2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
olanzapine
What Olanzapine Accord is and what it is used for
Olanzapine Accord contains the active substance olanzapine. Olanzapine Accord 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 Accord prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
Olanzapine contained in Olanzapine Accord 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 take Olanzapine Accord
Do not take Olanzapine Accord
- 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 shortness of breath. If this happens, consult a 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 Accord
- The use of Olanzapine Accord in elderly patients with dementia is not recommended as it may cause serious side effects .
- Drugs of this type can cause unusual movements, mainly in the face or tongue. Contact a doctor if this happens.
- This type of medicine can also cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness or drowsiness. These side effects are extremely rare, but if they do occur, contact a doctor immediately.
- Weight gain has occurred in patients taking Olanzapine Accord. 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 Accord. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Accord 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.
Tell your doctor as soon as possible if you have or have had:
- 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 ).
If you have dementia, you or your caregiver/relative should inform your doctor if you have ever had a stroke or mild form of stroke.
If you are over 65, your blood pressure should be checked regularly by your doctor.
Children and young people
Olanzapine Accord is not for use in patients under 18 years of age.
Other medicines and Olanzapine Accord
Only take other medicines during Olanzapine Accord 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 Olanzapine Accord dose .
Olanzapine Accord with alcohol
Do not drink alcohol during treatment with Olanzapine Accord as it may cause drowsiness 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 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 used olanzapine 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 Accord. 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 Accord 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 Accord
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 Accord is 5−20 mg per day. Contact your doctor if symptoms return but do not stop taking Olanzapine Accord unless your doctor tells you to.
You should take Olanzapine Accord 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. Film-coated Olanzapine Accord tablets should be taken by mouth and swallowed whole with water.
If you take more Olanzapine Accord 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 Accord have the following symptoms: rapid heart rate, agitation/aggression, difficulty speaking, involuntary movements (especially of the face or tongue), and decreased 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 or low blood pressure, abnormal heart rhythm. Contact a doctor or hospital immediately if you experience any of the listed symptoms. Show your doctor your tablet pack.
If you forget to take Olanzapine Accord
Take your tablets as soon as you remember. Do not take two doses on the same day.
If you stop taking Olanzapine Accord
Do not stop taking Olanzapine Accord just to make you feel better. You must continue to take Olanzapine Accord for as long as your doctor prescribes it.
If you suddenly stop taking Olanzapine Accord, 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 in 10 people) 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 levels of blood cells, blood fats and at the beginning of treatment, temporary increase in 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 sex 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 spasm (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; dragline; 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 in yellowing of the skin and whites of the eyes; muscle disease manifested in unexplained aches and pains; and 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 ).
During treatment with olanzapine, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, elevated 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 Accord may worsen the symptoms.
How to store Olanzapine Accord
- 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 blister and carton after “EXP”. The expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- 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 package and other information
Content declaration
The active substance is olanzapine.
Each film-coated tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of active substance.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, and magnesium stearate.
The film coating contains hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433). The file coating on 15 mg tablets also contains indigo carmine aluminum lacquer (E132) and the 20 mg tablets red iron oxide (E172)
What the medicine looks like and contents of the pack
Olanzapine Accord 2.5 mg: white to off-white, round, biconvex, film-coated tablets, smooth on both sides
Olanzapine Accord 5 mg: white to off-white, round, biconvex, film-coated tablets, debossed with “O1” on one side and smooth on the other side.
Olanzapine Accord 7.5 mg: white to off-white, round, biconvex, film-coated tablets, debossed with “O2” on one side and smooth on the other.
Olanzapine Accord 10 mg: white to off-white, round, biconvex, film-coated tablets, debossed with “O3” on one side and smooth on the other side.
Olanzapine Accord 15 mg tablets: light blue, round, biconvex, film-coated tablets, smooth on both sides
Olanzapine Accord 20 mg tablets: light pink, round, biconvex, film-coated tablets, smooth on both sides
The tablets are available in packs of 15, 28, 30, 35, 56, or 70 tablets for strengths of 2.5 mg, 5 mg, 10 mg and 15 mg.
The tablets are available in packs of 28, 30, 35, 56, or 70 tablets for the strengths of 7.5 mg and 20 mg.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Accord Healthcare Polska Sp.z oo, ul. Lutomierska 50,95-200 Pabianice, Poland