Kizofrin 25 mg/100 mg/200 mg/300 mg Tablets

The active substance is quetiapine. KIZOFRIN 25 mg: Each film-coated tablet contains quetiapine fumarate equivalent to quetiapine 25 mg. KIZOFRIN 100 mg: Each film-coated tablet contains quetiapine fumarate equivalent to quetiapine 100 mg. KIZOFRIN 200 mg: Each film-coated tablet contains quetiapine fumarate equivalent to quetiapine 200 mg. KIZOFRIN 300 mg: Each film-coated tablet contains quetiapine fumarate equivalent to quetiapine 300 mg. The other ingredients of KIZOFRIN are calcium hydrogen phosphate; cellulose microcrystalline; lactose; magnesium stearate; povidone; silica colloidal anhydrous; sodium starch glycolate and talc. The coating material of KIZOFRIN 25 mg contains hypromellose; iron oxide red (C.I. No: 77491); iron oxide yellow (C.I. No: 77492); macrogol / PEG 400 and titanium dioxide (C.I. No: 77891). The coating material of KIZOFRIN 100 mg contains hypromellose; iron oxide yellow (C.I. No: 77492); macrogol / PEG 400 and titanium dioxide (C.I. No: 77891). The coating material of KIZOFRIN 200 mg contains hypromellose; macrogol 400 and titanium dioxide (C.I. No: 77891). The coating material of KIZOFRIN 300 mg contains hypromellose; macrogol 400 and titanium dioxide (C.I. No: 77891).

KIZOFRIN belongs to a group of medicines called anti-psychotics. KIZOFRIN are used to treat some types of mental illness such as:

• Schizophrenia. Symptoms of schizophrenia include hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act, and feeling alone and confused.
• Manic episodes that occur with a bipolar disorder. Symptoms of mania include effects on your mood and feeling very “high” or excited. You may feel that you need to sleep less than usual. You may also be more talkative and have racing thoughts or ideas. You may also feel more irritable than usual.

Do not take KIZOFRIN:

• If you are hypersensitive (allergic) to quetiapine, or any of the other ingredients of KIZOFRIN.
• If you are pregnant or breast-feeding.
• In children and adolescents – Because the safety and effectiveness of KIZOFRIN has not been determined in this age group.
• If you have advanced liver and kidney problems.

Take special care with KIZOFRIN:

• Before taking KIZOFRIN, tell your doctor:

• If you have diabetes or are at risk of getting diabetes (e.g. if you are obese or have a family history of diabetes). If you have diabetes, your doctor will check your blood sugar levels regularly while you are taking KIZOFRIN.
• If you are at risk for getting diabetes, your doctor will monitor you for symptoms of high blood sugar such as excessive thirst and fluid intake, passage of large volume of urine, excessive eating and weakness.
• If you have liver or kidney problems.
• If you have heart problems.
• If you have had a stroke.
• If you have low blood pressure.
• If you have ever had a fit (seizure).

KIZOFRIN may cause lightheadedness or dizziness when getting up from a lying or sitting position, particularly when you first begin treatment. This is more likely to occur in elderly patients. Avoid getting up too fast from a sitting or lying position.

KIZOFRIN may cause a condition called “tardive dyskinesia”. Contact your doctor straight away if you develop any of the following symptoms of tardive dyskinesia: uncontrollable movements, mainly of your face or tongue.

KIZOFRIN may cause a condition called “neuroleptic malignant syndrome”. Contact your doctor straight away if you develop any of the following symptoms of neuroleptic malignant syndrome: extremely high body temperature, faster breathing, fast heart rate, sweating, stiff muscles, feeling very sleepy or faint, agitation; confusion; tremor (shakes); large increase in blood pressure.

KIZOFRIN may cause a worsening of depression or suicidal thoughts and behaviour whether or not you are taking antidepressant medication. Contact your doctor straight away if you are experiencing this condition.

If you are taking KIZOFRIN your doctor should be monitoring you at the beginning of your treatment or when you experience any changes in your dose to make sure you do not experience worsening of your symptoms or suicidality.

Taking KIZOFRIN with food and drink:

• KIZOFRIN can be taken with or without food.
• Be careful how much alcohol you drink. This is because the combined effect of KIZOFRIN and alcohol can make you feel sleepy.

KIZOFRIN should be taken twice a day, with or without food.

Adults:

• Your doctor will decide on your starting dose and may gradually increase it.
• After this the dose will usually be between 150 mg and 800 mg each day. It depends on your illness and needs.

Elderly people:

• If you are elderly your doctor may give you a lower dose.

Kidney and liver problems:

• If you have kidney and liver problems your doctor may give you a lower dose.

If you take more KIZOFRIN than you should:

The symptoms of overdose include sleepiness, increased rate of heart beat and low blood pressure. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of KIZOFRIN with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice. Always take KIZOFRIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of KIZOFRIN is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take KIZOFRIN:

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

KIZOFRIN can have side effects. If any of the following happens, stop taking KIZOFRIN and tell your doctor immediately to go to the casualty department of your nearest hospital:

• Hives/rash; difficulty breathing; swelling of your face, lips, tongue, or throat. These are all very serious side effects. If you have them, you have had a serious allergic reaction to KIZOFRIN. You may need urgent medical attention or hospitalization.
• Neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome include: extremely high body temperature, faster breathing, fast heart rate, sweating, stiff muscles, feeling very sleepy or faint, agitation; confusion; tremor (shakes); large increase in blood pressure (manifesting as symptoms of headache, blurred vision, vomiting and nosebleeds).
• KIZOFRIN may cause a condition called “Tardive dyskinesia”. Symptoms of tardive dyskinesia include: uncontrollable movements, mainly of your face or tongue.
• Seizures (fits)
• Painful erection of the penis which lasts for hours.
• Changes in vision

Tell your doctor if you notice any of the following side effects:

• feeling sleepy (this may go away with time, as you keep taking KIZOFRIN); dizziness; dry mouth; lack of energy; constipation; increased rate of heart beat; low blood pressure when standing (this may make you feel dizzy or faint); indigestion; weight gain; fainting; swelling of hands and feet due to retained fluid; stuffy nose; fever; lack of appetite; drowsiness; difficulty speaking;

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek contact the nearest hospital.

Store at or below 30 °C (room temperature). Do not remove the blister strip from the carton until required for use. Keep the container well closed. Store all medicines out of the reach and sight of children.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).