Compral Pain Powders Aspirin 453,6 mg/64,8 mg/324 mg

COMPRAL PAIN POWDERS belongs to a group of medicines called analgesic combinations. COMPRAL PAIN POWDERS is used for the symptomatic relief of mild to moderate pain such as headaches, dysmenorrhoea (painful menstrual period), pain in muscles and joints, dental pain and inflammation, pain associated with colds or flu and fever.

Do not take COMPRAL PAIN POWDERS:

• If you have or ever had a problem of your blood not clotting properly, have severe liver function problems or if you are taking medicines to reduce blood clotting.
• If you are hypersensitive (allergic) to aspirin or other NSAIDs, paracetamol, caffeine or to any of the other ingredients of COMPRAL PAIN POWDERS (listed in section 6).
• If you have a history of asthma, bronchospasm (sudden constrictions of the muscles of the passage ways by which air passes through the nose to the air sacs of the lungs), angioedema (painless swelling of the tissue layer under the skin), rhinitis (irritation and inflammation of the mucous membranes inside the nose), urticaria (hives), when you take aspirin or NSAIDsS. (NSAIDs-class of medicines which aspirin belongs to).
• If you have or ever had a stomach ulcer, damage or bleeding of the stomach related to previous use of aspirin and other NSAID’s (class of medicines which aspirin belongs to) including COMPRAL PAIN POWDERS.
• If you have kidney failure, liver failure or heart failure.
• If you have or ever had gout.
• If you are pregnant, do not use NSAIDs at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby.
• If your child is under the age of 18 years (see Warnings and precautions).

Warning and precautions

COMPRAL PAIN POWDERS contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose even if the person may not be showing or experiencing any symptoms, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Take special care with COMPRAL PAIN POWDERS:

• To not exceed the recommended daily dose as it may cause serious harm to your liver.
• COMPRAL PAIN POWDERS contains paracetamol. Do not take COMPRAL PAIN POWDERS if you are taking any other prescription or nonprescription medicines containing paracetamol due to the possibility of paracetamol overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
• To not give it to children and adolescents under the age of 18 years of age.
• If your symptoms do not improve within 10 days of continuous use, please consult your doctor.
• If no relief is obtained with the recommended dosage, consult your doctor. Excessive and prolonged use of COMPRAL PAIN POWDERS may be dangerous.
• Seek medical advice if cough persists, or if it is accompanied by high fever, skin rash or persistent headache.
• If you suffer from liver or kidney disease, you should take COMPRAL PAIN POWDERS under medical supervision.
• If you have existing liver disease as it increases the risk of paracetamol-related liver damage.
• If you are pregnant or plan to become pregnant, tell your doctor or health care provider. Taking NSAIDs at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs around 30 weeks of pregnancy or later (see Do not take COMPRAL PAIN POWDERS).
• Do not take NSAIDs such as COMPRAL PAIN POWDERS regularly during the third trimester of pregnancy. This may result in premature closure of the foetal ductus arteriosus in utero (closure before desirable time, of the unborn baby’s blood vessel which is part of the vessels connecting the lungs and heart), and possibly, in persistent pulmonary hypertension (high blood pressure in blood vessels of the lungs) of the new-born. The onset of labour may be delayed, and its duration increased (see Pregnancy, breastfeeding, and fertility).
• Avoid use of COMPRAL PAIN POWDERS with other systemic NSAID’s (non-steroidal antiinflammatory medicines, the class to which aspirin belongs) including cyclooxygenase-2(COX-2) selective inhibitors (e.g., piroxicam), due to the potential for additive undesirable effects. Serious hypersensitivity (allergic) reactions can occur and bronchospasm (sudden constrictions of the muscles of the passage ways by which air passes through the nose to the air sacs of the lungs) may suddenly occur in patients suffering from or with previous history of asthma, allergic disease or nasal polyps (sac like growths of inflamed tissue lining the nose or sinuses). See Other medicines and COMPRAL PAIN POWDERS.
• If you suffer from or have a previous history of asthma, allergic disease, or nasal polyps (sac like growths of inflamed tissue lining the nose or sinuses).
• If you are scheduled to undergo any surgical procedures as the use of COMPRAL PAIN POWDERS should be stopped several days before any scheduled surgical procedures.
• Aspirin, as in COMPRAL PAIN POWDERS, prevents blood cells called platelets from clumping together to form a clot, thereby increasing bleeding time. You should report any unusual bleeding symptoms to your doctor.
• If you suffer from G-6-PD deficiency (a hereditary condition leading to low red blood cell counts), you should consult your doctor, pharmacist, or healthcare professional. Taking high doses of Aspirin, as in COMPRAL PAIN POWDERS, more than 1g daily, may worsen acute haemolytic anaemia (increased red blood cell breakdown).
• Paracetamol, as in COMPRAL PAIN POWDERS, can cause serious skin reactions known as severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE). You can identify these reactions by severe skin peeling, painful blisters, extremely serious allergic skin reactions accompanied by fever or flu-like symptoms, facial swelling, and painful blisters, abdominal pains, abdominal heartbeat. If you experience any of these skin reactions, stop taking COMPRAL PAIN POWDERS and consult your doctor immediately.
• Aspirin may cause Reye’s syndrome. Reye’s syndrome is a rare but serious illness, in children and teenagers with chickenpox or influenza. Consult a doctor before using aspirin in such patients. For this reason, do not give COMPRAL PAIN POWDERS to children under 18 years of age unless prescribed by a doctor. If the child changes in behaviour with nausea and vomiting, consult your doctor because these symptoms could be an early sign of Reye’s syndrome.
• Check with your doctor before taking COMPRAL PAIN POWDERS if you:
• have a history of high blood pressure or heart disease, as you may experience water retention and swelling. Heart failure may suddenly occur.
• are an elderly, as you may experience an increased frequency of side effects especially having an ulcer, stomach, and intestinal bleeding, which may cause death. Your risk of experiencing these side effects is higher with increasing doses of COMPRAL PAIN POWDERS.
• have a history of ulcers, because your risk of having an ulcer, stomach and intestinal bleeding is higher, with increasing doses of COMPRAL PAIN POWDERS.
• have a history of:
• ulcerative colitis,
• stomach and intestinal diseases e.g. Crohn’s disease (inflammatory disease of the stomach and intestine),
• hiatus hernia (stomach pushing up into the chest),
• gastro-oesophageal reflux disease (digestive disorder which affects the lower gut sphincter),
• angiodysplasia (vascular malformation of the gut). These conditions may worsen.

