Package Insert: Information for the User

OLANZAPINA DARI PHARMA 7.5 mg Film-Coated Tablets

OLANZAPINA DARI PHARMA belongs to a group of medicines called antipsychotics and is indicated for the treatmentof the following diseases:

•Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn.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 DARI PHARMA has shown that it can prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take OLANZAPINA DARI PHARMA

• If you are allergic to olanzapine 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 eye pressure).
• This medication contains soy oil. Do not use it if you are allergic to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take OLANZAPINA DARI PHARMA.

• OLANZAPINA DARI PHARMA 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 DARI PHARMA, tell your doctor.
• In very 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 DARI PHARMA. 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 DARI PHARMA. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting OLANZAPINA DARI PHARMA 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 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 monitor your blood pressure.

Children and adolescents

Patients under 18 years old should not take OLANZAPINA DARI PHARMA.

Use of OLANZAPINA DARI PHARMA with other medications

Only use other medications at the same time as OLANZAPINA DARI PHARMA if your doctor authorizes it. You may feel drowsy if you combine OLANZAPINA DARI PHARMA 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 dose of OLANZAPINA DARI PHARMA.

Use of OLANZAPINA DARI PHARMA with alcohol

You should not drink alcohol if you have been given OLANZAPINA DARI PHARMA as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant orbreastfeeding,believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.This medication should not be taken while breastfeeding as small amounts of OLANZAPINA DARI PHARMA may pass into breast milk.

The following symptoms may occur in newborns of mothers who used OLANZAPINA DARI PHARMA 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 experiences any of these symptoms, contact your doctor.

Driving and operating machinery

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

OLANZAPINA DARI PHARMA contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, 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. Consult your doctor or pharmacist if you have any doubts.

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

You should take your OLANZAPINA DARI PHARMA 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 DARI PHARMA tablets are for oral administration. You should swallow the OLANZAPINA DARI PHARMA tablets whole with water.

If you take more OLANZAPINA DARI PHARMA than you should

Patients who have taken more OLANZAPINA DARI PHARMA than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, 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 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 DARI PHARMA

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 DARI PHARMA

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

If you stop taking OLANZAPINA DARI PHARMA 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 medications,this medicationcan 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)

Very frequent side effects (which can affect more than 1 in 10people) include

weight gain, drowsiness, and increased levels of prolactin in the blood.

Frequent side effects (can affect up to 1 in 10people) include changes in the levels of some blood cells and circulating lipids, increased levels of blood sugar 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 feetand 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 not, inform your doctor.

Rare side effects (can affect up to 1 person in 100) include slow pulse, sensitivity to sunlight, urinary incontinence,inability 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 and excessive salivation.

Other side effectsin whichits frequency cannot be estimated from available datanotknown), including allergic reaction (e.g. inflammation of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma, decrease in normal body temperature, convulsions, in most cases related to a history of seizures (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 appearance of yellowish coloration on the skin and in the white areas of the eye, muscular disorder presenting as unexplained pain and prolonged and/or painful erection.

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 deathshave been reportedin this particular groupof patients.

OLANZAPINA DARI PHARMA may worsen symptoms in patients with Parkinson's disease.

Ifyou experienceside effects, consultyour doctor or pharmacist, even if it is a side effect that does not appear in this prospectus.

Keep 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 DARI PHARMA does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of OLANZAPINA DARI PHARMA 2,5 mg

• The active ingredient is olanzapina. Each film-coated tablet contains 2.5 mg of active ingredient.
• The other components are:

Nucleus of the tablet: lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropyl cellulose (E-463a), crospovidone, anhydrous colloidal silica (E-551), and magnesium stearate (E-470b).

Coating of the tablet: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soy lecithin (E-322), and xanthan gum (E-415).

Appearance of the product and contents of the packaging

The film-coated tablets of OLANZAPINA DARI PHARMA 2,5 mg are round, white in color.

OLANZAPINA DARI PHARMA is available in packs of 28 tablets.

Other presentations:

OLANZAPINA DARI PHARMA 5 mg film-coated tablets

OLANZAPINA DARI PHARMA 7.5 mg film-coated tablets

OLANZAPINA DARI PHARMA 10 mg film-coated tablets

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Dari Pharma, S.L.U

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Responsible Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970, Sant Joan Despi (Barcelona) Spain

Last review date of this leaflet: August 2021.

Other sources of information

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