Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Theophylline
Viatris UK Healthcare Ltd
R03DA04
Theophylline
250mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010300; GTIN: 0000050485567
• you have a headache • you feel restless or agitated • you have difficulty sleeping (insomnia) • you feel light headed or dizzy • you get muscle pain or weakness • you get high blood sugar or blood creatinine levels • you need to urinate more frequently. Nuelin SA are prolonged release tablets. This means they release the medicine slowly over a long period of time. This reduces the chance of you getting any side effects and makes any side effects milder. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Nuelin SA Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Nuelin SA contains • The active substance in Nuelin SA is theophylline. Each 175 mg tablet contains 175 mg theophylline. Each 250 mg tablet contains 250 mg theophylline. • The other ingredients are lactose, cellulose acetate phthalate and magnesium stearate. What Nuelin SA looks like and contents of the pack Nuelin SA prolonged release tablets come in two strengths: 175 mg and 250 mg. The tablets are white, round, biconvex, uncoated tablets with “T” on one face and “175” “or “250” on the other Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nuelin SA 250 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Theophylline 250mg Excipients with known effect: Each tablet contains Lactose Ph Eur. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet The tablets are white, round, biconvex, uncoated tablets with “T” on one face and “250” on the other with a score line The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nuelin SA are indicated for the prophylaxis and treatment of reversible bronchospasm associated with asthma and chronic obstructive pulmonary disease. Because effective plasma levels are maintained for up to twelve hours from a single dose, less frequent dosing is required than with conventional theophylline preparations. 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 One tablet twice daily, preferably after food, increasing to two tablets twice daily, if necessary. _Paediatric population _ Below 6 months: Nuelin should not be used in children below 6 months of age. Below 6 years: Nuelin should not be used in children below 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years. 6 to 12 years: One tablet twice daily, preferably after food. _Elderly _ Elderly patients may require lower doses due to reduced theophylline clearance. Method of administration Nuelin SA-250 tablets are scored and may be halved but should not be crushed or chewed. The dosage should be titrated for each individual and adjusted with caution. Serum theophylline levels should be monitored to ensure that they remain within the therapeutic range. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, xanthines or any of the excipients listed in section 6.1 Recent myocardial infarction Acute tachy Прочитајте комплетан документ