Olanzapine Kern Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OLANZAPINE KERN PHARMA 10 MG TABLETS EFG

OLANZAPINE

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and additional 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 sensing things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. People with this condition 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 having 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 Olanzapina 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 may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If you experience these symptoms, stop taking the medication and contact your doctor immediately.

• 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 ischemic 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 ischemic attack.

As a routine precaution, if you are over 65 years of age, 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 clot formation.

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

Use of Olanzapina Kern Pharma with other medicines

Only use other medicines together with Olanzapina Kern Pharma if your doctor has authorized it. You may experience increased drowsiness 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.

Tell 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.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Use of Olanzapina Kern Pharma with food, beverages, 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 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 capacity. These effects, as well as the underlying 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 that you have an intolerance to certain sugars, consult with him before taking this medication.

3. How to take Olanzapina Kern Pharma

Follow exactly the instructions for use of 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 between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina Kern Pharma unless your doctor tells you to do so.

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 administration. 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 advises.

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

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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Patients who have taken more Olanzapina Kern Pharma than prescribed 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 possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness 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 stop treatment with Olanzapina Kern Pharma

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

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina Kern Pharma for as long as your doctor recommends.

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 can produce adverse effects, although not everyone will experience 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 and/or initial symptoms of worsening diabetes, with ketones 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 problems such as repetitive abnormal movements including twisting, jerking, and rigidity
• Sweating, inability to sleep, tremor, anxiety, nausea or vomiting when stopping 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

Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, facial rash that later spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cells (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse events. In this group of patients, walking difficulties and falls have been observed 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 group of patients.

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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 the 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 is 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 dispose of containers and medicines you no longer need. 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 10 mg of olanzapine.

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

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Appearance of the product and contents of the pack

Olanzapine is presented as round, biconvex, yellow tablets, marked with "Y10" on one side. Each pack contains 28 or 56 tablets.

Other presentations

Olanzapine KERN PHARMA 2.5 mg tablets: pack of 28 tablets
Olanzapine KERN PHARMA 5 mg tablets: pack of 28 tablets
Olanzapine KERN PHARMA 7.5 mg tablets: packs of 56 tablets

Marketing Authorization Holder and Manufacturer

KERN PHARMA, S.L.
Vernus, 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/.