Olanzapine Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Olanzapine Sandoz 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start using 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT OLANZAPINE SANDOZ IS AND WHAT IT IS USED FOR

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

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING OLANZAPINE SANDOZ

Do not take Olanzapine Sandoz
if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may manifest as skin rash, itching, facial swelling,
swelling of the lips, or shortness of breath. If you have experienced any of these symptoms, inform your doctor.
if you have previously been diagnosed with an eye condition such as certain types of glaucoma (increased pressure within the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapine Sandoz.
The use of Olanzapine Sandoz in elderly patients with dementia is not recommended, as it may lead to serious adverse effects.

• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs, inform your doctor.
• Rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapine Sandoz. You and your doctor should monitor your weight regularly. If necessary, consult a dietitian or follow a diet program.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine Sandoz. Your doctor should order blood tests to check your blood sugar and certain fat levels before you start taking Olanzapine Sandoz and regularly during treatment. Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:
Stroke or "mini" strokes (transient ischemic attacks, TIA)
Parkinson’s disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures
If you know you may experience excessive loss of salts due to severe and prolonged diarrhea 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 ever had a stroke or a "mini" stroke in the past.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.

Children and adolescents
Olanzapine Sandoz is not indicated for patients under 18 years of age.

Other medicines and Olanzapine Sandoz
Take other medicines while on treatment with Olanzapine Sandoz only if your doctor has told you it is safe to do so. You may feel drowsy if Olanzapine Sandoz is taken together with antidepressants or medicines for anxiety or to help you sleep (tranquilizers).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines used to treat Parkinson’s disease;
• carbamazepine (an antiepileptic and antidepressant), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – because the dose of Olanzapine Sandoz may need to be adjusted.

2/8

Olanzapine Sandoz and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Sandoz, as taking it together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. You must not take this medicine during breastfeeding, as small amounts of Olanzapine Sandoz may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken Olanzapine Sandoz during the third trimester (last 3 months of pregnancy): tremors, muscle stiffness and/or muscle 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
When taking Olanzapine Sandoz, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzapine Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE OLANZAPINE SANDOZ

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many Olanzapine Sandoz tablets to take and for how long you should
continue treatment. The daily dose of Olanzapine Sandoz ranges from 5 mg to 20 mg per day.
If your symptoms return, consult your doctor, but do not stop taking Olanzapine Sandoz unless your doctor
specifically instructs you to do so.
You should take Olanzapine Sandoz tablets once daily, following your doctor's instructions.
Try to take the tablets at the same time every day. It does not matter whether you take them with or
without food. Olanzapine Sandoz film-coated tablets are for oral use.
Swallow the Olanzapine Sandoz tablets with a glass of water.
5 mg, 10 mg film-coated tablets:
The film-coated tablets may be divided into equal doses.
If you take more Olanzapine Sandoz than you should
Patients who have taken more Olanzapine Sandoz 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 somnolence, slowed breathing rate, aspiration, increased or decreased
blood pressure, and changes in heart rhythm.
Contact your doctor immediately or go to hospital if you experience any of the symptoms listed above.
Show the healthcare staff the tablet packaging.
3/8
If you forget to take Olanzapine Sandoz
If you forget to take a tablet, take it as soon as possible. Do not take two doses on the same day.
If you stop taking Olanzapine Sandoz
Do not stop taking your tablets just because you feel better. It is important that you continue taking
Olanzapine Sandoz for the entire duration prescribed by your doctor.
If you stop treatment with Olanzapine Sandoz abruptly, you may experience symptoms such as
sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may prescribe a
gradual reduction of the dose before stopping treatment completely.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if you experience:
Unusual movements (a common effect which may affect up to 1 in 10 patients), especially of the
face or tongue
Blood clots in the veins (an uncommon adverse reaction which may affect up to 1 in 100 patients),
particularly in the lower limbs (symptoms include swelling, pain and redness in the legs), which may
travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you
notice any of these symptoms, consult a doctor immediately.
Combination of fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness (a rare
adverse effect which may affect up to 1 in 1,000 patients)

Very common adverse reactions (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 feel dizzy or faint (with a slowed heartbeat), especially
when standing up from a lying or sitting position. These symptoms usually resolve spontaneously, but if
they do not, inform your doctor.

Common adverse reactions (may affect up to 1 in 10 people) include:
Changes in levels of certain blood cells and circulating fats
Temporary increases in liver enzymes, especially 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
Skin rash
Loss of strength
Extreme tiredness
Fluid retention leading to swelling of the hands, ankles or feet
Fever
Joint pain
Sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.

