Olanzapine Flas Cinfia 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

olanzapina flas cinfa 5 mg orodispersible tabletsEFG

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

Contents of the leaflet

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 things that are not real, 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 the 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 olanzapine flas cinfa

Do not take olanzapine flas cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting olanzapine flas cinfa

• The use of olanzapine 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 in the face or tongue. If this occurs after taking olanzapine 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 this happens, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine 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 nutritionist.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking olanzapine flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking olanzapine 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 (temporary stroke-like symptoms).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart diseases.
• Diabetes.
• Seizures.
• If you think you may have loss of body salts due to prolonged severe diarrhea or vomiting, or due to the use of 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 olanzapine flas.

Taking olanzapine flas cinfa with other medicines

Only use other medicines together with olanzapine flas if authorized by your doctor. You may feel drowsy if olanzapine 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). Your olanzapine flas dose may need to be adjusted.

Taking olanzapine flas cinfa with alcohol

Do not drink alcohol while taking olanzapine flas, as combining olanzapine flas 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 before using this medicine.

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

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine flas during the third trimester of pregnancy (last three months of pregnancy): tremors, 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

Olanzapine may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. 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.

olanzapine flas cinfa contains lactose.

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

olanzapine flas cinfa contains aspartame.

This medicine contains 0.53 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful in patients with 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 instructions for use of this medicine 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 to be taken 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.

Olanzapine flas cinfa orodispersible tablets are for oral use.

Olanzapine flas cinfa orodispersible tablets dissolve 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 strip 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 off aluminum” (Figures 3 and 4).

1. Remove the orodispersible tablet

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

Alternatively, the tablet may be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. It should be drunk 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, aspiration, increased 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 packaging of the medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the name of 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, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. 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 which may affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (an uncommon adverse effect which 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 standing up from a lying or sitting position. 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; muscle weakness; 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; 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). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes seen 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, elevated body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapina 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 refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. 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 5 mg of the active substance.
• The other components are: monohydrate lactose, calcium silicate, low-substituted hydroxypropyl cellulose, crospovidone, aspartame, orange flavour, banana flavour, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

olanzapina flas cinfa 5 mg orodispersible tablets are yellow, round tablets.

olanzapina flas cinfa 5 mg orodispersible tablets are available in packs of 28 tablets.

Other presentations:

olanzapina flas cinfa 10 mg orodispersible tablets: packs of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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. de Barcelona, 69

Sant Joan Despí (Barcelona)

Spain

Date of latest 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 updated information about this medicinal product 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/73686/P_73686.html

QR code link: https://cima.aemps.es/cima/dochtml/p/73686/P_73686.html