Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Theophylline
Mundipharma Pharmaceuticals Limited
R03DA; R03DA04
Theophylline
300 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Xanthines; theophylline
Marketed
1989-03-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UNIPHYLLIN® CONTINUS® 200 MG, 300 MG AND 400 MG PROLONGED-RELEASE TABLETS Theophylline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. IN THIS LEAFLET: 1. What _UNIPHYLLIN CONTINUS_ tablets are and what they are used for 2. What you need to know before you take _UNIPHYLLIN CONTINUS_ tablets 3. How to take _UNIPHYLLIN CONTINUS_ tablets 4. Possible side effects 5. How to store _UNIPHYLLIN CONTINUS_ tablets 6. Contents of the pack and other information 1. WHAT _UNIPHYLLIN CONTINUS_ TABLETS ARE AND WHAT THEY ARE USED FOR These tablets are used to treat asthma, long-term breathing difficulties such as emphysema and chronic bronchitis, and are sometimes used to treat heart failure in adults. They contain the active ingredient theophylline which belongs to a group of medicines called bronchodilators. Bronchodilators help stop you wheezing and being breathless. Theophylline also reduces swelling in the lungs of asthma patients and relieves the feeling of ‘tightness’ in their chest. These tablets may be taken by adults and children aged 6 years and above (and weighing no less than 22 kg). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _UNIPHYLLIN CONTINUS_ TABLETS DO NOT TAKE _UNIPHYLLIN CONTINUS_ TABLETS IF YOU: • are allergic to theophylline, aminophylline or any of the other ingredients of the tablets (listed in section 6). Do not give _UNIPHYLLIN CONTINUS_ to your child if they are under 6 years of age (or less than 22 kg). Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 13 March 2023 CRN00DFF9 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT UNIPHYLLIN Continus 300 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains theophylline 300 mg as theophylline monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. White, capsule shaped tablet, plain on one side and marked ‘U300’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment and prophylaxis of bronchospasm and inflammation associated with asthma, chronic bronchitis and emphysema. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure. UNIPHYLLIN CONTINUS tablets are indicated for use in adults and children aged 6 years and above (and weighing no less than 22 kg). Theophylline should not be used as first drug of choice in the treatment of asthma in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Asthma _Adults and the elderly_ The usual maintenance dose is 200 mg 12-hourly. In more severe cases, the dosage may be increased to 300 mg 12-hourly or 400 mg 12-hourly. For asthmatic patients whose nocturnal symptoms are particularly troublesome, a higher dose at night may provide additional bronchodilator benefit. _Paediatric population aged 6 years and above (equating to body weight of 22 kg)_ The usual paediatric maintenance dose is 200 mg 12-hourly but some children with chronic asthma require and tolerate much higher doses for which purpose UNIPHYLLIN CONTINUS tablets 300 mg may be prescribed. Clearance is increased in children compared to values observed in adult subjects. The rapid clearance observed in children decreases towards adult values in late teens. Therefore, lower dosages (based on usual adult dose) may be required for adolescents. UNIPHYLLIN CONTINUS tablets should not be used in children below 6 years of age. Other dosage forms are available that are more sui Olvassa el a teljes dokumentumot