Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE
Duopharma Marketing Sdn. Bhd.
BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE
80tablet Tablets; 16tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
SOBENZ LOZENGE ® Benzydamine hydrochloride, Cetylpyridinium chloride (3mg/1.33mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Sobenz Lozenge is used for 2. How Sobenz Lozenge works 3. Before you use Sobenz Lozenge 4. How to use Sobenz Lozenge 5. While you are using it 6. Side effects 7. Storage and Disposal of Sobenz Lozenge 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SOBENZ LOZENGE IS USED FOR Benzydamine hydrochloride in Sobenz Lozenges is used to relieve inflammation and pain in the throat. Cetylpyridium chloride has antiseptic activities and is used in the treatment of infections of the mouth and throat. Ask your doctor if you have any questions about why Sobenz Lozenge has been prescribed for you. Your doctor may have prescribed it for another purpose. HOW SOBENZ LOZENGE WORKS Sobenz Lozenges contains the principle active ingredient, Benzydamine hydrochloride for fast effective action. Sobenz Lozenges directly target the site of inflammation to reduce swelling and pain. It gently numbs the throat in a matter of seconds. BEFORE YOU USE SOBENZ LOZENGE - _When you must not use it_ Do not take Sobenz Lozenge if you have ever had an allergic reaction to: • Any medicine containing Benzydamine hydrochloride or Cetylpyridinium chloride • Any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty in breathing • Swelling of the face, lips, tongue or any other parts of the body • Rash, itching or hives on the skin Do not take Sobenz Lozenge if you have: • Severe asthma, bronchitis or other serious respiratory conditions Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. Talk to your doctor or pharmacist if you are not sure whether you should start taking this medicine. _Pregnancy and lactation _ Do not take Sobenz Lozenge if you are pregnant, or plan Lire le document complet
SOBENZ LOZENGE ANTI-INFLAMMATORY LOZENGES (with antibacterial) COMPOSITION Actives: Benzydamine hydrochloride 3 mg, and Cetylpyridinium chloride 1.33 mg. DESCRIPTION Orange Flavour: A 16mm, round, flat, orange coloured tablet and beveled edge. Melon Flavour: A 16mm, round, flat, green coloured tablet and bevelled edge. This product containing ASPARTAME 7.8mg (Artificial sweetening substance) . UNSUITABLE FOR PHENYLKETONURICS. PHARMACODYNAMICS BENZYDAMINE HYDROCHLORIDE The mechanism of anti-inflammatory action is not related to stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory agents, benzydamine inhibits the biosynthesis of prosta- glandins under certain conditions, but its properties in this respect have not been fully elucidated. The stabilizing effect on cellular membranes may also be involved in the mechanism of action. CETYLPYRIDINIUM CHLORIDE Cetylpyridinium Chloride is a quarternary pyridinium antiseptic with actions and uses similar to those of other cationic surfactants. It is used chiefly as lozenges or solutions for the treatment of minor infections of the mouth and throat. It is a broad spectrum antimicrobial agent with a long history of use to promote gingival health. PHARMACOKINETICS BENZYDAMINE HYDROCHLORIDE _Absorption_ - Benzydamine is well absorbed following oral administration. Benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use of benzydamine orally are low and parallel the amount actually ingested. _Excretion_ - Benzydamine and its metabolites are excreted largely in the urine. Metabolism is largely by oxidative pathways, although dealkylation can be shown. Most of the absorbed dose was eliminated in the first 24 hours. Repeated administration for 7 days did not result in accumulation of benzydamine in plasma. CETYLPYRIDINIUM CHLORIDE Cetylpyridinium chloride is a quaternary pyridinium antiseptic with actions and uses similar to those of other cat Lire le document complet