Package Leaflet: Information for the User

Olanzapina Tarbis Farma 5 mg Film-Coated Tablets

Olanzapina Tarbis Farma belongs to a group of medicines called antipsychotics and is indicated for the treatment ofthe 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a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

Olanzapina Tarbis Farmahas demonstrated the prevention of recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina Tarbis Farma

• if you are allergic to olanzapina or any of the other ingredients of this medicine (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 Tarbis Farma.

• Olanzapina Tarbis Farma is not recommended for elderly patients with dementia as it may have serious adverse effects.

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Tarbis Farma, tell your doctor.
• In very rare cases, medicines 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 Tarbis Farma. You and your doctor should check your weight regularly.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Tarbis Farma. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina Tarbis Farma and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medicines 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 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 advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina Tarbis Farma.

Use of Olanzapina Tarbis Farma with other medicines

Only use other medicines at the same time as Olanzapina Tarbis Farma if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Tarbis Farma with antidepressants or medicines for anxiety or to help sleep (tranquilizers).

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

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 dose of Olanzapina Tarbis Farma.

Use of Olanzapina Tarbis Farma with alcohol

You should not drink alcohol if you have been given Olanzapina Tarbis Farma as it may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.Do not take this medicine while breastfeeding as small amounts of Olanzapina Tarbis Farma may pass into breast milk.

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

Driving and operating machinery

Olanzapina Tarbis Farma may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Olanzapina Tarbis Farma contains lactose

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

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

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

If you take more Olanzapina Tarbis Farma than you should

Patients who have taken more Olanzapina Tarbis Farma than they should have experienced the following symptoms: rapid heartbeat, 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.

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

If you forget to take Olanzapina Tarbis Farma

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

If you interrupt treatment with Olanzapina Tarbis Farma

Do not stop treatmentsimply because you feelbetter. It is very important that you continue taking Olanzapina Tarbis Farma as long as your doctor tells you to.

If you stop takingOlanzapina Tarbis Farmaabruptly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, or 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 medicinecan cause side effects, although not everyone will experience them.

Contact your doctor immediately 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 (which can affect more than 1 in 10 people) includeweight gain, drowsiness, and increased levels of prolactin in the blood.

Frequent side effects (which can affect up to 1 in 10 people)include changes in the levels of some blood cells and circulating lipids, increased levels of sugar in the blood and urine, increased appetite, dizziness, agitation, tremor, muscle stiffness or spasms (including eye movements), language alterations, constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation of the hands, ankles, or feet,and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Rare side effects (which can affect up to 1 in 100 people) include slow pulse, sensitivity to sunlight, urinary incontinence,loss of ability to urinate, hair loss, excessive salivation, absence or decrease of menstrual periods, changes in the breast gland in men and women such as abnormal milk production or abnormal growth andrestless legs syndrome.

Other side effectsin whichits frequency cannot be estimated from available data (unknown), include allergic reaction (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, decrease in normal body temperature, convulsions, in most cases related to a history of convulsions (epilepsy), eye muscle spasms causing circular movements of the eyes, abnormal heart rhythm, sudden death without apparent explanation, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellow discoloration of the skin and white areas of the eye, muscle disorder presenting as unexplained pain and prolonged and/or painful erection.Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes 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 difficulty walking. Some deaths have been reportedin this particular groupof patients.

Olanzapine Tarbis Farma 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 side effect that does not appear in this leaflet. 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 after CAD. The expiration date is the last day of the month indicated.

Olanzapina Tarbis Farma does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of 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.

Composition ofOlanzapina Tarbis Farma5 mg

• The active ingredient is olanzapina. Each film-coated tablet contains 5 mg of active ingredient.
• The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose E-460, low-substituted hydroxypropyl cellulose E-463, crospovidone, anhydrous colloidal silica, and magnesium stearate E-470.

Tablet coating:polyvinyl alcohol, titanium dioxide E-171, talc, lecithin E-322, and xanthan gum E-415.

Appearance of the product and contents of the packaging

Thefilm-coated tabletsofOlanzapina Tarbis Farma5 mg areround, white in color, and have the inscription “5” on one face.

Olanzapina Tarbis Farma is availablein packs of 28 tablets.

Other presentations:

Olanzapina Tarbis Farma2.5 mg film-coated tablets EFG

Olanzapina Tarbis Farma7.5 mg film-coated tablets EFG

Olanzapina Tarbis Farma10 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: June 2020

Other sources of information

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/.