Regulatory Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Therapeutic
General Sale List
Formulation Information
TABLET, FILM COATED
**How to take Maxigesic®** **Follow all directions given to you by your doctor and pharmacist carefully.** These directions may differ from the information contained in this leaflet. **If you do not understand the instructions on the label, ask your pharmacist or doctor for help.** _**How much to take**_ **Adults and Children over 12 years:** The usual dosage is 1–2 tablets taken every six hours, as required, up to a maximum of eight tablets in 24 hours. **Children under 12 years:** Maxigesic® is not recommended for children under 12 years. **Do not take more than 8 tablets in a 24 hours period.** If your doctor prescribes a different dose, follow directions given by your doctor. Do not break the tablet when taking the medicine. _**How to take it**_ Take Maxigesic® tablets with or straight after food with a full glass of water. _**How long to take it**_ **Adults and children over 12 years:** Only take Maxigesic® tablets for a few days at a time unless your doctor tells you to take it for longer. **Children under 12 years:** Maxigesic® is not recommended for children under 12 years. **Do not take Maxigesic® for longer than your doctor says.** Maxigesic® only helps to control pain but will not cure your condition. **If your symptoms persist, worsen or new symptoms develop, talk to your doctor or pharmacist.** _**If you forget to take it**_ If it is almost time for your next dose, skip the dose missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablets as you would normally. Do not take a double dose to make up for the dose that you missed. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. _**If you take too much (overdose)**_ **Immediately telephone your doctor for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Maxigesic®. Do this even if there are no signs of discomfort or poisoning.** Taking too many Maxigesic® tablets can lead to delayed, serious liver and renal damage. You may need urgent medical attention. If you take too much Maxigesic® you may: - feel sick or vomit - have stomach pain - have convulsions - feel dizzy or even become unconscious
ORAL
Medical Information
**What Maxigesic® is used for** Maxigesic® contains paracetamol and ibuprofen. Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces fever. Maxigesic® tablets are indicated for temporary relief of mild to moderate pain associated with headache, dental pain, period pain, migraine, backache, rheumatic pain, muscular pain, pain after vaccination and sore throat, and reduction of fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. Maxigesic® is not addictive. **Ask your pharmacist or doctor if you have any questions about this medicine.**
**Before you take Maxigesic®** _**When you must not take it**_ **Do not take Maxigesic® if you have an allergy to:** - any medicine containing paracetamol; - any medicine containing ibuprofen; - any of the ingredients listed at the end of this leaflet; - aspirin or any other NSAIDs Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist. Some of the symptoms of an allergic reaction may include: - shortness of breath - wheezing or difficulty breathing - swelling of the face, lips, tongue or other parts of the body - rash, itching, hives or blisters on the skin - stomach ache, fever, chills, nausea and vomiting - fainting If you are allergic to aspirin or NSAID medicines and take Maxigesic®, these symptoms may be severe. **Do not take this medicine if:** - you are pregnant or intend to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby; - you are breast-feeding or intend to breast-feed; - you are (or have previously) bled from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea; - you have a peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before; - You have, or have a history of, ulcerative colitis or Crohn’s Disease. **Do not take Maxigesic® if you regularly drink large quantities of alcohol.** **Do not take Maxigesic® after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.** If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking Maxigesic®, talk to your pharmacist or doctor.
M01AE51
ibuprofen, combinations
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
SIGMA LABORATORIES PRIVATE LIMITED
Active Ingredients
Documents
Patient Information Leaflets
Maxigesic Tablet PIL.pdf
Approved: October 4, 2021