Zolinda O.Soln 1mg/1ml 150ml P

What ZOLINDA is and what it is used for

• ZOLINDA contains the active substance aripiprazole and belongs to 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 flatness. People with this condition may also feel depressed, guilty, anxious or tense.
• ZOLINDA 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 ZOLINDA.
• ZOLINDA is used also for the management of irritability associated with autistic disorder.

Do not take ZOLINDA

• If you are allergic to aripiprazole or any of the other ingredients of this medicine.

Warnings and precautions

• Talk to your doctor before taking ZOLINDA.
• Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
• Before treatment with ZOLINDA, tell your doctor if you suffer from:
• high blood sugar (characterized by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes
• fits (seizures) since your doctor may want to monitor you more closely
• involuntary, irregular muscle movements, especially in the face
• cardiovascular diseases (diseases of the heart and circulation), 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 with excessive gambling.

How to take ZOLINDA

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Schizophrenia :
• The recommended dose for adults is 15 ml solution (corresponding to 15mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i.e. 30 ml) once a day.
• Use in children and adolescents
• The recommended dose for adolescents is 10 ml solution (corresponding to 10 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 ml (i.e. 30 mg) once a day.
• Irritability Associated with Autistic Disorder:
• Pediatric Patients (6 to 17 years)
• The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day. Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects

• Diabetes mellitus,
• 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,
• Sleepiness,
• Lightheadedness,
• Shaking and blurred vision,
• Decreased number of or difficulty making bowel movements,
• Indigestion,
• Feeling sick,
• More saliva in mouth than normal,
• Vomiting,
• Feeling tired.

How to store ZOLINDA

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Use within 6 months after first opening.

What ZOLINDA contains

• The active substance is aripiprazole: Each 1 ml of Zolinda oral solution contains 1 mg of aripiprazole.

What does ZOLINDA look like and contents of the pack

• A clear, colourless to light yellow syrup with a characteristic odour and taste of orange, free from particles of foreign matters.
• ZOLINDA oral solution is supplied in a 150ml Amber glass bottle, child resistant cap.