Leaflet:information for the patient

Olanzapina Krka 5mg buccodispersible tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Olanzapina Krka is and for what it is used

2.What you need to knowbeforestarting totake Olanzapina Krka

3.How to take Olanzapina Krka

4.Possible side effects

5Storage of Olanzapina Krka

6.Contents of the pack and additional information

Olanzapina Krka contains the active ingredient olanzapina.Olanzapina Krka belongs to the therapeutic group of antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

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

Do not take Olanzapina Krka

-if you are allergic to olanzapina or any of the other ingredients in this medicine (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 pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Krka

• No use Olanzapina Krka in elderly patients with dementia as it may have serious adverse effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Krka, tell your doctor.
• Very rarely, medicines 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 olanzapina. You and your doctor should check your weight regularly. Consider consulting a dietitian or help yourself with a diet plan if necessary.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapina. Your doctor should do blood tests to control your blood sugar and fat levels before starting Olanzapina Krka and regularly during treatment.
• If you or a family member 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 (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 salts due to prolonged diarrhea and vomiting (being sick) or the use of diuretic medicines (tablets to make you urinate)

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, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina Krka.

Other medicines and Olanzapina Krka

Only take other medicines at the same time as Olanzapina Krka if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Krka with antidepressants or medicines for anxiety or to help you sleep (tranquilizers).

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

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 change your Olanzapina Krka dose.

Use of Olanzapina Krka with alcohol

You should not drink alcohol while taking Olanzapina Krka as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medicine. Do not take this medicine while breastfeeding as small amounts of Olanzapina Krka may pass into breast milk.

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

Driving and operating machinery

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

Olanzapina Krka contains aspartame

This medicine contains 0.50 mg of aspartame in each 5 mg buccal dispersible tablet.

This medicine contains 0.75 mg of aspartame in each 7.5 mg buccal dispersible tablet.

This medicine contains 1.00 mg of aspartame in each 10 mg buccal dispersible tablet.

This medicine contains 1.50 mg of aspartame in each 15 mg buccal dispersible tablet.

This medicine contains 2.00 mg of aspartame in each 20 mg buccal dispersible tablet.

Aspartame is a source of phenylalanine.

Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Your doctor will tell you how many Olanzapina Krka tablets to take and for how long. The daily dose of olanzapine ranges from 5mg to 20mg.

Consult your doctor if you experience the symptoms again, but do not stop taking Olanzapina Krka unless your doctor tells you to.

Olanzapina Krka tablets should be taken 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.

How to take Olanzapina Krka

Olanzapina Krka bucodispersable tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate. Remove the tablet from the packaging as follows:

1. Hold the blister pack by the sides and separate an individual package from the rest along the perforations.
2. Pull the aluminum edge and remove it completely.
3. Drop the tablet into your hand.
4. Place the tablet on your tongue immediately.

In a few seconds, the tablet will start to disintegrate and can be swallowed with or without water. Your mouth should be empty before placing it on your tongue.

You can also drop the tablet into a glass of water, orange juice, apple juice, milk, or coffee, stirring it. With a little liquid, the mixture may change color and possibly become cloudy. It should be consumed immediately.

If you take more Olanzapina Krka than you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heart rate, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced 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.

Get in touch with your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olanzapina Krka

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina Krka

Do not stop treatment simply because you feel better. It is very important that you continue taking Olanzapina Krka as long as your doctor tells you to.

If you stop taking Olanzapina Krka suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

Like all medicines, this medicine may 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 (the frequency of this side effect cannot be estimated from the available data).

Frequent side effects (which can affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. In the early stages of treatment, some people feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will pass on its own, but if not, inform your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and, in the early stages of treatment, temporary increases in liver enzymes; increased levels of blood sugar and urine; 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 fatigue; fluid retention causing inflammation of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., swelling in the mouth or throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in the 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, nasal bleeding; abdominal distension; excessive salivation; memory loss or forgetfulness, urinary incontinence, inability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1000 people) include decreased body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain; prolonged and/or painful erection.

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).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, increased body temperature, skin redness, falls, and walking difficulties. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the reach and sight of children.

Store in the original packaging to protect it from light and moisture. This medication does not require any special storage temperature.

Do not usethis medicationafter the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed ofdown the drainsor in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose ofthepackaging andthemedicines that you no longer need. This will help protect the environment.

Composition of Olanzapina Krka

• The active ingredient is olanzapine. Each Olanzapina Krka tablet contains 5 mg of olanzapine.
• The other components are: mannitol, microcrystalline cellulose, crospovidone, hydroxypropylmethylcellulose with low substitution degree LH-21, aspartame, calcium silicate, and magnesium stearate.

See section 2 “Olanzapina Krka contains aspartame”.

Appearance of Olanzapina Krka and contents of the packaging

Olanzapina Krka 5 mg buccal dispersible tablets EFG are yellow, round (diameter = 5.5 mm), slightly biconvex, with possible isolated spots.

Olanzapina Krka 5 mg buccal dispersible tablets EFG are available in packs with 14, 28, 35, 56, or 70 tablets conditioned in blisters.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warsaw, Poland

For further information about this medicinal product, please contact the Local Representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Ground floor, Office 1, 28108 Alcobendas, Madrid.

Last review date of this leaflet: April 2020

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/) .