Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Paracetamol 500mg; ; Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine; ;
Haleon New Zealand ULC
Paracetamol 500 mg
Tablet
Active: Paracetamol 500mg Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine Excipient: Maize starch Microcrystalline cellulose Potassium sorbate Povidone Pregelatinised maize starch Purified talc Sodium laurilsulfate Stearic acid
Blister pack, Aclar (PVC/Al foil) or Triplex (PVC/PE/PVdC/Al foil); 20 tablets, 20 tablets
General sale
General sale
Granules India Limited
Fast, effective, temporary relief of sinusitis symptoms including sinus headache, sinus pain, nasal congestion
Package - Contents - Shelf Life: Blister pack, Aclar (PVC/Al foil) or Triplex (PVC/PE/PVdC/Al foil); 20 tablets - 20 tablets - 36 months from date of manufacture stored at or below 30°C
2008-08-25
COLDREX ® PE PHENYLEPHRINE SINUS _Paracetamol 500 mg and Phenylephrine Hydrochloride 5 mg _ CONSUMER MEDICINE INFORMATION Please read this information before you start using this medicine. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COLDREX PE PHENYLEPHRINE SINUS. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking COLDREX PE PHENYLEPHRINE SINUS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COLDREX PE PHENYLEPHRINE SINUS IS USED FOR COLDREX PE PHENYLEPHRINE SINUS is used for the fast, effective temporary relief of sinusitis symptoms including sinus headache, sinus pain, and nasal congestion. Reduces fever. COLDREX PE PHENYLEPHRINE SINUS contain the active ingredients paracetamol and Phenylephrine hydrochloride Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever. Phenylephrine hydrochloride belongs to a group of medicines called sympathomimetic decongestants. It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, and making it easier to breathe. ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. Your pharmacist or doctor may have given it for another reason. This medicine is not addictive. It is only available from your pharmacist. BEFORE YOU TAKE/GIVE COLDREX PE PHENYLEPHRINE SINUS Taking too much paracetamol can cause serious harm to your liver. _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE COLDREX PE PHENYLEPHRINE SINUS IF YOU HAVE AN ALLERGY TO: any medicine containing paracetamol or Phenylephrine hydrochloride any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allerg Lestu allt skjalið
Page 1 of 11 COLDREX, PANADOL COLD & FLU and PANADOL SINUS -Data Sheet NEW ZEALAND DATA SHEET 1 PRODUCT NAMES COLDREX ® PE PHENYLEPHRINE SINUS COLDREX ® PE PHENYLEPHRINE CONGESTION CLEAR PANADOL ® COLD & FLU MAX + DECONGESTANT PANADOL ® SINUS PAIN & CONGESTION RELIEF 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Paracetamol (BP) 500 mg and Phenylephrine Hydrochloride (BP) 5 mg CAS: 103-90-2 Paracetamol C 8 H 9 NO 2 CAS: 61-76-7 Phenylephrine Hydrochloride C 9 H 13 NO 2 . HCl For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White capsule-shaped tablets (caplets) with flat edges, 17.7 mm, one face embossed with sun graphic within an oval. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications COLDREX PE Phenylephrine Sinus PANADOL Sinus Pain & Congestion Relief PE Fast, effective, temporary relief of sinusitis symptoms including sinus headache, sinus pain, nasal congestion. Page 2 of 11 COLDREX, PANADOL COLD & FLU and PANADOL SINUS -Data Sheet COLDREX PE Phenylephrine Congestion Clear Fast, effective temporary relief of cold and flu symptoms including headache, body aches and pain, blocked or runny nose, sore throat. Reduces fever PANADOL Cold & Flu Max + Decongestant Tablet Fast, effective temporary relief of cold and flu symptoms including headache, body aches and pain, blocked or runny nose, sore throat. Reduces fever. 4.2 Dose and method of administration Adults and children aged 12 years and over Two caplets every four to six hours as necessary, taken with water. Maximum of 8 caplets within 24 hours. Do not use for more than a few days at a time in adults without medical advice. Should not be used for more than 48 hours in children aged 12 to 17 except on medical advice. Do not use in children under 12 years of age. Do not exceed the stated dose or frequency of dose. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Should not be used with other paracetamol-containing products, decongestants or cough and cold medicines. D Lestu allt skjalið