2.5 mg film-coated tablets
olanzapine
What Olanzapine Sandoz is and what it is used for
Olanzapine Sandoz contains the active substance olanzapine. It belongs to the group of antipsychotics and is used to treat the following conditions:
- Schizophrenia, a disease with symptoms such as hearing, seeing or feeling something that does not exist, delusions, unusual suspicion and withdrawal. People with these conditions may also feel depressed, anxious or tense.
- Moderate to severe manic episodes, a condition with symptoms such as arousal and euphoria .
Olanzapine Sandoz prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
Olanzapine contained in Olanzapine Sandoz may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Olanzapine Sandoz
Do not take Olanzapine Sandoz
- if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching , swollen face, swollen lips or difficulty breathing. If this happens to you, consult a doctor.
- if you have previously had eye problems, e.g. certain types of glaucoma (increased pressure in the eye).
Warnings and cautions
Talk to your doctor or pharmacist before taking Olanzapine Sandoz.
- The use of Olanzapine Sandoz in elderly patients with dementia is not recommended as it may cause serious side effects .
- Drugs of this type can cause abnormal movements of the face or tongue. Contact your doctor if this happens after taking Olanzapine Sandoz.
- This type of medicine can cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness. These side effects are rare but if they occur, contact your doctor immediately.
- Weight gain has occurred in patients taking Olanzapine Sandoz. You and your doctor should check your weight regularly. Consider contacting a dietitian or asking for help with a diet plan if necessary.
- High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have been reported in patients taking Olanzapine Sandoz. Your doctor should do blood tests for blood sugar and certain fat levels before you start taking Olanzapine Sandoz and then at regular intervals during treatment.
- Tell your doctor if you or anyone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
You must tell your doctor as soon as possible if you suffer from any of the following diseases:
- Stroke or mild form of stroke (temporary symptoms of stroke )
- Parkinson’s disease
- Prostate problem
- Intestinal upset (paralytic ileus )
- Liver or kidney disease
- Blood disease
- Heart disease
- Diabetes
- Seizures
- If you know you may have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics ).
For dementia patients, the doctor should be informed if the patient has had a stroke or a mild form of stroke.
If you are over 65, your blood pressure should be checked regularly by your doctor.
Children and young people
Olanzapine Sandoz is not for use in patients under 18 years of age.
Other medicines and Olanzapine Sandoz
Only take other medicines during Olanzapine Sandoz treatment if your doctor advises you to do so. Along with the following medicines, drowsiness may occur medicines for depression and anxiety and sleeping pills (sedatives).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- medicines for Parkinson’s disease .
- carbamazepine (for epilepsy and mood stabilizers), fluvoxamine (for depression) or ciprofloxacin ( antibiotics ) – it may be necessary to adjust your dose of Olanzapine Sandoz .
Olanzapine Sandoz with alcohol
Do not drink alcohol while taking Olanzapine Sandoz as it may make you drowsy with alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine while breastfeeding as small amounts of Olanzapine Sandoz may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used olanzapine during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, upset, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor
Driving and using machines
There is a risk that you may feel drowsy when using Olanzapine Sandoz. If this happens, do not drive or use any tools or machines. Consult your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Olanzapine Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Olanzapine Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one and the duration of treatment is determined by your doctor. Dose one of Olanzapine Sandoz is 5-20 mg per day. Contact your doctor if symptoms return but do not stop taking the medicine unless your doctor tells you to.
You should take Olanzapine Sandoz once a day according to your doctor’s instructions. Try to take Olanzapine Sandoz at the same time each day either at mealtime or between meals. The tablets should be taken by mouth and swallowed with water.
If you take more Olanzapine Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Patients who have taken too much Olanzapine Sandoz have the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, involuntary movements (especially of the face and tongue), and decreased level of consciousness. Other symptoms may include acute confusion, seizures ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness, drowsiness or drowsiness, slow breathing, difficulty breathing, high blood pressure, or low blood pressure, abnormal heart rhythm. Contact your doctor or hospital immediately if you experience any of the listed symptoms. Take the remaining tablets with you.
If you forget to take Olanzapine Sandoz
Take your tablets as soon as you remember. Do not take two doses on the same day.
