Acurate Tablets

ACURATE has pain relieving, fever reduction and allergic reaction reduction properties. ACURATE can be used for mild to moderate pain associated with tension such as tension headache or muscle contraction, neuralgia (a sharp, shocking pain that follows the path of a nerve and is due to irritation or damage to the nerve), period pain and for pain relief following surgery or injury.

Do not take ACURATE:

• If you are hypersensitive (allergic) to paracetamol, doxylamine succinate, caffeine, codeine phosphate or any of the other ingredients of ACURATE (see section 6).
• If you suffer from severe liver and kidney function impairment.
• If you suffer from acute intermittent porphyria.
• If you are experiencing inadequate ventilation, especially if you are experiencing bluish coloration of your skin, secretion of phlegm in your lungs, head injury or a condition in which the pressure exerted on your brain is increased. ACURATE should not be taken during an attack of bronchial asthma or in heart failure caused by long term lung disease.
• If you suffer from acute alcoholism.
• If you are taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
• If you are pregnant.
• If you are known to be a CYP2D6 ultra-rapid metaboliser where you metabolise codeine into morphine very rapidly.

Warnings and precautions:

• Do not use continuously for longer than 5 days without consulting your doctor.
• If you use ACURATE along with alcohol or central nervous system depressants, you may experience drowsiness and impaired concentration.
• If you take more ACURATE than is prescribed, it may cause severe liver damage.
• If you suffer from liver or kidney disease you should take ACURATE under medical supervision.
• If you suffer from high blood pressure, hypothyroidism, adrenocortical insufficiency (hormonal problems), myasthenia gravis (a condition which weakens muscles), an enlarged prostate, problems with passing urine, shock, inflammatory or obstructive bowel syndrome.
• If you have acute abdominal (stomach) conditions (e.g. peptic ulcer), recent gastrointestinal surgery, gallstones, a history of irregular heartbeats or fits.
• If you have a history of drug abuse, mood swings or are under psychiatric treatment.
• If you have asthma.
• If you are elderly or debilitated.
• If you suffer from porphyria, glaucoma or prostatic hypertrophy.
• Exceeding the prescribed dose, together with prolonged and continuous use of ACURATE, may lead to dependency and addiction.
• If you develop any adverse skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-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), treatment with ACURATE must be discontinued immediately. 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 healthcare provider immediately.

Other medicines and ACURATE:

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Do not share ACURATE with any other person. Always use ACURATE exactly as described in this leaflet or as your healthcare provider has told you. Check with your healthcare provider if you are not sure. The usual dose for adults and children 12 years and older is 2 tablets every 4 hours as needed. Do not exceed 8 tablets per day. Do not use continuously for longer than 5 days without consulting your doctor. If you have the impression that the effect of ACURATE is too strong or too weak, talk to your doctor or pharmacist. ACURATE tablets must be swallowed.

If you take more ACURATE than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. This product contains 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.

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

• swelling of the hands, feet, ankles, face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• itchy, lumpy skin rash (hives) or nettle rash (urticaria)
• rash, fever, swelling, bruising or tiredness
• difficulty in breathing or dizziness

These are all very serious side effects. If you have them, you may have had a serious reaction to ACURATE. 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:

• severe stomach pain, which may reach to your back, as this could be a sign of inflammation of the pancreas (pancreatitis)
• you get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis or thrombocytopenia)
• yellowing of the skin or the whites of the eyes
• skin reactions such as toxic epidermal necrolysis (TEN), Stevens-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). These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain (sometimes accompanied by fever) (see Warnings and precautions).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following frequent side effects which lasts longer than a few days or gets serious:

• drowsiness
• constipation
• headaches, psychomotor impairment (slowed speech, decreased movement and impaired mental function)

Tell your doctor if you notice any of the following which may occur less frequently and lasts longer than a few days or gets serious:

• skin reactions
• loss of appetite
• hallucinations, nightmares, mental depression, confusion, depression, sleep disturbances
• dizziness, fits, uncontrolled muscle movements, muscle stiffness
• blurred or double vision
• irregular heartbeat
• sweating, facial flushing, low blood pressure (causing light-headedness or fainting when standing up)
• shortness of breath
• nausea (feeling sick), vomiting (being sick), dry mouth, stomach cramps
• difficulty passing urine, increased frequency of urination, decreased urine
• feeling unwell, tiredness.

Tell your doctor if you notice any of the following which may also occur:

• dependence on ACURATE (when you need to take ACURATE for longer periods of time or you need to take more than the recommended dose or if you stop taking ACURATE you feel very unwell but you feel better if you start taking ACURATE again)
• restlessness, excitement
• difficulty sleeping
• ringing in the ears
• increased stomach acid, stomach ulcers
• thick phlegm.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. 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 ACURATE.

KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN. Store at or below 25 °C in a dry place, in order to protect from moisture. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).