Leaflet: information for the user

Olanzapina Normon 10 mg tablets EFG

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

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

2. What you need to know before starting to take Olanzapina Normon

3. How to take Olanzapina Normon

4. Possible side effects

5. Storage of Olanzapina Normon

6. Contents of the pack and additional informationl

Therapeutic group: antipsychotic.

Olanzapina Normon is used for:

-Treating a disease with symptoms such as hearing, seeing, or feeling things that are not real, holding false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from these diseases may also be depressed, anxious, or tense.

-Treating a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking very quickly with a flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the onset of extreme variations in mood.

?Do not takeOlanzapina Normon:

-If you are allergic (hypersensitive) to olanzapina or to any of the other components ofolanzapina Normon(including those listed in section 6). An 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.

• 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 takingolanzapina Normon, tell your doctor. Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this happens, stop taking the medication and contact your doctor immediately.

-The use ofolanzapina Normon in elderly patients with dementia is not recommended as it may have 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

•Cerebral infarction or transient cerebral ischemia

•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 the formation of blood clots.

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 old should not take Olanzapina Normon.

?Use of Olanzapina Normon with other medicines

Only use other medicines at the same time asolanzapina Normon, if your doctor authorizes it. You may feel drowsy if you combineolanzapina Normon 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 Olanzapina Normon.

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

?Taking Olanzapina Normon with food and drinks

The tablets can be taken with or without food, and you should swallow them whole with water.

Do not drink alcohol while taking Olanzapina Normon as the combination with alcohol may cause drowsiness.

?Pregnancy and breastfeeding

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

Pregnancy: Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. Do not take this medicine during pregnancy unless your doctor recommends it.

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

Newborn babies of mothers who have used Olanzapina Normon in the last trimester of pregnancy may experience the following symptoms: tremor, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn baby experiences any of these symptoms, contact your doctor.

?Driving and operating machinery

Olanzapina Normon may cause symptoms such as drowsiness, dizziness, or visual disturbances and may impair your ability to react. These effects, as well as the underlying illness, 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.

?Olanzapina Normon contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for Olanzapina Normon as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many tablets of Olanzapina Normon to take and for how long. The normal daily dose ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina Normon unless your doctor tells you to.

You should take your Olanzapina Normon 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. Olanzapina Normon tablets are for oral administration. You should swallow the tablets whole with water.

Do not interrupt treatment when you think you are feeling better. It is very important to continue taking it as long as your doctor tells you to.

?If you take more Olanzapina Normon than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount used.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more Olanzapina Normon than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, 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 interrupt treatment with Olanzapina Normon

If you suddenly stop taking Olanzapina Normon, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, or vomiting. Your doctor may suggest gradually reducing the dose before stopping treatment.

Do not interrupt treatment when you think you are feeling better. It is very important to continue taking Olanzapina Normon as long as your doctor tells you to.

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

Like all medications,olanzapinemay cause side effects, although not everyone will experience them. The side effects observed are classified according to their frequency of occurrence:

Very common(In at least 1 in 10 patients):

Weight gain.

Drowsiness.

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

Common(In at least 1 in 100 patients):

Increased levels of a type of white blood cell (eosinophils).

Increased appetite.

High blood sugar levels, elevated triglyceride levels.

Restlessness, parkinsonism, dyskinesia, unusual movements (especially of the face or tongue).

Decreased blood pressure.

Mild gastrointestinal disorders such as constipation and dry mouth.

Transient and asymptomatic increases in liver enzymes (ALT, AST), especially at the beginning of treatment.

Fatigue, fluid retention inflammation.

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

Elevated levels of the enzyme creatine phosphokinase.

Sensitivity to sunlight.

Abnormal heart rhythms, such as slowed heart rate.

Restless legs syndrome.

Excessive salivation.

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

Decreased white blood cells.

Seizures

Skin eruptions.

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

Decreased platelets.

Decreased levels of certain white blood cells (neutrophils).

High blood sugar levels and/or initial symptoms of worsening diabetes, with acetone in the blood and urine or coma.

Elevated triglyceride levels in the blood, decreased normal body temperature.

Cases of identified as Malignant Neuroleptic Syndrome (SNM) have been reported in association with olanzapine.

Parkinsonism, abnormal repetitive movement disorders such as contortions, tremors, and rigidity.

Sweating, inability to sleep, tremors, anxiety, nausea, or vomiting, upon discontinuing treatment.

Pancreatitis.

Liver disease.

Allergic reaction (e.g. anaphylactic 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, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, 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 effects. In this group of patients, very frequently (at least 1 in 10 patients), problems walking and falls have been observed. Also, frequently (at least 1 in 100 patients), pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have been observed. Deaths have been reported in this particular group of patients.

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), may occur. These clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

If you consider any of the side effects you are experiencing to be severe or if any side effect not mentioned in this prospectus is observed, inform your doctor or pharmacist.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Olanzapina Normon

The active ingredient is: olanzapina 10 mg.

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

Appearance of Olanzapina Normon contained in the packaging.

Olanzapina Normon 10 mg is presented in the form of cylindrical, biconvex tablets, yellow in color.

Each package 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

Trade name of the marketing authorization holder and responsible manufacturer

Normon Laboratories, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos, (Madrid)-Spain

Date of the last review of this leaflet: March 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68838/P_68838.html