Aripiprazole Actavis

Aripiprazole.

Each tablet contains 5 mg, 10 mg, or 15 mg of aripiprazole.
Excipients/Inactive Ingredients: The other ingredients are cellulose, microcrystalline Type 101, lactose monohydrate, maize starch, hydroxypropyl cellulose, cellulose, microcrystalline Type 102, magnesium stearate, purified water.

Aripiprazole Actavis Tablet is one of a group of medicines called antipsychotics.

Aripiprazole is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Actavis Tablet is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Actavis Tablet.

The recommended dose for adults is 15 mg once a day. However a lower or higher dose to a maximum of 30 mg once a day may be prescribed.
Use in children and adolescents: Aripiprazole Actavis Tablets may be started at a low dose with the oral solution (liquid) form. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However a lower or higher dose to a maximum of 30 mg once a day may be prescribed.
If patient has the impression that the effect of Aripiprazole Actavis Tablet is too strong or too weak, he/she should talk to the doctor or pharmacist.
Try to take the Aripiprazole Actavis Tablet at the same time each day. It does not matter whether the patient takes it with or without food. Always take the tablet with water and swallow it whole.
Even if patients feel better, do not alter or discontinue the daily dose of Aripiprazole Actavis Tablets without first consulting a doctor.
If patient forgets to take Aripiprazole Actavis Tablets: If patient misses a dose, take the missed dose as soon as remembered but do not take two doses in one day.

If patient realises he/she has taken more Aripiprazole Actavis Tablet than recommended (or if someone else has taken some of Aripiprazole Actavis Tablet), contact the doctor right away. If patient cannot reach the doctor, go to the nearest hospital and take the pack.

Do not take Aripiprazole Actavis Tablet if patient is allergic to aripiprazole or any of the other ingredients of this medicine (listed in Description).

Talk to the doctor before taking Aripiprazole Actavis Tablet if patient suffers from: High blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes; Seizure; Involuntary, irregular muscle movements, especially in the face; Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure; Blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots; Past experience of excessive gambling.
If patient notices he/she is gaining weight, develops unusual movements, experiences somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, tell the doctor.
Tell the doctor immediately if patient is having any thoughts or feelings about hurting one's self. Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Tell the doctor immediately if patient suffers from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
Pathological Gambling and Other Compulsive Behaviours: Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviours. Because patients may not recognize these behaviours as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviours may result in harm to the patient and others if not recognized.
Consider dose reduction or stopping the medication if a patient develops such urges.
Aripiprazole Actavis Tablets contains lactose: If patient has been told that he/she has an intolerance to some sugars, contact the doctor before taking this medicine.
Driving and using machines: Do not drive or use any tools or machines, until patient knows how Aripiprazole Actavis Tablets affects him/her.
Use in Children: Children and adolescents: Aripiprazole Actavis Tablets is not for use in children and adolescents under 13 years. Ask the doctor or pharmacist for advice before taking Aripiprazole Actavis Tablets.

Pregnancy: Patient should not take Aripiprazole Actavis Tablets if she is pregnant unless she has discussed this with a doctor. Be sure to tell a doctor immediately if patient is pregnant, thinks she may be pregnant, or if she is planning to become pregnant.
Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.
These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Aripiprazole Actavis Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding: Patient should be sure to tell a doctor immediately if she is breastfeeding. If patient is taking Aripiprazole Actavis Tablets, she should not breast-feed.

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): Uncontrollable twitching or jerking movements, headache, tiredness, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased production of saliva, light-headedness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.
Uncommon side effects (may affect up to 1 in 100 people): Some people may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate or double vision. Some people may feel depressed. Some people may experience altered or increased sexual interest and increased blood levels of the hormone prolactin. Hiccups.
The following side effects have been reported since the marketing of Aripiprazole Tablets but the frequency for them to occur is not known (frequency cannot be estimated from the available data): Changes in the levels of some blood cells; unusual heartbeat, sudden unexplained death, heart attack; allergic reaction (e.g. swelling in 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 level in the blood; weight gain, weight loss, anorexia; nervousness, agitation, aggression, feeling anxious, excessive gambling; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), 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 in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if patient notices any of these symptoms, seek medical advice 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 white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/or painful erection; difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.
Additional side effects in children and adolescents: Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).
Reporting of side effects: If patient gets any side effects, he/she should talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. By reporting side effects, the patient can help provide more information on the safety of this medicine.

Other medicines and Aripiprazole Actavis Tablets: Tell the doctor or pharmacist if patient is taking, has recently taken or might take any other medicines.
Blood pressure-lowering medicines: Aripiprazole Actavis Tablets may increase the effect of medicines used to lower the blood pressure. Be sure to tell the doctor if patient takes a medicine to keep his/her blood pressure under control.
Taking Aripiprazole Actavis Tablets with some medicines may need to change the dose of Aripiprazole Actavis Tablets. It is especially important for patient to mention the following to a doctor: Medicines to correct heart rhythm; Antidepressants or herbal remedy used to treat depression and anxiety; Antifungal agents; Certain medicines to treat HIV infection; Anticonvulsants used to treat epilepsy.
Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John's Wort and venlafaxine.
These medicines increase the risk of side effects; if patient gets any unusual symptom taking any of these medicines together with Aripiprazole Actavis Tablets, patient should see a doctor.
Aripiprazole Actavis Tablets with food, drink and alcohol: Aripiprazole Actavis Tablets can be taken regardless of meals.
Alcohol should be avoided when taking Aripiprazole Actavis Tablets.

Do not throw away any medicines via wastewater or household waste.
Ask the pharmacist how to throw away medicines patient no longer use.
These measures will help protect the environment.

Antipsychotics

N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.

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