Olanzapine Sun 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapine SUN 5 mg tablets EFG

olanzapine

Read the entire 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 side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Olanzapine SUN tablets are and what they are used for
2. What you need to know before taking Olanzapine SUN tablets
3. How to take Olanzapine SUN tablets
4. Possible side effects
5. How to store Olanzapine SUN tablets

Pack contents and additional 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 experience depression, anxiety, or tension.

• 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 components 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 use in elderly patients with dementia, as it may cause serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this occurs, inform your doctor.
• Very rarely, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle rigidity, 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 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 at regular intervals during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications 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 ischaemic 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 severe diarrhoea 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 ischaemic attack.

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 SUN tablets.

Taking Olanzapine SUN tablets with other medicines

Only use other medicines together with Olanzapine SUN tablets if authorized by your doctor. You may feel drowsy if Olanzapine SUN tablets are taken together with antidepressants or medicines used to treat anxiety or help you 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.

Drinking alcohol while taking Olanzapine SUN tablets

You must not drink alcohol while taking Olanzapine SUN tablets, as combining it 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 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 while 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 of an intolerance to certain sugars, consult him or her 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 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 every day. You may take them with or without food. Olanzapine tablets are for oral administration. Swallow the Olanzapine 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 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 immediately, or call the Toxicology Information Service at 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 just because you feel better. It is very important to 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 cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• 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 experience dizziness or fainting (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 fat cells 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 the blood
• Increased appetite
• Dizziness
• Fatigue
• Tremor
• Abnormal movements (dyskinesia)
• Constipation
• Dry mouth
• Hives
• Weakness
• Extreme tiredness
• Fluid retention, which 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, 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
• Slowed heartbeat
• Sunlight sensitivity
• 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
• Unexplained sudden death
• Pancreatitis, 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 pain and aches
• Prolonged and/or painful erection

Very rare adverse effects include severe allergic reactions 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).

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 walking difficulties. Fatalities have been reported in this particular patient group.

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

Reporting of adverse effects:

If you experience any type of 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 Medicinal Products: 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 and blister. 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, please ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 5 mg of active substance.
• 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 5 mg tablets EFG are available as light yellow to yellow, slightly mottled, round, biconvex tablets, with the engraved mark “O5” on one side and smooth 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,
2132JH Hoofddorp, The Netherlands

Manufacturing Responsible Party:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

or

Terapia S.A.,
Str. Fabricii Nr. 124,
Cluj-Napoca, Romania

Further information on this medicinal product is available upon request by contacting 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 the EEA member countries under the following names:

Austria – Olanzapine Ranbaxy 5mg Tabletter
France – Olanzapine SUN, 5mg Comprime
Germany – Olanzapine Basics 5mg tabletten
Netherlands – Olanzapine SUN 5mg tablet
Spain – Olanzapina SUN 5mg comprimidos EFG
Sweden – Olanzapina Ranbaxy 5mg Tablett

Date of 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 Health Products (AEMPS): http://www.aemps.gob.es/