Olanzapine Normon 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Normon 2.5 mg tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not pass it on to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What Olanzapina Normon is and what it is used for
2. What you need to know before taking Olanzapina Normon
3. How to take Olanzapina Normon
4. Possible adverse effects
5. How to store Olanzapina Normon
6. Contents of the pack and other information

1. What Olanzapina Normon is and what it is used for

Pharmacotherapeutic group: antipsychotic.

Olanzapina Normon 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 this condition may also experience depression, anxiety, or tension.
• 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 marked irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood swings.

2. What you need to know before taking Olanzapina Normon

? Do not take Olanzapina Normon:

• If you are allergic (hypersensitive) to olanzapine or to any of the other components of Olanzapina Normon (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 immediately;

• If you have previously been diagnosed with narrow-angle glaucoma;

• If you are under 18 years of age.

• Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Normon. Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Normon, inform your doctor. Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, stop taking the medicine and contact your doctor immediately.

• The use of Olanzapina Normon in elderly patients with dementia is not recommended, as it may cause serious adverse effects.

If you suffer from 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 have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient cerebral ischemia.
• If you or a family member has a history of blood clots, these medicines may be associated with an increased risk of clot formation.

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

• Use in children

Patients under 18 years of age must not take Olanzapina Normon.

? Taking Olanzapina Normon with other medicines

Only use other medicines together with Olanzapina Normon if authorized by your doctor. You may feel increased drowsiness if Olanzapina Normon is taken together 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 your dose of Olanzapina Normon may need to be adjusted.

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

? Taking Olanzapina Normon with food and drink

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

You must not drink alcohol while taking Olanzapina Normon, as combining it with alcohol may cause drowsiness.

? Pregnancy and breastfeeding

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

Pregnancy: Inform your doctor as soon as possible if you are pregnant, think you may be pregnant, or are planning to become pregnant. You should not take this medicine during pregnancy unless specifically advised by your doctor.

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

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

? Driving and using machines

Olanzapina Normon may cause symptoms such as drowsiness, dizziness, vision disturbances, and reduced reaction time. 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 perform any other activities requiring special attention until your doctor has assessed your response to this medicine.

? Olanzapina Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to use Olanzapina Normon

Follow exactly the administration instructions for Olanzapina Normon given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapina Normon tablets to 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 Normon unless your doctor tells you to.

You should take your Olanzapina Normon 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 Normon tablets are for oral use. Swallow the tablets whole with water.

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

? If you take more Olanzapina Normon than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

Patients who have taken more Olanzapina Normon than recommended have experienced the following symptoms: rapid heartbeat, agitation/aggression, 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, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms.

? If you forget to take Olanzapina Normon

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

? If you stop taking Olanzapina Normon

If you suddenly stop taking Olanzapina Normon, 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 interrupt treatment when you feel better. It is very important that you continue taking Olanzapina Normon for as long as your doctor advises.

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

4. Possible adverse effects

Like all medicines, olanzapine normon may have adverse effects, although not everyone experiences them. The observed adverse effects are classified according to their frequency of occurrence:

Very common (at least 1 in 10 patients):

Weight gain.

Somnolence.

Increased plasma levels of prolactin (a hormone that stimulates milk production in the mammary glands).

Common (at least 1 in 100 patients):

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, fluid retention with swelling.

Uncommon (at least 1 in 1,000 patients):

Elevated levels of the enzyme creatine phosphokinase.

Sensitivity to sunlight.

Abnormal heart rhythms, such as slowed heartbeat.

Restless legs syndrome.

Excessive salivation.

Rare (at least 1 in 10,000 patients):

Decrease in white blood cells.

Seizures.

Skin rashes.

Very rare (less than 1 in 10,000 patients):

Reduction in platelets.

Reduction in certain white blood cells (neutrophils).

High blood sugar 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 when stopping treatment.

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.

Frequency not known:

Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial rash spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (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 (at least 1 in 10 patients). Pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have also been observed commonly (at least 1 in 100 patients). Fatalities have been reported in this particular group of patients.

Blood clots in the veins may occur, 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Olanzapine Normon

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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Normon

The active substance is: olanzapine 2.5 mg.

The other components are: microcrystalline cellulose (E-460), monohydrate lactose, crospovidone and magnesium stearate.

Appearance of Olanzapine Normon and contents of the pack

Olanzapine Normon 2.5 mg is presented as yellow, cylindrical, biconvex tablets.

Each pack contains 28 tablets.

Other presentations:

Olanzapine Normon 5 mg tablets EFG

Olanzapine Normon 7.5 mg tablets EFG

Olanzapine Normon 10 mg tablets EFG

Marketing Authorization Holder and Manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos, (Madrid), Spain

Date of the most recent review of this leaflet: March 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68835/P_68835.html.