Package Insert: Information for the User

OlanzapinaSUN 10mg buccal dispersible tabletsEFG

olanzapina

Olanzapinabuccal tablets contain the active ingredient olanzapina. Olanzapina buccal tabletsbelong to a group of medicines called antipsychotics and are indicated for the treatment of the following diseases:

• Schizophrenia,

a disease with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from this disease may also be depressed, anxious or tense.

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

Olanzapina buccal tablets have shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take OlanzapinaSUNtablets bucodispersable

• If you are allergic (hypersensitive) to olanzapina or to any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• 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 OlanzapinaSUNtablets bucodispersable

• Olanzapinatablets bucodispersableis not recommended for use in elderly patients with dementia as it may have severe adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapinatablets bucodispersable, tell your doctor.
• Very rarely, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapinatablets bucodispersable. You and your doctor should check your weight regularly.If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapinatablets bucodispersable. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina SUN tablets bucodispersable and regularly 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 ischemic attack (temporary lack of blood flow to the brain)
• 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 a loss of electrolytes due to prolonged diarrhea and vomiting or use of diuretic medications (water pills)

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 check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina tablets bucodispersable.

Use of OlanzapinaSUNtablets bucodispersable with other medications

Only use other medications at the same time as Olanzapina tablets bucodispersable if your doctor authorizes it. You may feel drowsy if you combine Olanzapina SUN tablets bucodispersable with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor if you are using, have used recently, or may need to use any other medication.

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). You may need to adjust your Olanzapina SUN tablets bucodispersable dosage.

Taking Olanzapina SUN tablets bucodispersable with alcohol

You should not drink alcohol if you have been given Olanzapina tablets bucodispersable, as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. You should not take this medication during pregnancy unless your doctor recommends it.

You should not take this medication while breastfeeding as small amounts of Olanzapina may pass into breast milk.

The following symptoms may occur in newborns of mothers who used OlanzapinaSUN tablets bucodispersablein the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina tablets bucodispersable. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina SUN tablets bucodispersable contains aspartame

Patients who cannot take phenylalanine should be aware that Olanzapina tablets bucodispersable contains aspartame, which is a source of phenylalanine. It may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Patients who cannot take mannitol should be aware that Olanzapina SUN tablets bucodispersable contains mannitol. It may cause a mild laxative effect due to the presence of mannitol.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

You should take your Olanzapina tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapina tablets are for oral administration.

Olanzapina tablets should be placed in the mouth, where they dissolve quickly with saliva, making it easy to swallow. Removing the buccal tablet from the mouth intact is difficult. Since the buccal tablet is fragile, it should be taken immediately once the blister is opened. Alternatively, you can also dissolve the tablet in a glass of water or another suitable beverage (orange juice, apple juice, milk, or coffee) just before administration.

With some beverages, the mixture may change color and possibly become cloudy. It should be consumed immediately. The buccal tablets are fragile and break easily, so handle them with care. Do not touch the tablets with wet hands, as they may break.

If you take more Olanzapina SUN tablets than you should

Patients who have taken more Olanzapina tablets than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and a 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 respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. It is recommended to show the medication packaging to your doctor.

Consult your doctor, pharmacist, or call the Toxicological Information Service at phone 91 562 04 20 immediately, indicating the medication and the amount used.

If you forgot to take Olanzapina SUN tablets

Take your tablet as soon as you remember. Do not take two doses in one day.

If you interrupt treatment with Olanzapina SUN tablets

Do not stop treatment when you think you are feeling better. It is very important that you continue taking Olanzapina tablets as long as your doctor tells you to.

If you suddenly stop taking Olanzapina tablets, you may experience symptoms such as sweating, inability to sleep, trembling, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

• Unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Very frequent side effects (can 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 (especially with slower heartbeats), especially when getting up from a sitting or lying position. This feeling usually disappears on its own, but if it doesn't, consult your doctor

Frequent side effects (can affect up to 1 in 10 people):

• Changes in levels of some blood cells, circulating fats, and temporary increases in liver enzymes at the beginning of treatment
• Increased levels of blood sugar and urine
• Increased levels of uric acid and creatine phosphokinase in the blood
• Increased appetite
• Dizziness
• Fatigue
• Tremor
• Strange movements (dyskinesia)
• Constipation
• Dry mouth
• Urticaria
• Loss of strength
• Extreme fatigue
• Fluid retention that can lead to swelling of hands, ankles, or feet.
• Fever
• Pain in the joints
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (can affect up to 1 in 100 people) include:

• Hyperensitivity (e.g. inflammation of the mouth and throat, itching, skin rash)
• Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the blood and urine) or coma
• Seizures, in most cases related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stammering
• Slowed heart rate
• Sensitivity to sunlight
• Nasal bleeding
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence
• Loss of ability to urinate
• Hair loss
• Absence or increase of menstrual periods
• Changes in breasts in men and women, such as abnormal milk production or growth

Rare side effects (can affect up to 1 in 1000 people):

• Decreased normal body temperature
• Abnormal heart rhythm
• Sudden and inexplicable death
• Pancreatitis, which can cause stomach pain, fever, and dizziness.
• Liver disease, which manifests as yellowing of the skin and white part of the eyes.
• Muscle disease, manifested as unexplained 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 problems. Deaths have been reported in this particular group of patients.

Olanzapine orally disintegrating 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 symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect that doesn't appear in the leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina SUN buccal dispersible tablets

• The active ingredient is olanzapina. Each buccal dispersible tablet contains 10 mg of active ingredient.
• The other components are:mannitol, crospovidone, aspartame, talc, and magnesium stearate.

Appearance of Olanzapina SUN buccal dispersible tablets and contents of the package

Olanzapina SUN 10 mg buccal dispersible tablets EFG are presented in the form of buccal dispersible tablets, of a light yellow to yellow color, slightly speckled, round, with the inscription in low relief “OV2” on one of its faces and smooth on the other face.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia SA,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

For more information about this medication, 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 medication is authorized in the EEA member countries with the following names:

Austria- Olanzapine Ranbaxy 10mg Schmelzabletten

France- Olanzapine SUN, 10mg Comprime 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 tablet

Last review date of this leaflet: July 2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/