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

DO NOT EXCEED THE RECOMMENDED DOSE

Not for use in children and adolescents under 18 years of age. Use the lowest effective dose for the shortest possible duration of treatment.

Adults: One powder to be taken after a meal with water. May be repeated every four hours, if necessary. Do not exceed six powders per day.

If you take more COMPRAL PAIN POWDERS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Paracetamol You will require specialised treatment as soon as possible. A delay in starting treatment may mean that antidote (medicine to counteract the overdose) is given too late to be effective. Usually, liver damage can only be confirmed after the time for effective treatment has passed. You may be prone to paracetamol poisoning if you take repeated high doses (greater than 5 -10 g/day) of COMPRAL PAIN POWDERS for several days, if you suffer from chronic alcoholism, chronic liver disease, AIDS, malnutrition, and if you use medicines such as barbiturates (for anxiety, insomnia and seizures), isoniazid (for tuberculosis), rifampicin (for tuberculosis), phenytoin (for seizures) and carbamazepine (for seizures).

Symptoms of paracetamol overdosage seen in the first 24 hours are:

• pale skin
• nausea
• vomiting
• loss of appetite

Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage.

Other symptoms are:

• liver damage or injury 12 to 48 hours after taking COMPRAL PAIN POWDERS but sometimes delayed.
• abnormalities of glucose breakdown
• excess quantity of acid in the blood.
• liver damage which may progress to disease of the brain, coma and death.
• Cardiac arrhythmias (irregular heartbeat)
• Inflammation of the pancreas
• Cerebral oedema (swelling of the brain) and nonspecific myocardial depression
• Acute renal failure

N-acetylcysteine should be given to all cases of suspected overdose as soon as possible, preferably within 8 hours of overdosage, although treatment up to 36 hours after overdosing may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.

IV (via the vein): An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection, given intravenously (IV) over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml of dextrose injection over the next 4 hours and then 100 mg/kg in 1 000 ml over the next 16 hours. The volume of Intravenous fluids should be modified for children.

Orally (by mouth) not the treatment of choice: 140 mg/kg dissolved in water may be taken initially, followed by 70 mg/kg solution every four (4) hours for seventeen (17) doses.

Aspirin Symptoms of aspirin overdosage include:

• dizziness
• tinnitus (ringing in the ears) or deafness
• vertigo (loss of balance)
• sweating
• nausea or vomiting
• mental confusion
• increased respiratory rate (number of breaths per minute)

In children serious signs of overdosage may develop rapidly. Uncommon features include vomiting of blood, high body temperature, low blood sugar, low potassium blood level, low platelet blood count, delayed blood clotting, blood flow disruption, kidney failure and non-heart related excess of fluid in the lungs. Central nervous system features including confusion, disorientation, coma and involuntary contraction of muscles are less common in adults than in children.

