OLANZAPINE KERN PHARMA 5 mg TABLETS

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How to use OLANZAPINE KERN PHARMA 5 mg TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

Introduction
What Olanzapine Kern Pharma is and what it is used for
What you need to know before you take Olanzapine Kern Pharma
How to take Olanzapine Kern Pharma
Possible side effects
Storing Olanzapine Kern Pharma
Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Olanzapine Kern Pharma 5 mg Tablets EFG

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:

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

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 confusion or drowsiness. If this happens to you, 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 have serious adverse effects.

If you suffer from 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 have 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 should 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, as the combination with alcohol may 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 may 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 the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate 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.

Patient 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.

Patient 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, convulsions (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:

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 levels of sugar, high levels of triglycerides
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
Convulsions
Skin rashes

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

Decreased platelets
Decreased levels of certain white blood cells (neutrophils)
High levels of sugar and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma
Increased levels of triglycerides in the blood, decreased body temperature
Neuroleptic Malignant Syndrome (NMS) has been reported in association with olanzapine
Parkinsonism, problems with abnormal repetitive movements such as contortions, shakes, 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 erections 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 enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

In elderly patients with dementia, treatment with olanzapine may result in 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 adverse 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 immediately to your doctor.

Reporting of side effects

If you experience any side effect, consult 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's (AEMPS) online system: 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 5 mg of olanzapine.

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

Appearance and packaging of the product

Olanzapine Kern Pharma is presented in the form of round, biconvex tablets, yellow in color, and marked with "Y5" on one face. Each pack contains 28 tablets.

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Dr Anna Kondratiuk is a psychiatrist and psychotherapist with over 13 years of clinical experience in both inpatient and outpatient settings. She provides online consultations for adults, offering a balanced approach that combines evidence-based pharmacological treatment with psychotherapy.

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Daria Portnova

Psychiatry 31 years exp.

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations.

In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life.

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Frequently Asked Questions

Is a prescription required for OLANZAPINE KERN PHARMA 5 mg TABLETS?

OLANZAPINE KERN PHARMA 5 mg TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

What is the active substance in OLANZAPINE KERN PHARMA 5 mg TABLETS?

The active ingredient in OLANZAPINE KERN PHARMA 5 mg TABLETS is olanzapine. This information helps identify medicines with the same composition but different brand names.

How much does OLANZAPINE KERN PHARMA 5 mg TABLETS cost in pharmacies?

The average pharmacy price for OLANZAPINE KERN PHARMA 5 mg TABLETS is around 26.44 EUR. Prices may vary depending on the manufacturer and dosage form.

Who manufactures OLANZAPINE KERN PHARMA 5 mg TABLETS?

OLANZAPINE KERN PHARMA 5 mg TABLETS is manufactured by Kern Pharma S.L.. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of OLANZAPINE KERN PHARMA 5 mg TABLETS online?

Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether OLANZAPINE KERN PHARMA 5 mg TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

What are the alternatives to OLANZAPINE KERN PHARMA 5 mg TABLETS?

Other medicines with the same active substance (olanzapine) include ARENBIL 10 mg FILM-COATED TABLETS, ARENBIL 2.5 mg FILM-COATED TABLETS, ARENBIL 5 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

OLANZAPINE KERN PHARMA 5 mg TABLETS

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