Triparc

TRIPARC is an analgesic combination of aspirin, paracetamol and caffeine and is used for the symptomatic relief of mild to moderate pain and fever such as headaches, toothache, colds and flu.

Do not take TRIPARC:

• If you are hypersensitive (allergic) to aspirin, paracetamol, caffeine or any of the other ingredients of TRIPARC (listed in section 6).
• If you have a history of hypersensitivity reactions e.g. 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), rhinitis, irritation and inflammation of the mucous membranes inside the nose, urticaria (hives), nasal polyps (sac like growths of inflamed tissue lining the nose or sinuses) when you take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have a history of internal bleeding of the stomach or intestines, ulcers or perforation (PUBs) related to previous non-steroidal anti-inflammatories (NSAIDs) treatment, or if you have an active recurrent ulcer, bleeding or perforation of the stomach or intestines.
• If you suffer from haemophilia (bleeding disorder), that is if you have or ever had a problem of your blood not clotting properly.
• If you have kidney failure.
• If you have liver failure.
• If you are currently receiving oral anti-coagulant therapy (warfarin).
• If you suffer from heart failure.
• If you have a history of gout.
• If you are breastfeeding (see section on Pregnancy and breastfeeding).
• If you are pregnant and you are in the last 3 months of pregnancy.
• If your child is under the age of 12 years (see Children and adolescents).

Warnings and precautions

Take special care with TRIPARC:

• If you are taking more than the recommended dosage as this may cause severe damage to your liver.
• If you suffer from heart disease as TRIPARC could make your condition worse (see Do not take TRIPARC).
• TRIPARC contains paracetamol which may be fatal in overdose. In the event of overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.
• If you have liver or kidney disease as paracetamol as in TRIPARC should be used under medical supervision.
• Do not use continuously for more than 10 days without consulting your doctor.
• If you have a history of hypertension (high blood pressure) and/or heart disease as TRIPARC can make your condition worse. You may experience water retention and swelling (see Do not take TRIPARC).
• If you are an elderly person or you are suffering from dehydration as side effects are more common.
• If you have a history of stomach ulcers or are of advanced age, the risk of internal bleeding of the stomach or intestines or ulcers is higher if you take large amounts of TRIPARC. If you suspect that you have an ulcer, treatment with TRIPARC should be stopped and you should consult your doctor (see Do not take TRIPARC).
• If you have a history of stomach and intestinal diseases e.g. inflammatory disease of the stomach and intestine, stomach pushing up into the chest, digestive disorder which affects the lower gut sphincter and vascular malformation of the gut, as these conditions may worsen (see Do not take TRIPARC).
• If you are scheduled to undergo any surgical procedures as the use of TRIPARC should be stopped several days before any scheduled surgical procedures.
• 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.
• You should not use TRIPARC long term as it may cause iron deficiency anaemia (decreased number of red blood cells).
• If you are a diabetic as TRIPARC may interfere with your insulin.
• If you are checking your thyroid function as TRIPARC may interfere with the test.
• If you suffer from asthma or other allergic conditions as TRIPARC may make your allergies worse.
• If you suffer from malnutrition or you are an alcoholic as caution should be exercised before taking TRIPARC. Drinking alcohol at the same time as taking aspirin increases the risk of bleeding.
• Serious skin reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), can occur while taking TRIPARC. TRIPARC should be discontinued and your doctor or healthcare professional should be consulted at the first appearance of skin rash or any other sign of allergy.
• Do not take TRIPARC if you are already taking other medication that contains paracetamol.
• Avoid excessive intake of caffeine (e.g. coffee, tea and some canned drinks) while taking TRIPARC.
• If you think you are dehydrated (you may feel thirsty with a dry mouth).
• TRIPARC is not for use during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery (see Do not take TRIPARC).
• Mothers using TRIPARC should not breastfeed their babies as aspirin passes into breast milk.
• Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
• If you are between 12 and 16 years old and you are recovering from an infection caused by a virus (such as chickenpox or flu-like symptoms), as there is a risk of developing Reye’s syndrome (see section Children and adolescents below).

Do not share medicines prescribed for you with any other person. Always take TRIPARC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the recommended dose. Use the lowest effective dose for the shortest possible duration of treatment.

The usual dose of TRIPARC is:

• Adults: One powder to be taken with water every three hours. Do not use more than one powder every 3 to 4 hours if necessary and not more than 6 powders during a 24-hour period.

Maximum daily dose: 6 powder sachets

Minimum dosing interval: 3 hours

Do not take TRIPARC with other paracetamol or aspirin containing medicines.

If you take more TRIPARC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

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

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

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Severe cutaneous adverse reactions (SCARs) including, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrosis (TEN), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), Drug-induced hypersensitivity syndrome (DIHS) or fixed drug eruption (FDE).

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

• Inflammation of the pancreas (pancreatitis), that may present with symptoms such as severe belly pain that may spread to your back or chest (it may feel worse after you eat), nausea and vomiting,
• inflammation of the liver (hepatitis), liver damage (hepatic necrosis), liver failure (hepatic failure), that may present with symptoms such as dark urine and pale or clay-coloured stools, yellowing of the skin or eyes, loss of appetite,
• kidney failure/dysfunction (renal colic, renal failure), that may present with symptoms such as swollen ankles and feet, foamy urine, urinating more often than usual,
• blood disorders with symptoms such as fever, chills, swelling, sore throat, fatigue, which may be signs of an infection due to low white blood cell count (leucopenia, agranulocytosis, neutropenia), any unusual or unexplained bruising or bleeding due to a low blood platelet count (thrombocytopenia), weakness, bruising or increased likelihood of an infection due to too few blood cells of all types (pancytopenia),
• stomach ulceration or perforation: symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black stools,
• bleeding within the skull (intracranial haemorrhage), that may present with symptoms such as extreme headache, sudden tingling, weakness, numbness or paralysis of face, arm or leg, nausea and vomiting,
• breathing problems: wheezing and breathing difficulties may be triggered in patients suffering from or with a previous history of asthma, shortness of breath,
• heart failure,
• irregular heartbeat (palpitations) with high doses,
• bleeding after childbirth,
• occasionally the blood does not clot well, which may result in bruising or bleeding, or yellowing of the skin and eyes may occur (jaundice),
• temporary hearing loss,
• iron-deficiency anaemia after prolonged use, with symptoms such as extreme tiredness, weakness and pale skin,
• Reye’s syndrome (in teenagers and children under 16), 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.

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:

• Nausea, vomiting, diarrhoea,
• excess amount of air/gas in the stomach, indigestion, stomach irritation, stomach pain,
• sneezing, stuffy, runny nose, swelling or irritation in the nose (rhinitis).

Less frequent side effects:

• Raised liver enzymes,
• pus in the urine,
• constipation, swelling and ulcer in the mouth or lips (ulcerative stomatitis),
• worsening of inflammation of the colon,
• inflammation of the stomach,
• anxiety, restlessness,
• vertigo,
• tremor (with high doses),
• prolonged pregnancy and labour.

Side effects with an unknown frequency:

• Noise bleeds,
• red or purple discolourations on the skin (purpura),
• confusion, dizziness,
• ringing in the ears, light-headedness,
• swelling due to fluid retention,
• increased blood pressure,
• nervousness, headache,
• insomnia,
• generalised swelling or water retention.

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, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

By reporting side effects, you can help provide more information on the safety of TRIPARC.

Store all medicines out of reach of children. Store in a cool, dry place at or below 30 °C. Keep well closed. Use sachet immediately after opening. Do not remove the product from the carton until required for use. Do not store in bathrooms. Do not use 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).