Aspirin Tablets

The active ingredient aspirin has analgesic (reduces pain), antipyretic (reduces fever) and anti-inflammatory (reduces inflammation) actions. ASPIRIN 300 UNIMED is indicated for the relief of mild to moderate pain and fever.

Do not take ASPIRIN 300 UNIMED

• if you have stomach ulcers,
• if you have a bleeding disorder such as haemophilia,
• if you suffer from severe kidney impairment,
• if you are taking oral anti-coagulant medicines (medicines that prevent the blood from clotting),
• if you have an intolerance or are hypersensitive (allergic) to aspirin or to any of the other ingredients in ASPIRIN 300 UNIMED (listed in section 6),
• if you have or have had severe heart problems,
• if you have a history of stomach or intestinal perforation, ulcers or bleeding due to previous NSAIDs use, including ASPIRIN 300 UNIMED,
• if you suffer from or have suffered from a recurring ulcer, bleeding or perforation,
• if you are pregnant or breastfeeding your infant,
• if you are under 12 years of age (see Warnings and precautions).

Warnings and precautions

You should not use ASPIRIN 300 UNIMED continuously for longer than ten (10) days without consulting your doctor.

Take special care with ASPIRIN 300 UNIMED:

• when given to children or teenagers ASPIRIN 300 UNIMED may cause Reye’s syndrome. Reye's syndrome is a rare but serious illness in children and teenagers with chickenpox and flu. For this reason, ASPIRIN 300 UNIMED should not be given to children aged under the age of 12 years and teenagers, unless on the advice of a doctor (see Do not take ASPIRIN 300 UNIMED),
• if you continue to take large amounts of ASPIRIN 300 UNIMED it may cause anaemia, abnormal conditions or diseases of the blood, gastrointestinal bleeding, stomach ulcers and kidney damage,
• if you develop serious skin reactions, skin rash, chest tightness, wheezing or difficulty breathing, you should stop taking ASPIRIN 300 UNIMED immediately.

Tell your doctor or pharmacist before taking ASPIRIN 300 UNIMED:

• if you have high blood pressure and/or suffer from heart problems. ASPIRIN 300 UNIMED may be associated with a small increased risk of heart failure,
• if you are elderly, as you may be more susceptible to the side effects of ASPIRIN 300 UNIMED,
• 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 ASPIRIN 300 UNIMED,
• if you suspect that you have an ulcer, treatment with ASPIRIN 300 UNIMED should be stopped and you should consult your doctor,
• 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,
• if you are scheduled for a surgical procedure. You must stop using ASPIRIN 300 UNIMED several days before your surgery,
• if you have a history of allergic reactions to NSAIDs, including attacks of asthma, swelling of your face, lips and tongue, hives, itchy skin or runny nose,
• if you have other allergies or asthma,
• if you suffer from kidney problems,
• if you suffer from indigestion,
• if you have anaemia or suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD),
• if you are dehydrated (you may feel thirsty and have a headache, dry mouth and lips),
• if you develop symptoms such as a high body temperature, widespread rash, swollen glands or facial swelling. This reaction can also include kidneys, liver, and heart dysfunction as well as abnormal blood test results (for example an abnormal increase in the number of disease-fighting white blood cells.

Do not share medicines prescribed for you with any other person. Always take ASPIRIN 300 UNIMED exactly as directed 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.

Use the lowest effective dose for the shortest possible duration of treatment.

Adults: Take one or two tablets every four hours with water. Do not use continuously for longer than ten (10) days without consulting your doctor.

If you take more ASPIRIN 300 UNIMED than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of an overdose include ringing in the ears, spinning sensation, deafness, sweating, nausea, headache, vomiting, confusion, fast breathing rate, fever, coma and heart failure. In children, serious signs of overdosage may develop rapidly.

If you forget to take ASPIRIN 300 UNIMED

If you missed a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablets at the usual time. Do not take a double dose to make up for the forgotten individual doses.

ASPIRIN 300 UNIMED can have side effects. Not all side effects reported for ASPIRIN 300 UNIMED are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ASPIRIN 300 UNIMED, please consult your health care provider for advice.

If any of the following happens, stop taking ASPIRIN 300 UNIMED and tell your doctor immediately or go to the casualty department at your nearest hospital:

• you have an allergic reaction. The signs may include a skin rash, swallowing or breathing problems, wheezing, worsening of asthma, swelling of your lips, face, throat or tongue,
• you get blistering, peeling, bleeding, scaling or fluid filled patches on any part of your skin. You may have a serious skin problem,
• you have a fever and yellowing of the skin or whites of the eyes, feel tired, weak or generally unwell, loss of appetite (anorexia), feeling sick (nausea), being sick (vomiting). These may be early signs of liver problems,
• stomach ulcers or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling or being sick),
• if you develop flu-like symptoms with a high body temperature, widespread rash, swollen glands, facial swelling and abnormal blood results (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

These are all very serious side effects. If you have them, you may have had a serious reaction to ASPIRIN 300 UNIMED. You may need urgent medical attention or hospitalisation.

Other side effects include:

• longer bleeding time,
• blood does not clot well, which may result in easy bruising or bleeding,
• dizziness,
• swelling,
• high blood pressure and heart failure,
• stomach ulcers,
• bleeding from the gastrointestinal tract,
• nausea (feeling sick), vomiting (being sick), diarrhoea,
• indigestion, constipation, stomach pain,
• vomiting blood or blood in your stool,
• worsening of inflammatory bowel diseases,
• liver problems,
• itchy skin rash caused by allergic reaction, pale or red irregular raised patches with severe itching (hives),
• blistering, peeling, bleeding, scaling or fluid filled patches on any part of the skin,
• runny nose,
• difficulty breathing or wheezing, worsening of asthma.

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. 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 ASPIRIN 300 UNIMED.

• Store in a well closed container, at or below 25 ° C. Exposure to air should be minimum.
• Store in the original package.
• Do not use after the expiry date stated on the pack.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• Store all medicines out of reach of children.