2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
olanzapine
What Olanzapine Teva is and what it is used for
Olanzapine Teva contains the active substance olanzapine. Olanzapine Teva 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 Teva prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.
What you need to know before you take Olanzapine Teva
Do not take Olanzapine Teva
- 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 Teva.
- The use of Olanzapine Teva 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 Teva. 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 Teva. Your doctor should do blood tests for blood sugar and fat levels before you start taking Olanzapine Teva 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
- 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 Teva is not for use in patients under 18 years of age.
Other medicines and Olanzapine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Only take other medicines during treatment with Olanzapine Teva 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).
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 Teva dose .
Olanzapine Teva with alcohol
Do not drink alcohol during treatment with Olanzapine Teva, as together with alcohol it 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 Teva may pass into breast milk.
The following symptoms may occur in newborns, whose mothers used Olanzapine Teva during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If your child develops 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 Teva. If this happens, do not drive or use any tools or machines and consult your doctor.
Olanzapine Teva 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 Teva
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 Teva 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 Teva once a day. Try to take Olanzapine Teva at the same time each day either at mealtime or between meals. The tablets should be taken by mouth and swallowed whole with water.
If you take more Olanzapine Teva than you should
Patients who have taken too much Olanzapine Teva 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, 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 take Olanzapine Teva
Take your tablets as soon as you remember. Do not take two doses on the same day.
If you stop taking Olanzapine Teva
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 Teva, 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 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; involuntary movements ( 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 a 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 by 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 ).
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 Teva may make the symptoms worse.
How to store Olanzapine Teva
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to light.
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 Olanzapine Teva 2.5 mg film-coated tablet contains 2.5 mg of the active substance.
Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance.
Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of the active substance.
Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance.
Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance.
Each Olanzapine Teva 20 mg film-coated tablet contains 20 mg of the active substance. - Other ingredients are; Tablet core: lactose monohydrate , hydroxypropylcellulose, crospovidone (type A), colloidal , anhydrous silicon, microcrystalline cellulose and magnesium stearate. Tablet coating: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171). The different tablet strengths also include: Olanzapine Teva 15 mg film-coated tablets: indigo carmine (E132). Olanzapine Teva 20 mg film-coated tablets: red iron oxide (E172).
What the medicine looks like and contents of the pack
Olanzapine Teva 2.5 mg film-coated tablets are white, biconvex, round with the inscription “OL 2.5” on one side.
Olanzapine Teva 5 mg film-coated tablets are white, biconvex, round with the inscription “OL 5” on one side.
Olanzapine Teva 7.5 mg film-coated tablets are white, biconvex, round with the inscription “OL 7.5” on one side.
Olanzapine Teva 10 mg film-coated tablets are white, biconvex, round with the inscription “OL 10” on one side.
Olanzapine Teva 15 mg film-coated tablets are light blue, biconvex, oval with the inscription “OL 15” on one side.
Olanzapine Teva 20 mg film-coated tablets are pink, biconvex, oval with the inscription “OL 20” on one side.
Olanzapine Teva 2.5 mg film-coated tablets are supplied in packs of 28, 30, 35, 56, 70, or 98 tablets.
Olanzapine Teva 5 mg film-coated tablets are supplied in packs of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 tablet.
Olanzapine Teva 7.5 mg film-coated tablets are supplied in packs of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 tablets .
Olanzapine Teva 10 mg film-coated tablets are supplied in packs of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 tablets.
Olanzapine Teva 15 mg film-coated tablets are supplied in packs of 28, 30, 35, 50, 56, 70, or 98 tablets.
Olanzapine Teva 20 mg film-coated tablets are supplied in packs of 28, 30, 35, 56, 70, or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
Teva BV, Swensweg 5, 2031GA Haarlem, The Netherlands
Manufacturer:
Teva Pharmaceutical Works Co. Ltd, Pallagi from 13, 4042 Debrecen, Hungary
Contact the representative of the marketing authorization holder to find out more about this medicine
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 38207373 | LithuaniaUAB Sicor BiotechTel: +370 52660203 |
| BulgariaTeva TV LADTel .: +359 24899585 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AGBelgium / BelgiumTel: +32 38207373 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 | HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400 |
| DenmarkSanoSwiss UABLithuaniaTel: +370 70001320 | MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +44 2075407117 |
| GermanyTeva GmbHTel: +49 73140208 | The NetherlandsTeva Nederland BVTel: +31 8000228400 |
| EestiUAB Sicor Biotech Eesti branchTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66775590 |
| GreeceSpecify ABEE:Ηλ: +30 2118805000 | Austriaratiopharm Arzneimittel Vertriebs GmbHTel: +43 1970070 |
| SpainTeva Pharma, SLUTel: +34 913873280 | PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300 |
| FranceTeva HealthTel: +33 155917800 | PortugalTeva Pharma – Pharmaceutical Products Lda.Tel: +351 214767550 |
| CroatiaPliva Hrvatska dooTel: +385 13720000 | RomaniaTeva Pharmaceuticals SRLTel: +40 212306524 |
| IrelandTeva Pharmaceuticals IrelandTel: +44 2075407117 | SloveniaPliva Ljubljana dooTel: +386 15890390 |
| IcelandTeva Pharma Iceland ehf.Phone: +354 5503300 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911 |
| ItalyTeva Italia SrlTel: +39 028917981 | Finland / Finlandratiopharm OyPuh / Tel: +358 201805900 |
| .ΠροςSpecify ABEEGreece:Ηλ: +30 2118805000 | SwedenTeva Sweden ABTel: +46 42121100 |
| LatviaUAB Sicor Biotech subsidiary LatvijāTel: +371 67323666 | United Kingdom (Northern Ireland)Teva Pharmaceuticals IrelandIrelandTel: +44 2075407117 |