Aryzalera

Aripiprazole.

Each tablet contains 5 mg or 10 mg aripiprazole.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose, and magnesium stearate.
5 mg: indigo carmine (E132).
10 mg: red iron oxide (E172).

Aryzalera contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.

Aryzalera 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.
Aryzalera 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 Aryzalera.

Always take this medicine exactly as advised by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
The recommended dose for adults is 15 mg once a day. However the doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Use in children and adolescents above 13 years: Treatment may be started at a low dose with aripiprazole oral solution (liquid) form. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However the doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
If having the impression that the effect of Aryzalera is too strong or too weak, talk to the doctor or pharmacist.
Try to take the Aryzalera tablet at the same time each day. It does not matter whether taken with or without food. Always take the tablet with water and swallow it whole.
Even if feeling better, do not alter or discontinue the daily dose of Aryzalera without first consulting the doctor.
If the patient forgets to take Aryzalera: If the patient misses a dose, take the missed dose as soon as remembered but do not take two doses in one day.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

If the patient realises he/she has taken more Aryzalera tablets than the doctor has recommended (or if someone else has taken some of the Aryzalera tablets), he/she should contact the doctor right away. If the patient cannot reach the doctor, he/she should go to the nearest hospital and take the pack with him/her.

Do not take Aryzalera: if allergic to aripiprazole or any of the other ingredients of this medicine (listed in Description).

Talk to the doctor before taking Aryzalera if suffering 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 the patient notices that he/she is gaining weight, develops unusual movements, experiences somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell the doctor.
If an elderly patient is suffering from dementia (loss of memory and other mental abilities), the doctor must know if the patient has ever had a stroke or "mini" stroke.
Tell the doctor immediately if the patient is having any thoughts or feelings about hurting himself/herself. Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Tell the doctor immediately if the patient suffers from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Aryzalera with food, drink and alcohol: Aryzalera can be taken regardless of meals.
Alcohol should be avoided when taking Aryzalera.
Aryzalera contains lactose: If the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Driving and using machines: Do not drive or use any tools or machines, until the patient knows how Aryzalera affects him/her.
Use in Children: Aryzalera is not for use in children and adolescents under 13 years. Ask the doctor or pharmacist for advice before taking Aryzalera.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, the patient should ask the doctor for advice before taking this medicine.
The following symptoms may occur in newborn babies, of mothers that have used aripiprazole in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If the baby develops any of these symptoms the mother may need to contact the doctor.
Be sure to tell the doctor immediately if the patient is breast-feeding.
If the patient is taking Aryzalera, the patient 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.
Some people may feel depressed.
The following side effects have been reported since the marketing of aripiprazole 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 heart beat, 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, 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 the patient notices any of these symptoms, he/she should 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).
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.

Tell the doctor or pharmacist if the patient is, has recently taken or might take any other medicines.
Blood pressure-lowering medicines: Aryzalera may increase the effect of medicines used to lower the blood pressure. Be sure to tell the doctor if the patient takes a medicine to keep the blood pressure under control.
Taking Aryzalera with some medicines may need to change the dose of Aryzalera. It is especially important to mention the following to the 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 the patient gets any unusual symptom taking any of these medicines together with Aryzalera, the patient should see the doctor.

Store below 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Antipsychotics

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

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