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What ARICOG AN is and what it is used for
ARIKOGAN contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents 15 years of age and older who suffer from a disease characterized by symptoms such as hearing, seeing or feeling things that do not really exist, suspicion, misconceptions, confused (unrelated) speech and behavior. as well as boredom. People in this condition may become depressed, feel guilty, anxious or tense,
ARIKOGAN is used to treat adults and adolescents 13 years of age and older who suffer from a condition characterized by symptoms such as bloating, overexertion, need for much less sleep than usual, very fast talking with competing ideas, and sometimes severe irritability. In adults, it also prevents these symptoms from recurring in patients who have responded to ARIKOGAN treatment.
2. What you need to know before you take ARIKOGAN
Do not take ARIKOGAN
• 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 ARIKOGAN if you suffer from:
• high blood sugar (characterized by symptoms such as excessive thirst, excessive urine output, increased appetite, feeling weak) or you have a previous family history of diabetes
• Involuntary, irregular muscle movements, especially of the face
• cardiovascular disease, previous family cardiovascular disease, stroke or "micro" stroke, abnormal blood pressure
• the presence of blood clots or family data for such clots, as the use of antipsychotics is associated with the formation of blood clots.
• strong attraction to gambling in the past
If you notice weight gain, develop unusual movements, experience somnolence that interferes with your normal daily activities, have difficulty swallowing or have allergic symptoms, please tell your doctor.
If you are an adult patient and suffer from dementia (memory loss or other mental abilities), you or your loved one should tell your doctor if you have had a stroke or a 'micro' stroke.
Tell your doctor immediately if you have any thoughts or feelings about self-harm. Thoughts and suicide attempts have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or lack of flexibility, accompanied by fever, sweating, altered mental state or rapid or uneven heartbeat.
Children and adolescents
ARIKOGAN is not for use by children and adolescents under 13 years of age. Ask your doctor or pharmacist for advice before taking ARIKOGAN.
Other medicines and ARIKOGAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Blood pressure lowering drugs: ARIKOGAN may increase the effect of medicines used to lower blood pressure. Make sure your doctor knows that you are taking medicines to control your blood pressure.
Taking ARIKOGAN with other medicines may require a change in the dosage of ARIKOGAN. It is especially important to tell your doctor about the following medicines:
• Medications to correct heart rhythm
• Antidepressants or herbal preparations used to treat depression and anxiety
• Some medicines to treat HIV infection
• Anticonvulsants used to treat epilepsy
• Drugs that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (eg 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 ARIKOGAN, talk to your doctor.
ARIKOGAN with food, drinks and alcohol
ARIKOGAN can be taken with or without diet (with or without food) Alcohol consumption should be avoided during treatment with ARIKOGAN.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns whose mothers have used ARIKOGAN during the last trimester (last three months of pregnancy): tremors, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and difficulty eating. If your baby develops any of these symptoms, talk to your doctor.
If you are breast-feeding, tell your doctor immediately.
If you are taking ARIKOGAN, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines
If you forget to take ARIKOGAN
If you forget to take a dose, take it as soon as you remember, but do not take two doses on the same day.
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 people): uncontrolled twitching or sudden movements, headache, tiredness, nausea, vomiting, stomach upset, constipation, increased salivation, dizziness, sleep problems, anxiety, feeling anxious , drowsiness, tremors and blurred vision.
Uncommon side effects (may affect up to 1 in 100 people): Some patients may feel dizzy, especially when getting up from a lying or sitting position, or have a fast heart rate or double vision.
Some patients may feel depressed. Hiccups may occur in some patients. Some people may experience altered or increased sexual interest.
The following side effects have been reported during marketing of ARICOG AN, but their frequency is unknown (frequency cannot be determined from the available data):
Changes in the levels of some blood cells; unusual pulse, 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 blood sodium; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious, strong desire to gamble; suicidal thoughts, suicide attempts and suicide; speech disorders, seizures, serotonin syndrome (a reaction that can cause feelings of excessive happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating or muscle stiffness), a combination of fever, muscle stiffness, rapid breathing, sweating , blurred consciousness and a sudden change in blood pressure and heart rate; fainting, high blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling of the limbs, pain and redness), which can reach the lungs and cause chest pain and difficulty breathing (in the presence of these symptoms consult a doctor immediately); muscle spasm around the vocal cords, accidental inhalation of food at risk of pneumonia, difficulty swallowing; inflammation of the pancreas; liver failure, inflammation of the liver, yellowing of the skin and white of the eyes, reports of abnormal values on examination of the liver, abdominal and stomach discomfort, diarrhea; skin rash and sensitivity to light, unusual hair loss or thinning, increased sweating; stiffness or cramps, muscle pain, weakness; involuntary urination, difficulty urinating; prolonged and / or painful erection; difficulty controlling body temperature or overheating, chest pain, and swelling of the arms, ankles, or legs.
Elderly patients with dementia have been reported to be more fatal while taking aripiprazole. Cases of stroke or "micro" stroke have also been reported.
Additional side effects in children and adolescents
Adverse reactions in adolescents 13 years of age and older are similar in frequency and type to those in adult patients, except for insomnia, uncontrolled convulsions and twitching, anxiety and fatigue, which are very common (more common in 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle cramps, uncontrolled limb movements, dizziness, especially when getting up from a lying or sitting position, which are common side effects ( more common than 1 in 100 patients).
5. How to store ARIKOGAN
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the blister or carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What ARIKOGAN contains
• The active substance is: aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, hypromellose, crospovidone type A, colloidal anhydrous silica
What ARIKOGAN looks like and contents of the pack
ARIKOGAN 15 mg tablets are yellow, round, bevelled, engraved with “253” on one side and smooth on the other.
They are available in unit dose blisters in cartons containing 7,10, 14,20,28,30, 50, 56,60,72, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.
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