In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

Caffeine Symptoms of caffeine overdosage include:

• epigastric pain (pain in the upper region of the abdomen)
• vomiting
• diuresis (increased urination)
• facial flushing (an involuntary reddening of the face)
• cardiac arrhythmia
• restlessness
• excitement
• agitation
• anxiety
• convulsions (seizures)
• muscle tremor
• tinnitus (ringing in the ears)
• visual spot disturbances
• increased rate or rhythm of heartbeat
• abnormal heartbeats.

In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

If you forget to take a dose of COMPRAL PAIN POWDERS Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happen, stop taking COMPRAL PAIN POWDERS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Fever, skin rash, swelling of the lymph nodes and/or swelling of the face (also known as DRESS) The rash may be red or itchy with swelling but sometimes may be more serious and accompanied by fever and ulcers or abscesses.
• Blisters on your skin or inside your mouth, nose, vagina, or bottom.
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day).
• Other allergic reactions such as itching, or wheezing, coughing or difficulty breathing, or swelling of the lips and tongue.
• You experienced any bleeding from your stomach (symptoms can include blood in your stools or vomit)
• You experienced an increase in the number of nosebleeds or bruising.
• You experienced ringing in your ears or temporary hearing loss.
• You experienced any water retention.
• When used in children, changes in behaviour, nausea and vomiting occur (it could be early signs of Reye’s syndrome).
• Serious skin reactions such as swelling, itching, red severe rash especially those covering your whole body (appearing as allergic wheals). See section 2 (Warning and precautions, Take special care with COMPRAL PAIN POWDERS).

These are very serious side effects. If you have them, you may have had a serious reaction to COMPRAL PAIN POWDERS. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Less frequent: Paracetamol Blood related reactions including low blood platelet count, lack of white blood cells, and a type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number.
• Pyroglutamic aciduria (an inherited disorder of amino acid metabolism)
• Hearing loss
• Skin rashes and other allergic reactions such as itching, or wheezing, coughing or difficulty breathing, or swelling of the lips, tongue and face. The rash may be red or itchy with swelling but sometimes may be more serious and accompanied by fever and ulcers or abscesses.
• Liver problems (yellow eyes and skin, nausea, stomach pain).

Frequency unknown: Paracetamol Drug-induced hypersensitivity syndrome (severe reaction usually characterized by fever, rash, and multiorgan failure).

• Kidney problems
• High blood pressure
• Inflammation of the pancreas
• Fixed drug eruptions (these are dermatological manifestations of medicine reactions that often occur in the same location upon re-exposure to a medicine).

Aspirin Blood and lymphatic system disorders: Prolonged bleeding time, anaemia

• Immune system disorders: Hypersensitivity reactions
• Metabolism and nutrition disorders: Sodium retention and fluid retention
• Ear and labyrinth disorders: Temporary hearing loss
• Nervous system disorders: Dizziness, aseptic meningitis (inflammation of the tissues surrounding the brain and spinal cord), and headache
• Cardiovascular: Swelling, high blood pressure, heart failure
• Respiratory, thoracic, and mediastinal disorders: Difficulty in breathing or wheezing, worsening of asthma.
• Gastrointestinal: Ulcers in stomach or duodenum, gastrointestinal bleeding, which can sometimes cause death. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, faeces containing digested blood, vomiting blood, mouth ulcers and cold sores, worsening of inflammation of the colon and inflammatory disease which affects the stomach and intestinal tract, inflammation of the stomach.
• Hepatobiliary: Raised liver enzymes, Reye’s syndrome (in children and adolescents under the age of 18 years of age), which can be fatal that causes brain and liver damage. Usually occurs in children who have had a recent viral infection, such as chickenpox or the flu.
• Skin reactions: Raised bumps which contain fluid, including Stevens-Johnson syndrome (rare skin disorder) and severe skin reaction.
• Kidney and Urinary Disorders: Kidney problems, increased uric acid in urine. Prolonged use of high doses may lead to renal papillary necrosis (a type of damage that occurs in your kidneys).

Caffeine Gastrointestinal disorders: Nausea, increased stomach secretions and stomach ulcers.

• Cardiac disorders: Palpitations, tachycardia (abnormally fast heartbeat).
• Psychiatric disorders: Difficulty sleeping, restlessness, anxiety, irritability, and nervousness.
• Nervous system disorders: Dizziness, headache, convulsions (uncontrollable shaking that is rapid and rhythmic, with the muscles contracting and relaxing repeatedly), excitement, loss of one or more types of sensory perception and muscle tremor (involuntary movements).
• Vertigo (sensation of spinning or swaying).
• Tinnitus (ringing in the ears)
• Increased urination.

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, or nurse. 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 COMPRAL PAIN POWDERS. You may also report to Adcock Ingram Limited using the following e-mail address: [email protected].

Store all medicines out of reach of children. Store in airtight containers, protected from light at or below 25 °C. Do not store in a bathroom. Do not use after the expiry date stated on the polypaper or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).