2.5 / 5 / 7.5 / 10/15/20 mg tablet; 5/10/15/20 mg orodispersible tablet
olanzapine
What Olanzapine SUN is and what it is used for
Olanzapine SUN contains the active substance olanzapine. Olanzapine SUN belongs to the group of drugs neuroleptics 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 agitation and euphoria .
Olanzapine SUN prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
Olanzapine contained in Olanzapine SUN may also be approved for the treatment of other conditions not mentioned in this product information. 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 use Olanzapine SUN
Do not take Olanzapine SUN
- 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, consult your doctor.
- if you have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).
Warnings and cautions
Talk to your doctor or pharmacist before taking Olanzapine SUN
- The use of Olanzapine SUN 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.
- This type of medicine can also cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness. These side effects are extremely rare, but if they do occur, contact your doctor immediately.
- Weight gain has occurred in patients taking Olanzapine SUN. You and your doctor should check your weight regularly. Consider referral to a dietitian or help with a diet list if necessary.
- High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have been reported in patients taking Olanzapine SUN. Your doctor should do blood tests to check your blood sugar and levels of certain blood fats before you start taking Olanzapine SUN and regularly during treatment.
- Tell your doctor if you or anyone in your family has had a blood clot in the past, as medicines like this have been linked to blood clots.
You must tell your doctor if you suffer from any of the following diseases:
- stroke or mild form of stroke (temporary symptoms of stroke )
- Parkinson’s disease
- prostate problem
- blockage in the intestine (so-called intestinal upset or paralytic ileus )
- liver or kidney disease
- blood disease
- heart disease
- diabetes
- seizures
- if you know you may be salt deficient due to prolonged severe diarrhea and vomiting or using diuretics ( diuretics ).
For dementia patients, the doctor should be informed if the patient has had a stroke or a milder form of stroke.
If you are over 65, your blood pressure should be checked regularly by your doctor.
Children and young people
Olanzapine SUN is not for use in patients under 18 years of age.
Other medicines and Olanzapine SUN
Only take other medicines during Olanzapine SUN 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 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 SUN.
Olanzapine SUN with alcohol
Do not drink alcohol during treatment with Olanzapine SUN, as Olanzapine SUN in combination with alcohol may cause drowsiness.
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 if you are breastfeeding, as small amounts of Olanzapine SUN may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken Olanzapine SUN during the last trimester (the last three months of pregnancy): tremors, stiff and/or weak muscles, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child gets any of these symptoms, you may need to contact your doctor.
Driving and using machines
There is a risk that you may feel drowsy when using Olanzapine SUN. If this happens, do not drive or use any tools or machines and 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 SUN tablets contain lactose. Olanzapine SUN orodispersible tablets contain aspartame.
Olanzapine SUN tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Olanzapine SUN orodispersible tablets contain aspartame
Patients intolerant to phenylalanine: Olanzapine SUN orodispersible tablets contain aspartame, a source of phenylalanine. This can be harmful to people with phenylketonuria.
How to use Olanzapine SUN
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. The recommended dose of Olanzapine SUN 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 SUN once a day. Try to take Olanzapine SUN at the same time each day either at mealtime or between meals. The tablets should be taken by mouth.
Olanzapine SUN tablets:
You should swallow Olanzapine SUN tablets whole with water.
Olanzapine SUN orodispersible tablets:
Olanzapine SUN orodispersible tablets break easily, so you should handle them carefully. Do not take the tablets with wet hands, as the tablets may dissolve.
- Hold the edges of the blister card and separate a blister cell from the rest of the card by gently tearing along the perforation.
- Carefully pull off the back of the separated cell.
- Gently push out the tablet.
- Put the tablet in your mouth. It will immediately dissolve in your mouth so that it can be easily swallowed.
You can also put the mouth-watering tablet in a glass or cup filled with water, orange juice, apple juice, milk, or coffee and stir. Along with some beverages, the mixture may change color and possibly become cloudy. Drink it immediately.
If you take more Olanzapine SUN 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. Take the remaining tablets with you.
Patients who have taken too much Olanzapine SUN have the following symptoms:
- fast heart rate
- anxiety / aggression
- speech difficulties
- involuntary movement disorders (especially in the face or tongue)
- lowering consciousness.
Other symptoms may include:
- acute confusion
- seizures ( epilepsy )
- coma
- a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness or drowsiness, slow breathing, difficulty breathing, high or low blood pressure , abnormal heart rhythm.
Contact your doctor or hospital immediately if you get any of the above symptoms. Take the remaining tablets with you.
If you forget to take Olanzapine SUN
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Olanzapine SUN
It is important that you follow your doctor’s instructions and do not stop taking the medicine because you feel better.
