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What is Abizol and what is it used?
Abizol is one of a group of medicines called antipsychotics. Abizol is used in adults and adolescents aged 15 years to treat schizophrenia. This is a condition characterized by symptoms such as hearing, seeing or sensing things that are not there, suspiciousness, mistaken beliefs, (unbound) speech and behavior and emotional flatness. People with this condition may be depressed, to feel guilt, anxiety or stress.
Abizol is used in adults and adolescents 13 years and above for the treatment of moderate to severe manic episodes in bipolar affective disorder characterized by symptoms such as feeling of elation, having excessive, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults, it also prevents the resumption of these symptoms in patients who responded to treatment with Abizol.
2. What you need to know before taking Abizol?
Do not take Abizol:
if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Abizol if:
suffer from high blood sugar (characterized by symptoms such as excessive thirst, excessive amounts of urine, increased appetite, feelings of weakness) or have a history of diabetes in the family;
involuntary, irregular muscle movements, especially of the face;
cardiovascular disease, history of cardiovascular disease in the family, stroke or "mini" stroke, abnormal blood pressure;
presence of blood clots, or family history such as antipsychotics have been associated with formation of blood clots;
strong attraction to gambling in the past.
If you notice weight gain, develop unusual movements, experience somnolence, which interferes with your normal daily activities, have difficulty swallowing or allergic symptoms, please tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your relative should tell your doctor if you have had a stroke or "mini" stroke.
Tell your doctor immediately if you have any thoughts or feelings about hurting yourself. There have been a manifestation of thoughts and suicide attempts during treatment with aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility, accompanied by high fever, altered mental status, or very rapid or irregular heartbeat.
Children and adolescents
Abizol is not for use in children and adolescents under 13 years. Ask your doctor or pharmacist before taking Abizol.
Other medicines and Abizol
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Blood pressure lowering drugs: Abizol may increase the effect of the drugs used to lower blood pressure. Make sure your doctor knows you are taking medications to control blood pressure.
The adoption of Abizol with other medicines may require dosage adjustment of Abizol. It is particularly important to tell your doctor about the following medicines:
- Medicines to correct heart rhythm;
- Antidepressants or herbal remedy used to treat depression and anxiety;
- Certain medicines to treat HIV infection;
- Anticonvulsants used to treat epilepsy.
Drugs that increase the level of serotonin: triptans, tramadol, tryptophan, SSRI (eg paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John's Wort and venlafaxine. Since these drugs increase the risk of side effects if you get any unusual symptom when taking any of these medicines in combination with Abizol, consult your doctor.
Abizol with food, drinks and alcohol
Abizol can be taken regardless of the diet (with or without food).
Alcohol should be avoided during treatment with Abizol.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 patients):
uncontrolled twitching or jerking movements, headache, fatigue, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased salivation, dizziness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.
Uncommon adverse reactions (may affect up to 1 in 100 patients):
some patients may feel dizzy, especially when getting up from a lying or sitting position or accelerated heart rate. Some patients may feel depressed.
Side effects with unknown frequency (frequency can not be estimated from available data):
Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (eg. swelling of the mouth, tongue, face and throat, itching, rash); high blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious, strong attraction to gambling; suicidal thoughts, suicide attempt and suicide; speech disorder, seizure, serotonin syndrome (a reaction that can cause a feeling of excessive happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or stiffness in muscles), a combination of fever, muscle stiffness, faster breathing, sweating , reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blood clots in the veins especially in the legs (symptoms include swelling, pain and redness) that can reach the lungs and cause chest pain and difficulty breathing (in the presence of these symptoms contact a doctor immediately); spasm of the muscles around the voice box, accidental inhalation of food with risk of pneumonia, difficulty in swallowing; inflammation of the pancreas; liver failure, inflammation of the liver, yellowing of the skin and whites of the eyes, reports of abnormal test values of the liver, abdominal and stomach discomfort, diarrhea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; prolonged and / or painful erection; difficulty controlling core body temperature or overheating, chest pain, and swelling of the hands, ankles or feet.
In elderly patients with dementia reported more fatalities while taking aripiprazole. It is further reported cases of stroke or "mini" stroke.
Additional side effects in children and adolescents
Adverse reactions in adolescents aged 13 years were similar in frequency and type to those in adults except that sleepiness and uncontrollable twitching or jerking movements anxiety and fatigue, which are very common (more than 1 in 10 patients) and pain in the upper abdomen, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable movements of limbs, dizziness, especially on getting up from a lying or sitting position, which are common side effects (more than 1 in 100 patients).
By reporting side effects, you can do your bit for getting more information on the safety of this medicine.
5. How to store Abizol
Keep out of reach of children. Do not store above 25 ° C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
In order to protect from moisture store in the original packaging.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
Other ingredients are:
Crospovidone (Particle size: d90 <60 μ);
Crospovidone (Particle size: d90 <100 μ);
Povidone K 30;
Yellow iron oxide (E172);
Abizol looks like and contents of the pack?
Abizol 15 mg tablets are round, yellow, embossed marking "15" on one side of the tablet, packaged in blister Al / Al. Each blister contains 14 tablets, and each box contains 2 blisters (28 tablets).
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