PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION
Toll Free No.: 1800 222 434 & 1800 222 825 Keeping medicines affordable | At Taj Pharma HELPING DELIVER LIFE-CHANGING THERAPIES All trademarks mentioned enjoy legal protection. www.tajpharma.com / www.tajoncology.com E-mail: info@tajpharma.com / tajgroup@tajpharma.com
Date of Revision: May 30th, 2019
Submission Control No: TAJ/1229
®
© 2019 Taj Pharmaceuticals Ltd. Trademarks are owned by or licensed to the Taj Pharmaceuticals Ltd.
.
Page 1
aripiprazole 10 tablet, aripiprazole high, aripiprazole 5 tablet, aripiprazole dosage, aripiprazole interactions, aripiprazole mechanism of action, aripiprazole 15 tablet, aripiprazole brand name, aripiprazole high, aripiprazole interactions, aripiprazole dosage, aripiprazole side effects, aripiprazole 10 mg, aripiprazole mechanism of action, aripiprazole 2mg, aripiprazole overdose, abilify reviews, aripiprazole interactions, aripiprazole high, abilify dosage, abilify for anxiety, what is good about abilify?, is abilify dangerous, abilify and alcohol, Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazoleis known as an antipsychotic drug (atypical type).
depressed, guilty, anxious or tense. Aripiprazole 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.
Package leaet: Information for the user Aripiprazole 5 mg tablets Aripiprazole 10 mg tablets Aripiprazole 15 mg tablets Aripiprazole 30 mg tablets Aripiprazole Read all of this leaet carefully before you start taking this medicine because it contains important information for you. • Keep this leaet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaet. See section 4. What is in this leaet 1. What Aripiprazole is and what it is used for 2. What you need to know before you take Aripiprazole 3. How to take Aripiprazole 4. Possible side effects 5. How to store Aripiprazole 6. Contents of the pack and other information 1. What Aripiprazole is and what it is used for Aripiprazole is one of a group of medicines called antipsychotics. It 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 atness. People with this condition may also feel
2. What you need to know before you take Aripiprazole Do not take Aripiprazole • 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 Aripiprazole if you suffer 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 you notice you are gaining weight, develop unusual movements, experience somnolence (sleepiness or drowsiness) that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor. If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you suffer from muscle stiffness or inexibility with high fever,
sweating, altered mental status, or very rapid or irregular heart beat. Children and adolescents Do not use this medicine in children and adolescents under 13 years. It is not known if it is safe and effective in these patients. Other medicines and Aripiprazole 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 may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control. Taking Aripiprazole with some medicines may need to change your dose of Aripiprazole. It is especially important to mention the following to your 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 uoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole, you should see your doctor. Aripiprazole with food, drink and alcohol Aripiprazole can be taken regardless of meals. Alcohol should be avoided. Pregnancy and breast-feeding 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 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 your baby develops any of these symptoms you may need to contact your doctor. Be sure to tell your doctor immediately if you
are breast-feeding. If you are taking Aripiprazole, you should not breast-feed. Driving and using machines Do not drive or use any tools or machines, until you know how Aripiprazole affects you. Aripiprazole 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 Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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 Aripiprazole 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 your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. If you have the impression that the effect of Aripiprazole is too strong or too weak, talk to your doctor or pharmacist. Try to take the Aripiprazole tablet at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole. Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole without first consulting your doctor. If you take more Aripiprazole than you should If you realise you have taken more Aripiprazole tablets than your doctor has recommended (or if someone else has taken some of your Aripiprazole tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you. If you forget to take Aripiprazole If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day. If you stop taking Aripiprazole Do not stop your treatment just because you feel better. It is important that you carry on
aripiprazole 10 tablet, aripiprazole high, aripiprazole 5 tablet, aripiprazole dosage, aripiprazole interactions, aripiprazole mechanism of action, aripiprazole 15 tablet, aripiprazole brand name, aripiprazole high, aripiprazole interactions, aripiprazole dosage, aripiprazole side effects, aripiprazole 10 mg, aripiprazole mechanism of action, aripiprazole 2mg, aripiprazole overdose, abilify reviews, aripiprazole interactions, aripiprazole high, abilify dosage, abilify for anxiety, what is good about abilify?, is abilify dangerous, abilify and alcohol, Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazoleis known as an antipsychotic drug (atypical type).
