5 mg / 10 mg / 15 mg / 20 mg orodispersible tablets
olanzapine
What Olanzapine Orion is and what it is used for
Olanzapine Orion 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 arousal and euphoria .
Olanzapine prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
Olanzapine contained in Olanzapine Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Olanzapine Orion
Do not use Olanzapine Orion
- if you are allergic (hypersensitive) 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 Orion.
- The use of Olanzapine Orion 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. 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 Orion. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Orion 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 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
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 Orion is not for use in patients under 18 years of age.
Other medicines and Olanzapine Orion
Only take other medicines during treatment with Olanzapine Orion if your doctor recommends it. 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 stabilization), fluvoxamine (for depression), or ciprofloxacin ( antibiotics ) – it may be necessary to adjust your Olanzapine Orion dose.
Olanzapine Orion with food, drink and alcohol
Do not drink alcohol during treatment with Olanzapine Orion as it may cause drowsiness with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take this medicine if you are breastfeeding as small amounts of olanzapine may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Olanzapine Orion during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, 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 Orion. 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 Orion contains aspartame
Patients who are unable to take phenylalanine should note that Olanzapine Orion contains aspartame, which is a source of phenylalanine. This can be harmful to people with phenylketonuria.
How to use Olanzapine Orion
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 Orion is 520 mg per day. Contact your doctor if your symptoms return but do not stop taking Olanzapine Orion unless your doctor tells you to.
You should take Olanzapine Orion tablets once a day according to your doctor’s instructions. Try to take the tablets at the same time each day. It does not matter if you take them with or without food. Olanzapine Orion orodispersible tablets should be taken by mouth.
Olanzapine Orion tablets break easily and should therefore be handled with care. The tablets can fall apart if you take them with damp hands.
You can also put the tablet in a glass of water, orange juice, apple juice, milk, or a cup of coffee and stir. Depending on the drink, the mixture may change color and possibly become cloudy. Drink up immediately.
If you use more Olanzapine Orion than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Patients who have taken too much Olanzapine Orion have the following symptoms: rapid heart rate, agitation / aggression, speech difficulties, involuntary movement disorders (especially in the face or tongue) and loss of 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 experience any of the listed symptoms. Take the remaining tablets with you
If you forget to use Olanzapine Orion
Take your tablets as soon as you remember. Do not take two doses on the same day.
If you stop using Olanzapine Orion
It is important that you follow your doctor’s instructions and do not stop taking Olanzapine Orion to make you feel better.
If you suddenly stop taking Olanzapine Orion, 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 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 (occurs in an unknown number of users).
Very rare side effects 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 ).
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 blood cells and blood fats; and at the beginning of treatment, temporarily increasing 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 ( dyskinesia )
- 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)
- hypersensitivity (eg swelling of the mouth and throat, itching , rash)
- onset of diabetes or worsening 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
- slow heartbeat
- sun sensitivity
- nosebleed
- stretched abdomen
- memory loss or forgetfulness
- urinary incontinence, difficulty urinating
- hair loss
- missed or shortened menstruation
- breast changes in men and women such as abnormal breast milk production 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 caused severe stomach pain, fever and vomiting
- 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 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.
In patients with Parkinson’s disease, Olanzapine Orion may make the symptoms worse.
How to store Olanzapine Orion
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 after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
The medicine 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.
Each orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg olanzapine.
The other ingredients are: Mannitol (SD 200), mannitol (Mannitol 35) polyacrylic potassium, crospovidone (type A), anhydrous colloidal silica, aspartame (E951), microcrystalline cellulose (grade 112), sodium stearyl fumarate and artificial pineapple flavor (FL SD # 883) contains flavorings and modified food starch].
What the medicine looks like and contents of the pack
Mouth-disintegrating tablet.
Olanzapine Orion 5 mg orodispersible tablets:
yellow, round, flat with beveled edges, embossed with “C” on one side and “51” on the other side.
Olanzapine Orion 10 mg orodispersible tablets:
yellow, round, flat with beveled edges, embossed with “C” on one side and “52” on the other side.
Olanzapine Orion 15 mg orodispersible tablets:
yellow, round, flat with beveled edges, embossed with “C” on one side and “53” on the other side.
Olanzapine Orion 20 mg orodispersible tablets:
yellow, round, flat with beveled edges, embossed with “C” on one side and “54” on the other side.
Olanzapine Orion 5 mg, 10 mg, 15 mg, and 20 mg orodispersible tablets are available in blisters.
Blister: Polyamide / Aluminum foil coated with EAA / polyethylene with desiccant / Aluminum foil coated with PE as a cover foil.
Pack sizes:
Blister packs: 1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate
Hal Far Birzebbuga BBG 3000
Malta
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB
medinfo@orionpharma.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Olanzapine “Orion”
Finland: Olanzapine Orion 5 mg / 10 mg / 15 mg / 20 mg tablets, suussa hajoava
Sweden: Olanzapine Orion 5 mg / 10 mg / 15 mg / 20 mg orodispersible tablets