Olanzapine Aurobindo Pharma Italia

Package leaflet: Information for the user

Olanzapina Aurobindo Pharma Italia 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olanzapina Aurobindo Pharma Italia is and what it is used for

Olanzapina Aurobindo Pharma Italia belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspiciousness, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a condition characterized by symptoms of excitement or euphoria. Olanzapine has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Olanzapine Aurobindo Pharma Italia

Do not take Olanzapine Aurobindo Pharma Italia

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, swelling of the face, lips or difficulty breathing. If this has ever happened to you, tell your doctor.
• If you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapine Aurobindo Pharma Italia:

• The use of Olanzapine Aurobindo Pharma Italia in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, particularly of the face or tongue. If this occurs after taking Olanzapine Aurobindo Pharma Italia, inform your doctor.
• Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this occurs, consult your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or following a dietary program.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to check sugar and certain fat levels before you start taking Olanzapine Aurobindo Pharma Italia and periodically during treatment.
• Inform your doctor if you or someone in your family has suffered from blood clots, as medicines like this have been associated with blood clot formation. Inform your doctor as soon as possible if you have any of the following conditions:
• Stroke or "mini" stroke (transient ischemic attack).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart conditions.
• Diabetes.
• Epilepsy.
• If you know you may lose excessive amounts of salt due to severe and prolonged diarrhoea and vomiting (due to illness) or due to the use of diuretics (water tablets).

If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or a "mini" stroke.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Olanzapine Aurobindo Pharma Italia is not indicated for patients under 18 years of age.
Other medicines and Olanzapine Aurobindo Pharma Italia
During treatment with Olanzapine Aurobindo Pharma Italia, take other medicines only after obtaining approval from your doctor. You may experience drowsiness if Olanzapine Aurobindo Pharma Italia is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• Medicines for Parkinson's disease;
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – it may be necessary to adjust the dose of Olanzapine Aurobindo Pharma Italia.

Olanzapine Aurobindo Pharma Italia and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Aurobindo Pharma Italia, as taking Olanzapine Aurobindo Pharma Italia together with alcohol may cause drowsiness.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
You should not take this medicine while breastfeeding, as small amounts of Olanzapine Aurobindo Pharma Italia may pass into breast milk.
Newborns whose mothers have taken Olanzapine Aurobindo Pharma Italia during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.
Driving and using machines
When taking Olanzapine Aurobindo Pharma Italia, you may experience drowsiness.
If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapine Aurobindo Pharma Italia contains aspartame
This medicine contains 0.5 mg of aspartame per 5 mg orodispersible tablet.
This medicine contains 1 mg of aspartame per 10 mg orodispersible tablet.
This medicine contains 1.5 mg of aspartame per 15 mg orodispersible tablet.
This medicine contains 2 mg of aspartame per 20 mg orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Olanzapina Aurobindo Pharma Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you how many tablets of Olanzapina Aurobindo Pharma Italia to take and for how long. The daily dose of Olanzapina Aurobindo Pharma Italia ranges from 5 mg to 20 mg. If your symptoms return, speak to your doctor, but do not stop taking Olanzapina Aurobindo Pharma Italia unless your doctor tells you to do so.

Take the Olanzapina Aurobindo Pharma Italia tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. The orodispersible tablets of Olanzapina Aurobindo Pharma Italia are for oral use.

The Olanzapina Aurobindo Pharma Italia tablets break easily, so handle them carefully. Do not touch the tablets with wet hands, as they may disintegrate.

You may also place the tablet in a glass or cup filled with water, orange juice, apple juice, milk, or coffee and stir until dissolved. With some beverages, the mixture may change colour and become cloudy. Drink it immediately.

If you take more Olanzapina Aurobindo Pharma Italia than you should
Patients who have taken more Olanzapina Aurobindo Pharma Italia than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, speech difficulties, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, and drowsiness or lethargy, slowed breathing, aspiration, high or low blood pressure, and changes in heart rhythm. If any of these symptoms occur, contact your doctor or go to hospital immediately. Show your tablet pack to the doctor.

If you forget to take Olanzapina Aurobindo Pharma Italia
Take the missed dose as soon as you remember. Do not take a double dose to make up for the forgotten dose.

If you stop taking Olanzapina Aurobindo Pharma Italia
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapina Aurobindo Pharma Italia for the entire duration recommended by your doctor.

If you stop treatment with Olanzapina Aurobindo Pharma Italia suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
Immediately inform your doctor if you experience:

• unusual movements (a common side effect affecting up to 1 in 10 people), mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect affecting up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness in the leg), which may travel from the blood vessels to the lungs causing chest pain and breathing difficulties. If you experience any of these symptoms, seek immediate medical attention;
• a combination of fever, rapid breathing, sweating, muscle stiffness and weakness, or drowsiness (the frequency of this adverse reaction cannot be estimated from the available data).

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterised by flu-like symptoms such as rash on the face, later spreading to other parts of the body, high temperature, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia).
Very common side effects (may affect more than 1 in 10 people) include:

• Weight gain.
• Drowsiness.
• Increased levels of prolactin in the blood.

