Leaflet: Information for the User

Olanzapine Kern Pharma 5 mg Tablets EFG

Olanzapine

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

• Keep this leaflet, 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 only, and you must not give it 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 leaflet.

1. What Olanzapine Kern Pharma is and what it is used for

2. What you need to know before you start taking Olanzapine Kern Pharma

3. How to take Olanzapine Kern Pharma

4. Possible side effects

5. Storage of Olanzapine Kern Pharma

6.Contents of the pack and additional information

This medication belongs to a group of medications called antipsychotics.

Olanzapina Kern Pharma is used for:

• Treating a disease with symptoms such as hearing, seeing, or feeling things that are not real, holding false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from these diseases may also be depressed, anxious, or tense.
• Treating a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking very quickly with a rapid flow of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme variations in mood.

Do not take Olanzapina Kern Pharma

• If you are allergic (hypersensitive) to olanzapina or to 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 narrow-angle glaucoma.
• If you are under 18 years old.

Warnings and precautions

• This type of medication may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Kern Pharma, tell your doctor.

Very rarely, this type of medication produces a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, discontinue the medication and immediately contact your doctor.

• The use of Olanzapina Kern Pharma in elderly patients with dementia is not recommended as it may have severe adverse effects.

If you have any of the following conditions, inform your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (Paralytic ileus)
• Blood disorders
• Cerebral infarction or transient cerebral ischemia

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.

If you or a family member has a history of blood clots, these medications may be associated with the formation of the same.

Consult your doctor or pharmacist before starting to take this medication.

Use of Olanzapina Kern Pharma with other medications

Only use other medications at the same time as Olanzapina Kern Pharma if your doctor authorizes it. You may feel a certain sense of drowsiness if you combine Olanzapina Kern Pharmawith antidepressants or medications for anxiety or that help you sleep (tranquilizers). Inform your doctor especially if you are taking medication for Parkinson's disease.

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapina Kern Pharma.

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Use of Olanzapina Kern Pharma with food, drinks, and alcohol

The tablets can be taken with or without food and should be swallowed whole with water.

You should not drink alcohol while taking Olanzapina Kern Pharma as the combination with alcohol may produce drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Newborns of mothers who have used olanzapina in the last trimester of pregnancy may exhibit the following symptoms: tremor, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn exhibits any of these symptoms, contact your doctor.

Breastfeeding:

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

Driving and operating machinery

Olanzapina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. 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 medication.

Olanzapina Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, 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 tablets of Olanzapina Kern Pharma you should take and for how long. The usual daily dose ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina Kern Pharma unless your doctor tells you to.

You should take your Olanzapina Kern 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 Kern Pharma tablets are for oral administration. You should swallow the tablets whole with water.

Do not interrupt treatment when you think you are feeling better. It is essential that you continue taking it as long as your doctor tells you to.

Patients under 18 years old should not take Olanzapina Kern Pharma.

If you take more Olanzapina Kern Pharma than you should

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

Patients who have taken more Olanzapina Kern Pharma than they should have experienced the following symptoms: rapid heartbeats, agitation/aggression, 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.

If you forgot to take Olanzapina Kern Pharma

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you interrupt treatment with Olanzapina Kern Pharma

If you stop taking Olanzapina Kern Pharma suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

Do not interrupt treatment when you think you are feeling better. It is very important that you continue taking Olanzapina Kern Pharma as long as your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Olanzapina Kern Pharma can cause side effects, although not everyone will experience them.

The observed side effects are classified according to their frequency of presentation:

Very common (may affect more than 1 in 10 people):

• Weight gain
• Drowsiness
• Increased plasma levels of prolactin (hormone that stimulates milk production)

Common (may affect up to 1 in 10 people):

• Increased eosinophils (a type of white blood cell)
• Increased appetite
• High blood sugar, high triglyceride levels
• Agitation, parkinsonism, dyskinesia, unusual movements (especially of the face or tongue)
• Decreased blood pressure
• Mild gastrointestinal disturbances such as constipation and dry mouth
• Transient and asymptomatic increases in liver enzymes (ALT, AST), especially at the beginning of treatment
• Fatigue, fluid retention inflammation

Uncommon (may affect up to 1 in 100 people):

• High levels of creatine phosphokinase enzyme
• Sensitivity to sunlight
• Abnormal heart rhythms, such as bradycardia
• Restless legs syndrome
• Excessive salivation

Rare (may affect up to 1 in 1,000 people):

• Decreased white blood cells
• Seizures
• Skin eruptions

Very rare (may affect up to 1 in 10,000 people):

• Decreased platelets
• Decreased neutrophils (a type of white blood cell)
• High blood sugar and/or initial symptoms of worsening diabetes, with acetone in the blood and urine or coma
• Increased triglycerides in the blood, decreased normal body temperature
• Neuroleptic Malignant Syndrome (NMS) cases have been reported in association with olanzapina
• Parkinsonism, abnormal repetitive movements such as contortions, tremors, and rigidity
• Sweating, inability to sleep, tremors, anxiety, nausea, or vomiting upon discontinuing treatment
• Blood clot formation
• Pancreatitis
• Liver disease
• Allergic reaction (e.g. anaphylactoid reaction, angioedema, pruritus, or urticaria)
• Rhabdomyolysis (increased creatine kinase enzyme concentration and myoglobinuria)
• Difficulty initiating urination
• Prolonged and/or painful erection or difficulty urinating

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 eosinophils.

Patients with advanced age and dementia may experience cerebrovascular side effects during treatment with olanzapina. In this group of patients, very common (affecting more than 1 in 10 people) problems walking and falls have been observed. Frequent (affecting up to 1 in 10 people) pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have also been observed. Fatalities have been reported in this particular group of patients.

Other observed side effects include blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can migrate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed 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 medication.

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the 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 Kern Pharma

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

The other components are: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Olanzapina Kern Pharma is presented in the form of round, biconvex tablets, yellow in color, and marked with “Y5” on one face. Each package contains 28 tablets.

Other presentations

Olanzapina KERN PHARMA 2.5 mg tablets: package of 28 tablets

Olanzapina KERN PHARMA 7.5 mg tablets: package of 56 tablets

Olanzapina KERN PHARMA 10 mg tablets: packages of 28 and 56 tablets

Holder of the marketing authorization and Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – 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/.