Ariphrenz 5 mg Tablets

Ariphrenz contains the active substance aripiprazole and belongs to a group of medicines called antipsychotic.

Schizophrenia:

Ariphrenz is used to treat adults 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.

Bipolar mania:

Ariphrenz is used to treat patients with a mental health condition that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression), having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

Do not take Ariphrenz:

• If you are allergic to aripiprazole or any other ingredients of this medicine,
• If you are under the age of 18

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ariphrenz tablets.

Warnings and special precautions

Take special care with Ariphrenz if:

• you are having any thoughts or feelings about hurting yourself (feeling suicidal),
• you have high blood sugar (characterised by the symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes,
• you get fits (seizures) since your doctor may want to monitor you more closely,
• you have involuntary, irregular muscle movements, especially in the face,
• you have cardiovascular disease (disease of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure,
• you have blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots,
• you have experience with excessive gambling,
• you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms,
• you are an elderly patient suffering from dementia (loss of memory and other mental abilities),
• if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

If you notice that you are developing urges or cravings to behave in ways that are unusual for you, and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorder and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.

Ariphrenz may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are an elderly patient or have some debility.

If you have difficulty in eating or swallowing food or liquid (dysphagia), this could lead to tube feeding, with a resultant food and drink entering the lungs (referred to as aspiration). Aspiration could lead to risk of infection of the lungs (pneumonia).

Attention deficit - hyperactivity disorder (ADHD) often co-exists with bipolar disorder in adults. Caution should be taken in these patients when aripiprazole and stimulants, such as atomoxetine, are given together. Your doctor may need to adjust or stop your dose.

Children and adolescents:

Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Using other medicines with Ariphrenz:

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Always inform your doctor if you take any medication as this may interact with Ariphrenz.

Do not take the following list of medicines with Ariphrenz and tell your doctor if you are taking any of these:

• Blood pressure - lowering medicines: Ariphrenz 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 Ariphrenz with some medicines may mean the doctor will need to change your dose of Ariphrenz or the other medicines. It is especially important to mention to your doctor if you are taking the following:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide),
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s Wort),
• antifungal medicines (such as ketoconazole, itraconazole),
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors e.g. indinavir, ritonavir),
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital),
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin),
• triptans (such as sumatriptan and zolmitriptan), tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain.

Do not share medicines prescribed for you with any other person. Always take Ariphrenz exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is as follows: The recommended dose is 10 mg - 15 mg once a day with a maintenance dose of 15 mg daily with or without meals. Your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you take more Ariphrenz than you should: In the event of overdosage, contact your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take Ariphrenz: If you forget to take your tablets, take them as soon as you remember. However, if it is nearly time for the next tablets, skip the missed tablets. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ariphrenz: Keep taking Ariphrenz tablets for as long as your doctor has told you. Do not stop your treatment just because you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Ariphrenz can have side effects. Not all side effects reported for Ariphrenz are included in this leaflet. Should your general health worsen while taking Ariphrenz please consult your doctor, pharmacist, or other healthcare professional for advice.

If any of the following happens, stop taking Ariphrenz and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sudden signs of allergy such as rash, hives (also known as nettle rash or urticaria), severe irritation of your skin, swelling of the face, lips, tongue, or other parts of the body. These may be signs of a severe allergic reaction.
• Severe skin disorders with peeling and/or rashes with small pustules (with a fever) or blistering of the skin, mouth, eyes and genitals, with fever, chills, aching muscles and generally feeling unwell.
• A tingling sensation, numbness or weakness in your limbs.

Severe lack of appetite, feeling sick (nausea), being sick (vomiting), unusual, tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of the eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a liver problem.

Shortness of breath, unexpected weight gain. Swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night. These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs.

Serious diabetes complications, such as diabetic coma (a life threatening disorder that causes unconsciousness).

Sudden unexplained death, heart stops beating (cardiac arrest). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side - effects:

• Difficulty sleeping, feeling anxious, feeling restless and unable to keep still, difficulty sitting still, uncontrollable twitching, jerking or writhing movements, restless legs, trembling, headache, tiredness, weakness, sleepiness, light-headedness, shaking, blurred vision,
• Decreased number of or difficulty making bowel movements, indigestion, feeling sick, more saliva in mouth than normal, vomiting.

Less frequent side - effects:

• Low levels of white blood cells, low levels of blood platelets, high blood sugar (diabetes), not enough sodium in the blood,
• Higher than normal blood levels of the hormone prolactin, decreased prolactin levels,
• Loss of appetite (anorexia),
• Depression, altered or increased sexual interest, agitation, persistent, unwanted erection of the penis,
• Uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), muscle disorder causing twisting movements (dystonia), speech difficulty, double vision, sensitivity to light,
• Fast heartbeat, a fall in blood pressure on standing up which causes dizziness, high-headedness or fainting,
• Hiccups, infection of the lungs due to food or fluid (aspiration pneumonia),
• Liver failure, inflammation of the liver,
• Inflammation of the pancreas, difficulty swallowing foods and liquids, loose watery stool (diarrhoea),
• Allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching),
• Inability to regulate core body temperature, chest pain, swelling in your lower legs or hands,
• Increased blood pressure on standing.

Frequency unknown:

• Weight loss, weight gain,
• Thoughts of suicide, suicide attempt and suicide, feeling aggressive, agitation, nervousness, binge eating, compulsive shopping, tendency to wander away,
• Combination of fever, muscle stiffness, faster breathing, 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),
• Spasmodic movement of the eyeballs into fixed position, usually upward,
• Fast heart rhythm, abnormal heart rhythm, irregular slow heart rate,
• Contraction of the vocal cords, abnormal contraction of the muscle on the throat, stomach pain,
• Hair loss, excessive sweating, heightened skin sensitivity to sunlight,
• Muscle injury, muscle pain, muscle stiffness,
• Loss of bladder control, difficulty in urinating,
• Withdrawal symptoms in newborn babies including shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding (see “Pregnancy and breastfeeding”),
• High blood pressure, loss of consciousness, clots in the veins.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C (room temperature). Store in the original package until ready for use. KEEP ALL MEDICINES OUT OF REACH OF CHILDREN. Do not use the medicine after the expiry date shown on the label or carton. Return the expired medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).