210 mg; 300 mg; 405 mg powder and liquid for injection, depot suspension
Olanzapine
WHAT ZYPADHERA IS AND WHAT IT IS USED FOR
ZYPADHERA contains the active substance olanzapine. ZYPADHERA belongs to the neuroleptic drug group and is used to treat schizophrenia – a disorder with symptoms such as hearing, seeing or sensing something that is not there, delusions, unusual suspiciousness, and withdrawal. People with this disorder may also feel depressed, anxious, or tense.
ZYPADHERA should be administered to adult patients stabilized on oral olanzapine therapy.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ZYPADHERA
You should not receive ZYPADHERA 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 has happened to you, contact your nurse or doctor.
- previously had eye problems such as certain types of glaucoma (increased pressure in the eye)
Warnings and caution
Talk to your doctor or nurse before you are given ZYPADHERA.
- A less common but serious reaction may occur after injection. ZYPADHERA can sometimes enter the bloodstream too quickly. If this occurs, you may have the following symptoms after injection. In some cases, these symptoms can lead to unconsciousness.
| extreme sleepiness | dizziness |
| confusion | disorientation |
| irritability | anxiety |
| aggression | increased blood pressure |
| difficulty speaking | weakness |
| difficulty walking | muscle stiffness or tremors |
| cramps |
These symptoms usually disappear within 24 to 72 hours after injection one. You will be observed for the appearance of the above symptoms in the medical ward for at least 3 hours.
You are not likely to get such symptoms after more than 3 hours after injection, but if they do, contact your doctor or nurse immediately. Because of this risk, you should not drive or operate machinery for the remainder of the day after injection one.
- Tell your doctor or nurse if you feel dizzy or faint after injection one. You will probably need to lie down until you feel better. Possibly, your doctor or nurse will measure blood pressure and pulse.
- The use of ZYPADHERA in elderly patients with dementia (confusion and memory loss) is not recommended as it may cause serious side effects.
- It is very rare, but sometimes this type of medicine can cause abnormal movements, especially of the face or tongue, or a combination of fever, shortness of breath, sweating, muscle stiffness, and drowsiness or sleepiness. If this happens after receiving ZYPADHERA, contact your doctor or nurse immediately.
- Weight gain has occurred in patients taking ZYPADHERA. You and your doctor should check your weight regularly. If necessary, consider a referral to a dietitian or help with a diet plan.
- High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have occurred in patients taking ZYPADHERA. Your doctor should do blood tests for blood sugar and lipid levels before you start taking ZYPADHERA 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 as soon as possible if any of the following apply to you:
– had a stroke (stroke) or a mild form of stroke (temporary symptoms of stroke )
– has Parkinson’s disease
– have prostate problems
– has intestinal inflammation (paralytic ileus )
– have liver or kidney disease
– have any blood disease
– recently had a heart attack, have heart disease, have sick sinus syndrome (abnormal heart rhythm), unstable angina, or have low blood pressure
– have diabetes
– have seizures
– if you know you may have a salt deficiency as a result of prolonged severe diarrhea and vomiting or use diuretics ( diuretics )
If you are over 65 years old, as a precautionary measure, the doctor may need to regularly check your blood pressure, etc.
It is not recommended to start ZYPADHERA if you are over 75 years of age.
Children and young people
ZYPADHERA should not be used by patients under 18 years of age.
Other medicines and ZYPADHERA
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 (anti-epileptic and mood stabilizer), fluvoxamine (a medicine for depression), or ciprofloxacin (an antibiotic ) – it may be necessary to change your ZYPADHERADA dose.
If you are already taking medicines for depression, medicines for anxiety, or sleeping pills, you may feel drowsy when you receive ZYPADHERA.
ZYPADHERA with alcohol
Do not drink alcohol after receiving ZYPADHERA because ZYPADHERA together with alcohol can cause drowsiness.
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 receiving this medicine. You should not receive this medicine if you are breastfeeding, as small amounts of olanzapine may pass into breast milk.
