OLANZAPINE KERN PHARMA 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Kern Pharma 2.5 mg EFG tablets

Olanzapine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What Olanzapine Kern Pharma is and what it is used for
2. What you need to know before you take Olanzapine Kern Pharma
3. How to take Olanzapine Kern Pharma
4. Possible side effects
5. Storing Olanzapine Kern Pharma

1. Contents of the pack and further information

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

This medicine belongs to a group of medicines called antipsychotics.

Olanzapine Kern Pharma is used to:

• Treat a disease with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and tendency to withdraw. People suffering from these diseases may also be depressed, anxious, or tense.
• Treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme variations in mood.

2. What you need to know before you take Olanzapine Kern Pharma

Do not take Olanzapine Kern Pharma

• If you are allergic (hypersensitive) to olanzapine or any of the other components of this medicine (listed in section 6). The 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

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Kern Pharma, tell your doctor.

Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of clouding or drowsiness. If this happens to you, stop the medication and contact your doctor immediately.

• The use of Olanzapine Kern Pharma in elderly patients with dementia is not recommended, as it may have serious side effects.

If you have any of the following diseases, tell 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
• Stroke or transient cerebral ischemia

If you suffer from 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 medicines may be associated with the formation of clots.

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

Using Olanzapine Kern Pharma with other medicines

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

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

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

Using Olanzapine 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 Olanzapine Kern Pharma because the combination with alcohol can cause drowsiness.

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Newborns of mothers who have used olanzapine in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Breastfeeding:

You should not take this medicine while breastfeeding, as small amounts of Olanzapine Kern Pharma may pass into breast milk.

Driving and using machines

Olanzapine may cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Olanzapine Kern Pharma contains lactose

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

3. How to take Olanzapine Kern Pharma

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

Your doctor will tell you how many Olanzapine Kern Pharma tablets you should take and for how long. The normal daily dose ranges from 5 to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking Olanzapine Kern Pharma unless your doctor tells you to.

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

Do not interrupt treatment when you feel better. It is important that you continue taking it while your doctor tells you to.

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

If you take more Olanzapine 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 medicine and the amount ingested.

Patients who have taken more Olanzapine Kern Pharma than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapine Kern Pharma

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

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

If you stop taking Olanzapine Kern Pharma

If you suddenly stop taking Olanzapine Kern Pharma, you may have symptoms such as sweating, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may suggest gradually reducing the dose before stopping treatment.

Do not interrupt treatment when you feel better. It is very important that you continue taking Olanzapine Kern Pharma while your doctor tells you to.

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

4. Possible side effects

Like all medicines, Olanzapine Kern Pharma can cause side effects, although not everybody gets them.

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

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

• Weight gain
• Drowsiness
• Increased levels of prolactin (hormone that stimulates milk production in the breast)

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

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

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

• Increased levels of the enzyme creatine phosphokinase
• Sensitivity to sunlight
• Abnormal heart rhythms, such as slowed heartbeat
• Restless legs syndrome
• Excessive salivation

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

• Decreased white blood cells
• Seizures
• Skin rashes

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

• Decreased platelets
• Decreased levels of certain white blood cells (neutrophils)
• High sugar levels and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma
• Increased triglycerides in blood, decreased body temperature
• There have been reports of Neuroleptic Malignant Syndrome (NMS) associated with olanzapine
• Parkinsonism, problems with abnormal repetitive movements such as contortions, jerks, and stiffness
• Sweating, insomnia, tremors, anxiety, nausea, or vomiting when stopping treatment
• Blood clots
• Pancreatitis
• Liver disease
• Allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus, or urticaria)
• Rhabdomyolysis (increased concentration of the enzyme creatine kinase and myoglobinuria)
• Difficulty starting 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 is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and increased levels of a type of white blood cell (eosinophilia).

In elderly patients with dementia, olanzapine treatment may cause cerebrovascular adverse effects. In this group of patients, very common (affecting more than 1 in 10 people) problems walking and falls have been observed. Also, common (affecting up to 1 in 10 people) pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, increased body temperature, and skin redness have been observed. Deaths have been reported in this particular group of patients.

Other side effects observed are blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olanzapine Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Olanzapine Kern Pharma.

The active substance is olanzapine. Each tablet contains 2.5 mg of olanzapine.

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

Appearance of the product and contents of the pack

Olanzapine is presented in the form of round, biconvex tablets, yellow in color, marked with "Y2" on one face. Each pack contains 28 tablets.

Other presentations

Olanzapine KERN PHARMA 5 mg tablets: pack of 28 tablets

Olanzapine KERN PHARMA 7.5 mg tablets: pack of 56 tablets

Olanzapine KERN PHARMA 10 mg tablets: packs of 28 and 56 tablets

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of last revision of this leaflet: April 2020.

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