Package Insert: Information for the Patient

Olanzapina Alter 5 mg Bucodispersable Tablets EFG

Olanzapina Alter 10 mg Bucodispersable Tablets EFG

Olanzapina Alter 15 mg Bucodispersable Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Olanzapina Alter contains the active ingredient olanzapina. Olanzapina belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn.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, a disease whose symptoms are excitement or euphoria.

Olanzapina has demonstrated the ability 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 Alter

• 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 this medication.

• Olanzapina is not recommended for use in elderly patients with dementia as it may have severe 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.
• In rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, 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 may help you plan a diet or refer 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 this medication 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 cerebral ischemia (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 (diuretics).

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

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

Children and adolescents

Patients under 18 years old should not take olanzapina.

Taking Olanzapina Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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 dose.

Taking Olanzapina Alter with alcohol

You should not drink alcohol while taking this medication, 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 taking this medication. Do not take this medication while breastfeeding, as small amounts of olanzapina may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapina in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

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

Olanzapina Alter contains lactose

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

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

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

Olanzapine tablets should be taken 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. Olanzapine buccal tablets are for oral administration.

Olanzapine buccal tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate. Carefully remove the tablet.

Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also place the tablet in a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. It should be consumed immediately.

If you take more Olanzapina Alter than you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced 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 experience any of the above symptoms. Show the packaging with the tablets to the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Olanzapina Alter

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina Alter

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

If you stop taking olanzapine 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 swelling, 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 a lying or sitting position. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (can affect up to 1 in 10 people) includechanges in levels of some blood cells, 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; tremor; 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); spasms (including eye movements);restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; 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 death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Very rare side effects (can affect up to 1 in 10,000 people) 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, increased body temperature, skin redness, and walking difficulties. Some deaths have been reported in this particular group of patients.

Olanzapine 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 a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Olanzapina Alter

• The active ingredient is olanzapine. Each buccal dispersible tablet contains 5 mg, 10 mg, or 15 mg of olanzapine. The exact amount is shown on your medication packaging.
• The other components are crospovidone, lactose monohydrate, colloidal silicon dioxide, hydroxypropylcellulose, flavoring, talc, and magnesium stearate.

Appearance of the product and content of the packaging

A buccal dispersible tablet is the technical name for a tablet that dissolves directly in the mouth for easier swallowing.

Olanzapina Alter 5 mg: round, biconvex, and yellow tablets.

They are presented in packs of 28 tablets.

Olanzapina Alter 10 mg: round, flat, and yellow tablets.

They are presented in packs of 28 tablets or 56 tablets.

Olanzapina Alter 15 mg: round, biconvex, and yellow tablets.

They are presented in packs of 28 tablets.

Only some pack sizes may be commercially available.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen International S.A.

Sapes Industrial Park, Block 5, 69300 Rodopi

Greece

or

Pharmaten S.A.

6 Dervenakion str.; Pallini 153 51; Attiki

Greece

Last review date of this leaflet:May 2020.

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