning and evening doses.

If you stop taking Mirtazapine Aurobindo
→ You should only stop taking Mirtazapine Aurobindo 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 Aurobindo suddenly, even if your depression has resolved. If you stop Mirtazapine Aurobindo suddenly, you may feel unwell, experience dizziness, agitation or anxiety, and have headaches. These symptoms can be avoided by gradually discontinuing treatment. Your doctor will advise you on 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 everybody gets them.
If you experience any of the following serious side effects, stop taking
Mirtazapine Aurobindo and contact your doctor immediately.
Uncommon (may affect up to 1 in 100 people):

• euphoria or emotional excitement (mania)

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

• yellowing of the eyes and skin; 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 Aurobindo may cause a disorder in blood cell production (bone marrow depression). Some people may become less resistant to infections because Mirtazapine Aurobindo may cause a temporary deficiency of white blood cells (granulocytopenia). In very rare cases, Mirtazapine Aurobindo 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).
• epileptic seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrolled muscle contractions, tremor, hyperactive reflexes, exhaustion, mood changes, loss of consciousness, and increased salivation. Very rarely, these may be symptoms of serotonin syndrome.
• thoughts of harming yourself or taking your life
• reddish spots on the trunk, or target-shaped or circular rashes, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals, and eyes. These severe skin eruptions 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).

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

• increased appetite and body weight
• drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• tremors
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling dizzy or faint 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
• memory problems, which in most cases resolved after stopping treatment

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

• abnormal sensations on the skin, e.g. burning, stinging, itching, or tingling (paraesthesia)
• restless legs syndrome
• fainting (syncope)
• numbness of 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; 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)
• sleepwalking (somnambulism)
• speech disorders
• increased blood levels of creatine kinase
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, dark or discoloured urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms of breast enlargement and/or milky discharge from the nipple)

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

Reporting of side effects
If you get 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 http://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 Aurobindo

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 carton and on the blister after 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 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 Aurobindo contains

• The active substance is mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine.
• The other components are: crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), colloidal anhydrous silica, magnesium stearate, strawberry and guarana flavour [maltodextrin, propylene glycol, artificial flavours, acetic acid], and peppermint flavour [artificial flavours, corn starch].

Description of the appearance of Mirtazapina Aurobindo and package contents
Orodispersible tablet.
White, spherical orodispersible tablets (8.0 mm diameter), with a raised circular edge and the number “37” engraved on one side and the letter 'A' on the opposite side.
Mirtazapina Aurobindo orodispersible tablets are available in perforated blisters made of polyamide/aluminium/PVC/paper/polyester/aluminium containing 30 tablets.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturers:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road, South Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, no 19,
2700-487 Amadora
Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Mirtazapina Aurobindo 30 mg orodispersible tablets