Država: Malta
Jezik: engleski
Izvor: Medicines Authority
CETYLPYRIDINIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
DDD Limited 94 Rickmansworth Road, Watford Herts WD18 7JJ, United Kingdom
N01BB52
CETYLPYRIDINIUM CHLORIDE 0.1 % (W/W) LIDOCAINE HYDROCHLORIDE 0.33 % (W/W)
DENTAL GEL
CETYLPYRIDINIUM CHLORIDE 0.1 % (W/W) LIDOCAINE HYDROCHLORIDE 0.33 % (W/W)
OTC
ANESTHETICS
Suspended
2006-03-28
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet, you may need to read it again. If you need more information or advice speak to your health visitor, pharmacist or doctor. IN THIS LEAFLET: 1. What Dentinox Teething Gel is and what it is used for 2. Before you use Dentinox Teething Gel 3. How you use Dentinox Teething Gel 4. Possible side effects 5. How to store Dentinox Teething Gel 6. Further information 1. WHAT DENTINOX TEETHING GEL IS AND WHAT IT IS USED FOR Dentinox Teething Gel contains the active ingredients lidocaine and cetylpyridinium. Lidocaine is one of a group of medicines called local anesthetics, which numb pain. Cetylpyridinium is an antiseptic that is used to treat minor wounds and minor infections of the mouth. Dentinox Teething Gel relieves teething pain and soothes the gums from birth onwards. 2. BEFORE YOU USE DENTINOX TEETHING GEL You should not use Dentinox Teething Gel if your baby is allergic (hypersensitive) to lidocaine, cetylpyridinium or any other ingredients (see list of ingredients in Section 6). See a doctor at once if you notice the following: rash, swelling of the face, neck, tongue or throat (severe allergic reaction). DO NOT USE Dentinox Teething Gel if the seal on the nozzle is broken. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if your baby is taking, or has recently taken, any other medicines, including medicines obtained without a prescription. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF DENTINOX TEETHING GEL Dentinox Teething Gel contains SORBITOL. If you have been told by your doctor that your baby has AN INTOLERANCE TO SOME SUGARS, contact your doctor before using this product. This medicine also contains small amounts of ethanol, less than 100mg per dose. DENTINOX TEETHING GEL LIDOCAINE HYDROCHLORIDE/CETYLPYRIDINIUM CHLORIDE STUDIO DETAILS Client: Dendron Job No: 26378-01 Version No: V2 Date: 09/04/2015 Originator: Dave Simpson Am ended by: - Description/Public Pročitajte cijeli dokument
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT. Dentinox Teething Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine Hydrochloride 0.33%w/w Cetylpyridium Chloride BP 0.10%w/w. For excipients, see 6.1. 3. PHARMACEUTICAL FORM. Dental gel Greenish yellow brown gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dentinox Gel relieves the pain of baby’s teething and soothes the gums. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION. Place a small quantity of Dentinox Teething Gel on a pad of cotton wool or a clean finger and rub gently on baby’s gum. Repeat after 20 minutes if necessary. Use when necessary during the teething period. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. Keep all medicines out of the reach of children. Do not use if seal on nozzle is broken. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION. None known. Page 2 of 4 4.6 PREGNANCY AND LACTATION Not applicable. 4.7 EFFECT AND ABILITY TO DRIVE AND USE MACHINES. Not applicable. 4.8 UNDESIRABLE EFFECTS. None known. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting: Website: www.medicinesauthority.gov.mt/adrportal 4.9 OVERDOSE No apparent problems with overdosage. 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES. Cetylpyridium chloride is a cationic disinfectant which is used for minor wounds, treating superficial infections of the mouth and preserving the product. Lidocaine hydochloride is a local anaesthetic. It works by blocking nerve conduction when applied topically to nerve tissue. It acts on any part of the nervous system and on every type of nerve fibre. For example, when it is applied to the motor cortex, Pročitajte cijeli dokument