Centalify indicated for:

• Treatment of schizophrenia.
• Treatment of moderate to severe manic states in bipolar disorder type 1 and for the prevention of new manic episodes in patients who predominantly experienced manic episodes and whose
  previous manic episodes responded to aripiprazole treatment.
• Combined treatment of major depressive disorder (MDD) in patients who experienced a partial response to treatment with antidepressants.
• Treatment of irritability associated with autistic disorder in children (aged 6-17 years).

Compostion

• Centalify 10 mg tablets: Each tablet contains 10 mg Aripiprazole.
• Centalify 15 mg tablets: Each tablet contains 15 mg Aripiprazole.

Pharmaceutical form:

• Centalify 10 mg tablets: Pink round plain biconvex Tablet.
• Centalify 15 mg tablets: Yellow round biconvex Tablet.

Dosage and method of administration

Always use this medicine according to your doctor’s instructions.

Check with your doctor or pharmacist if you are not sure about your dose or about how to take this medicine. Only your doctor will determine your dose and how you should take this medicine.

The recommended dosage is usually:

• Schizophrenia and bipolar disorder: The usual dosage for adults is 15 mg once a day. However, the doctor may prescribe a lower or higher dosage for you, up to a maximum of 30 mg once a day.
• For adolescents 15 years of age and older, at the beginning of treatment, Centalify may be given in lower dosages, with a gradual increase up to the usual dosage of 10 mg once a day. However, the doctor may prescribe a lower or higher dosage for you, up to a maximum of 30 mg once a day.
• Combined treatment in major depressive disorder: The usual starting dosage is 2.5 mg (another medicine containing aripiprazole may be used to achieve this dosage) up to 5 mg a day. If necessary, the doctor may increase the dosage gradually.
• Treatment of irritability associated with autistic disorder in children: The usual starting dosage is 2.5 mg a day (another medicine containing aripiprazole may be used to achieve this dosage). The doctor will gradually increase the dosage to 5 up to 15 mg a day, in accordance with each patient’s response to the medicine.

If you feel that the effect of the medicine is too strong or too weak, consult the doctor or pharmacist.

• Do not exceed the recommended dose.
• Swallow the medicine with water. Do not crush/split/chew the tablet.
• Try to take the medicine at fixed times each day.

If you have accidentally taken a higher dose: Patients who have taken an overdose of the medicine have reported the following symptoms:

• rapid heartbeat, agitation/aggressiveness, problems with speech.
• unusual movements (especially in the facial area or tongue) and reduced level of consciousness.
• acute confusion, seizures (epilepsy), coma, a combination of fever, fast breathing, sweating.
• muscle stiffness drowsiness or sleepiness, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

If you have accidentally taken an overdose, or if a child has accidentally swallowed some medicine, immediately see a doctor or go to a hospital emergency room and bring the medicine package with you.

If you forget to take the medicine at the scheduled time, do not take a double dose. Take the next dose at the usual time and consult the doctor.

Adhere to the treatment as recommended by your doctor. Even if your health improves, do not stop taking this medicine without consulting your doctor.

Do not take medicines in the dark! Check the label and dose every time, you take medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

Special warnings and precautions for use

Before using Centalify, tell your doctor if:

• you have suicidal thoughts, thoughts about self injury, tell your doctor immediately, since suicidal thoughts and behavior have been reported during the course of treatment with aripiprazole.
• you suffer from a high blood sugar level (characterized by symptoms such as increased thirst, passing large amounts of urine, increased appetite, and weakness) or a family history of diabetes.
• you suffer from epileptic seizures, since your doctor may want to monitor your condition more closely.
• you suffer from uncontrolled and irregular muscle movements, particularly in the facial area.
• you suffer from cardiovascular diseases (heart and blood vessels), a family history of cardiovascular diseases, abnormal blood pressure, a stroke or a transient ischemic attack (a “mini” stroke).
• you suffer from blood clots or a family history of blood clots, as there is an association between antipsychotics and formation of blood clots.
• you have suffered from gambling addiction in the past.

Tell your doctor if you have noticed weight gain, if you experience difficulty swallowing or allergic reactions, involuntary movements, sleepiness that interferes with daily activities.

If you are an elderly patient suffering from dementia (loss of memory and other cognitive capacities), you or your caregiver must tell your doctor if you had a stroke or a transient ischemic attack (a “mini” stroke).

Tell your doctor immediately if you suffer from muscle stiffness or lack of flexibility accompanied by fever, excessive sweating, change in mental state or irregular or increased heart rate.

Tell your doctor if your family/caregiver notices that you are experiencing urges or cravings to abnormal behavior, or if you cannot resist the impulses to carry out certain activities that could harm yourself or others. These are called “impulse control disorders” and can include behaviors such as addictive gambling, excessive eating or spending, an abnormal sex drive or preoccupation with an increase in sexual thoughts or feelings.

Centalify may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are elderly or have some debility.

Do not use the medicine for any purpose other than that for which it was prescribed.

Tests and follow up: During treatment with this medicine, there may be a drop in blood pressure. You should therefore be under medical supervision and regularly monitor your blood pressure.

Children and adolescents: This medicine is not intended for use in children below the age of 6.

Side effects

Like with all medicines, using Centalify may cause side effects in some users. Do not be alarmed by this list of side effects; you may not experience any of them.
Common side effects (occurring in 1-10 in 100 users):

Diabetes, involuntary twitching or movements, headache, tiredness, vomiting, nausea, an uncomfortable feeling in the stomach, constipation, increased secretion of saliva, light-headedness, difficulty sleeping, anxiety and feeling of agitation, difficulty standing or sitting still, akathisia (an uncomfortable inner feeling of restlessness and a compelling need to move constantly), sleepiness, tremor, blurred vision.

Uncommon side effects (occurring in 1-10 in 1,000 users):

Excessive secretion of the hormone prolactin; high blood sugar levels; altered or increased sexual interest; involuntary movements of the mouth, tongue and limbs (tardive dyskinesia); muscle disorder causing twisting movements (dystonia); restless legs; a fall in blood pressure on standing up which may cause dizziness or fainting; rapid heartbeat; double vision; eye sensitivity to light; depression; hiccups.

Centalify – Product Information

• License Holder: Growth Pharma – Egypt.
• ATC code: N05AX12 / aripiprazole .

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