OLANZAPINE CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

olanzapina cinfa 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is olanzapina cinfa and what is it used for
2. What you need to know before taking olanzapina cinfa
3. How to take olanzapina cinfa
4. Possible side effects
5. Storage of olanzapina cinfa
6. Package Contents and Additional Information

1. What is olanzapina cinfa and what is it used for

Olanzapina cinfa contains the active ingredient olanzapina, which belongs to a group of medications called antipsychotics, and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

2. What you need to know before taking olanzapina cinfa

Do not take olanzapina cinfa

• If you are allergic to olanzapina or any of the other components of this medication (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 eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take olanzapina cinfa

• Olanzapina is not recommended for use in elderly patients with dementia, as it may have serious side effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapina, tell your doctor.
• In very rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness.
• If this happens, contact your doctor immediately.
• A weight gain has been observed in patients taking olanzapina. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking olanzapina. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking olanzapina and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with the formation of blood clots.

If you have any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient cerebral ischemia (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have loss of salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or 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.

Children and Adolescents

Patient under 18 years old should not take olanzapina.

Taking olanzapina cinfa with other medications

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

Only use other medications at the same time as olanzapina if your doctor authorizes it. You may feel drowsy if you combine olanzapina with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

In particular, tell your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of olanzapina may need to be changed.

Taking olanzapina cinfa with alcohol

You should not drink alcohol if you have been given olanzapina, as it 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 medication.

You should not take this medication while breastfeeding, as small amounts of olanzapina may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used olanzapina in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and Using Machines

Olanzapina may cause symptoms such as drowsiness, dizziness, or changes in vision and reduce your reaction ability. These effects, as well as the disease itself, may impair your ability 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 medication.

olanzapina cinfa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take olanzapina cinfa

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

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

You should take your olanzapina cinfa 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 olanzapina cinfa tablets are for oral administration. You should swallow the olanzapina cinfa tablets whole with water.

If you take more olanzapina cinfa than you should

Patient who have taken more olanzapina than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, 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 stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

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 medication and the amount ingested.

If you forget to take olanzapina cinfa

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking olanzapina cinfa

Do not stop treatment just because you feel better. It is very important that you continue taking olanzapina cinfa while your doctor tells you to.

If you stop taking olanzapina cinfa suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you have:

• unusual movements (a frequentside effect, may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (a less frequentside effect, may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain or difficulty breathing. If you experience any of these symptoms, see a doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (side effect of unknown frequency, cannot be estimated from available data).

Very frequentside effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood.

In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This sensation usually disappears on its own, but if it does not, consult your doctor.

Frequentside effects (may affect up to 1 in 10 people) include changes in blood cell counts, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Less frequentside effects (may affect up to 1 in 100 people) include excessive salivation, hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of urination ability; hair loss; absence or decrease of menstrual periods; and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rareside effects (may affect up to 1 in 1,000 people) include a drop in body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white parts of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rareside effects (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with a widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapina, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapina may worsen symptoms in patients with Parkinson's disease.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of olanzapina cinfa

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

Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of olanzapina cinfa

• The active ingredient is olanzapina. Each tablet contains 10 mg of active ingredient.
• The other components are: microcrystalline cellulose (E-460), lactose monohydrate, crospovidone, and magnesium stearate.

Appearance of the Product and Package Contents

The olanzapina cinfa 10 mg tablets are cylindrical, biconvex, yellow, and marked with the code "Y10".

olanzapina cinfa 10 mg is available in packages of 28, 56, or 100 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:April 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68830/P_68830.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68830/P_68830.html