Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
J01CR02
CLAVULANIC ACID 125 mg AMOXICILLIN 875 mg
POWDER FOR ORAL SUSPENSION
CLAVULANIC ACID 125 mg AMOXICILLIN 875 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2023-08-08
1.3.1 SPC, PACKAGE LEAFLET AND LABELLING MARKETING AUTHORISATION APPLICATION AMOXICILLIN/CLAVULANIC ACID AUROBINDO 875 MG/125 MG & 1000 MG/125 MG PFOS IN SACHET PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN/CLAVULANIC ACID AUROBINDO 875 MG/125 MG POWDER FOR ORAL SUSPENSION IN SACHET AMOXICILLIN/CLAVULANIC ACID AUROBINDO 1000 MG/125 MG POWDER FOR ORAL SUSPENSION IN SACHET amoxicillin/clavulanic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine is usually prescribed for you (or for your child). Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amoxicillin/clavulanic acid Aurobindo is and what it is used for 2. What you need to know before you use Amoxicillin/clavulanic acid Aurobindo 3. How to use Amoxicillin/clavulanic acid Aurobindo 4. Possible side effects 5. How to store Amoxicillin/clavulanic acid Aurobindo 6. Contents of the pack and other information 1. WHAT AMOXICILLIN/CLAVULANIC ACID AUROBINDO IS AND WHAT IT IS USED FOR Amoxicillin/clavulanic acid Aurobindo is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. Amoxicillin/clavulanic acid Aurobindo is used in adults and children to treat the following infections: • middle ear and sinus infections • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental in Aqra d-dokument sħiħ
1.3.1 SPC, PACKAGE LEAFLET AND LABELLING MARKETING AUTHORISATION APPLICATION AMOXICILLIN/CLAVULANIC ACID AUROBINDO 875 MG/125 MG & 1000 MG/125 MG PFOS IN SACHETS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg powder for oral suspension in sachet Amoxicillin/clavulanic acid Aurobindo 1000 mg/125 mg powder for oral suspension in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid. Excipients with known effect : Each 875 mg/125 mg sachet contains 22.5 mg aspartame (E 951). The flavouring in Amoxicillin/clavulanic acid Aurobindo contains maltodextrin (glucose) (see section 4.4). Each 1000 mg/125 mg sachet contains 25 mg aspartame (E 951). The flavouring in Amoxicillin/clavulanic acid Aurobindo contains maltodextrin (glucose) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension in sachet. Off white to pale yellow coloured powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin/clavulanic acid Aurobindo is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. • Bone and joint infections, in particular osteomyelitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1.3.1 SPC, PACKAGE LEAFLET AND LABELLING Aqra d-dokument sħiħ