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 decide on the dose of Abilify Maintena that is right for you. The recommended 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).

There are two ways to start Abilify Maintena, your doctor will decide which way is right for you.

• If you are given one injection of Abilify Maintena on your first day the treatment with aripiprazole by mouth is continued for 14 days after the first injection.
• If you are given two injections of Abilify Maintena on your first day, you will also take one tablet of aripiprazole by mouth at this visit.

After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.

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.

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
• diabetes mellitus
• weight loss
• feeling restless
• feeling anxious
• unable to keep still, difficulty sitting still
• difficulty sleeping (insomnia)
• jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
• shaking or trembling
• uncontrollable twitching, jerking or writhing movements
• changes in your level of alertness, drowsiness
• sleepiness
• dizziness
• headache
• dry mouth
• muscle stiffness
• inability to have or maintain an erection during sexual intercourse
• pain at the injection site, hardening of the skin at the injection site
• weakness, loss of strength or extreme tiredness
• during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)

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

• 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
• 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
• decreased or increased appetite
• thoughts about suicide
• mental disorder characterized by defective or lost contact with reality
• hallucination
• delusion
• increased sexual interest
• panic reaction
• depression
• affect lability
• state of indifference with lack of emotion, feelings of emotional and mental discomfort
• sleep disorder
• grinding of teeth or clenching of the jaw
• reduced sexual interest (libido is decreased)
• altered mood
• muscle problems
• 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 - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling
• movement problems
• extreme restlesness and restless legs
• distortion of the senses of taste and smell
• fixation of the eyeballs in one position
• blurred vision
• eye pain
• double vision
• eye sensitivity to light,
• abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, abnormal reading (ECG) of the heart
• high blood pressure
• dizziness when getting up from a lying or sitting position due to a drop in blood pressure
• cough
• hiccups
• gastroesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the esophagus (gullet or the tube that goes from mouth to stomach through which food passes), causing heartburn and possibly damaging the esophagus
• heartburn
• vomiting
• diarrhoea
• feeling sick
• stomach ache
• stomach discomfort
• constipation
• frequent bowel movement
• drooling, more saliva in mouth than normal
• 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
• joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth
• kidney stones, sugar (glucose) in urine
• spontaneous flow of milk from the breasts (galactorrhoea)
• enlargement of breast in men, breast tenderness, vaginal dryness
• fever
• loss of strength
• gait disturbance
• chest discomfort
• injection site reactions such as redness, swelling discomfort and injection site itching
• thirst
• sluggishness
• liver function tests may show abnormal results
• during tests your doctor may find
  • higher amounts of liver enzymes
  • higher amounts of alanine aminotransferase
  • higher amounts of gamma-glutamyl transferase
  • higher amounts of bilirubin in your blood
  • higher amounts of aspartate aminotransferase
  • higher or lower amounts of blood glucose
  • higher amounts of glycosylated haemoglobin
  • lower amounts of cholesterol in your blood
  • lower amounts of triglycerides in your blood
  • a higher 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 (frequency cannot be estimated from the available data):

• low levels of white blood cells
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash
• unusual heartbeat, sudden unexplained death, heart attack
• diabetic ketoacidosis (ketones in the blood and urine) or coma
• loss of appetite (anorexia), difficulty in swallowing
• low sodium level in the blood
• suicide attempt and suicide
• 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.
• nervousness
• aggression
• neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
• seizure (fits)
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• speech disorders
• heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG) QT prolongation
• fainting
• symptoms related to blood clots in the veins 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
• spasm of the muscles around the voice box
• accidental inhalation of food with risk of pneumonia (lung infection)
• inflammation of the pancreas
• difficulty swallowing
• liver failure
• jaundice (yellowing of the skin and white part of eyes)
• inflammation of the liver
• rash
• skin sensitivity to light
• excessive sweating
• 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 in blood tests and an increase in a type of white blood cell (eosinophilia).
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
• difficulty in passing urine
• involuntary loss of urine (incontinence)
• drug withdrawal symptoms in new-born infant
• prolonged and/or painful erection
• difficulty controlling core body temperature or overheating
• chest pain
• swelling of hands, ankles or feet
• during tests your doctor may find
  • higher amounts alkaline phosphatase
  • fluctuating results during tests to measure glucose in your blood

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 and the pre-filled syringe. 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.

6. Contents of the pack and other information