In newborn babies whose mothers received ZYPADHERA 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
Do not drive or operate machinery for the remainder of the day you receive an injection.
Sodium
After preparation, this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is almost “sodium-free”.
HOW ZYPADHERA IS GIVEN
Your doctor will decide how much ZYPADHERA you need and how often you need to have an injection. ZYPADHERA is given in doses of 150 and mg-300 mg every two weeks or 300 mg-405 mg every four weeks.
ZYPADHERA is a powder. Your doctor or nurse prepares a suspension of the powder, which will then be injected into the muscle of your buttock
If you have been given too much ZYPADHERA
This medicine will be given to you under medical supervision, so it is unlikely that you will get too much.
Patients who have received too much olanzapine have experienced the following symptoms:
- fast heart rate, agitation/aggressiveness, 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, rapid breathing, sweating, muscle stiffness, drowsiness or sleepiness, slow breathing, breathing problems, high or low blood pressure, and abnormal heart rhythm.
Contact your doctor or hospital immediately if you experience any of the above symptoms.
If you skip an injection of ZYPADHERA
Do not stop treatment because you feel better. You must continue to receive ZYPADHERA for as long as your doctor has prescribed.
If you forget to get an injection, you should contact your doctor to get the next injection as soon as possible.
If you have any further questions about this medicine, ask your doctor or nurse.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you get:
- extreme sleepiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or tremors, weakness, irritability, aggression, anxiety, increased blood pressure, or seizures and may lead to unconsciousness. These signs and symptoms can sometimes occur if ZYPADHERA enters the bloodstream too quickly (a common side effect that may affect up to 1 in 10 people);
- 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).
Other common side effects (may affect up to 1 in 10 people) with ZYPADHERA include sleepiness and pain at the injection site.
Rare side effects (may affect up to 1 in 1,000 people) of ZYPADHERA include injection site infection.
The side effects below have been observed when olanzapine has been given orally (by mouth), but they can also occur after the ZYPADHERA injection.
Other very common side effects (which may affect more than 1 in 10 users) include weight gain; 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.
Other 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 ); constipation; dry mouth; rash; impotence; extreme fatigue; fluid retention leading to swelling of the hands, ankles or feet; fever; joint pain; sexual problems such as reduced sex drive in men and women or erectile problems in men.
Other less common side effects (which 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 seizures ( 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 manifesting as 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, olanzapine given orally may worsen symptoms.
HOW TO STORE ZYPADHERA
Store out of sight and reach of children.
Injection one must be used before the expiry date stated on the carton.
Store protected from cold. Do not freeze.
Chemical and physical in-use stability for 24 hours at 20-25 °C has been demonstrated for the suspension in the vial. From a microbiological perspective, the drug should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and would normally not be longer than 24 hours at 20-25°C. Do not use the medicine if you see discoloration or other visible signs that the medicine has deteriorated.
If the medicine is not used at once, it should be shaken vigorously so that it forms a suspension again. Once the suspension has been withdrawn from the vial into the syringe, it should be used immediately.
Medicines 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.
PACKAGING CONTENTS AND OTHER INFORMATION
Contents declaration for ZYPADHERA
The active substance is olanzapine.
ZYPADHERA 210 mg: One vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
ZYPADHERA 300 mg: One vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
ZYPADHERA 405 mg: One vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
After preparation: 1 ml suspension contains 150 mg/ml olanzapine.
The diluent contains carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, and sodium hydroxide.
Appearance and package sizes of the medicine
ZYPADHERA powder for injection for preparation of the extended-release suspension is a yellow powder in a clear glass vial. Your doctor or nurse makes a suspension of the powder using the diluent for ZYPADHERA, which is a clear, colorless pale yellow solution in a clear glass vial.
ZYPADHERA consists of a powder and diluent for prolonged-release suspension for injection. The package contains one vial of powder for injection for the preparation of extended-release suspension, one vial of 3 ml diluent, one syringe with attached safety needle, 19 gauge, 38 mm and three separate safety needles, one 19 gauge 38 mm needles and two 19 gauge 50, etc. cannulas.
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.