Bio – Sulpiride Tablets

BIO-SULPIRIDE 200 belongs to a group of medicines called benzamides. It works by blocking the effect of a chemical in the brain. BIO-SULPIRIDE 200 is used to treat acute episodes of schizophrenia (a mental illness with behaviour problems), and the prevention of future episodes.

Do not take BIO - SULPIRIDE 200:

• If you are hypersensitive (allergic) to sulpiride or any of the other ingredients of BIO - SULPIRIDE 200 (listed in section 6).
• If you have a tumour on the adrenal gland called phaeochromocytoma.
• If you are pregnant or breastfeeding your baby.
• If you have bone marrow depression.
• With any other medication that may decrease your white blood cell count or affect the cellular elements of the blood. If you are unsure, please ask your doctor or pharmacist.
• If you have porphyria, which affects your metabolism of medicine.
• If you suffer from prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Prolactin is a hormone.
• If you are taking levodopa, amantadine, bromocriptine, cabergoline, lisuride, pergolide, piribedil or ropinirole used for Parkinson’s disease (see “Other medicines and BIO-SULPIRIDE 200”).
• If you have a heart condition that involves the prolongation of the QT interval.

Warnings and precautions
Take special care with BIO - SULPIRIDE 200 if:

• you have periods of aggressive behaviour or are very agitated
• you have kidney problems
• you have ever had a stroke.
• you have heart problems or a family history of heart problems and your doctor instructed that you should avoid any fall in your blood pressure
• you have Parkinson’s disease
• you have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these.
• you have diabetes
• you are 65 years of age or older
• you have dementia
• you are currently on medication to treat your high blood pressure that belongs to the adrenergic neurone blocker class (e.g. guanethidine). Your dosage may need to be adjusted
• you have epilepsy or have had fits (seizures)
• you have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual
• you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia'
• medicines of this type (antipsychotics) can cause a combination of fever, muscle rigidity and vegetative symptoms, such as sweating or faster breathing (called “neuroleptic malignant syndrome”). If this happens, treatment must be stopped and you should talk to a doctor immediately
• you have high blood pressure
• you have a type of bowel obstruction (ileus)
• you have a digestive problem called congenital digestive stenosis
• you or your family have a history of stomach problems
• you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
• you have a history of glaucoma
• you have difficulty passing water (urine)
• you have an enlarged prostate.

Do not share medicines prescribed for you with any other person. Always take BIO-SULPIRIDE 200 exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Initial doses are 200 to 800 mg daily in divided doses, 8 or 12 hourly over 24 hours. Duration is one to six weeks. Usual maintenance dose is 600 - 800 mg daily in divided doses. Duration is as long as necessary. BIO-SULPIRIDE 200 should be given in reduced doses to elderly patients and patients with kidney problems. Your doctor will tell you how long your treatment with BIO-SULPIRIDE 200 will last. Do not stop treatment early without consulting your doctor. If you have the impression that the effect of BIO-SULPIRIDE 200 is too strong or too weak for you, tell your doctor or pharmacist. If you take more BIO - SULPIRIDE 200 than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest poison centre. If you forget to take BIO - SULPIRIDE 200 Do not take a double dose to make up for forgotten individual doses.

BIO-SULPIRIDE 200 can have side effects. Not all side effects reported for BIO-SULPIRIDE 200 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIO-SULPIRIDE 200, please consult your healthcare provider for advice. If any of the following happens, stop taking BIO-SULPIRIDE 200 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

• you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia'
• you get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia)
• abnormal fast heartbeat, life threatening irregular heartbeat including cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
• yellowing of the skin and eyes, also called jaundice
• movements of the tongue, mouth, jaw, arms and legs that you cannot control
• fits
• neuroleptic malignant syndrome (the syndrome is characterised by fever, involuntary continuous muscle tension and altered mental status such as confusion or memory loss)
• 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. If left untreated, it is possible that it could lead to a blockage of the main artery of the lung (pulmonary embolism). Symptoms of this include very fast or very slow, uneven forceful heartbeats. You may also have problems breathing such as wheezing, shortness of breath, tightness and or pain in your chest.
• muscle breakdown resulting in kidney damage (rhabdomyolysis)
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)

• production of breast milk in men and abnormal production of breast milk in women
• difficulty sleeping (insomnia)
• feeling drowsy of sleepy
• feeling dizzy, light-headed or faint when you stand or sit up quickly
• rigid or stiff muscles, trembling or shaking, difficulty when moving
• feeling restless and not being able to keep still (akathisia)
• weight gain
• painful breasts in men and women, spontaneous flow of milk from the breast
• constipation
• problems with your liver, which will show up on blood tests
• a rash with both flat and raised parts

• arms or legs, for example, are stiff and difficult to move
• uncontrolled, involuntary muscle movement
• rolling of the eyes
• lower chambers of the heart (ventricles) beat very quickly or irregular
• feeling dizzy, light-headed or faint when you stand or sit up quickly
• breast enlargement
• loss of menstrual periods and menstrual irregularities
• difficulty in getting or keeping an erection or of ejaculating
• producing more saliva than usual

• blood disorders e.g., low numbers of red blood cells, your body doesn’t produce enough new blood cells or low levels of platelets
• feeling confused
• sleep disturbances, overstimulation, feeling agitated, dry mouth, depression
• There have been reports of sudden death with BIO-SULPIRIDE 200. These are possibly caused by heart problems
• high blood pressure
• you develop a lung infection after inhaling food, liquid, saliva or nasal secretions (pneumonia aspiration)
• dilated pupils, small pupils, blurred vision, scarred (white or clouded cornea)
• the level of sugar in your blood is too high
• high cholesterol levels
• blood tests showing less sodium than usual in your blood
• feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)
• difficulty urinating and completely emptying the bladder
• problems with your liver, which will show up on blood tests
• sun allergy, is an immune system reaction that is triggered by sunlight
• your neck becomes twisted to one side
• your jaw is tight and stiff
• condition caused when a baby withdraws from certain drugs he's exposed to in the womb before birth
• dangerous drop in body temperature or an abnormally high body temperature or overheating

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the securitainer, HDPE container or Patient-Ready-Pack.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).