Sinutab ® Sinus Pain Extra Strength Tablets

SINUTAB ® SINUS PAIN EXTRA STRENGTH contains two analgesics (paracetamol and codeine), a decongestant (pseudoephedrine) and an antihistamine (chlorphenamine). It belongs to a class of medicines which are used to relieve the symptoms of cold and flu. SINUTAB ® SINUS PAIN EXTRA STRENGTH is used to relieve nasal and sinus congestion, fever, headaches and body pains from hay fever, cold and flu. Paracetamol is an analgesic and an antipyretic which means that it helps to relieve pain and fever (high temperature). Chlorphenamine is an antihistamine which helps to relieve coughing, sneezing, watery eyes, itchy and runny noses. Pseudoephedrine is a decongestant which helps unblock stuffy noses and blocked sinuses. Codeine is an analgesic which also helps to relieve headache, pain and body aches.

Do not take SINUTAB ® SINUS PAIN EXTRA STRENGTH • If you are hypersensitive (allergic) to paracetamol, codeine phosphate, pseudoephedrine, chlorphenamine or any of other ingredients in SINUTAB ® SINUS PAIN EXTRA STRENGTH. • If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOI)s in the last 14 days, which are used for depression. • If you suffer from chronic respiratory problems • If you have severe liver or kidney disease. • If you suffer from any type of cardiovascular disease, including angina, high blood pressure, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed angle glaucoma. • If you are undergoing anaesthesia with halothane or other halogenated anaesthetic agents.

Warnings and precautions

Take special care with SINUTAB ® SINUS PAIN EXTRA STRENGTH • SINUTAB ® SINUS PAIN EXTRA STRENGTH contains paracetamol which can cause severe liver or kidney damage when you take the tablets in excess of the recommended dose. • SINUTAB ® SINUS PAIN EXTRA STRENGTH may affect your attention and make you sleepy. This effect can be aggravated when SINUTAB ® SINUS PAIN EXTRA STRENGTH is used with alcohol or other medicines that also cause drowsiness or affect attention. • If you have kidney or liver problems. • If you have alcoholic dependence. • If you have difficulty passing water (urinary retention). • If you suffer from a prostate disease. • If you suffer from an obstruction in the stomach or intestines. • If you are receiving treatment for high blood pressure. • If you suffer from diabetes (high blood sugar levels). • If you have asthma or other respiratory conditions. • If you develop a severe skin reaction while taking SINUTAB ® SINUS PAIN EXTRA STRENGTH, contact your doctor immediately. • If you are over 60 years of age or in poor health. If pain or fever persists or gets worse, or if new symptoms occur, speak to your doctor.

Children and adolescents

Do not give SINUTAB ® SINUS PAIN EXTRA STRENGTH to children under 12 years of age.

DO NOT TAKE MORE THAN THE RECOMMENDED DOSE. Do not share medicines prescribed for you with any other person. The usual dose is: Adults and children over 12 years: One to two tablets every four to six hours. Do not take more than eight tablets in 24 hours. Always take SINUTAB ® SINUS PAIN EXTRA STRENGTH exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. If you have the impression that the effect of SINUTAB ® SINUS PAIN EXTRA STRENGTH is too strong or too weak, tell your doctor or pharmacist. If you take more SINUTAB ® SINUS PAIN EXTRA STRENGTH than you should Overdose may lead to liver damage. Signs may include lack of appetite, nausea, vomiting, excessive sweating, abnormal paleness of the skin and general feeling of being unwell. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, contact the nearest hospital or poison control centre. Take along the rest of the remaining SINUTAB ® SINUS PAIN EXTRA STRENGTH and the leaflet so that the doctor can easily tell what medicine you have taken. If you forget to take SINUTAB ® SINUS PAIN EXTRA STRENGTH If you forget to take a dose, take it as soon as you remember provided the last dose was at least four to six hours ago If it is almost time for your next dose, skip the missed dose and take SINUTAB ® SINUS PAIN EXTRA STRENGTH at the next scheduled time. Do not take a double dose to make up for the forgotten individual doses.

SINUTAB ® SINUS PAIN EXTRA STRENGTH can have side effects. Not all side effects reported for SINUTAB ® SINUS PAIN EXTRA STRENGTH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SINUTAB ® SINUS PAIN EXTRA STRENGTH, please consult your health care provider for advice. If any of the following happens, stop taking SINUTAB ® SINUS PAIN EXTRA STRENGTH and tell your doctor immediately or go to the casualty department at your nearest hospital: • Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. • Skin rash or itching. • Fainting. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SINUTAB ® SINUS PAIN EXTRA STRENGTH. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: Less frequent side effects: • Becoming unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than usual. • Abnormal blood test results for liver function tests have been observed less frequently. • Hallucinations (seeing or hearing things that are not there) and paranoid delusions. • Fits (seizures) have been experienced less frequently. These are all serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you notice any of the following: Frequent side effects: • Dizziness. • Drowsiness to deep sleep, including some difficulty performing tasks that require attention and concentration, confusion. • Headache. • Upset stomach, constipation. • Feeling sick (nausea), being sick (vomiting). • Difficulty in passing urine. • Blurred vision. • Dry mouth. • Tight chest, and thickened mucus. Less frequent side effects: • An increased heartbeat, an increased awareness of the heartbeat (palpitations) and high blood pressure, have been experienced less frequently. • Restlessness and sleep disturbances. • Irritability, anxiety, excitability. • Low blood pressure, tremor, shakiness, slurred speech, ringing in the ears, confusion, depression, lack of sleep, rash, mood changes, vomiting, diarrhoea and blood disorders. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SINUTAB ® SINUS PAIN EXTRA STRENGTH.

• Store all medicines out of reach of children. • Store at or below 25 °C. • Store in a cool, dry place. • Protect from light and moisture. • Do not remove the tablets from the outer carton until required for use. • Do not use your medicine after the expiry date stated on the label. • Return all unused medicine to your pharmacist. • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).