Olanzapine Aurobindo

Package leaflet: Information for the user

Olanzapine Aurobindo 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets

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 their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Olanzapina Aurobindo contains the active substance olanzapine. Olanzapina Aurobindo belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing or sensing things that are not real, believing false ideas, unusual suspiciousness, and becoming withdrawn. People with this disorder may also feel depressed, anxious or tense.
• Moderate to severe manic episodes; a condition with symptoms such as feelings of euphoria. Olanzapina Aurobindo has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Aurobindo

Do not take Olanzapina Aurobindo

• If you are allergic (hypersensitive) to olanzapine or to any of the excipients of this medicine (listed in section 6). An allergic reaction may present as skin rash, itching, swelling of the face or lips, or shortness of breath. If this applies to you, speak with your doctor.
• If you have previously been diagnosed with certain types of eye problems, such as certain forms of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapina Aurobindo.

• The use of Olanzapina Aurobindo in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
• Medicines of this type may cause unusual movements, mainly of the face or tongue. If this occurs after taking Olanzapina Aurobindo, inform your doctor.
• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation. If this happens to you, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Aurobindo. You and your doctor should monitor your weight regularly. Consult a dietitian or follow a diet if necessary.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Aurobindo. Your doctor should perform blood tests and monitor your sugar levels and certain blood fats before you start treatment and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this may be associated with blood clot formation.

If you suffer from any of the following conditions, inform your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epileptic seizures
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or "mini" strokes (transient ischemic attacks)
• If you know you may have a salt deficiency due to severe and prolonged diarrhoea and vomiting (feeling unwell) or use of diuretics.

If you have dementia, you, healthcare staff, or a relative should inform the doctor if you have had a stroke or a "mini" stroke.
If you are over 65 years old, your blood pressure may need to be monitored as a routine precaution.
Children and adolescents
Olanzapina Aurobindo is not indicated for patients under 18 years of age.
Other medicines and Olanzapina Aurobindo
Take other medicines with Olanzapina Aurobindo only after obtaining approval from your doctor. You may feel drowsy if you take Olanzapina Aurobindo together with antidepressants or medicines for anxiety or to help you sleep (tranquillisers).
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 stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Olanzapina Aurobindo may be necessary.

Olanzapina Aurobindo and alcohol
You must not drink alcohol while taking Olanzapina Aurobindo, as taking them together may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You must not take this medicine during pregnancy unless specifically instructed by your doctor. You must not take this medicine while breastfeeding, as small amounts of Olanzapina Aurobindo may pass into breast milk.
The following symptoms may occur in newborns whose mothers have used olanzapine during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Driving and using machines
There is a risk that you may feel drowsy while taking Olanzapina Aurobindo. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapina Aurobindo contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olanzapina Aurobindo

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 Olanzapina Aurobindo tablets to take and for how long you should continue taking them. The daily dose of Olanzapina Aurobindo ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina Aurobindo unless your doctor tells you to do so.
You should take Olanzapina Aurobindo tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food.
Olanzapina Aurobindo tablets are for oral use. Swallow the tablets whole with some water.

If you take more Olanzapina Aurobindo than you should
Patients who have taken more Olanzapina Aurobindo than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, difficulty speaking, unusual movements (particularly 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 stiffness, and drowsiness or sleepiness, slowed breathing, aspiration, low or high blood pressure, or irregular heartbeat. Contact your doctor or go to hospital immediately if any of the symptoms described above occur. Show your doctor the tablet pack.

If you forget to take Olanzapina Aurobindo
Take the tablets as soon as you remember. Do not take two doses on the same day.

If you stop taking Olanzapina Aurobindo
Do not stop taking the tablets just because you feel better. It is important that you continue taking Olanzapina Aurobindo for the entire duration indicated by your doctor.
If you suddenly stop taking Olanzapina Aurobindo, symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Tell your doctor immediately if you have:

• unusual movements mainly affecting the face or tongue (a common side effect which may affect 1 in 10 people)
• blood clots in the veins (an uncommon side effect which may affect 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately
• a combination of fever, rapid breathing, sweating, muscle stiffness, numbness, drowsiness or sedation (the frequency of this side effect cannot be estimated from available data).

