Sudafed ® Sinus Pain Tablets

SUDAFED ® SINUS PAIN contains an analgesic (paracetamol) and a decongestant (pseudoephedrine). It belongs to a class of medicines which are used to relieve the symptoms of colds and flu. SUDAFED ® SINUS PAIN is used to help relieve the symptoms of a blocked nose or sinuses and helps to relieve pain (including sinus pain) and fever, caused by colds and flu.

Do not take SUDAFED ® SINUS PAIN:

• If you are hypersensitive (allergic) to paracetamol, pseudoephedrine or any of other ingredients in SUDAFED ® SINUS PAIN (see section 6).
• If you are taking or have taken monoamine oxidase inhibitors (MAOI) for depression within the last 2 weeks.
• If you are taking furazolidone.
• If you have severe liver or kidney disease.
• If you suffer from high blood pressure, heart disease, diabetes, phaeochromocytoma or an overactive thyroid.
• If you suffer from prostate disease or glaucoma (pressure in the eye).
• If you are taking any other cough and cold medicines or medicines containing paracetamol.
• If you are taking stimulants or appetite suppressants or medicines used to treat congestion and asthma (sympathomimetic medicines).

Safety in pregnancy and during breastfeeding has not been established.

Warnings and precautions

Take special care with SUDAFED ® SINUS PAIN:

• SUDAFED ® SINUS PAIN contains paracetamol which can cause severe liver or kidney damage when you take the tablets more than the recommended dose.
• If you suffer from an obstruction in the stomach or intestines.
• Do not use SUDAFED ® SINUS PAIN continuously for more than 10 days without consulting a doctor.
• If you have alcohol dependence, you should talk to your doctor before taking SUDAFED ® SINUS PAIN.
• If pain or fever persists or gets worse, or if new symptoms occur, speak to your doctor.

Stop taking SUDAFED ® SINUS PAIN if the following happens to you:

You develop any skin adverse reaction, such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), treatment with SUDAFED ® SINUS PAIN must immediately be discontinued. These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain. Should you experience any of these symptoms, contact your health care provider immediately.

Children and adolescents

Do not give SUDAFED ® SINUS PAIN to children under 12 years of age.

Other medicines and SUDAFED ® SINUS PAIN

Always tell your health care provider if you are taking any other medicines. (This includes complementary or traditional medicines.) Talk to your doctor or pharmacist before taking SUDAFED ® SINUS PAIN if you are taking or using:

• Sympathomimetic medicines (stimulants or appetite suppressants and medicines used to treat congestion).
• Antihypertensives (medicines for high blood pressure including alpha and beta blockers).
• Monoamine oxidase inhibitors, moclobemide or antidepressants (to treat mood disorders), antipsychotics (medicines used to treat mood disorders) and inhalation anaesthetics (for general surgery).
• Cardiac glycosides (medicines used to treat heart disorders).
• Anticoagulants (medicines that prevent blood clots, such as warfarin).
• Anticonvulsants (medicines used to treat epilepsy).
• Flucloxacillin (used to treat bacterial infections).

Ask your health care provider before use if you are taking the antibiotic flucloxacillin. Do not take SUDAFED ® SINUS PAIN with other medicines containing paracetamol or pseudoephedrine or medicines that have similar acting components. If you are not sure about any of the medicines you are taking, show the pack to your pharmacist or healthcare professional for advice.

SUDAFED ® SINUS PAIN with food, drink and alcohol:

Do not take SUDAFED ® SINUS PAIN with alcohol.

Pregnancy, breastfeeding and fertility:

Safety in pregnancy and during breastfeeding has not been established. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.

Driving and using machines:

It is not known if SUDAFED ® SINUS PAIN has an effect on the ability to drive or operate machinery. SUDAFED ® SINUS PAIN can cause dizziness. Do not drive or operate machinery until you know how it affects you. It is not always possible to predict to what extent SUDAFED ® SINUS PAIN may interfere with the daily activities of a patient. Do not engage in the above activities until you are aware of the measure to which SUDAFED ® SINUS PAIN affects you.

DO NOT TAKE MORE THAN THE RECOMMENDED DOSE.

Adults and children over 12 years: One tablet orally three times daily.

Children under 12 years: Not recommended.

Always take SUDAFED ® SINUS PAIN 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 SUDAFED ® SINUS PAIN is too strong or too weak, tell your doctor or pharmacist.

If you take more SUDAFED ® SINUS PAIN than you should:

Overdose may lead to liver damage. 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 SUDAFED ® SINUS PAIN and the leaflet so that the doctor can easily tell what medicine you have taken.

If you forget to take SUDAFED ® SINUS PAIN:

If you forget to take a dose, take it as soon as you remember provided the last dose was at least 8 hours ago. If it is almost time for your next dose, skip the missed dose and take SUDAFED ® SINUS PAIN at the next scheduled time. Do not take a double dose to make up for the forgotten individual doses.

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

If any of the following happens, stop taking SUDAFED ® SINUS PAIN 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 SUDAFED ® SINUS PAIN. 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:

• Heart disorders such as an irregular heart rhythm or heart failure.
• An increased heartbeat, an increased awareness of the heartbeat (palpitations).
• Difficulty in breathing (dyspnoea).
• 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.
• Posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) (symptoms such as headaches, seizures, vision problems, changes in your mental status).
• The inability to empty the bladder completely or partially (urinary retention), painful urination or difficulty in passing urine.
• Severe skin reactions, such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS), or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) (symptoms include red, inflamed, scaly or swollen skin, blisters, itching and sometimes peeling or painful skin rashes).

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: Headache.
• Nervousness.

Less frequent:

• Restlessness, difficulty falling or staying asleep (insomnia).
• Irritability, anxiety, feeling of fear, confusion.
• Involuntary shaking of one or more parts of your body (tremor).
• Weakness.

Frequency unknown:

• Sleep disturbances.
• Tingling or numbness of your hands and feet (pins and needles).
• High blood pressure.
• Low blood pressure with dizziness, fainting.
• Flushing.
• Nausea and vomiting.
• Diarrhoea, stomach pain.
• Loss of appetite.
• Increased saliva or sweating.
• Hives.
• Euphoria (an overwhelming feeling of happiness, joy, and well-being).
• Blood disorders or changes in your blood glucose levels.

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 SUDAFED ® SINUS PAIN. For further information, please contact the Johnson and Johnson call centre on 0860 410032 (landline).

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Protect from light.
• Keep dry.
• 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).