Olanzapine Flas CINFA 20 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

olanzapina flas cinfa 20 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What olanzapine flas cinfa is and what it is used for

Olanzapine flas cinfa contains the active substance olanzapine. Olanzapine flas cinfa belongs to the therapeutic group of antipsychotics.

Olanzapine flas cinfa is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.

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

2. What you need to know before starting to take olanzapina flas cinfa

Do not take olanzapina flas cinfa

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may present 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 eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take olanzapina flas cinfa.

• The use of olanzapina flas is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medicines of this type may cause unusual movements, especially of the face or tongue. If this happens after taking olanzapina flas, 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 you experience these symptoms, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapina flas. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a dietitian.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapina flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking olanzapina flas and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.

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

• Stroke or transient ischemic attack (TIA, temporary stroke-like 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 body salts due to prolonged severe diarrhea or vomiting, or due to taking diuretic medicines (water tablets).

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.

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

Children and adolescents

Patients under 18 years of age must not take olanzapina flas.

Taking olanzapina flas cinfa with other medicines

Only use other medicines together with olanzapina flas if authorized by your doctor. You may feel increased drowsiness if olanzapina flas is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

Specifically, 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). These may require adjustment of your olanzapina flas dose.

Taking olanzapina flas cinfa with alcohol

You should not drink alcohol while taking olanzapina flas, as the combination of olanzapina flas with alcohol may cause drowsiness.

Pregnancy and breastfeeding

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

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

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapina flas during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines

Olanzapina may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

olanzapina flas cinfa contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

olanzapina flas cinfa contains aspartame.

This medicine contains 0.53 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take olanzapine flas cinfa

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Olanzapine flas cinfa orodispersible tablets are for oral use.

Olanzapine flas cinfa orodispersible tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Take the orodispersible tablet as follows:

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press on the blister (Figure 1).

1. Separate one blister

Each blister pack contains seven blisters, separated by perforations. Separate one blister along the perforated lines (Figure 2).

1. Remove the foil

Carefully peel off the foil, starting at the corner marked “peel aluminum” (Figures 3 and 4).

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue (Figure 5). It will dissolve directly in the mouth, making it very easy to swallow.

Alternatively, the tablet can be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some drinks, the mixture may change color and become cloudy. It should be consumed immediately.

If you take more olanzapine flas cinfa than you should

Patients who have taken more olanzapine flas than prescribed 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.

Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the medicine packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take olanzapine flas cinfa

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

If you stop taking olanzapine flas cinfa

Do not stop treatment just because you feel better. It is very important that you continue taking olanzapine flas for as long as your doctor advises.

If you stop taking olanzapine flas suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you have:

• Unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency not known – frequency cannot be estimated from available data).

Very common adverse effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing 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.

Uncommon adverse effects (may affect up to 1 in 100 people) include excessive salivation; hypersensitivity (e.g. mouth and throat swelling, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are 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; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in both men and women such as abnormal production of breast milk or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pain and prolonged and/or painful erection.

Very rare adverse 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 presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of olanzapine flas cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of olanzapina flas cinfa

• The active substance is olanzapine. Each olanzapina flas cinfa orodispersible tablet contains 20 mg of active substance.
• The other components are monohydrate lactose, calcium silicate, low-substituted hydroxypropyl cellulose (E-463), crospovidone, aspartame (E-951), orange flavour, banana flavour, colloidal anhydrous silica, and magnesium stearate (E-470).

Appearance of the product and contents of the pack

olanzapina flas cinfa 20 mg orodispersible tablets are yellow, round tablets with a diameter of approximately 9 mm.

olanzapina flas cinfa 20 mg tablets are available in packs of 28 tablets.

Other presentations:

olanzapina flas cinfa 15 mg orodispersible tablets: packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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 packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75237/P_75237.html

QR code link: https://cima.aemps.es/cima/dochtml/p/75237/P_75237.html