Olanzapine Krka 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Olanzapina Krka 10 mg tablets EFG
Read all of 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others, 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 it is a side effect not listed in this leaflet. See section 4.
Contents of this leaflet
- What Olanzapina Krka is and what it is used for
- What you need to know before taking Olanzapina Krka
- How to take Olanzapina Krka
- Possible side effects
- How to store Olanzapina Krka
- Contents of the pack and other information
1. What Olanzapina Krka is and what it is used for
Olanzapina Krka contains the active substance olanzapine. Olanzapina Krka belongs to the therapeutic group of antipsychotics and is 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 episode, characterized by symptoms such as excitement or euphoria.
Olanzapina Krka has 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 taking Olanzapina Krka
Do not take Olanzapina Krka
- if you are allergic 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, 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
Talk to your doctor or pharmacist before taking Olanzapina Krka.
- The use of Olanzapina Krka is not recommended in 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 Olanzapina Krka, inform your doctor.
- Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
- Weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. Consider consulting a dietitian or following a diet plan if necessary.
- 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 fat levels before you start taking Olanzapina Krka 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 (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 loss of salts due to prolonged severe diarrhea and vomiting (being unwell) or due to taking diuretic medicines (water tablets)
If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient cerebral ischemia.
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 Olanzapina Krka.
Other medicines and Olanzapina Krka
Only take other medicines together with Olanzapina Krka if your doctor authorizes it. You may feel drowsy if Olanzapina Krka is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, tell your doctor if you are taking:
- Medicines for Parkinson's disease;
- Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapina Krka may need to be adjusted.
Taking Olanzapina Krka with alcohol
Do not drink alcohol while taking Olanzapina Krka, as it 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 must not take this medicine while breastfeeding, as small amounts of Olanzapina Krka may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapina Krka 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 Olanzapina Krka. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Olanzapina Krka contains 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 Olanzapina Krka
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. If you have any further 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 between 5 mg and 20 mg.
Consult your doctor if your symptoms return, but do not stop taking Olanzapina Krka unless your doctor tells you to.
Olanzapina Krka tablets should be taken 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. The tablets must be swallowed whole with water.
If you take more Olanzapina Krka than you should
Patients who have taken more olanzapine 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 immediately to the hospital if you notice any of the symptoms listed above. Show the doctor the package and tablets.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 make up for the forgotten dose.
If you stop taking Olanzapina Krka
Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina Krka for as long as your doctor tells you to.
If you stop taking Olanzapina Krka suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. 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 have adverse effects, although not everyone gets 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, leg pain, and redness), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
- a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness (the frequency of this adverse effect cannot be estimated from the available data).
Very common adverse effects (may affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. During the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when standing up from a lying or sitting position. This will usually resolve on its own, but if it does not, inform your doctor.
Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells, circulating lipids, and, during the early stages 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; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing swelling 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.
Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g., swelling of the mouth or throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, usually in patients with a history of seizures (epilepsy); muscle rigidity or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduced menstrual periods; and changes in the breast gland in both men and women such as abnormal production of breast milk or abnormal growth.
Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; irregular heartbeat; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pains; prolonged and/or painful erection.
Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. 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, extreme fatigue, visual hallucinations, increased body temperature, skin redness, falls, and difficulty walking. Some deaths have been reported in this particular patient group.
Olanzapine Krka may worsen symptoms in patients with Parkinson's disease.
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 national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olanzapine Krka
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect it from light and moisture. This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
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. Ask your pharmacist how to properly 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 Krka
- The active substance is olanzapine. Each Olanzapine Krka tablet contains 10 mg of olanzapine.
- The other components are: monohydrate lactose, powdered cellulose, pregelatinized starch, corn starch, colloidal anhydrous silica and magnesium stearate.
- See section 2 “Olanzapine Krka contains lactose”.
Appearance of Olanzapine Krka and contents of the pack
Olanzapine Krka 10 mg tablets EFG are round tablets (diameter = 9 mm), slightly biconvex, light yellow in colour, possibly with isolated yellow specks, and engraved with “10”.
Olanzapine Krka 10 mg tablets EFG are available in cartons containing 7, 14, 28, 35, 56 or 70 tablets in blisters.
Only some pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
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
Further information about this medicinal product is available upon request from the Local Representative of the Marketing Authorisation Holder:
KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Planta baja, Oficina 1, 28108 Alcobendas, Madrid.
Date of the most recent review of this leaflet: April 2020
Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).