Olanzapine Normon 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Normon 10 mg tablets EFG

Read all of this 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 you should not give it 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 the effects are not listed in this leaflet.

Contents of the leaflet

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 towards social withdrawal. People suffering from 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 considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood fluctuations.

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;

• 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 cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If you experience this, 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 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 have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.
• If you or a family member has a history of blood clots, these medicines may be associated with 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 drowsy 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.

Inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapina Normon may need to be adjusted.

Tell 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 can 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 may 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 plan to become pregnant. You should not take this medicine during pregnancy unless your doctor specifically recommends it.

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

Newborns whose mothers have used Olanzapina Normon during the last trimester of pregnancy may experience symptoms such as 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, or vision disturbances and may reduce reaction time. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in any other activity 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 diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Olanzapina Normon

Follow exactly the administration instructions for Olanzapina Normon provided 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 instructed by your doctor.

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 to 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 medication packaging 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 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 advise you to gradually reduce the dose before stopping treatment.

Do not interrupt treatment when you feel better. It is very important to continue taking Olanzapina Normon for as long as your doctor instructs.

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 breasts).

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, swelling due to fluid retention.

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):

Decrease in platelets.

Reduction in certain white blood cells (neutrophils).

High blood sugar levels and/or early signs of worsening diabetes, with acetone in blood and urine or coma.

Increased blood triglycerides, decreased normal body temperature.

Cases identified as Neuroleptic Malignant Syndrome (NMS) have been reported in association 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.

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, skin rash starting on the face and spreading 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 events. In this group of patients, walking difficulties and falls are very commonly observed (at least 1 in 10 patients). Pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have also been commonly observed (at least 1 in 100 patients). Deaths have been reported in this particular patient group.

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

6. Contents of the pack and other information

Composition of Olanzapina Normon

The active substance is: olanzapine 10 mg.

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

Appearance of Olanzapina Normon and contents of the pack

Olanzapina Normon 10 mg is presented as yellow, cylindrical, biconvex tablets.

Each pack contains 28 or 56 tablets.

Other presentations:

Olanzapina Normon 2.5 mg tablets EFG

Olanzapina Normon 5 mg tablets EFG

Olanzapina Normon 7.5 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 of 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 may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68838/P_68838.html