Regulatory Information
APEX PHARMA MARKETING PTE. LTD.
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Therapeutic
General Sale List
Formulation Information
TABLET, FILM COATED
**3\. How to take Maxigesic PE** Always take this medicine exactly as your doctor or pharmacist has told you. These directions may differ from the information contained in this leaflet. Check with your doctor or pharmacist if you are not sure. **Do not take for more than 3 days**. The recommended dose is: **Adults and children over 12 years:** The usual dosage is 1–2 two tablets taken every four hours, as required up to a maximum of 8 eight in 24 hours. Use the lowest effective dose for the shortest time necessary to relieve symptoms. The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days. **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. Take Maxigesic PE tablets with a full glass of water. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. **Use in children under 12 years** Maxigesic PE is not recommended for children under 12 years. **If you take more Maxigesic PE than you should** If you have taken more Maxigesic PE than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. Do this even if there are no signs of discomfort or poisoning. Taking too many Maxigesic PE tablets can lead to delayed, serious liver and renal damage. You may need urgent medical attention. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported. **If you forget to take Maxigesic PE** If it is almost time for your next dose, skip the missed dose 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 a forgotten dose. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
ORAL
Medical Information
**1\. What Maxigesic PE is and what it is used for** Maxigesic PE contains 500 mg paracetamol, 150 mg ibuprofen and 2.5 mg phenylephrine hydrochloride in each tablet dose. Paracetamol works to stop the pain messages from getting through to the brain. It also acts to reduce fever. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness or soreness). Phenylephrine hydrochloride acts as a decongestant to reduce mucosal lining swelling and suppress the production of mucus. Maxigesic PE is used for temporary relief of cold and flu symptoms including: - Headache - Fever - Pain - Nasal congestion Ask your doctor or pharmacist if you have any questions about this medicine. You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
**2\. What you need to know before you take Maxigesic PE** **Do not take Maxigesic PE:** - if you are allergic to the active substance(s) or any of the other ingredients of this medicine (listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); - if 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; - with any other medicines containing paracetamol or ibuprofen - if you regularly drink large quantities of alcohol - if you have severe heart failure, hepatic failure or renal failure - if you have active or history of gastrointestinal bleeding or peptic ulceration. - if you have cerebrovascular or other active bleeding - if you have blood-formation disturbances - if you have hypertension - if you have coronary heart disease and cardiovascular disorders - if you have asthma, urticaria or allergic-type reactions after taking aspirin/acetylsalicylic acid or other aniti-inflammatory medicines - during the last three months of pregnancy - with other medicines intended to treat the symptoms of the common cold except on the advice of a healthcare professional **Unless a doctor has told you to, do not give or take Maxigesic PE:** - with other medicines you are taking regularly - if you have asthma - for more than a few days at a time - if you have kidney problems or impaired renal function - if trying to become pregnant, or during the first 6 months of pregnancy - if you are aged 65 years or over
N02BE51
paracetamol, combinations excl. psycholeptics
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
SIGMA LABORATORIES PRIVATE LTD
Active Ingredients
Documents
Patient Information Leaflets
Maxigesic PE PIL.pdf
Approved: February 21, 2023