Olanzapine Sun 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

OlanzapinaSUN 10 mg orodispersible tablets EFG

olanzapine

Read the entire leaflet carefully before you start using this medicine, as 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Olanzapina orodispersible tablets contain the active substance olanzapine. Olanzapina orodispersible tablets belong to a group of medicines called antipsychotics and are indicated for the treatment of the following conditions:

• Schizophrenia,

a disorder characterized by symptoms such as hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and a tendency to withdraw. People with this illness may also feel depressed, anxious, or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina orodispersible tablets have been shown to prevent 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 SUN orodispersible tablets

Do not take Olanzapine SUN orodispersible 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 occurs, inform your doctor immediately.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine SUN orodispersible tablets.

• Olanzapine orodispersible tablets are not recommended for elderly patients with dementia, as they 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 orodispersible tablets, inform your doctor immediately.
• Very rarely, medicines of this type may cause a combination of symptoms including 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 orodispersible tablets. 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 dietitian.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine orodispersible tablets. Your doctor should perform blood tests to monitor your blood sugar and lipid 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 (TIA, 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 salt loss due to prolonged severe diarrhea 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 ischemic attack.

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

Children and adolescents

Olanzapine orodispersible tablets are not recommended for patients under 18 years of age.

Use of Olanzapine SUN orodispersible tablets with other medicines

Only take other medicines together with Olanzapine orodispersible tablets if authorized by your doctor. You may feel increased drowsiness if Olanzapine SUN orodispersible tablets are taken together 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 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 orodispersible tablets may need to be adjusted.

Taking Olanzapine SUN orodispersible tablets with alcohol

You should not drink alcohol while taking Olanzapine orodispersible tablets, as combining with alcohol may increase 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. Do 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 SUN orodispersible tablets 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 orodispersible tablets. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine SUN orodispersible tablets contain aspartame

Patients who cannot tolerate phenylalanine should be aware that Olanzapine orodispersible tablets contain aspartame, which is a source of phenylalanine. It may be harmful for people with phenylketonuria (PKU), a rare inherited disorder in which phenylalanine accumulates because the body cannot process it properly.

Patients who cannot tolerate mannitol should be aware that Olanzapine SUN orodispersible tablets contain mannitol. This may cause a mild laxative effect due to the presence of mannitol.

3. How to take Olanzapina SUN orodispersible tablets

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

You should take your Olanzapina orodispersible tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. Olanzapina orodispersible tablets are intended for oral administration.

Olanzapina orodispersible tablets must be placed in the mouth, where they rapidly dissolve with saliva and can therefore be easily swallowed. It is difficult to remove the orodispersible tablet from the mouth intact. Because the orodispersible tablet is fragile, it should be taken immediately after opening the blister. Alternatively, the tablet may also be dissolved in a glass of water or another suitable drink (orange juice, apple juice, milk, or coffee) immediately before administration.

With some drinks, the mixture may change color and possibly become cloudy. It should be drunk immediately. Orodispersible tablets break easily and must therefore be handled with care. Do not touch the tablets with wet hands, as they may break.

If you take more Olanzapina SUN orodispersible tablets than you should

Patients who have taken more Olanzapina orodispersible tablets than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, 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 immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olanzapina SUN orodispersible tablets

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

If you stop taking Olanzapina SUN orodispersible tablets

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

If you suddenly stop taking Olanzapina orodispersible 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 will experience 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 blood 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 certain blood cells, circulating fats, 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
• Fatigue
• Tremor
• Strange 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. inflammation of the mouth and throat, 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 stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stuttering
• Slowing of the heartbeat
• 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 pain and aches
• Prolonged and/or painful erection

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

Severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. 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).

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 SUN orodispersible tablets

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Medicines and their empty containers should be returned to a pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines and their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine SUN orodispersible tablets

• The active substance is olanzapine. Each orodispersible tablet contains 10 mg of active substance.
• The other components are: mannitol, crospovidone, aspartame, talc, and magnesium stearate.

Appearance of Olanzapine SUN orodispersible tablets and contents of the pack

Olanzapine SUN 10 mg orodispersible tablets EFG are presented as orodispersible tablets, light yellow to yellow in colour, slightly speckled, round, with the engraved marking “OV2” on one side and smooth on the other side.

This medicine is available in packs of 7, 10, 14, 28, 30, 35, 56 and 70 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

or

Terapia S.A.,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

For further information about this medicinal product, please contact 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 countries under the following names:

Austria - Olanzapine Ranbaxy 10mg Schmelzabletten
France - Olanzapine SUN, 10mg Comprimé Orodispersible
Germany - Olanzapine Basics 10mg Schmelztabletten
Netherlands - Olanzapine SUN 10mg orodispersible tablet
Poland - Olanzapine Lekam 10mg tabletka Ulegajaca rozpadowi w jamie ustnej
Romania - Olanzapina Terapia 10mg comprimate orodispersabile
Spain - Olanzapina SUN 10mg comprimidos bucodispersables EFG
Sweden - Olanzapine Ranbaxy 10mg Munsönderfallande tablett

Date of the most recent review of this summary: 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/