Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amoxicillin trihydrate
Sigma Pharmaceuticals Plc
J01CA04
Amoxicillin trihydrate
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010103
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXIL ® 500MG CAPSULES (amoxicillin) 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 has been prescribed for you (or for your child) only. 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. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Amoxil 500mg capsules but will be referred to as Amoxil throughout the leaflet. Please note that the leaflet also contains information about other strength such as Amoxil 250mg capsules. WHAT IS IN THIS LEAFLET 1. What Amoxil is and what it is used for 2. What you need to know before you take Amoxil 3. How to take Amoxil 4. Possible side effects 5. How to store Amoxil 6. Contents of the pack and other information 1 WHAT AMOXIL IS AND WHAT IT IS US WHAT AMOXIL IS Amoxil is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’. WHAT AMOXIL IS USED FOR Amoxil is used to treat infections caused by bacteria in different parts of the body. Amoxil may also be used in combination with other medicines to treat stomach ulcers. DO NOT TAKE AMOXIL: if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6). if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. Do not take Amoxil if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxil. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Amoxil if you: have glandular fever (fever, sore throat, swollen glands and extreme tiredness) have ki Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxil Capsules 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard Yellow and red capsules printed with 'GS JVL'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxil 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 • Acute otitis media • Acute streptococcal tonsillitis and pharyngitis • Acute exacerbations of chronic bronchitis • Community acquired pneumonia • Acute cystitis • Asymptomatic bacteriuria in pregnancy • Acute pyelonephritis • Typhoid and paratyphoid fever • Dental abscess with spreading cellulitis • Prosthetic joint infections • _Helicobacter pylori_ eradication • Lyme disease Amoxil is also indicated for the prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of Amoxil that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection • The age, weight and renal function of the patient; as shown below The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy). ADULTS AND CHILDREN ≥ 40 KG_ _ INDICATION* DOSE* Acute bacterial sinusitis Asymptomatic bacteriuria in pregnancy Acute pyelonephritis Dental abscess with spreading cellulitis Acute cystitis 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cyst Read the complete document