Very common side effects: (may affect more than 1 in 10 patients) include weight gain, drowsiness and increased levels of prolactin in the blood.
In the early stages of treatment, some people may experience dizziness or fainting (with slow heart rate), particularly when getting up from a lying or sitting position. These symptoms usually resolve on their own, but if they do not, inform your doctor.
Common side effects: (may affect up to 1 in 10 patients) include:

• changes in levels of certain blood cells, blood fats, and temporary increase in liver enzymes at the beginning of treatment
• 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 strength
• extreme tiredness
• water retention leading to swelling of the hands, hips and feet
• fever
• joint pain and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.
  Uncommon side effects: (may affect up to 1 in 100 patients) include
• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash)
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma
• seizures, usually in patients with a history of epileptic seizures (epilepsy)
• muscle stiffness or spasm (including eye movements)
• restless legs syndrome
• problems with speech
• slow heart rate
• sensitivity to sunlight
• nosebleeds
• abdominal distension
• memory loss or forgetfulness
• urinary incontinence, inability to urinate
• hair loss
• absence or reduction of menstrual cycles and breast changes in men and women such as abnormal milk production from the breast or abnormal growth.
  Rare side effects: (may affect up to 1 in 1,000 patients) include
• reduced normal body temperature
• abnormal heart rhythm
• unexplained sudden death
• inflammation of the pancreas causing severe stomach pain, fever and malaise
• liver disease manifesting as yellowing of the skin and whites of the eyes
• muscle disease presenting as tenderness and unexplained muscle pains
• prolonged and/or painful erection

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms such as rash on the face subsequently 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).
Elderly patients with dementia who take olanzapine may experience stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness and difficulty walking. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, Olanzapina Aurobindo may worsen their 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapina Aurobindo

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25 °C.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle label.
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 contains

• The active substance is olanzapine. Each tablet of Olanzapina Aurobindo contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of active substance. The exact amount is indicated on the packaging of Olanzapina Aurobindo.
• The excipients are: monohydrate lactose, crospovidone (type B), hydroxypropylcellulose and magnesium stearate.

Description of the appearance of Olanzapina Aurobindo and package contents
Olanzapine 2.5 mg tablets:
Yellow, round (5.2 mm in diameter), biconvex, uncoated tablets, imprinted with
“C” on one side and “45” on the other side.
Olanzapine 5 mg tablets:
Yellow, round (6.5 mm in diameter), biconvex, uncoated tablets, imprinted with
“C” on one side and “46” on the other side.
Olanzapine 7.5 mg tablets:
Yellow, round (7.5 mm in diameter), biconvex, uncoated tablets, imprinted with
“C” on one side and “47” on the other side.
Olanzapine 10 mg tablets:
Yellow, round (8.0 mm in diameter), biconvex, uncoated tablets, imprinted with
“C” on one side and “48” on the other side.
Olanzapina Aurobindo tablets are available in:
PVC/polyamide/aluminum/PVC/aluminum blister packs:
7, 14, 28, 30, 35, 50, 56, 70, 96, 98 and 100 tablets.
HDPE bottle with polypropylene closure and silica gel desiccant:
30 and 1000 tablets.

Marketing Authorization Holder and Manufacturer
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Orion Corporation, Orion Pharma
Orionintie 1,
FI-02200 Espoo,
Finland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium Olanzapine AB 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tabletten
Cyprus Olanzapine Aurobindo 5 mg/ 10 mg tablets
Denmark Olanzapin "Orion"
Finland Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tabletit
France OLANZAPINE ARROW 5mg/ 7.5mg/ 10mg comprimé
Germany Olanzapin Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20 mg Tabletten
Italy Olanzapina Aurobindo
Malta Olanzapine Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
Netherlands Olanzapine Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg, tabletten
Norway Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tabletter
Poland Sizin/Olanzapina Aurobindo
Portugal Olanzapina Aurobindo
Romania Olanzapina Aurobindo 5mg/ 10mg/ 15mg/ 20 mg comprimate
Spain OLANZAPINA AUROBINDO 2.5mg/ 5mg/ 7.5mg/ 10mg, comprimidos EFG
Sweden Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tabletter
United Kingdom Olanzapine 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets