Olanzapine Flas Stada 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Flas Stada 10 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, pharmacist, or nurse.
• 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 effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Olanzapina Flas Stada is and what it is used for

Olanzapina Flas Stada contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following disorders:

• Schizophrenia, a condition with symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and tendency to withdraw. People with this illness may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a disorder characterized by symptoms of excitement or euphoria.

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

2. What you need to know before starting to take Olanzapine Flas Stada

Do not take Olanzapina Flas Stada

• 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

Talk to your doctor, pharmacist, or nurse before starting to take olanzapine.

• The use of olanzapine in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this occurs after taking olanzapine, inform your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of 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 blood sugar levels and high levels of fat (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor should perform blood tests to check your blood sugar and certain fat levels before you start taking olanzapine and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as this type of medicine has been associated with blood clot formation.

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

• Stroke or "mini" stroke (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 body salts due to prolonged severe diarrhea and 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 reduced blood flow to the brain.

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

Children and adolescents

Patients under 18 years of age must not take olanzapine.

Other medicines and Olanzapina Flas Stada

Only take other medicines together with olanzapine if authorized by your doctor. You may feel drowsiness if olanzapine 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.

In particular, inform your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as your olanzapine dose may need to be adjusted.

Taking Olanzapina Flas Stada with alcohol

You must not drink alcohol while taking olanzapine, as the combination of olanzapine and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 olanzapine may pass into breast milk.

The following symptoms may occur in newborns of mothers who have taken olanzapine during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

There is a risk of experiencing somnolence when taking olanzapine. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzapine Flas Stada contains aspartame (E951)

This medicine contains 5.6 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapina Flas Stada

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

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

You should take your olanzapine tablets 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 orodispersible tablets are administered orally.

Olanzapine tablets break easily, so handle them carefully. Do not handle the tablets with wet hands, as they may break.

For peelable foil blisters:

1. Hold the blister at the edges and separate one of the pockets by gently breaking it along the perforations surrounding it.
2. Gently peel back the backing of the pocket.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, allowing it to be swallowed easily.

You may also place the tablet in a glass or cup of water, orange juice, apple juice, milk, or coffee and stir. With some beverages, the mixture may change color and become cloudy. Drink it immediately.

If you take more Olanzapina Flas Stada 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 symptoms may 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.

If you experience any of the above symptoms, in case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Olanzapina Flas Stada

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

If you stop taking Olanzapina Flas Stada

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

If you stop taking olanzapine suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you 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 can cause adverse effects, although not everyone will experience them.

Inform your doctor immediately if you have:

• unusual movements (a common adverse effect that may affect up to 1 in 10 people), mainly 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 blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy (the frequency of this adverse effect cannot be estimated from available data);
• severe allergic reactions, e.g. swelling of the mouth and throat, itching, rash (an uncommon adverse effect that may affect up to 1 in 100 people);
• prolonged and/or painful erection (a rare adverse effect that may affect up to 1 in 1,000 people);
• inflammation of the pancreas, causing severe stomach pain, fever and malaise (a rare adverse effect that may affect up to 1 in 1,000 people);
• muscle disorders, e.g. rhabdomyolysis, presenting as unexplained muscle aches (a rare adverse effect that may affect up to 1 in 1,000 people);
• liver disease with nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (a rare adverse effect that may affect up to 1 in 1,000 people).

Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Very common adverse effects (may affect more than 1 in 10 people), including:

• weight gain
• drowsiness
• increased plasma levels of prolactin

In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from a lying or sitting position.

This sensation usually resolves spontaneously, but if it does not, inform your doctor.

Common adverse effects (may affect up to 1 in 10 people), including:

• changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the start of treatment;
• increased blood and urine sugar levels;
• increased levels of uric acid and creatine phosphokinase in the blood;
• increased appetite;
• dizziness;
• agitation;
• tremor;
• unusual movements (dyskinesias);
• constipation;
• dry mouth;
• skin rash;
• loss of strength;
• excessive tiredness;
• fluid retention causing swelling of the hands, ankles or feet;
• fever, joint pain;
• 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), including:

• diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones in blood and urine) or coma;
• seizures, usually associated with 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;
• inability to urinate;
• hair loss;
• absence or reduction of menstrual periods;
• changes in the breast gland in 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), including:

• decrease in normal body temperature;
• abnormal heart rhythm;
• sudden unexplained death.

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 Flas STADA may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Flas Stada

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapina Flas Stada

• The active substance is olanzapine.

Each orodispersible tablet contains 10 mg of olanzapine. The exact amount is shown on the packaging of olanzapine.

• The other components are: magnesium stearate, L-methionine, anhydrous colloidal silica, low-substituted hydroxypropylcellulose, aspartame (E-951), microcrystalline cellulose, guar gum, heavy magnesium carbonate and orange flavour.

Nature of the product and pack sizes

Olanzapina Flas Stada 10 mg orodispersible tablets are yellow, round, biconvex tablets, 8 mm in diameter, marked with "O1" on one side.

Pack sizes:

Blister pack with push-through foil: 10 (sample), 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets

Blister pack with peelable foil: 10 (sample), 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Coripharma ehf.
Reykjavíkurvegur 78
IS-220 Hafnarfjörður
Iceland

or

Actavis Ltd.
B16, Bulebel Industrial Estate
Zejtun ZTN 08
Malta

or

Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary
Ireland

or

LAMP S. Prospero S.P.A.
Via della Pace 25/A, 41030 San Prospero (Modena)
Italy

or

STADA Arzneimittel AG
Stadastrasse 2-18, 61118 Bad Vilbel
Germany

or

STADA Arzneimittel GmbH
Muthgasse 36/2, A-1190 Wien
Austria

or

N.V. Eurogenerics S.A.
Heizel Esplanade Heysel b22, 1020 Brussel
Belgium

or

Sanico N.V.
Industriezone, Veedijk 59, BE - 2300 Turnhout
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Belgium Olanzapine Instant EG 10 mg orodispersible tablets
Spain Olanzapina Flas Stada 10 mg orodispersible tablets EFG
Italy OLANZAPINA EUROGENERICI 10 mg orodispersible tablets
Luxembourg Olanzapin Instant EG 10 mg orodispersible tablets
Portugal Olanzapina Ciclum
Sweden Olanzapine STADA 10 mg dispersible tablets

Date of the most recent revision of this leaflet: June 2020

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