In the early stages of treatment, some people may experience dizziness or fainting (with a slowed heart rate), especially when standing up from a lying or sitting position. This usually resolves on its own, but if it does not, contact your doctor.
Common side effects (may affect up to 1 in 10 people) include:

• Changes in levels of certain blood cells, circulating fats, and, at the beginning of treatment, a temporary increase in liver enzymes.
• Increased levels of sugar in the blood and urine.
• Increased levels of uric acid and creatine phosphokinase in the blood.
• Increased feeling of hunger.
• Dizziness.
• Restlessness.
• Tremor.
• Unusual movements (dyskinesia).
• Constipation.
• Dry mouth.
• Rash.
• Loss of energy.
• Extreme tiredness.
• Fluid retention causing swelling of the hands, ankles or feet.
• Fever.
• Joint pain and sexual dysfunction such as reduced libido in men and women or erectile dysfunction in men.

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

• Hypersensitivity (for example, swelling of the mouth and throat, itching and rash).
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in the blood and urine) or coma.
• Seizures, usually in patients with a history of seizures (epilepsy).
• Muscle stiffness or spasms (including eye movements).
• Restless legs syndrome.
• Speech problems.
• Stuttering.
• Slowed heartbeat.
• Sensitivity to sunlight.
• Nosebleeds.
• Abdominal swelling.
• Drooling.
• Memory loss or forgetfulness.
• Urinary incontinence.
• Inability to urinate.
• Hair loss.
• Absence or reduction of menstrual cycles.
• Changes in the breasts in males and females such as abnormal growth or abnormal milk secretion.

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

• Lowering of normal body temperature.
• Abnormal heart rhythms.
• Unexplained sudden death.
• Inflammation of the pancreas causing severe stomach pain, fever and nausea.
• Liver disease manifesting as yellowing of the skin and whites of the eyes.
• Muscle disease presenting as unexplained muscle pain.
• Prolonged and/or painful erection.

During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking difficulties. Fatal outcomes have been reported in some cases within this specific patient group.
In patients with Parkinson's disease, Olanzapina Aurobindo Pharma Italia may worsen symptoms.
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.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 Olanzapina Aurobindo Pharma 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 on the blister pack label after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and 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 Olanzapina Aurobindo Pharma Italia contains

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg/10 mg/15 mg/20 mg of olanzapine.
• The other components are: mannitol (SD 200), mannitol (mannitol 35), potassium polacrilin, crospovidone (type A), anhydrous colloidal silica, aspartame (E951), microcrystalline cellulose (grade 112), sodium stearil fumarate and artificial pineapple flavour (FL SD # 883) [containing flavouring ingredients and modified food starch].

Description of the appearance of Olanzapina Aurobindo Pharma Italia and contents of the pack
Orodispersible tablet.
Olanzapina Aurobindo Pharma Italia 5 mg orodispersible tablets:
Yellow, round, flat tablet with bevelled edges, marked with ‘C’ on one side and ‘51’ on the other side.
Olanzapina Aurobindo Pharma Italia 10 mg orodispersible tablets:
Yellow, round, flat tablet with bevelled edges, marked with ‘C’ on one side and ‘52’ on the other side.
Olanzapina Aurobindo Pharma Italia 15 mg orodispersible tablets:
Yellow, round, flat tablet with bevelled edges, marked with ‘C’ on one side and ‘53’ on the other side.
Olanzapina Aurobindo Pharma Italia 20 mg orodispersible tablets:
Yellow, round, flat tablet with bevelled edges, marked with ‘C’ on one side and ‘54’ on the other side.
Olanzapina Aurobindo Pharma Italia 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are available in blisters.
Blister: Polyamide/Aluminium foil coated with primer, PE Coex/Polyethylene with desiccant and PE Coex coating as cavity material/Aluminium foil coated with PE as cover material.
Pack sizes:
Blister pack: 1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe 102
21047 Saronno (VA)
Italy

Responsible producer for batch release
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD
United Kingdom
Orion Corporation, Orion Pharma
Orionintie 1,
FI-02200 Espoo
Finland

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium: Olanzapine AB 5 mg/10 mg/15 mg/20 mg orodispergeerbare tabletten
Czech Republic: Olanzapine Aurovitas
France: Olanzapine Arrow 5 mg/10 mg/15 mg/20 mg, comprimé orodispersible
Italy: Olanzapina Aurobindo Pharma Italia
Malta: Olanzapine Aurobindo 5 mg/10 mg/15 mg/20 mg orodispersible tablets
Portugal: Olanzapina Aurobindo
Romania: Olanzapina Aurobindo 5 mg/10 mg/15 mg/20 mg comprimate orodispersabile
Spain: Olanzapina Aurobindo 5 mg/10 mg/15 mg/20 mg comprimidos bucodispersables EFG
United Kingdom: Olanzapine 5 mg/10 mg/15 mg/20 mg orodispersible tablets