5 mg, 10 mg, 15 mg, and 20 mg freeze-dried tablets (Olanzapine)
ZYPREXA VELOTAB AND WHAT IT IS USED FOR
ZYPREXA VELOTAB belongs to the drug group neuroleptics.
ZYPREXA VELOTAB contains the active substance olanzapine. ZYPREXA VELOTAB belongs to the drug group neuroleptics and is used to treat the following conditions:
- Schizophrenia, is a disease with symptoms such as hearing, seeing, or sensing something that is not there, delusions, unusual suspiciousness, and withdrawal. People with these conditions may also feel depressed, anxious, or tense.
- Moderate to severe manic episodes, a condition with symptoms such as excitement and euphoria.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYPREXA VELOTAB
Do not take ZYPREXA VELOTAB
- 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 skin rash, itching, swollen face, swollen lips, or difficulty breathing. If this should occur, contact your doctor.
- if you have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before taking ZYPREXA VELOTAB.
- Use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may cause serious side effects.
- Medicines of this type can cause abnormal movements of the face or tongue. Contact your doctor if this occurs.
- This drug can also cause a combination of fever, shortness of breath, sweating, muscle stiffness, and drowsiness. These side effects occur extremely rarely, but if they occur, contact your doctor immediately.
- Weight gain has occurred in patients taking ZYPREXA VELOTAB. You and your doctor should check your weight regularly. Consider referral to a dietitian or help with the diet list if necessary.
- High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have occurred in patients taking ZYPREXA VELOTAB. Your doctor should do blood tests for blood sugar and lipid levels before you start taking ZYPREXA VELOTAB and then at regular intervals during treatment.
- Tell your doctor if you or someone in your family has a history of blood clots, as medicines like these have been associated with 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 problems
- irritable bowel (paralytic ileus )
- liver or kidney disease
- blood disease
- heart disease
- if you know you may have a salt deficiency as a result of prolonged severe diarrhea and vomiting or use diuretics ( diuretics )
For demented patients, the doctor must 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
Other medicines and ZYPREXA VELOTAB
Only take other medicines during treatment with ZYPREXA VELOTAB if advised by your doctor. Together with the following medicines, drowsiness can occur anti-depressants and anti-anxiety drugs, and sleeping aids (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:
- drugs against Parkinson’s disease
- carbamazepine (for epilepsy and mood stabilizer), fluvoxamine (for depression), or ciprofloxacin ( antibiotic ) – it may be necessary to adjust your ZYPREXA VELOTAB dose.
ZYPREXA VELOTAB with alcohol
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. You should not take this medicine if you are breastfeeding, as small amounts of ZYPREXA VELOTAB may pass into breast milk.
In newborn babies whose mothers have taken ZYPREXA VELOTAB during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, sleepiness, agitation, breathing problems, and difficulty eating. If your child develops any of these symptoms, you may need to contact your doctor.
Driving ability and use of machinery
ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate, and sodium propyl parahydroxybenzoate.
This medicine contains a maximum of 1.6 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that accumulates high levels of phenylalanine in the body.
This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate which may cause an allergic reaction (possibly delayed). . An allergic reaction can manifest itself as a rash, itching, or shortness of breath. It may come immediately or sometime after you take ZYPREXA VELOTAB.
YOU ARE TAKING ZYPREXA VELOTAB
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor determines the dose and duration of treatment. Does one of ZYPREXA VELOTAB 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 ZYPREXA VELOTAB once a day. Try to take ZYPREXA VELOTAB at the same time each day either with a meal or between meals. ZYPREXA VELOTAB should be taken by mouth.
ZYPREXA VELOTAB tablets break easily and should therefore be handled with care. The tablets may crumble if handled with wet hands.
- Hold the tablet map by the edge and detach a “square” by carefully tearing along the perforation.
- Pull off the foil.
- Gently push the tablet open.
- Put the tablet in your mouth, and it immediately dissolves and can then be easily swallowed.
You can also put the tablet in a glass of water, orange juice, apple juice, milk, or in a cup of coffee and stir. Depending on the drink, the mixture may change color and possibly become cloudy. Drink up immediately.
If you have taken too much ZYPREXA VELOTAB
Patients who have taken too much ZYPREXA VELOTAB have experienced the following symptoms: Fast heart rate, agitation/aggressiveness, difficulty speaking, involuntary movements (especially of the face or tongue), and loss of consciousness. Other symptoms may be Acute confusion, convulsions ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness, drowsiness or sleepiness, slow breathing, difficulty breathing, high or low blood pressure, and 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 ZYPREXA VELOTAB
If you stop taking ZYPREXA VELOTAB
It is important that you follow your doctor’s instructions and not stop taking the medicine because you feel better.
If you suddenly stop taking ZYPREXA VELOTAB, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting. Your doctor may advise you to reduce the dose gradually before stopping treatment.
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 may affect up to 1 in 10 users) especially in the face or tongue
- blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms are swelling, pain, and redness of 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 sleepiness (the frequency of this side effect cannot be estimated from the available data).
Very common side effects (which may affect more than 1 in 10 users) include weight gain; sleepiness 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 goes away on its own. If not, contact your doctor.
Common side effects (may affect up to 1 in 10 users) include changes in levels of blood cells, blood lipids and, at the start of treatment, temporarily increased liver enzymes; increased sugar levels in the blood and urine; increased level of uric acid and creatinine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremors; movement difficulties ( dyskinesia ); speech difficulties; 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 reduced sex drive in men and women or erectile problems in men.
Uncommon side effects (may affect up to 1 in 100 users) include hypersensitivity (eg swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones in the blood and urine) or coma; convulsions, generally in case of a known tendency to convulsions ( epilepsy ); muscle stiffness or spasm (including eye movements); crawling and feeling of restlessness in the legs when resting (restless legs); speech difficulties; stuttering; slow heartbeat; sun sensitivity; nosebleed; distended abdomen; drooling; memory loss or forgetfulness; urinary incontinence; difficulty urinating; hair loss; absent 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 users) include lowering of the normal body temperature; abnormal heart rhythm; sudden, unexplained death; inflammation of the pancreas causing severe stomach pain, fever, and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease that manifests itself in unexplained aches and pains and prolonged and/or painful erection.
Very rare side effects include serious allergic reactions such as drug reactions with eosinophilia and systemic symptoms (DRESS). DRESS presents initially with flu-like symptoms with a 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 medication with olanzapine, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this specific patient group.
For patients with Parkinson’s disease, ZYPREXA VELOTAB may worsen symptoms.
ZYPREXA VELOTAB SHOULD BE STORED
Store out of sight and reach of children.
Use before the expiry date stated on the carton. Store in the original packaging. Light sensitive. Moisture sensitive.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
CONTENTS OF THE PACKAGE AND OTHER INFORMATION
- The active substance is olanzapine. Each freeze-dried tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of the active substance olanzapine. The exact amount is indicated on your ZYPREXA VELOTAB packaging.
- Other ingredients are: – gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), and sodium propyl parahydroxybenzoate (E217).
Appearance and package sizes of the medicine
ZYPREXA velotab 5 mg, 10 mg, 15 mg, and 20 mg are yellow, freeze-dried tablets. ZYPREXA VELOTAB dissolves as soon as you put it in your mouth, making it easy to swallow.
ZYPREXA VELOTAB is supplied in packs of 28, 35, 56, 70, or 98 tablets. Not all pack sizes may be marketed.
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.