Go Pain Paracetamol 500 mg Film-Coated Tablets

GO PAIN PARACETAMOL Tablets contain paracetamol, a medicine which has analgesic (pain reliever) and antipyretic (reduces fever) activity. GO PAIN PARACETAMOL Tablets are therefore used in the relief of mild to moderate pain and fever such as headaches, toothache and pain associated with colds and flu.

Do not take GO PAIN PARACETAMOL Tablets if:

• you are hypersensitive (allergic) to paracetamol or any of the other ingredients of GO PAIN PARACETAMOL Tablets.
• you suffer from severe liver function impairment.

Warnings and precautions

Special care should be taken with GO PAIN PARACETAMOL Tablets: GO PAIN PARACETAMOL Tablets contain paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor hospital or Poison Centre must be contacted immediately.

• if you take more GO PAIN PARACETAMOL Tablets than you should as it can cause damage to your liver.
• if pain or fever persists or gets worse at the recommended dosage, or if new symptoms occur.
• do not take GO PAIN PARACETAMOL Tablets continuously for pain for more than 7 days in adults (5 days for children); and for fever for more than 3 days. Consult your doctor if your symptoms worsen or do not improve after these periods.
• when suffering from hepatitis or alcoholism, or recovering from any form of liver disease.
• if you are suffering from moderate renal failure or are on dialysis as this may increase the concentration of GO PAIN PARACETAMOL Tablets in the blood.
• if you are diagnosed with renal impairment, chronic malnutrition or dehydration.
• if you experience any serious skin reactions, often together with flu-like symptoms after you start taking GO PAIN PARACETAMOL Tablets. Stop taking GO PAIN PARACETAMOL Tablets and seek urgent advice from your doctor. The skin reactions such as swelling, itching, red severe rash especially those covering the whole body (appearing as allergic wheals) may progress to widespread blistering or peeling of the skin and can be a serious reaction to GO PAIN PARACETAMOL Tablets, called severe cutaneous adverse reactions (SCARs) (see section 4, Possible side effects).

Children

Do not give GO PAIN PARACETAMOL Tablets to children between the ages of 0 and 6 years because it is unlikely to be safe.

Other medicines and GO PAIN PARACETAMOL Tablets

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following medicines:

• medicines that may be damaging or destructive to liver cells.
• medicines that increase liver enzymes and may therefore result in a further risk for liver damage and a possible decrease in therapeutic effect of GO PAIN PARACETAMOL Tablets.
• certain medicines for nausea and vomiting like metoclopramide and domperidone which may accelerate the absorption of GO PAIN PARACETAMOL Tablets.
• medicines used to treat gout and high blood levels of uric acid, such as probenecid, can decrease the elimination of GO PAIN PARACETAMOL Tablets from the body.
• certain medicines, such as cholestyramine, that are used to lower high cholesterol levels, may reduce the absorption of GO PAIN PARACETAMOL Tablets if given within one hour after taking GO PAIN PARACETAMOL Tablets.
• prolonged concurrent use of GO PAIN PARACETAMOL Tablets with salicylates, such as aspirin, increases the risk of adverse kidney effects.
• chronic use of isoniazid and/or rifampicin, antibiotic medicines often prescribed for tuberculosis. It may increase the risk of liver damage when combined with GO PAIN PARACETAMOL Tablets, even at recommended doses.
• warfarin or other blood thinning medicines (anticoagulants) together with GO PAIN PARACETAMOL Tablets may increase the risk of bleeding. Your doctor might monitor your blood clotting factors more regularly.
• medicines used for epilepsy, such as carbamazepine, phenobarbital, phenytoin, or primidone. Your doctor might lower the dosage of GO PAIN PARACETAMOL Tablets.
• zidovudine used to treat viral infections and co-trimoxazole used to treat bacterial infections. These medicines together with GO PAIN PARACETAMOL Tablets can cause damage to the liver.
• the effect of Interferon alfa used to treat cancers and viral infections, can be increased when used together with GO PAIN PARACETAMOL Tablets and your doctor might change the dose.

