ZYPADHERA 210 mg.

What is ZYPADHERA and what it is used
ZYPADHERA contains the active substance olanzapine. ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
ZYPADHERA is intended for adult patients who are sufficiently stabilized during treatment with oral olanzapine.

2. What you need to know before you are given ZYPADHERA
You should not apply ZYPADHERA, if:
you have an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized as a rash, itching, swollen face, swollen lips or shortness of breath. If this happens to you, tell your nurse or doctor;
previously diagnosed with eye problems such as certain kinds of glaucoma (increased eye pressure).
Warnings and Precautions
Talk to your doctor or nurse before you are given ZYPADHERA.

An uncommon but serious reaction might occur after you receive each injection. ZYPADHERA can sometimes enter the bloodstream too quickly. If this happens, then your injection may have the following symptoms. In some cases, these symptoms can lead to unconsciousness:
excessive sleepiness;
confusion;
irritability;
aggression;
speech difficulties;
difficulty walking;
seizures;
dizziness;
disorientation;
anxiety;
hypertension;
weakness;
muscle stiffness or tremor.
These symptoms usually resolve within 24 to 72 hours after your injection. After each injection you will be observed in your healthcare facility for at least 3 hours for the above symptoms.
Although unlikely, you may get the symptoms more than 3 hours after injection. If this happens, contact your doctor or nurse immediately. Because of this risk, do not drive or operate machinery for the remainder of the day after each injection.

Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor or nurse may also want to measure your blood pressure and your pulse.
Not recommended use of ZYPADHERA in elderly patients with dementia (confusion and memory loss), as they this medicine can cause serious side effects.
Very rarely, drugs of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness. If this happens after you have been given ZYPADHERA, immediately tell your doctor or nurse.
Observed weight gain in patients taking ZYPADHERA. You and your doctor should regularly check your weight. Consider referral to a dietitian or to help with a diet plan, if necessary.
In patients taking ZYPADHERA, observed high levels of blood sugar and blood fat (triglycerides and cholesterol). Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPADHERA and regularly during treatment.
Tell the doctor if you or anyone in your family ever had blood clots, as medicines and this is associated with formation of blood clots.

Tell your doctor as soon as possible if any of the following apply to you:
stroke or "mini" stroke (temporary symptoms of stroke);
Parkinson's disease;
prostate problems;
bowel obstruction (paralytic ileus);
liver or kidney disease;
blood diseases;
recent heart attack, heart disease, syndrome sick sinus (irregular heartbeat), unstable angina or low blood pressure;
diabetes;
seizures.
If you are over 65, your doctor may monitor your blood pressure, as a routine precaution.
Not recommended starting ZYPADHERA, if you are over the age of 75 years.

Children and adolescents
ZYPADHERA is not intended for patients under 18 years.

Other medicines and ZYPADHERA
Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you take:
drugs for the treatment of Parkinson's disease;
carbamazepine (antiepileptic and mood stabilizing drug), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to alter your dose of ZYPADHERA.
If you are already taking antidepressants, medicines for anxiety or to help you sleep (tranquillizers), you may feel drowsy if given ZYPADHERA.

ZYPADHERA with alcohol
Do not drink alcohol if you are given ZYPADHERA, as together with alcohol it can cause drowsiness.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before you are given this injection. You should not be given this injection if you are breast feeding, as small amounts of olanzapine can pass into breast milk.
The following symptoms may occur in infants whose mothers used ZYPADHERA in the last trimester (last three months of pregnancy): shaking, stiffness and / or muscle weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms contact your physician.

Driving and using machines
After each injection, do not drive or operate machinery for the rest of the day.

3. How ZYPADHERA is administered
Your doctor will decide how much ZYPADHERA you need and how often you should have an injection. ZYPADHERA is administered in doses of 150 mg to 300 mg every 2 weeks, or 300 mg to 405 mg every 4 weeks.
ZYPADHERA comes as a powder which your doctor or nurse will make into a suspension that will then be injected into the muscle in your buttock.

If you are given more ZYPADHERA dose
This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.

Patients who have been given too much olanzapine have also experienced the following symptoms:
palpitations, agitation / aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Other symptoms may include:
sudden confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness, slowed breathing, aspiration, high or low blood pressure, irregular heart rhythm.
If you experience any of the above symptoms, call your doctor immediately or go straight to the nearest hospital.

If you miss an injection of ZYPADHERA
Do not stop your treatment just because you feel better. It is important to keep taking ZYPADHERA for as long as you told your doctor.
If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you have:
excessive sleepiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness. These symptoms can sometimes occur as a result of too rapid penetration of ZYPADHERA in circulation (a common side effect that may affect up to 1 in 10 people);
unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of 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 (signs include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs, causing pain chest and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately;
combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect can not be estimated from available data).
Other common side effects (may affect up to 1 in 10 people) for use with ZYPADHERA include sleepiness and pain at the injection site.

Rare side effects (may affect up to 1 in 1000 people) for use with ZYPADHERA include infection at the injection site.
Adverse reactions listed below were observed with oral olanzapine but may occur following administration of ZYPADHERA.

Other very common side effects (may affect more than 1 in 10 people) 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 usually resolves on its own, but if it does not, tell your doctor.

Other common side effects (may affect up to 1 in 10 people) include changes in the number of certain blood cells in the levels of blood lipids and early treatment transient increase in liver enzymes; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine in the blood; increased hunger; dizziness; anxiety; tremors; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; excessive fatigue; water retention leading to swelling of the wrists, ankles, or feet; fever; joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in men.

Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity reactions (eg. Swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with seizures in the past (epilepsy); muscle stiffness or spasm (including eye movements); problems with speech; slow heartbeat; makes you sensitive to sunlight; nosebleeds; bloating; memory loss or forgetfulness; urinary incontinence; difficulty in urination; hair loss; absence or decrease in menstrual cycles and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; heart rhythm disorders; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and vomiting; liver disease appearing as yellowing of the skin and whites of the eyes; muscle disease presenting as unexplained aches and prolonged and / or painful erection.

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. In this particular group of patients have been reported several cases fatal.
In patients with Parkinson's disease oral olanzapine may worsen the symptoms.

Adverse event reporting
If you get any side effects, tell your doctor or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store ZYPADHERA
Keep out of the reach and sight of children.
The injection should not be placed after the expiry date stated on the carton.
Do not refrigerate or freeze.