Uncommon adverse reactions (may affect up to 1 in 100 people) include:
Hypersensitivity (e.g., swelling of the mouth and throat, itching, skin 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 seizures (epilepsy)
Muscle stiffness or spasms (including eye movements)
Restless legs syndrome
Speech problems
Stuttering
Slow heart rate
Sensitivity to sunlight
Nosebleeds
Abdominal distension
Drooling
Memory loss or forgetfulness
Urinary incontinence, loss of ability to urinate
Hair loss
Absence or reduction of menstrual cycles
Breast changes in males and females, such as abnormal production of breast milk or abnormal growth

Rare adverse reactions (may affect up to 1 in 1,000 people) include:
Lowering of normal body temperature
Changes in heart rhythm
Unexplained sudden death
Inflammation of the pancreas causing severe stomach pain, fever, and malaise
Liver disease presenting as yellowing of the skin and whites of the eyes
Muscle disorders presenting as tenderness and unexplained muscle pain
Prolonged and/or painful erection

Very rare adverse reactions include severe allergic reactions such as Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms and a skin rash on the face,
followed by widespread rash, high fever, swollen lymph nodes, increased levels of liver enzymes observed
in blood tests, and an increase in a type of white blood cells in the blood (eosinophilia).

In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls,
extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and gait disturbances may
occur. In this particular group of patients, some fatal cases have been reported.

In patients with Parkinson's disease, Olanzapina Sandoz may worsen symptoms.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLANZAPINE SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, or label of the HDPE bottle after "Exp". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Storage conditions after first opening of the bottle: Do not store above 25°C.
Validity period after first opening of the bottle:
6 months
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Olanzapina Sandoz contains
The active substance is olanzapine.
Each film-coated tablet contains 2.5 mg of olanzapine.
Each film-coated tablet contains 5 mg of olanzapine.
Each film-coated tablet contains 10 mg of olanzapine.

The other components are:
Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.
Tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc.

Description of the appearance of Olanzapina Sandoz and package contents
2.5 mg film-coated tablets:
White, round tablets, approximately 6.5 mm in diameter.
5 mg film-coated tablets:
White, round tablets, approximately 8 mm in diameter, with a score line on one side.
10 mg film-coated tablets:
White, round tablets, approximately 10 mm in diameter, with a score line on one side.

The film-coated tablets are packaged in AL/AL blisters placed in a carton, or in HDPE bottles with a desiccant in the cap.

Pack sizes:
Blister packs of 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70, 98, 100, and 500 film-coated tablets.
HDPE bottles containing 50, 100, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Responsible manufacturers for batch release
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen (Germany)
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben (Germany)
LEK S.A., Ul. Domaniewska 50 C, PL-02-672 Warszawa (Poland)
LEK S.A., Ul. Podlipie 16, 95-010 Strykow (Poland)
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana (Slovenia)

This medicinal product has been authorized in the EEA Member States under the following names:

Austria:
Olanzapin Sandoz 2.5 mg - Filmtabletten
Olanzapin Sandoz 5 mg - Filmtabletten
Olanzapin Sandoz 10 mg - Filmtabletten
Olanzapin Sandoz 15 mg - Filmtabletten
Olanzapin Sandoz 20 mg - Filmtabletten

Belgium:
Olanzapine Sandoz 5 mg filmomhulde tabletten
Olanzapine Sandoz 7.5 mg filmomhulde tabletten
Olanzapine Sandoz 10 mg filmomhulde tabletten

Czech Republic:
Olanzapin Sandoz 10 mg

Denmark:
Olanzapin “Sandoz”

Finland:
Olanzapin Sandoz 5 mg tabletti, kalvopäällysteinen
Olanzapin Sandoz 7.5 mg tabletti, kalvopäällysteinen
Olanzapin Sandoz 10 mg tabletti, kalvopäällysteinen
Olanzapin Sandoz 15 mg tabletti, kalvopäällysteinen
Olanzapin Sandoz 20 mg tabletti, kalvopäällysteinen

France:
OLANZAPINE SANDOZ 5 mg, comprimé pelliculé
OLANZAPINE SANDOZ 7.5 mg, comprimé pelliculé
OLANZAPINE SANDOZ 10 mg, comprimé pelliculé

Greece:
Olanzapin/Sandoz

Iceland:
Olanzapin Sandoz 5 mg filmuhúðaðar töflur
Olanzapin Sandoz 10 mg filmuhúðaðar töflur
OLANZAPIN SANDOZ

Italy:
OLANZAPINA Sandoz

Netherlands:
Olanzapine Sandoz 2.5 mg, filmomhulde tabletten
Olanzapine Sandoz 5 mg, filmomhulde tabletten
Olanzapine Sandoz 10 mg, filmomhulde tabletten
Olanzapine Sandoz 15 mg, filmomhulde tabletten
Olanzapine Sandoz 20 mg, filmomhulde tabletten

Spain:
Olanzapina Sandoz 2.5 mg comprimidos recubiertos con película EFG
Olanzapina Sandoz 5 mg comprimidos recubiertos con película EFG
Olanzapina Sandoz 7.5 mg comprimidos recubiertos con película EFG
Olanzapina Sandoz 10 mg comprimidos recubiertos con película EFG

Sweden:
Olanzapin Sandoz

United Kingdom:
Olanzapine Sandoz 2.5 mg Film-coated Tablets
Olanzapine Sandoz 5 mg Film-coated Tablets
Olanzapine Sandoz 7.5 mg Film-coated Tablets
Olanzapine Sandoz 10 mg Film-coated Tablets
Olanzapine Sandoz 15 mg Film-coated Tablets
Olanzapine Sandoz 20 mg Film-coated Tablets