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Aripiprazole 15 mg. 28 tablets

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What is Aripiprazole Accord and what it is used for
Aripiprazole Accord contains the active substance aripiprazole, which 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, misconceptions, confused speech and behavior, As well as boredom. People in such a state may experience depression, feeling guilty, anxious or tense.
This medicine 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 racing ideas, and Sometimes severe irritability. In adults, they also prevent these symptoms from resuming in patients who have responded to treatment with this medicine.

2. What you need to know before taking Aripiprazole Accord
Do not take Aripiprazole Accord:
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 this medicine 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 blood clotting;
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 Drugs And Aripiprazole Accord
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: Aripiprazole Accord 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 Aripiprazole Accord with other medicines may require a change in the dosage of Aripiprazole Accord. 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;
Antifungal agents;
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. Because these medicines increase the risk of side effects, if you get any unusual symptoms while taking any of these medicines in combination with Aripiprazole Accord, talk to your doctor.
Aripiprazole Accord with food, beverages and alcohol
This medicine can be taken regardless of diet (with or without food). Alcohol should be avoided when taking this medicine.

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 used this medicine during the last trimester (the last three months of pregnancy): tremor, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and eating difficulties. If any of these symptoms occur with your baby, contact your doctor.
When you are breast-feeding, tell your doctor immediately. If you are taking this medicine, you should not breast-feed.

Driving and using machines
Do not drive or use any tools or machines before you know how this medicine affects you.

Aripiprazole Accord contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Aripiprazole Accord
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 dose for adults is 15 mg once a day. However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents
Treatment may be initiated at lower doses using an alternative oral solution (liquid) that is more appropriate than Aripiprazole Accord. The dose may be progressively increased to 10 mg daily, which is the recommended dose for adolescents. Your doctor may prescribe a lower or higher dose, but not more than 30 mg daily.
If you think the effect of this medicine is too strong or too weak for you, talk to your doctor or pharmacist.
Try to take Aripiprazole Accord at the same time each day. It does not matter if you take them with or without food. Always take the tablets whole with water.
Even if you feel better, do not change the dose of this medicine and do not stop treatment without first consulting your doctor.

If you take more Aripiprazole Accord than you should
If you find that you have taken more Aripiprazole Accord than you prescribed (or if someone else has taken your Aripiprazole Accord), contact your doctor immediately. If you can not find it, go to the nearest hospital and take the medicine pack with you.
If you forget to take Aripiprazole Accord
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 Aripiprazole Accord
Do not stop your treatment just because you feel better. It is important that you continue to use Aripiprazole Accord 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):
Sleep problems;
Feeling unrestrained and unable to sit together, sitting problems in one place;
Uncontrolled twitching, convulsions or convulsions, restless leg syndrome;
Trembling and blurred vision;
A reduced number of stools or difficulty walking;
More saliva in the mouth than usual;
Feeling fatigued.
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);
Double vision;
Rapid heartbeat;
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)
Weight reduction;
Weight gain;
Suicidal thoughts, attempted suicide and suicide;
Strong gambling appeal;
A sense of aggression;
Combination of high fever, muscle stiffness, rapid breathing, sweating, blurred consciousness and sudden change 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, intoxication, fever, sweating, or stiffness in the muscles);
Speech disorders;
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 in 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;
Swallowing difficulties;
Abdominal discomfort;
Stomach discomfort;
Hepatic failure;
Inflammation of the liver;
Yellowing of the skin and white eyes;
Reports of liver function test abnormalities;
Skin rash;
Sensitivity to light;
Increased sweating;
Abnormal muscle breakdown that can lead to kidney problems;
Muscle pain;
Involuntary urine (incontinence);
Difficulty urinating;
Withdrawal symptoms in neonates in case of exposure during pregnancy;
Prolonged and / or painful erection;
Problems in body thermoregulation or overheating;
Chest pain;
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, except for insomnia, uncontrolled convulsions and shivers, restlessness and tiredness, which are very common (may affect more than 1 in 10 people) , And 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 (Mo To affect up to 1 in 10 people).

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 Aripiprazole Accord
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister, label or carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The packaging, a HDPE bottle, should be used within 30 days of the first opening. (For 30 pieces)
The HDPE bottle package should be used within 100 days of the first opening. (For 100 pieces)
Do not dispose of medicines in the sewage system 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 Aripiprazole Accord Contains
The active substance is aripiprazole.
Aripiprazole Accord 5 mg tablets: Each tablet contains 5 mg of aripiprazole.
Aripiprazole Accord 10 mg tablets: Each tablet contains 10 mg of aripiprazole.
Aripiprazole Accord 15 mg tablets: Each tablet contains 15 mg of aripiprazole.
Aripiprazole Accord 30 mg tablets: Each tablet contains 30 mg of aripiprazole.
The other ingredients are: lactose monohydrate, cellulose microcrystalline, corn starch, hydroxypropyl cellulose, magnesium stearate and indigo carmine aluminum lacquer (E132) (for 5 mg) or iron oxide, red (E172) (for 10 mg and 30 mg) Yellow (E172) (for 15 mg).

What the Aripiprazole Accord looks like and what the package contains
Aripiprazole Accord 5 mg tablets are blue, approximately 8.1 mm long, 4.6 mg wide, modified rectangular, biconvex, uncoated tablets debossed with "A5" on one side and smooth on the other.
Aripiprazole Accord 10 mg tablets are pink, about 8.1 mm long, 4.6 mg wide, modified rectangular, biconvex, uncoated tablets debossed with "A10" on one side and smooth on the other.
Aripiprazole Accord 15 mg tablets are yellow, approximately 7,14 mm in diameter, round, bevelled, biconvex, uncoated tablets debossed with "A15" on one side and smooth on the other.
Aripiprazole Accord 30 mg tablets are pink, about 9.1 mm in diameter, round, bevelled edges, biconvex, uncoated tablets with debossed "A30" on one side and smooth on the other.
Aripiprazole Accord 5/10/15/30 mg tablets are available in Aluminum / Aluminum perforated single dose blister packs containing 14 x 1, 28 x 1, 56 x 1 or 98 x 1 tablet.
Aripiprazole Accord 5/10/15 mg tablets are also available in a HDPE bottle with a PPCRC stopper containing 30 or 100 tablets.
Not all pack sizes may be marketed.


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