2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
olanzapine
What Olanzapine Actavis is and what it is used for
Olanzapine Actavis contains the active substance olanzapine.
Olanzapine Actavis belongs to a group of medicines called 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 such a disease may also feel depressed, anxious or tense.
- Moderate to severe manic episodes, a condition with symptoms such as arousal and euphoria .
Olanzapine Actavis prevents recurrence of these symptoms in patients with bipolar disorder in which olanzapine treatment is effective during the manic phase.
Olanzapine contained in Olanzapine Actavis 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 Actavis
Do not use Olanzapine Actavis
- if you are allergic to olanzapine, peanuts, soy 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 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 Actavis.
- Olanzapine Actavis is not recommended for elderly patients with dementia as it can cause severe side effects .
- Drugs of this type can cause abnormal movements, especially in the face and tongue. If this happens after you receive Olanzapine Actavis, talk to your doctor.
- In very rare cases, drugs of this type can cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness or drowsiness. If this happens, consult a doctor immediately.
- Weight gain has occurred in patients taking Olanzapine Actavis. 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 Actavis. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Actavis and 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.
If you have any of the following conditions, tell your doctor as soon as possible:
- 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 healthcare provider should tell your doctor if you have had a stroke or a milder form of stroke.
If you are over 65, your doctor may want to do regular check-ups of your blood pressure.
Children and young people
Olanzapine Actavis is not for use in patients under 18 years of age.
Other medicines and Olanzapine Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Only use other medicines during treatment with Olanzapine Actavis if you have been given the go-ahead by your doctor. You may feel drowsy if you take Olanzapine Actavis with medicines for depression, medicines for anxiety, or sedatives.
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 Actavis dose .
Olanzapine Actavis with alcohol
Do not drink alcohol during treatment with Olanzapine Actavis, as Olanzapine Actavis in combination with alcohol may make you drowsy.
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 Actavis may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapine Actavis 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 Actavis. If this happens, do not drive or use any power 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 Actavis contains lactose and soy lecithin (E322)
If you have been told by your doctor that you have an allergy to certain sugars, contact your doctor before taking this medicine.
If you are allergic to peanuts or soy, do not use this medicine.
How to take Olanzapine Actavis
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide how many tablets to take and how long to treat. The daily dose of olanzapine is between 5 mg and 20 mg. Talk to your doctor if symptoms return but do not stop taking Olanzapine Actavis unless your doctor tells you to.
You should take the tablets once a day according to your doctor’s instructions. Try to take the tablets at the same time each day.
You can take them with or without meals.
The film-coated tablets should be taken orally. Swallow the tablets whole with water.
If you take more Olanzapine Actavis than you should
Patients who have taken too much Olanzapine Actavis have the following symptoms: rapid heart rate, agitation/aggression, difficulty speaking, involuntary movements (especially of the face or tongue) and decreased level of consciousness. Other symptoms may include: acute confusion, seizures ( epilepsy ), coma, a combination of fever, faster breathing, 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. Take the pack with the remaining tablets with you.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Olanzapine Actavis
Take the tablets as soon as you remember. Do not take a double dose to compensate for a missed dose.
If you stop taking Olanzapine Actavis
You should not stop taking the tablets even if you feel better. You must continue to take Olanzapine Actavis for as long as your doctor prescribes it.
If you suddenly stop taking Olanzapine Actavis, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting. Your doctor may suggest a gradually decreasing dose before stopping treatment completely.
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 (the presence 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, consult a doctor.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of certain types of blood cells, blood fats and, at the beginning 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 ( dyskinesia ); constipation; dry mouth; rash; impotence; extreme fatigue; fluid retention leading to swollen 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; sensitivity to sunlight; nosebleeds; abdominal swelling; dragline; 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) include lowering of normal body temperature; abnormal heart rhythm; sudden, unexplained death; inflammation of the pancreas that causes severe abdominal pain, fever, and vomiting; liver disease manifesting as yellowish skin and yellowing of the whites of the eyes; muscle disease that manifests itself as unexplained aches and pains; prolonged and/or painful erection.
Very rare side effects ( may affect up to 1 in 10,000 people) 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 Actavis, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, reddening of the skin, and difficulty walking. Some deaths have been reported in this patient group.
In patients with Parkinson’s disease, Olanzapine Actavis may make the symptoms worse.
How to store Olanzapine Actavis
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 or blister. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
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 package and other information
Content declaration
- The active substance is olanzapine. Each tablet of Olanzapine Actavis contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance.
- The other ingredients are: Tablet core: lactose , microcrystalline cellulose, crospovidone and magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322) and xanthan gum (E415). Furthermore, the tablets with the strength of 15 mg contain indigo carmine (E132) and the tablets with the strength of 20 mg contain red iron oxide (E172).
What the medicine looks like and contents of the pack
Film-coated tablet 2.5 mg: Round, biconvex, white film-coated tablets, 6 mm in diameter, marked with “O” on one side.
Film-coated tablet 5 mg: Round, biconvex, white film-coated tablets, 8 mm in diameter, marked with “O1” on one side.
Film-coated tablet 7.5 mg: Round, biconvex, white film-coated tablets, 9 mm in diameter, marked with “O2” on one side.
Film-coated tablet 10 mg: Round, biconvex, white film-coated tablets, 10 mm in diameter, marked with “O3” on one side.
Film-coated tablet 15 mg: Oval, biconvex, light blue film-coated tablets, 7.35 x 13.35 mm in diameter, marked with “O” on one side.
Film-coated tablet 20 mg: Oval, biconvex, light pink film-coated tablets, 7.5 x 14.5 mm in diameter, marked with “O” on one side.
Pack sizes:
Blisters: 7, 14, 28, 30, 35, 56 or 70 film-coated tablets.
Jars: 100 and 250 film-coated tablets. (15 mg and 20 mg are only available as 100 tablets).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis Ltd., B16, Bulebel Industrial Estate, Zejtun ZTN 08, Malta
Actavis Group PTC ehf., Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland
Balkanpharma-Dupnitsa AD, 3 Samakovsko Shosse Str., Dupnitsa, 2600, Bulgaria