Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Package leaflet: Information for the user

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

aripiprazole

1. What Abilify Maintena is and what it is used for

Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.

2. What you need to know before you are given Abilify Maintena

3. How Abilify Maintena is given

Abilify Maintena comes as a pre-filled syringe. Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the injections between your right and left side. The injections will not be given intravenously.

Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended and starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg). Treatment with aripiprazole by mouth is continued for 14 days after the first injection. After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.

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 immediately if you have any of the following serious side effects:

• a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.
• unusual movement mainly of the face or tongue, since your doctor may want to lower your dose.
• if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you have a blood clot, 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 since this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
• thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes.

The side effects listed below may also occur after receiving Abilify Maintena.

Common side effects (may affect up to 1 in 10 people):

• weight gain, weight loss
• feeling anxious, difficulty sleeping (insomnia)
• feeling restless and unable to keep still, difficulty sitting still, trembling, uncontrollable twitching, jerking or writhing movements, restless legs
• changes in your level of alertness, drowsiness
• muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements. They usually affect the face and mouth first but can affect other parts of the body. These could be signs of a condition called “tardive dyskinesia”.
• parkinsonism; this is a medical term that includes several symptoms such as muscle stiffness, jerks when bending the limbs, slow or impaired body movements, no expression on the face, muscle tightness, shuffling, hurried steps and lack of normal arm movements when walking
• jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, muscle stiffness, slow body movement
• dizziness, headache
• dry mouth
• pain at the injection site, hardening of the skin at the injection site
• weakness, loss of strength or extreme tiredness
• high blood levels of the enzyme creatine phosphokinase

Uncommon side effects (may affect up to 1 in 100 people):

• decreased or increased appetite, distortion of the senses of taste and smell
• low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
• allergic reactions (hypersensitivity)
• decreased or increased blood levels of the hormone prolactin
• high blood sugar, decreased blood sugar
• increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol and low level of triglycerides
• increased levels of insulin, a hormone regulating blood sugar levels
• thoughts about suicide
• mental disorder characterized by defective or lost contact with reality, hallucination, delusion
• altered or increased sexual interest
• panic reaction, depression, affect lability, state of indifference with lack of emotion, feelings of emotional and mental discomfort, altered mood
• sleep disorder
• grinding of teeth or clenching of the jaw
• hiccups
• fixation of the eyeballs in one position, blurred vision, eye pain, double vision
• abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, abnormal reading (ECG) of the heart
• dizziness when getting up from a lying or sitting position due to a drop in blood pressure, high blood pressure
• cough
• upset stomach, indigestion, drooling, more saliva in mouth than normal, vomiting, nausea, diarrhoea, constipation, stomach ache or discomfort, frequent bowel movement
• abnormal liver blood values
• abnormal hair loss
• acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening
• muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity, gait disturbance,joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth
• kidney stones, sugar (glucose) in urine
• enlargement of breast in men, breast tenderness, vaginal dryness
• loss of strength
• chest discomfort
• injection site reactions such as redness, swelling discomfort and injection site itching
• increased waist circumference

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

• low levels of white blood cells
• unusual heartbeat, sudden unexplained death, heart attack
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash
• ketoacidosis (ketones in the blood and urine) or coma, low sodium level in the blood
• loss of appetite (anorexia), difficulty in swallowing
• aggression
• nervousness, suicide attempt and suicide; speech disorder, seizure, serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate (neuroleptic malignant syndrome)
• fainting, spasm of the muscles around the voice box, accidental inhalation of food with risk of pneumonia (lung infection), inflammation of the pancreas
• liver failure, inflammation of the liver, yellowing of the skin and white part of eyes, sensitivity to light, excessive sweating, stiffness or cramps, muscle pain, weakness
• involuntary loss of urine (incontinence), difficulty in passing urine
• prolonged and/or painful erection
• difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
  
  • strong impulse to gamble excessively despite serious personal or family consequences
  • altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
  • uncontrollable excessive shopping
  • binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
  • a tendency to wander away
  Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

5. How to store Abilify Maintena

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: