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What ABILIFY oral solution is and what it is used for
ABILIFY oral solution contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 or over who suffer from a condition characterized by symptoms such as hearing, seeing or feeling things that do not really exist, suspicion, misconduct, confused speech and behavior, As well as boredom. People in such a state may experience depression, feeling guilty, anxious or tense.
ABILIFY oral solution is used to treat adults and adolescents aged 13 and over who suffer from a condition characterized by symptoms such as a feeling of elevation, excess energy, need for much less sleep than usual, very fast talking with race ideas And sometimes severe irritability. In adults, it also prevents these symptoms from resuming in patients who have responded to treatment with ABILIFY oral solution.
2. What you need to know before taking ABILIFY oral solution
Do not take ABILIFY oral solution
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 before taking ABILIFY oral solution if you suffer from:
High blood sugar (characterized by symptoms such as excessive thirst, excessive urine output, increased appetite, feeling weak) or have previous diabetes in the family;
Involuntary, irregular movements of the muscles, especially the face;
Cardiovascular disease, previous cardiovascular disease in the family, stroke or "micro" stroke, abnormal blood pressure;
The presence of blood clots or familial data for them as the use of antipsychotic agents is associated with the formation of blood clots;
A strong attraction to gambling in the past.
If you notice weight gain, develop unusual movements, have somnolence that interferes with your normal daily activities, have difficulty in swallowing or allergic symptoms, please tell your doctor.
If you are an adult patient and suffer from dementia (loss of memory or other mental abilities), you or your relative should tell your doctor whether you have had a stroke or a "micro" stroke.
Tell your doctor immediately if you have thoughts or feelings that are aimed at self-harm. There have been reports of thoughts and suicidal attempts during treatment with aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or lack of flexibility accompanied by fever, sweating, altered mental status, or an accelerated or uneven heartbeat.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and ABILIFY oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Blood pressure lowering medicines: ABILIFY oral solution may increase the effect of medicines used to lower blood pressure. Make sure your doctor knows you are taking medicines to control your blood pressure.
Taking ABILIFY oral solution together with other medicines may require a change in the dosage of ABILIFY oral solution. It is especially important to tell your doctor about the following medicines:
Heart rate correction medications;
Antidepressants or herbal preparations used to treat depression and anxiety;
Some medicines to treat HIV infection;
Anticonvulsants used to treat epilepsy.
Serotonin elevators: tryptans, tramadol, tryptophan, SSRI (for example paroxetine and fluoxetine), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John's wort and venlafaxine. As these medicines increase the risk of side effects, if you get any unusual symptoms while taking any of these medicines in combination with ABILIFY oral solution, talk to your doctor.
ABILIFY oral solution with food, beverages and alcohol
ABILIFY oral solution can be taken regardless of diet (with or without food). However, the oral solution should not be diluted with other fluids or mixed with other food before intake.
Alcohol should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have used ABILIFY oral solution during the last trimester (the last three months of pregnancy): tremor, muscle stiffness
Driving and using machines
Do not drive or use any tools or machines before you can tell how your ABILIFY oral solution works.
ABILIFY oral solution contains fructose, sucrose and parahydroxybenzoates
Each ml of ABILIFY oral solution contains 200 mg of fructose and 400 mg of sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Parahydroxybenzoate may cause allergic reactions (may occur later).
3. How to take ABILIFY oral solution
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended adult dose is 15 ml of solution (corresponding to 15 mg aripiprazole) once a day. However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg (ie 30 ml) once a day.
Use in children and adolescents
The recommended dose for adolescents is 10 ml (corresponding to 10 mg aripiprazole) once daily. However, your doctor may prescribe a lower or higher dose to a maximum of 30 ml (ie 30 mg) once a day.
When dosing ABILIFY oral solution, use the graduated measuring cup or the dropper calibrated for 2 ml in the carton.
If you think the effect of ABILIFY oral solution is too strong or too weak for you, talk to your doctor or pharmacist.
Try to take ABILIFY oral solution at the same time each day.
It does not matter if you take it with or without food. However, before taking ABILIFY oral solution, you should not dilute it with other liquids or mix it with other foods.
Even if you feel better, do not change the dose of ABILIFY oral solution and do not stop treatment without first consulting your doctor.
