Sinutab ® 200 mg/30 mg Tablets

SINUTAB ® 3-WAY contains a nonsteroidal anti-inflammatory (ibuprofen) and a decongestant (pseudoephedrine). It belongs to a class of medicines used to treat the common cold, nasal congestion and allergies. SINUTAB ® 3-WAY is used to relieve the symptoms of colds, sinusitis or the flu, including nasal congestion, headache, fever, body aches and pain. Ibuprofen is an anti-inflammatory medicine which helps to relieve pain, headache, inflammation and fever (high temperature). Pseudoephedrine is a decongestant which helps to unblock stuffy noses and clear nasal and sinus congestion.

Do not take SINUTAB ® 3-WAY

• If you are hypersensitive (allergic) to ibuprofen, pseudoephedrine or any of the other ingredients in SINUTAB ® 3-WAY (see What SINUTAB ® 3-WAY contains).
• If you are taking, or have taken in the last 14 days, medicines for depression, known as monoamine oxidase inhibitors (MAOIs) or linezolid, a medicine used to treat bacterial infections.
• If you have had an allergic reaction to aspirin or any other nonsteroidal anti-inflammatory medicines (such as asthma, swelling, shock or hives).
• If you have any form of heart disease.
• If you are going for, or just after you have had heart surgery.
• If you have high blood sugar (diabetes), a hyperactive thyroid, phaeochromocytoma (a rare tumour which affects your heart rate and blood pressure), closed-angle glaucoma (increased pressure in your eye), hyperexcitability, or you have difficulty in passing urine because of an enlarged prostate (if you are male).
• If you have liver disease.
• If you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.
• If you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication.
• If you suffer from or have a history of stomach ulcers, perforation or any form of gastrointestinal bleeding.
• If you are pregnant (20 weeks or more), trying to become pregnant or are breastfeeding (see Take special care with SINUTAB ® 3-WAY and Pregnancy, breastfeeding and fertility).
• Do not give SINUTAB ® 3-WAY to children that are younger than 12 years of age.
• If you are taking digoxin (used to treat heart conditions).

DO NOT TAKE MORE THAN THE RECOMMENDED DOSE. Do not share medicines prescribed for you with any other person.

• For oral use only. The usual dose is: Adults and children over 12 years: Take one tablet every four to six hours. DO NOT TAKE MORE THAN SIX TABLETS IN 24 HOURS. You should take the tablet with milk or food or after your meal. High fat meals will delay the absorption of pseudoephedrine, resulting in a delay in providing relief of symptoms. Do not take SINUTAB ® 3-WAY for fever for more than 3 days, or for colds for more than 7 days unless directed by your doctor. If cold and/or fever symptoms persist or worsen, or if new symptoms develop, talk to your doctor or pharmacist. Children under 12 years: Do not give SINUTAB ® 3-WAY to children under 12 years of age (see Do not take SINUTAB ® 3-WAY). Always take SINUTAB ® 3-WAY 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 ® 3-WAY is too strong or too weak, tell your doctor or pharmacist.

If you take more SINUTAB ® 3-WAY than you should

Overdose symptoms with ibuprofen include abdominal pain, nausea, vomiting, lethargy and drowsiness. Overdose symptoms with pseudoephedrine are nausea, vomiting, lack of sleep, tremors, widening of the pupils of the eyes, anxiety, hallucinations, seizures and changes in your heartbeat. 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 ® 3-WAY and the leaflet so that the doctor can easily tell what medicine you have taken.

If you forget to take SINUTAB ® 3-WAY

If you forget to take a dose, take it as soon as you remember provided the last dose was at least 6 hours ago. If it is almost time for your next dose, skip the missed dose and take SINUTAB ® 3-WAY at the next scheduled time. Do not take a double dose to make up for the forgotten individual doses.

SINUTAB ® 3-WAY can have side effects. Not all side effects reported for SINUTAB ® 3-WAY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SINUTAB ® 3-WAY, please consult your health care provider for advice.

If any of the following happens, stop taking SINUTAB ® 3-WAY 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 ® 3-WAY. 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:

• Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• Stop using SINUTAB ® 3-WAY immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with a sudden onset
• feeling sick
• vomiting
• confusion
• seizures
• changes in vision
• Presence of blood either in your stools or vomit.
• Peptic ulcers (breach in the membrane lining the digestive tract) or gastrointestinal bleeding which can be fatal.
• Becoming unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than usual.
• Abnormal blood test results for liver function tests, yellowing of your eyes or skin, vanishing bile duct syndrome (pain of your stomach area, experience a loss of appetite or itching).
• An increased heart rate (tachycardia) or a rapid, strong or irregular heartbeat (palpitations), or high blood pressure and heart failure.
• Stroke (sudden numbness or weakness in your face, arm or leg on one side of your body, slurred speech or blurred vision).
• Heart attack (chest pain, difficulty breathing, pain in your arm, back or neck, sweating or light-headedness).
• Asthmatic conditions and bronchospasm (difficulty breathing, wheezing or shortness of breath).

Severe skin rash, including blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), exanthematous pustulosis (small fluid (pus) filled bumps on your skin, redness and fever) or drug reaction with eosinophilia and systemic symptoms (DRESS) (skin rash, fever, swollen lymph nodes and inflammation) [see Warnings and precautions].

Painful or difficult urination or the inability to completely empty your bladder.

Inflammation of your kidneys or kidney failure (pain in your pelvic area, burning or painful urination, cloudy urine, drowsiness, fluid retention).

Hypothermia (sudden drop in body temperature).

Pancreatitis (pain of your stomach area which radiates to your back, nausea, vomiting, fever and increased heart rate).

Aseptic meningitis (fever, headache, body aches, sensitivity to light, vomiting).

Sudden onset of severe headache, nausea, vomiting, confusion, fits, visual disturbances. 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:

More frequent side effects:

• Gastrointestinal side effects which may include dry mouth, nausea and pain in the upper abdomen.
• Constipation, diarrhoea, indigestion (dyspepsia), vomiting and flatulence (excessive wind).
• Nervousness, lack of sleep, dizziness, tremor, drowsiness (somnolence), ringing in the ears (tinnitus), thirst and feeling of weakness (asthenia).
• Eye problems.

Less frequent side effects:

• Anxiety.

The following side effects have been reported but the frequencies are not known:

• Headache.
• Changes in vision.
• Euphoric mood (exaggerated feeling of optimism and well-being) or hallucinations (seeing or hearing things that are not real).
• Feeling of extreme restlessness.
• Paraesthesia (numb, burning or tingling sensation of your skin).
• Swelling of your arms, legs, hands or feet due to water retention.
• Jittery feeling.

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 ® 3-WAY. For further information, please contact the Johnson & Johnson via www.kenvuecontact.eu or call centre on 0860 410032 (landline).

• Store all medicines out of reach of children.

• Store at or below 25 °C.

• Store in a cool, dry place.

• 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).