Package Insert: Information for the User

Olanzapina Qualigen 2.5 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others even if they have the same symptoms as you, 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 insert. See section 4.

OLANZAPINA QUALIGEN belongs to a group of medicines called 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a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

OLANZAPINA QUALIGEN 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 QUALIGEN

• If you are allergic to olanzapine or any of the other ingredients 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 QUALIGEN

• OLANZAPINA QUALIGEN 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 QUALIGEN, 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 QUALIGEN. 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 QUALIGEN. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting OLANZAPINA QUALIGEN 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 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, your doctor should monitor your blood pressure.

Children and adolescents

Patients under 18 years old should not take OLANZAPINA QUALIGEN

Use of OLANZAPINA QUALIGEN with other medications

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

Use of OLANZAPINA QUALIGEN with alcohol

You should not drink alcohol if you have been given OLANZAPINA QUALIGEN as it 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. Do not take this medication while breastfeeding as small amounts of OLANZAPINA QUALIGEN may pass into breast milk.

The following symptoms may occur in newborns of mothers who used OLANZAPINA QUALIGEN 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

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

OLANZAPINA QUALIGEN 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 for this medication as indicated by your doctor. If in 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 QUALIGEN to take and for how long. The daily dose of OLANZAPINA QUALIGEN ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking OLANZAPINA QUALIGEN unless your doctor tells you to.

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

If you take more OLANZAPINA QUALIGEN than you should

Patients who have taken more OLANZAPINA QUALIGEN than they should have experienced the following symptoms: rapid heart rate, 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 QUALIGEN

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 QUALIGEN

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

If you stop taking OLANZAPINA QUALIGEN 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, 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)

Very frequent side effects (which can affect more than 1 in 10 people) include weight 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 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 leg syndrome; speech problems; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension; loss of memory 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 and excessive salivation.

Other side effects in which the frequency cannot be estimated from available data (unknown), decrease in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellow discoloration of the skin and 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 deaths have been reported in this particular group of patients.

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

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, lymph node swelling, 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, including if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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.

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

Do not use Olanzapina Qualigen 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.

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 collection 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 QUALIGEN

• The active ingredient is olanzapine. Each tablet contains 2.5 mg of active ingredient.
• The other components are:Core: lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropyl cellulose (E-463a), crospovidone, anhydrous colloidal silica (E.551), and magnesium stearate (E-470b).Coating: 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

Olanzapine Qualigen 2.5 mg is presented in the form of film-coated tablets. The tablets are round, white.

They are presented in packs of 28 tablets.

Other presentations:

Olanzapine Qualigen 5 mg film-coated tablets EFG

Olanzapine Qualigen 7.5 mg film-coated tablets EFG

Olanzapine Qualigen 10 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Last review date of this leaflet:July 2021

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/.