OLANZAPINE CINFA 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Olanzapine Cinfa 10 mg hard capsules EFG

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. See section 4.

Contents of the pack

1. What Olanzapine Cinfa is and what it is used for
2. What you need to know before you take Olanzapine Cinfa
3. How to take Olanzapine Cinfa
4. Possible side effects
5. Storage of Olanzapine Cinfa
6. Contents of the pack and other information

1. What Olanzapine Cinfa is and what it is used for

Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following diseases:

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with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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

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

2. What you need to know before you take Olanzapine Cinfa

Do not take Olanzapine Cinfa

• If you are allergic to olanzapine or any of the other ingredients 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 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 this medicine.

• Olanzapine is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, 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, contact your doctor immediately.
• A weight gain has been observed in patients taking olanzapine. 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) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking olanzapine and regularly during treatment.
• If you or a family member have a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (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 a lack of blood flow to the brain.

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

Patients under 18 years of age should not take olanzapine.

Taking Olanzapine Cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

Only use other medicines at the same time as olanzapine if your doctor authorizes it. You may feel drowsy if you combine olanzapine 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). You may need to change your dose of olanzapine.

Taking Olanzapine Cinfa with alcohol

You should not drink alcohol if you have been given olanzapine because it can 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.

You should not take this medicine when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

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

Driving and using machines

There is a risk of drowsiness when taking olanzapine. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Cinfa contains lactose

This medicine 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 Cinfa

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

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

You should take your olanzapine capsules once a day, following your doctor's instructions. Try to take the capsules at the same time every day. You can take them with or without food. The hard capsules of olanzapine are for oral administration. You should swallow the olanzapine capsules whole with water.

If you take more Olanzapine Cinfa than you should

Patients who have taken more olanzapine 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 capsules.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Olanzapine Cinfa

Take your capsules as soon as you remember.

Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine Cinfa

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue;
• blood clots in the veins (a rare side effect that can 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 and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency not known).

Very common side 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 feeling usually goes away on its own, but if it doesn't, consult your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, 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 dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (may affect up to 1 in 1,000 people) include 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; excessive salivation; 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.

Very rare side effects 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; and muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects 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 an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

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

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

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, 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 Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Cinfa

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

Do not use this medicine after the expiration date that appears on the package after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Contents of the pack and other information

Composition of Olanzapine Cinfa

• The active ingredient is olanzapine. Each capsule contains 10 mg of active ingredient.
• The other ingredients are:

• Capsule content:microcrystalline cellulose, lactose monohydrate, hydroxypropyl methylcellulose, magnesium stearate.
• Capsule shell:gelatin, titanium dioxide (E-171), erythrosine-FD&C red 3 (E-127), quinoline yellow (E-104).
• Printing ink:shellac (E-904), propylene glycol (E-1520), strong ammonia solution (E-527), black iron oxide (E-172), potassium hydroxide (E-525).

Appearance of the product and package contents

Olanzapine Cinfa 10 mg are hard capsules with an orange cap marked with "OC 10.0" and an orange body, available in aluminum/aluminum blisters with 28 or 56 capsules.

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 leaflet: June 2020

Detailed information about this medicine 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 about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85116/P_85116.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85116/P_85116.html