If you suddenly stop taking Olanzapine SUN, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting. Your doctor may recommend 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 affect 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 (the frequency of this side effect can not be calculated from the available data).
Very common side effects (may affect more than 1 user in 10) include weight gain; drowsiness and 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) include changes in blood cell levels , blood fats and at the start of treatment, a temporary increase in the number of liver enzymes; increased blood sugar and urine levels; elevated levels of uric acid and creatinine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremors; movement difficulties (dyskinei); constipation; dry mouth; rash; impotence; extreme fatigue; fluid retention leading to swelling of the hands, ankles or feet; fever, joint pain and 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) include 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 spasmer (including eye movements); ant crawls and a 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; and breast changes in men and women such as abnormal production of breast milk or abnormal enlargement.
Rare side effects (may affect up to 1 in 1,000 people) include lowering of normal body temperature; abnormal heart rhythm; sudden, unexplained death; inflammation of the pancreas that caused severe stomach pain, fever and malaise; liver disease manifested by yellowing of the skin and whites of the eyes; muscle disease manifested in unexplained aches and pains; and prolonged and / or painful erection .
When taking olanzapine, 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 SUN may worsen the symptoms.
Very rare (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction 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 ).
How to store Olanzapine SUN
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister, jar, or carton after EXP. The expiry date refers to the last day of that month.
Olanzapine SUN tablets:
Do not store above 30 ° C.
Olanzapine SUN orodispersible tablets:
No special storage instructions.
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
Olanzapine SUN tablets:
- The active substance is olanzapine. Each Olanzapine SUN tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
- The other ingredients are: anhydrous lactose , microcrystalline cellulose, crospovidone type A, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal silica anhydrous.
Olanzapine SUN orodispersible tablets:
- The active substance is olanzapine. Each Olanzapine SUN orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg olanzapine.
- The other ingredients are: mannitol, microcrystalline cellulose, aspartame (E951), crospovidone type A, low-substituted hydroxypropylcellulose, colloidal silica anhydrous, magnesium stearate.
What the medicine looks like and contents of the pack
Olanzapine SUN tablets:
Olanzapine SUN 2.5 mg tablets are yellow, round, uncoated tablets that have “2.5” imprinted on one side and are smooth on the other.
Olanzapine SUN 5 mg tablets are yellow, oval, uncoated tablets that have “5” debossed on one side and are smooth on the other.
Olanzapine SUN 7.5 mg tablets are yellow, round, uncoated tablets that have “7.5” debossed on one side and are smooth on the other.
Olanzapine SUN 10 mg tablets are yellow, oval, uncoated tablets that have “10” debossed on one side and are smooth on the other.
Olanzapine SUN 15 mg tablets are yellow, oval, uncoated tablets that have “15” debossed on one side and are smooth on the other.
Olanzapine SUN 20 mg tablets are yellow, oval, uncoated tablets that have “20” imprinted on one side and are smooth on the other.
Olanzapine SUN 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg tablets are available in blister packs containing 28, 35, 56, or 70 tablets and HDPE cans containing 30 or 100 tablets.
Olanzapine SUN orodispersible tablets:
Olanzapine SUN 5 mg orodispersible tablets are yellow, round, uncoated tablets that have “O5” imprinted on one side and are smooth on the other.
Olanzapine SUN 10 mg orodispersible tablets are yellow, round, uncoated tablets that have “O10” debossed on one side and are smooth on the other. Olanzapine SUN 15 mg orodispersible tablets are yellow, round, uncoated tablets that have “O15” debossed on one side and are smooth on the other. Olanzapine SUN 20 mg orodispersible tablets are yellow, round, uncoated tablets that have “O20” imprinted on one side and are smooth on the other.
Olanzapine SUN 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are available in perforated unit dose blister packs containing 28 x 1, 35 x 1, 56 x 1 or 70 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV Polarisavenue 87 2132 JH Hoofddorp Netherlands
This medicinal product is authorized under the European Economic Area under the names
| Italy | Olanzapina SUN 2.5 / 5 / 7.5 / 10/15/20 mg compress;Olanzapina SUN 5/10/15/20 mg compresses orodispersible |
| Netherlands | Olanzapine SUN 2.5 / 5 / 7.5 / 10/15/20 mg tablets;Olanzapine SUN 5/10/15/20 mg orodispersible tablets |
| Sweden | Olanzapine SUN, 2.5 / 5 / 7.5 / 10/15/20 mg tablet;Olanzapine SUN, 5/10/15/20 mg orodispersible tablet |
| UK | Olanzapine SUN 2.5 / 5 / 7.5 / 10/15 / 20mg tablets;Olanzapine SUN 5/10/15/20 mg orodispersible tablets |