Olanzapine Sun 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OlanzapinaSUN 10 mg tablets EFG

olanzapine

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 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 harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Olanzapina SUN tablets are and what they are used for
2. What you need to know before taking Olanzapina SUN tablets
3. How to take Olanzapina SUN tablets
4. Possible side effects
5. How to store Olanzapina SUN tablets
6. Contents of the pack and other information

1. What Olanzapina SUN tablets are and what they are used for

Olanzapina SUN contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics, which are used to treat the following conditions:

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.

• Moderate to severe manic disorder, characterized by symptoms such as 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 to take Olanzapine SUN tablets

Do not take OlanzapineSUN tablets

• If you are allergic (hypersensitive) 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 to take Olanzapine SUN tablets.

• Olanzapine is not recommended for 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 occurs after taking olanzapine, inform your doctor immediately.
• Very rarely, medicines of this type can 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 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 also been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar and lipid levels before you start taking Olanzapine SUN tablets 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 suffer from 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 lost body salts due to prolonged and 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 SUN tablets.

Use of Olanzapine SUN tablets with other medicines

Only use other medicines together with Olanzapine SUN tablets if authorized by your doctor. You may experience increased drowsiness if Olanzapine SUN tablets are taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

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 dose of Olanzapine SUN tablets may need to be adjusted.

Taking Olanzapine SUN tablets with alcohol

You should not drink alcohol while taking Olanzapine SUN tablets, as combining this medicine with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or 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 during pregnancy unless specifically advised by your doctor.

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 whose mothers 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, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine SUN tablets. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine SUN tablets contain 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 SUN tablets

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 you should take and for how long. The daily dose of Olanzapine tablets ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine SUN tablets unless your doctor tells you to do so.

You should take your Olanzapine tablets 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 tablets are for oral use. Swallow the tablets whole with water.

If you take more Olanzapine SUN tablets than you should

Patients who have taken more Olanzapine tablets 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 or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the symptoms listed above. It is recommended to show the medicine packaging to the doctor.

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olanzapine SUN tablets

Take your tablet as soon as you remember. Do not take two doses on the same day.

If you stop taking Olanzapine SUN tablets

Do not stop treatment when you feel better. It is very important that you continue taking Olanzapine tablets for as long as your doctor tells you to.

If you suddenly stop taking Olanzapine tablets, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or vomiting. 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 can produce adverse effects, although not everyone experiences 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 sweating, 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 rigidity, and mental confusion or drowsiness (frequency cannot be estimated from available data).

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

• Weight gain
• Drowsiness
• Increased plasma levels of prolactin
• In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when standing up from a sitting or lying 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):

• Changes in levels of circulating blood lipids and, at the beginning of treatment, temporary increases in liver enzymes
• Increased blood and urine sugar levels
• Increased levels of uric acid and creatine phosphokinase in blood
• Increased appetite
• Dizziness
• Fatigue
• Tremor
• Unusual movements (dyskinesia)
• Constipation
• Dry mouth
• Hives
• Loss of strength
• Extreme tiredness
• Fluid retention that may lead to 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) 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; in most cases, these are related to a history of seizures (epilepsy)
• Muscle rigidity or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stuttering
• Slowed heart rate
• Sensitivity to sunlight
• Nosebleeds
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence
• Loss of ability to urinate
• Hair loss
• Absence or increased menstrual periods
• Breast changes in men and women such as abnormal milk production or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Decrease in normal body temperature
• Abnormal heart rhythm
• Sudden and unexplained death
• Inflammation of the pancreas, which may cause stomach pain, fever, and dizziness
• Liver disease, manifested as yellowing of the skin and the white part of the eyes
• Muscle disease, manifested as unexplained muscle pains and aches
• Prolonged and/or painful erection

Very serious adverse effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, a skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in 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 walking difficulties. Deaths have been reported in this particular group of patients.

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 SUN Tablets

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 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 SUN tablets

• The active substance is olanzapine. Each coated tablet contains 10 mg of active ingredient.
• The other components are: anhydrous lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

Appearance of Olanzapine SUN tablets and contents of the pack

Olanzapine SUN 10 mg tablets EFG are available as light yellow to yellow, slightly mottled, round, biconvex tablets, with the engraved mark “O7” on one side and plain on the other side.

This medicine is available in packs containing 7, 10, 14, 28, 30, 35, 56 and 70 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturing Responsible Party:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

or

Terapia SA,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in EEA member states under the following names:

Austria - Olanzapine Ranbaxy 10mg Tabletter

France - Olanzapine SUN, 10mg Comprime

Germany - Olanzapine Basics 10mg tabletten

Netherlands - Olanzapine SUN 10mg tablet

Spain - Olanzapina SUN 10mg comprimidos EFG

Sweden - Olanzapina Ranbaxy 10mg Tablett

Date of the most recent review of this leaflet: July 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/