Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Doxycycline hyclate
Accord-UK Ltd
J01AA02
Doxycycline hyclate
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010300; GTIN: 5012617004635
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Doxycycline, Capsules, 50, 100mg, All Pack Sizes, UK 296x210 (Reel Fed) 51012052 Leaflet for Blisters 4180 R.Paul 16.03.2022 page 4 page 1 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com DOXYCYCLINE HYCLATE ALL STRENGTHS TABLET, PIL (REEL FED) - UNITED KINGDOM Black Profile BBBB4259 R.Paul 31.03.2022 296 x 210mm (Reel fed) 9pt Accord Barnstaple N/A N/A 1 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): N/A Cartons and label leaflets only (labels only when specified) 51012052 BBBB4259 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, pharmacist or nurse. • This medicine has been prescribed for you 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT DOXYCYCLINE CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXYCYCLINE CAPSULES 3 HOW TO TAKE DOXYCYCLINE CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DOXYCYCLINE CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT DOXYCYCLINE CAPSULES ARE AND WHAT THEY ARE USED FOR Doxycycline is an antibiotic belonging to a group of medicines called tet Read the complete document
1 NAME OF THE MEDICINAL PRODUCT DOXYCYCLINE CAPSULES BP 50mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Doxycycline hyclate equivalent to 50mg of Doxycycline base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Green and white, hard gelatin capsules printed “C” and “DV” in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxycycline has been found clinically effective in the treatment of a variety of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria and certain other micro-organisms. RESPIRATORY TRACT INFECTIONS: Pneumonia and other lower respiratory tract infections due to susceptible strains of _Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella _ _pneumoniae_ and other organisms. _Mycoplasma pneumoniae_ pneumonia. Treatment of chronic bronchitis, sinusitis. URINARY TRACT INFECTIONS: caused by susceptible strains of Klebsiella species, Enterobacter species, _Escherichia coli, Streptococcus faecalis_ and other organisms. SEXUALLY TRANSMITTED DISEASES: Infections due to _Chlamydia trachomatis_ including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal, urethritis caused by _Ureaplasma urealyticum _(T-mycoplasma). Doxycycline Capsules are also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum . Doxycycline is an alternative drug in the treatment of gonorrhoea and syphilis. SKIN INFECTIONS: Acne vulgaris when antibiotic therapy is considered necessary. Since doxycycline is a member of the tetracycline series of antibiotics, it may be expected to be useful in the treatment of infections which respond to other tetracyclines, such as: OPHTHALMIC INFECTIONS: Due to susceptible strains of gonococci, staphylococci and _Haemophilus influenzae_. Trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral Vibramycin alone or in combination with topical agents. RICKETTSIAL INFECTIONS Read the complete document