Zypadhera

How to take it

These directions are for this exact strength and form. Another one is different.

• Your doctor will decide how much ZYPADHERA you need and how often you need to be given an injection. ZYPADHERA is given 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 than needed 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:
• rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
• Other symptoms may include:
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or sleepiness; slower breathing, aspiration, high or low blood pressure, abnormal rhythms of the heart.
• Contact your doctor or hospital straight away if you experience any of the above symptoms.
• If you miss an injection of ZYPADHERA Do not stop your treatment just because you feel better. It is important that you carry on receiving ZYPADHERA for as long as your doctor has told you to.
• 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.

From the package leaflet in EMA’s product information, p. 40–41.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 38–39.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 40.

Other medicines

From the package leaflet in EMA’s product information, p. 39–40.

Driving and using machines

• Do not drive or operate machinery for the remainder of the day after each injection.
• ZYPADHERA contains polysorbate 80 This medicine contains 1 mg of polysorbate 80 in each ml of solvent. After reconstitution ZYPADHERA 210 mg contains 1.3 mg, ZYPADHERA 300 mg contains 1.8 mg and ZYPADHERA 405 mg contains 2.3 mg of polysorbate 80. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
• ZYPADHERA contains sodium After reconstitution this medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free.

From the package leaflet in EMA’s product information, p. 40.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Tell your doctor immediately if you have:
• excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness. These signs and symptoms can sometimes occur as a result of ZYPADHERA entering the bloodstream too quickly (a common side effect that may affect up to1 in10 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 1in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice 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 injection site pain.
• Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
• The side effects listed below have been observed when oral olanzapine has been given but may occur following administration of ZYPADHERA.
• Other very common side effects (may affect more than 1 in 10 people) include weight gain; and increases in levels of prolactin in the blood. In the early stages 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 will usually pass 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 levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias);
• constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
• Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching; rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome;
• problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose:
• abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; 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;
• abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
• Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).
• 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. Some fatal cases have been reported in this particular group of patients.
• In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
• Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 41–42.

How to store it

• Keep this medicine out of the sight and reach of children.
• The injection must not be given after the expiry date which is stated on the carton.
• Do not refrigerate or freeze.
• Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 20- 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C. Do not use this product if you notice discolouration or other visible signs of deterioration.
• If the medicine is not used right away, it should be shaken vigorously to re-suspend. Once withdrawn from vial into the syringe, the suspension should be used immediately.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

From the package leaflet in EMA’s product information, p. 42.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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