Olanzapine Alter 15 mg orodispersible tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Olanzapine Alter 5 mg orodispersible tablets EFG

Olanzapine Alter 10 mg orodispersible tablets EFG

Olanzapine Alter 15 mg orodispersible tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olanzapina Alter contains the active substance olanzapine. Olanzapine belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, anxious, or tense.
• 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 taking Olanzapina Alter

Do not take Olanzapina Alter

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear 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

Talk to your doctor or pharmacist before taking this medicine.

• The use of olanzapine 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 to you after taking olanzapine, 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 occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. 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. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start treatment 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 disease.
• Diabetes.
• Seizures.
• If you think you may have loss of body salts due to prolonged severe diarrhea and 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 reduction in blood flow to the brain.

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.

Taking Olanzapina Alter with other medicines

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

Only take other medicines together with olanzapine if your doctor authorizes it. You may feel drowsiness if you combine olanzapine with antidepressants or medicines for anxiety or sleep (tranquilizers).

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 dose may need to be adjusted.

Taking Olanzapina Alter with alcohol

Do not drink alcohol while taking this medicine, as combining it 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 taking this medicine. You must not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine 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

There is a risk of drowsiness when taking olanzapine. If this happens, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Alter contains lactose

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

3. How to take Olanzapine Alter

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

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

Olanzapine tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. Olanzapine orodispersible tablets are for oral use.

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

Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.

Alternatively, the tablet may be placed into a glass or cup containing 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 Alter than you should

Patients who have taken more olanzapine 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, somnolence or lethargy, slowed breathing, 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 packaging of the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist 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 Alter

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 Alter

Do not stop treatment just because you feel better. It is very important that you continue taking this medicine for as long as your doctor tells you to.

If you stop taking olanzapine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce 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 may cause adverse effects, although not everyone gets them.

Contact your doctor immediately if you experience:

• 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 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 experience dizziness or fainting (with slower heartbeats), especially when getting 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 levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; 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 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); 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; inability to urinate; hair loss; absence or reduced menstrual periods; and changes in the breast gland in men and women such as abnormal milk production 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). DRESS initially 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 group of patients.

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

Reporting of adverse effects

If you experience any type of 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 Alter

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Alter

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg or 15 mg of olanzapine. The exact amount is shown on the packaging of the medicine.
• The other components are crospovidone, monohydrate lactose, colloidal silicon dioxide, hypromellose, flavouring, talc, magnesium stearate.

Appearance of the product and contents of the pack

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, making it easier to swallow.

Olanzapine Alter 5 mg: yellow, round, biconvex tablets.

Packaged in packs of 28 tablets.

Olanzapine Alter 10 mg: yellow, round, flat tablets.

Available in packs of 28 tablets or 56 tablets.

Olanzapine Alter 15 mg: yellow, round, biconvex tablets.

Packaged in packs of 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Pharmathen International S.A.

Sapes Industrial Park, Block 5, 69300 Rodopi

Greece

or

Pharmaten S.A.

6 Dervenakion str.; Pallini 153 51; Attiki

Greece

Date of the most recent revision of this leaflet: May 2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/