If you stop taking Olanzapine Sandoz
Do not stop taking the medicine just because you feel better. You must take Olanzapine Sandoz for as long as your doctor prescribes it.
If you suddenly stop taking Olanzapine Sandoz, symptoms such as sweating, insomnia, tremors, anxiety or nausea, and vomiting may occur. Your doctor may suggest that you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you get:
- involuntary movement disorders (a common side effect that can occur in up to 1 in 10 users) especially in the face or tongue
- blood clots in the veins (a less common side effect that can affect up to 1 in 100 people) especially in the legs (symptoms are swelling, pain and redness on the legs). The blood clots can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
- a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or drowsiness (a rare side effect that may affect up to 1 in 1,000 people).
Very common side effects (may affect more than 1 user in 10):
- weight gain
- somnolence
- increased levels of prolactin in the blood
- At the beginning of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This often disappears by itself. If not, contact your doctor.
Common side effects (may affect up to 1 in 10 people):
- changes in levels of certain blood cells and blood fats
- temporarily increasing the number of liver enzymes, especially at the beginning of treatment
- increased blood sugar and urine levels
- elevated levels of uric acid and creatine phosphokinase in the blood
- increased appetite
- dizziness
- restlessness
- tremors
- involuntary movements ( dyskinesia )
- constipation
- dry mouth
- rash
- impotence
- extreme fatigue
- fluid retention leading to swelling of the hands, ankles or feet
- fever
- joint pain
- sexual problems such as decreased sexual drive in men and women or erection problems in men
Uncommon side effects (may affect up to 1 in 100 people):
- hypersensitivity (eg swelling of the mouth and throat, itching , rash)
- diabetes or exacerbation of diabetes, sometimes associated with ketoacidosis (ketones in the blood and urine) or coma
- seizures, generally with known susceptibility to seizures ( epilepsy )
- muscle stiffness or spasms (including eye movements)
- ant crawls and feeling of restlessness in the legs at rest (restless legs)
- speech difficulties
- stuttering
- slow heartbeat
- sun sensitivity
- nosebleed
- stretched abdomen
- dreglande
- memory loss or forgetfulness
- urinary incontinence, difficulty urinating
- hair loss
- missed or shortened menstruation
- breast changes in men and women, e.g. abnormal production of breast milk or abnormal enlargement
Rare side effects (may affect up to 1 in 1,000 people):
- lowering of the normal body temperature
- abnormal heart rhythm
- sudden, unexplained death
- inflammation of the pancreas that led to severe stomach pain, fever and malaise
- liver disease that manifests itself in yellowing of the skin and whites of the eyes
- muscle disease that manifests itself in unexplained aches and pains
- prolonged and / or painful erection
Very rare side effects include severe allergic reactions such as drug reactions with eosinophilia and systemic symptoms (DRESS). DRESS initially appears with flu-like symptoms with rash on the face and then by more widespread rash, fever, enlarged lymph nodes, elevated levels of liver enzymes seen in blood tests, and elevated levels of a type of white blood cell ( eosinophils ).
When taking Olanzapine Sandoz, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, increased body temperature, reddening of the skin, and difficulty walking. Some deaths have been reported in this specific patient group.
For patients with Parkinson’s disease, Olanzapine Sandoz may make the symptoms worse.
How to store Olanzapine Sandoz
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 carton and blister/label on the HDPE tablet jar after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Storage after the first opening of the jar:
Do not store above 25 ° C.
Shelf life after the first opening of the jar:
6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is olanzapine.One film-coated tablet contains 2.5 mg olanzapine.
- The other ingredients areTablet core: lactose monohydrate , hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.Tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171) and talc.
What the medicine looks like and contents of the pack
White and round, about 6.5 mm in diameter.
The film-coated tablets are packed in aluminum/aluminum blisters and inserted in cardboard or are packed in HDPE jars with desiccant in the lid.
Pack sizes:
Blisters: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70, 98, 100, 500 film-coated tablets
HDPE can: 50, 100, 250, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
LEK SA, Ul. Podlipie 16 C, 95 010 Strykow, Poland
or
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia