Olanzapine Kern Pharma 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olanzapina Kern Pharma 2.5 mg tablets EFG

Olanzapine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

2. What you need to know before taking Olanzapina Kern Pharma

3. How to take Olanzapina Kern Pharma

4. Possible side effects

5. How to store Olanzapina Kern Pharma

6. Contents of the pack and other information

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

This medicine belongs to a group of medicines called antipsychotics.

Olanzapina Kern Pharma is used for:

• Treating an illness with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. People with these conditions may also feel depressed, anxious, or tense.
• Treating a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood swings.

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

Do not take Olanzapine Kern Pharma

• If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with narrow-angle glaucoma.
• If you are under 18 years of age.

Warnings and precautions

• Medications of this type may cause unusual movements, particularly of the face or tongue. If this occurs after taking Olanzapine Kern Pharma, inform your doctor.

Very rarely, medications of this type cause a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness. If you experience these symptoms, stop taking the medication immediately and contact your doctor without delay.

• The use of Olanzapine Kern Pharma in elderly patients with dementia is not recommended, as it may lead to serious 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
• Stroke or transient ischaemic attack (TIA)

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 ischaemic attack.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

If you or a family member has a history of blood clots, these medications may be associated with an increased risk of developing blood clots.

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

Use of Olanzapina Kern Pharma with other medicines

Only use other medicines at the same time as Olanzapina Kern Pharma if your doctor has authorized it. You may feel drowsy if Olanzapina Kern Pharma is combined with antidepressants or medicines for anxiety or 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 (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to adjust your dose of Olanzapina Kern Pharma.

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

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

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

You should not drink alcohol while taking Olanzapina Kern Pharma, as combining it with alcohol may cause drowsiness.

Pregnancy, breastfeeding and fertility

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

Pregnancy:

Newborns of mothers who have used olanzapine during the third trimester of pregnancy may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Breastfeeding:

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

Driving and operating machinery

Olanzapine may cause symptoms such as somnolence, dizziness, or visual disturbances, and may reduce reaction capability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medication.

Olanzapine Kern Pharma contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medication.

3. How to take Olanzapina Kern Pharma

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

You should take your Olanzapina Kern Pharma tablets once daily, as directed by your doctor.

Try to take the tablets at the same time every day. You may take them with or without food. Olanzapina Kern Pharma tablets are for oral use. Swallow the tablets whole with water.

Do not stop treatment when you feel better. It is important to continue taking it for as long as your doctor tells you to.

Olanzapina Kern Pharma must not be used in patients under 18 years of age.

If you take more Olanzapina Kern Pharmadel than you should

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

Patients who have taken more Olanzapina Kern Pharmadel than recommended have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, somnolence or lethargy, slowed breathing rate, aspiration, increased blood pressure 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 further questions about the use of this product, ask your doctor or pharmacist.

If you discontinue treatment with Olanzapine Kern Pharma

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

Do not stop treatment as soon as you feel better. It is very important that you continue taking Olanzapine Kern Pharma for as long as your doctor advises.

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

4. Possible adverse effects

Like all medicines, Olanzapine Kern Pharma may cause adverse effects, although not everyone experiences them.

The observed adverse effects are classified according to their frequency of occurrence:

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

• Weight gain
• Somnolence
• Increased plasma levels of prolactin (a hormone that stimulates milk production in the mammary glands)

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

• Increase in a type of white blood cells (eosinophils)
• Increased appetite
• High blood sugar levels, elevated 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 beginning of treatment
• Fatigue, swelling due to fluid retention

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

• Elevated 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):

• Decrease in white blood cells
• Seizures
• Skin rashes

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

• Decrease in platelets
• Decrease in certain white blood cells (neutrophils)
• High blood sugar levels and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma
• Increased blood triglycerides, decreased normal body temperature
• Cases have been reported identified as Neuroleptic Malignant Syndrome (NMS) associated with olanzapine
• Parkinsonism, movement disorders involving repetitive abnormal movements such as twisting, jerking, and rigidity
• Sweating, inability to sleep, tremor, anxiety, nausea, or vomiting upon discontinuation of treatment
• Formation of blood clots
• Inflammation of the pancreas
• Liver disease
• Allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus, or urticaria)
• Rhabdomyolysis (increased concentration of creatine kinase enzyme and myoglobinuria)
• Difficulty initiating urination
• Prolonged and/or painful erection or difficulty urinating

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, a skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse effects. In this group of patients, walking difficulties and falls have been reported very commonly (affecting more than 1 in 10 people). Pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have also been observed frequently (affecting up to 1 in 10 people). Deaths have been reported in this particular patient group.

Other observed adverse effects include blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Olanzapine Kern Pharma.

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

The other components 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, yellow tablets marked with "Y2" on one side. Each pack contains 28 tablets.

Other presentations

Olanzapine KERN PHARMA 5 mg tablets: package containing 28 tablets

Olanzapine KERN PHARMA 7.5 mg tablets: package containing 56 tablets

Olanzapine KERN PHARMA 10 mg tablets: packages containing 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 the most recent review of this leaflet: April 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.