Pregnancy, breastfeeding and fertility

GO PAIN PARACETAMOL Tablets are generally considered safe for use during pregnancy, if used infrequently (not daily / not on most days). GO PAIN PARACETAMOL Tablets are distributed into breastmilk, in amounts too small to be considered harmful to a breastfed infant. No significant adverse effects have been seen in breastfed infants whose mothers received paracetamol as contained in GO PAIN PARACETAMOL Tablets. If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking GO PAIN PARACETAMOL Tablets.

Driving and using machinery

It is not always possible to predict to what extent GO PAIN PARACETAMOL Tablets may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which GO PAIN PARACETAMOL Tablets affects them.

Do not share medicines prescribed for you with any other person. Always take GO PAIN PARACETAMOL Tablets exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

Children under 6 years: Not recommended.

Children 6 – 12 years: Take ½ - 1 tablet every 6 hours orally. Not more than 4 doses to be taken in any 24-hour period for not longer than 5 days.

Children over 12 years: Take 1 tablet every 4 – 6 hours orally. Not more than 4 tablets to be taken in any 24-hour period.

Adults: Take 1 – 2 tablets every 4 – 6 hours orally. Not more than 8 tablets to be taken in any 24-hour period.

If you take more GO PAIN PARACETAMOL Tablets than you should GO PAIN PARACETAMOL Tablets contain paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. Paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 – 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates (medicine to treat anxiety), isoniazid (antibiotic to treat tuberculosis), rifampicin (medicine to treat tuberculosis), phenytoin (medicine to treat epilepsy) and carbamazepine (medicine to treat epilepsy).

Symptoms in the first 24 hours of paracetamol overdosage include pale skin, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by evaluation of the serum blood levels by your doctor. Liver damage may lead to a decrease in brain function (encephalopathy), coma and death. Acute kidney failure may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis (when too much acid accumulates in the body) may occur. Cardiac arrhythmias (irregular heartbeats) have also been reported. Overdose during pregnancy when metabolites of paracetamol crosses the placenta and which may result in toxic liver metabolites and cause liver toxicity in the foetus.

If you forget to take a dose of GO PAIN PARACETAMOL Tablets do not take a double dose to make up for forgotten individual doses. Take the dose as soon as you remember, but do not exceed the recommended daily dose.

GO PAIN PARACETAMOL Tablets can have side effects. Not all side effects reported for GO PAIN PARACETAMOL Tablets are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GO PAIN PARACETAMOL Tablets, please consult your healthcare professional for advice.

If any of the following happens, stop taking GO PAIN PARACETAMOL Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic reaction, e.g. swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing; rash or itching; fainting; low blood pressure (hypotension),
• serious skin reactions called severe cutaneous adverse reactions (SCARS). SCARS are a group of potentially very serious adverse drug reactions that can be fatal and involve the skin and mucous membranes (the moist, inner lining of some organs and body openings, such as the nose, mouth, lungs, and stomach). Examples of SCARs includes toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/ drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruption (FDE) (see also section 2, Warnings and precautions).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to GO PAIN PARACETAMOL Tablets. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: The following side effects have been reported less frequently:

• feeling tired, pale skin, shortness of breath, light-headedness, dizziness or a fast heartbeat, increase in nose bleeds or unusual bleeding (blood test shows changes in the blood cell counts),
• loss of hearing,
• high blood pressure,
• inflammation of the pancreas (you may have pain in the upper part of your belly, nausea and vomiting),
• inflammation of the liver (you may feel nauseas, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine),
• pain caused by kidney stones,
• kidney problems (you may have blood in your urine, cloudy urine, change in how frequent you want to urinate),
• itching, red and inflamed skin.

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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 By reporting side effects, you can help provide more information on the safety of GO PAIN PARACETAMOL Tablets.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Store in the original package / container.
• Do not store in a bathroom
• Do not use after the expiry date stated on the label / carton / bottle
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• GO PAIN PARACETAMOL Tablets has a shelf life of 48 months if stored correctly.