Package Leaflet: Information for the User

Olanzapina Stada 5 mg Film-Coated Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as 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 they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Olanzapina Stada contains the active ingredient olanzapina. Olanzapina belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms include hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina Stada 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 Stada:

• If you are allergic to olanzapina or 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 pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Stada.

• Olanzapina Stada 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 Stada, tell your doctor.
• In rare cases, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.

A weight gain has been observed in patients taking Olanzapina Stada. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.

• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Stada. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina Stada 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:

• Cerebral infarction or transient cerebral ischemia (temporary symptoms of cerebral infarction).
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a cerebral infarction or transient cerebral ischemia.

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

Children and adolescents

Patients under 18 years old should not take Olanzapina Stada.

Use of Olanzapina Stada with other medications

Only use other medications at the same time as Olanzapina Stada if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Stada 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 adjust your Olanzapina Stada dosage.

Use of Olanzapina Stada with alcohol

You should not drink alcohol if you have been administered Olanzapina Stada as it may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

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

The following symptoms may occur in newborns of mothers who used Olanzapina Stada 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 experiences any of these symptoms, contact your doctor.

Driving and operating machinery

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

Olanzapina Stada contains lactose and soy lecithin

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains soy oil. Do not use it in case of an allergy to peanuts or soy.

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

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

You should take your Olanzapina Stada 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. The coated tablets of Olanzapina Stada are for oral administration. You should swallow the Olanzapina Stada tablets whole with water.

If you take more Olanzapina Stada than you should

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

Patients who have taken more Olanzapina Stada than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, 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 blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the doctor the packaging with the tablets.

If you forget to take Olanzapina Stada

Take your tablets as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Olanzapina Stada

Do not stop treatment simply because you feel better. It is very important that you continue taking Olanzapina Stada as long as your doctor tells you to.

If you stop taking Olanzapina Stada suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose 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, seek immediate medical attention.
• 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) include weight gain, drowsiness, and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (can affect up to 1 in 10 people) include changes in the levels of some blood cells and circulating lipids and at the beginning of treatment, temporary increases in liver enzymes, increased levels of blood sugar and urine, increased levels of uric acid and creatine phosphokinase in the blood, increased appetite, dizziness, agitation, tremors, strange movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation of the hands, ankles, or feet, fever, joint pain, and 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) include hypersensitivity (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, slow pulse, sensitivity to sunlight, nasal bleeding, abdominal distension, excessive salivation,memory loss or forgetfulness, urinary incontinence, loss of ability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (can affect up to 1 in 1,000 people) include a decrease in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and white parts of the eye, muscle disorder presenting as unexplained pain, and prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS for its acronym in English). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

Olanzapine Stada 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 nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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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, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Olanzapina STADA Composition

• The active ingredient is olanzapine. Each tablet contains 5 mg of active ingredient.

• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, soy lecithin (E322), xanthan gum, and purified water.

Appearance of the product and contents of the packaging

Olanzapina STADA 5 mg is presented in the form of film-coated tablets. The tablets are round, white, with the inscription “5” on one face.

It is presented in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

STADA Laboratory, S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:April 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http:// www.aemps.gob.es