taking your Aripiprazole tablets for as long as your doctor has told you to. 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): • diabetes mellitus, • difficulty sleeping, • feeling anxious, • feeling restless and unable to keep still, difficulty sitting still, • uncontrollable twitching, jerking or writhing • indigestion, • feeling sick, • more saliva in mouth than normal, • vomiting, • feeling tired. Uncommon side effects (may affect up to 1 in 100 people): • increased blood levels of the hormone prolactin, • too much sugar in the blood, • depression, • altered or increased sexual interest, • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), • muscle disorder causing twisting movements (dystonia), • double vision, • fast heart beat, The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: • low levels of white blood cells, • low levels of blood platelets, • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), • onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, • high blood sugar, • not enough sodium in the blood, • loss of appetite (anorexia), • weight loss, • weight gain, • thoughts of suicide, suicide attempt and suicide, • excessive gambling, • feeling aggressive,
• agitation, • nervousness, • combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), • seizure, • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), • speech disorder, • sudden unexplained death, • life-threatening irregular heart beat, • heart attack, • slower heart beat, • 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 you notice any of these symptoms, seek medical advice immediately), • high blood pressure, • fainting, • accidental inhalation of food with risk of pneumonia (lung infection), • spasm of the muscles around the voice box, • inammation of the pancreas, • difficulty swallowing, • diarrhoea, • abdominal discomfort, • stomach discomfort, • liver failure, • inammation of the liver, • yellowing of the skin and white part of eyes, • abnormal muscle breakdown which can lead to kidney problems, • muscle pain, • stiffness, • involuntary loss of urine (incontinence), • difficulty in passing urine, • withdrawal symptoms in newborn babies in case of exposure during pregnancy, • prolonged and/or painful erection, • difficulty controlling core body temperature or overheating, • chest pain, • swelling of hands, ankles or feet, • in blood tests: uctuating blood sugar,
increased glycosylated haemoglobin. 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaet. 5. How to store Aripiprazole Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Aripiprazole contains • The active substance is aripiprazole. Aripiprazole 5 mg tablet contains 5 mg of aripiprazole. Aripiprazole 10 mg tablet contains 10 mg of aripiprazole. Aripiprazole 15 mg tablet contains 15 mg of aripiprazole. Aripiprazole 30 mg tablet contains 30 mg of aripiprazole. • The other ingredients are lactose monohydrate, maize starch, microcrystalline
cellulose, hydroxypropylcellulose, crospovidone type A, silica, colloidal anhydrous and magnesium stearate. The 5 mg tablets also contain indigo carmine aluminium lake (E132). The 10 mg and 30 mg tablets also contain iron oxide red (E172). The 15 mg tablets also contain iron oxide yellow (E172). What Aripiprazole looks like and contents of the pack Aripiprazole 5 mg tablets are blue colour, modified rectangular shaped, uncoated, mottled tablets debossed with ‘TAJ’ on one side and plain on other side. Aripiprazole 10 mg tablets are pink colour, modified rectangular shaped, uncoated, mottled tablets debossed with ‘TAJ’ on one side and plain on other side. Aripiprazole 15 mg tablets are yellow colour, round shaped, bevelled edge, uncoated, mottled tablets debossed with ‘TAJ’ on one side and plain on other side. Aripiprazole 30 mg tablets are pink colour, round shaped, bevelled edge, uncoated, mottled tablets debossed with ‘TAJ’ on one side and plain on other side. The tablets are supplied in blisters packed in cartons containing 28,50,100 & 500 tablets. Marketing Authorisation Holder Manufactured in India by: TAJ PHARMACEUTICALS LTD. GROUP Mumbai, India Unit No. 214.Old Bake House, Maharashtra chambers of Commerce Lane, Fort, Mumbai - 400001 at : Ahmedabad - Gujarat, INDIA. Code No.: PRINTED ON BOX. This leaet was last revised in April 2019.