Package Insert: Information for the User

OlanzapinaSUN 2,5mg tabletsEFG

olanzapina

Contents of the package and additional information

Olanzapina SUN contains the active ingredient olanzapina.Olanzapina belongs to a group of medicines called antipsychotics that are used to treat the following conditions:

- Schizophrenia, a condition with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from this condition may also be depressed, anxious or tense.

– Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina has shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina SUN tablets

• If you are allergic (hypersensitive) to olanzapina or to any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina SUN tablets

• Olanzapina is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina, tell your doctor.
• Very rarely, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this happens, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina. You and your doctor should check your weight regularly.If necessary, your doctor mayhelp you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapina. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina SUN tablets and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with blood clot formation.

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

• Stroke or transient ischemic attack (temporary lack of blood flow to the brain)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretic medications (urine tablets)

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina SUN tablets.

Use of Olanzapina SUN tablets with other medications

Only use other medications at the same time as Olanzapina SUN tablets if your doctor authorizes it. You may feel drowsy if you combine Olanzapina SUN tablets with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease
• Carbamazepine (an antiepileptic and mood stabilizer), Fluvoxamine (an antidepressant), or Ciprofloxacin (an antibiotic). You may need to change your Olanzapina SUN tablets dosage.

Taking Olanzapina SUN tablets with alcohol

You should not drink alcohol if you have been given Olanzapina SUN tablets, as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. You should not take this medication during pregnancy unless your doctor recommends it.

You should not take this medication while breastfeeding as small amounts of Olanzapina may pass into breast milk.

The following symptoms may occur in newborns of mothers who used Olanzapina in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina SUN tablets. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina SUN tablets contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapina SUN tablets to take and for how long. The daily dose of Olanzapina SUN tablets ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina SUN tablets unless your doctor tells you to.

You should take your Olanzapina SUN tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapina SUN tablets are for oral administration. You should swallow the Olanzapina SUN tablets whole with water.

If you take more Olanzapina SUN tablets than you should

Patients who have taken more Olanzapina tablets than they should have experienced the following symptoms: rapid heart rate, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. It is recommended to show the medication packaging to your doctor.

Consult your doctor, pharmacist, or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Olanzapina SUN tablets

Take your tablet as soon as you remember. Do not take two doses in one day.

If you interrupt treatment with Olanzapina SUN tablets

Do not stop treatment when you think you are feeling better. It is very important that you continue taking Olanzapina tablets as long as your doctor tells you to.

If you suddenly stop taking Olanzapina tablets, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

• Unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Frequent side effects (can affect more than 1 in 10 people):

- Weight gain

- Drowsiness

- Increased plasma levels of prolactin

• During the initial stages of treatment, some people may feel dizzy or faint (especially with slower heartbeats), especially when getting up from a sitting or lying position. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Frequent side effects (can affect up to 1 in 10 people):

• Changes in levels of some circulating blood fat cells and temporary increases in liver enzymes at the beginning of treatment
• Increased levels of blood sugar and urine
• Increased levels of uric acid and creatine phosphokinase in the blood
• Increased appetite
• Dizziness
• Fatigue
• Tremor
• Abnormal movements (dyskinesia)
• Constipation
• Dry mouth
• Urticaria
• Loss of strength
• Extreme fatigue
• Fluid retention that can lead to swelling of hands, ankles, or feet.
• Fever
• Pain in the joints
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men

Rare side effects (can affect up to 1 in 100 people)

• Hyper-sensitivity (e.g. inflammation of the mouth and throat, itching, skin rash)
• Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the blood and urine) or coma
• Seizures, in most cases related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stuttering
• Slowed heart rate
• Sensitivity to sunlight
• Nosebleeds
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence
• Loss of ability to urinate
• Hair loss
• Absence or increase of menstrual periods
• Changes in breasts in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (can affect up to 1 in 1000 people):

• Decreased normal body temperature
• Abnormal heart rhythm
• Sudden and inexplicable death
• Pancreatitis, which can cause stomach pain, fever, and dizziness.
• Liver disease, which manifests as yellowing of the skin and white part of the eyes.
• Muscular disease, manifested as unexplained pain and aches.
• Prolonged and/or painful erection

Very rare side effects include severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, swelling of lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking problems. Deaths have been reported in this particular group of patients.

Olanzapine SUN tablets may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in the prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Olanzapine SUN Tablet Composition

• The active ingredient is olanzapine. Each coated tablet contains 2.5 mg of active ingredient.
• The other components are:anhydrous lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

Appearance of Olanzapine SUN Tablets and Packaging Contents

Olanzapine SUN 2.5 mg tablets EFG are presented in the form of tablets, with a light yellow to yellow color, slightly speckled, round, biconvex, with the inscription in low relief “O4” on one of its faces and smooth on the other face.

This medication is available in packaging of 7, 10, 14, 28, 30, 35, 56, and 70 mg tablets. Not all packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia SA,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

For more information about this medication, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

This medication is authorized in the EEA member countries with the following names:

Austria- Olanzapine Ranbaxy 2.5mg Tablets

France- Olanzapine SUN, 2.5mg Tablets

Germany- Olanzapine Basics 2.5mg Tablets

Netherlands- Olanzapine SUN 2.5mg Tablets

Spain- Olanzapina SUN 2.5mg Tablets EFG

Sweden- Olanzapina Ranbaxy 2.5mg Tablets

Last Review Date of this Prospectus:July 2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/