Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Phenylephrine hydrochloride; Caffeine
Haleon UK Ltd
N02BE51
Paracetamol; Phenylephrine hydrochloride; Caffeine
500mg ; 5mg ; 25mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 04070100; GTIN: 5000347028670
FLU PLUS CAPLETS Paracetamol, Phenylephrine, Caffeine PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Beechams Flu-Plus Caplets carefully to get the best results from it. • Keep this leaflet you may need to read it again. • If you have any questions, or if there is anything you do not understand, ask your pharmacist. IN THIS LEAFLET: 1. What Beechams Flu-Plus Caplets do 2. Check before you take Beechams Flu-Plus Caplets 3. How to take Beechams Flu-Plus Caplets 4. Possible side effects 5. How to store Beechams Flu-Plus Caplets 6. Further information 1. What Beechams Flu-Plus Caplets do BEECHAMS FLU-PLUS CAPLETS PROVIDE EFFECTIVE RELIEF FROM THE MAJOR COLD AND FLU SYMPTOMS. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh, sore throat, fatigue and tiredness. This medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Phenylephrine hydrochloride unblocks your nose and sinuses helping you to breathe more easily. Caffeine is present as a mild stimulant to relieve fatigue and tiredness. 2. Check before you take Beechams Flu-Plus Caplets DO NOT TAKE BEECHAMS FLU-PLUS CAPLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, phenylephrine hydrochloride, caffeine or any of the other ingredients (listed in Section 6). Colour SUNSET YELLOW (E 110) can cause allergic type reactions including asthma. • if you have KIDNEY or LIVER PROBLEMS, OVERACTIVE THYROID, DIABETES, HIGH BLOOD PRESSURE or HEART DISEASE. • if you have PHAEOCHROMOCYTOMA or GLAUCOMA • if you are taking TRICYCLIC ANTIDEPRESSANTS (e.g. imipramine or amitriptyline) or if you are taking or have taken within the last 2 weeks MONOAMINE OXIDASE INHIBITORS (MAOIs) (e.g. moclobemide) prescribed for DEPRESSION. • if you are taking BETA-BLOCKERS (e.g. atenolol). DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING T Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beechams Flu-Plus Caplets Beechams Active Cold Relief Caplets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each caplet contains Paracetamol 500 mg, Caffeine 25 mg and Phenylephrine Hydrochloride 5 mg. Excipients with known effect: Sodium 0.06mg (as sodium laurilsulfate) Sunset Yellow 0.62mg (E 110) For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The product is recommended for the relief of sinus pain and the symptoms of colds and influenza, including fatigue and drowsiness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including elderly) and children aged 16 years and over: 2 caplets every 4 to 6 hours as required. Do not take more than 8 caplets in 24 hours. Do not take continuously for more than 7 days without medical advice Do not exceed the stated dose. Use the lowest amount needed to achieve benefit for the shortest duration of treatment. Not recommended for children under the age of 16 years. 4.3 CONTRAINDICATIONS Concomitant use of other sympathomimetic decongestants Phaeochromocytoma Closed angle glaucoma Known hypersensitivity to paracetamol or any of the other constituents. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Patients should be advised not to take other paracetamol-containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Concomitant use of other decongestants or cold and flu medicines should be avoided. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver dis Read the complete document