If you take more ABILIFY oral solution than you should
If you find that you have taken more ABILIFY oral solution than prescribed (or if someone else has taken your ABILIFY oral solution), contact your doctor immediately. If you can not find it, go to the nearest hospital and carry the medicine pack with you.
If you forget to take ABILIFY oral solution
If you miss a dose, take it as soon as you remember but do not take two doses on the same day.
If you stop using ABILIFY oral solution
Do not stop your treatment just because you feel better. It is important that you continue to use ABILIFY oral solution for as long as your doctor tells you.
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 everyone gets them.
Common side effects (may affect up to 1 in 10 patients):
Feeling unrestrained and unable to sit together, sitting problems in one place;
Uncontrolled twitching, convulsions or convulsions, restless leg syndrome;
Trembling and blurred vision;
Reduced number of stools or difficulty walking;
More saliva in the mouth than usual;
Uncommon side effects (may affect up to 1 in 100 patients):
Increased levels of the hormone prolactin in the blood;
Increased blood sugar;
Changed or increased sexual interest;
Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia);
Muscle spasm causing spastic movements (dystonia);
Decreasing blood pressure when straightening, causing dizziness, dizziness or fainting.
The following side effects have been reported following oral aripiprazole, but the frequency of their occurrence is unknown:
Low levels of white blood cells;
Low levels of blood platelets;
An allergic reaction (eg swelling of the mouth, tongue, face and throat, itching, urticaria);
The onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma;
High blood glucose levels;
Insufficient sodium in the blood;
Loss of appetite (anorexia);
Suicidal thoughts, attempted suicide and suicide;
Strong gambling addiction;
A sense of aggression;
Combination of high fever, muscle stiffness, rapid breathing, sweating, blurred consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome);
Serotonin syndrome (a reaction that may cause a feeling of excessive happiness, drowsiness, clumsiness, restlessness, feeling of being intoxicated, fever, sweating, or stiffness in the muscles);
Sudden unexplained death;
Life-threatening irregular heartbeat;
Heart attack (heart attack);
Slow heart rate;
Blood clots in the veins, especially in the legs (symptoms include swelling of the limb, pain and redness) that can reach the blood vessels to the lungs and cause chest pain and difficulty breathing (in the presence of these symptoms, immediately look for medical assistance);
high blood pressure;
Accidental inhalation of food at risk of pneumonia (pulmonary infection);
Spasm of the muscles around the voice box;
Inflammation of the pancreas;
Inflammation of the liver;
Yellowing of the skin and white eyes;
Reports of liver function test abnormalities;
Sensitivity to light;
Abnormal muscle breakdown that can lead to kidney problems;
Involuntary urine (incontinence);
Withdrawal symptoms in neonates in case of exposure during pregnancy;
Prolonged and / or painful erection;
Problems in body thermoregulation or overheating;
Swelling of the hands, ankles or legs;
In blood tests: changing blood sugar levels, elevated glycated hemoglobin.
In elderly patients with dementia, more fatal cases have been reported during aripiprazole administration. In addition, cases of stroke or "micro" stroke have also been reported.
Additional side effects in children and adolescents
Adverse reactions in adolescents at or above 13 years of age are similar in frequency and type to those in adult patients, with the exception of insomnia, uncontrolled convulsions and shivering, restlessness and tiredness, which are very common (more than 1 in 10 patients); Upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable movements of the limbs, dizziness, especially when getting up from a lying or sitting position, which are common side effects - frequencies of 1 per 100 patients).
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store ABILIFY oral solution
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. To be used within 6 months after first opening.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What ABILIFY contains Oral solution
The active substance is aripiprazole.
Each ml contains 1 mg of aripiprazole.
The other ingredients are: edetate disodium, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water and natural orange cream with other natural flavors.
What ABILIFY looks like and contents of the pack
ABILIFY 1 mg / ml oral solution is a clear, colorless to pale yellow liquid. Available in bottles with child resistant polypropylene caps containing 50 ml, 150 ml or 480 ml per bottle.
Each carton contains one bottle and a graduated polypropylene measuring cup as well as a calibrated polypropylene low density polyethylene dropper.
Not all pack sizes may be marketed.
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