País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Clarithromycin
Viatris Healthcare Limited
J01FA; J01FA09
Clarithromycin
Film-coated tablet
Macrolides; clarithromycin
Marketed
1989-11-20
Package leaflet: Information for the user KLACID ® 250mg FILM-COATED TABLETS and KLACID ® FORTE 500mg FILM-COATED TABLETS (Clarithromycin) 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 further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Klacid tablets and Klacid Forte tablets are and what they are used for 2. What you need to know before you take Klacid tablets or Klacid Forte tablets 3. How to take Klacid tablets or Klacid Forte tablets 4. Possible side effects 5. How to store Klacid tablets or Klacid Forte tablets 6. Further information 1. WHAT KLACID TABLETS AND KLACID FORTE TABLETS ARE AND WHAT THEY ARE USED FOR Each Klacid tablet contains 250mg of the active ingredient clarithromycin. Each Klacid Forte tablet contains 500mg of the active ingredient clarithromycin. Klacid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. Klacid tablets and Klacid Forte tablets are used to treat infections such as: 1. Chest infections such as bronchitis and pneumonia 2. Throat and sinus infections 3. Skin and soft tissue infections such as cellulitis, folliculitis or erysipelas 4. Infections caused by certain types of bacteria called Mycobacteriae 5. _Helicobacter pylori _infection associated with duodenal ulcer 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID TABLETS OR KLACID FORTE DO NOT TAKE KLACID TABLETS OR KLACID FORTE TABLETS IF: you know that you are ALLERGIC to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients Llegiu el document complet
Health Products Regulatory Authority 17 November 2023 CRN00DWHR Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid 250 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of Clarithromycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet A yellow, ovaloid, film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for the treatment of infections due to susceptible organisms. Such infections include: 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity Testing). 2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing). 4. Disseminated or localised mycobacterial infections due to _Mycobacterium avium_ or _Mycobacterium intracellulare_. Localised infections due to _Mycobacterium chelonae_, _Mycobacterium fortuitum_ or _Mycobacterium kansasii_. 5. Clarithromycin is indicated for the prevention of disseminated _Mycobacterium avium_ complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm 3 . 6. Clarithromycin in the presence of acid suppression is indicated for the eradication of _H. pylori_, resulting in decreased recurrence of duodenal ulcer. (See further information). Clarithromycin tablets are indicated in adults and children 12 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. FURTHER INFORMATION: _H. pylori_ is strongly associated with peptic ulcer disease. Ninety to 100% of patients with duodenal ulcers are infected with this agent. Eradication of _H. pylori_ has been shown to markedly reduce the rate of duodenal ulcer recurrence, thereby reducing the need for maintenance anti-secretory therapy. In a well controlled double-blind study, _H. pylo Llegiu el document complet