国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Trimethoprim
Athlone Laboratories Ltd
J01EA; J01EA01
Trimethoprim
100 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Trimethoprim and derivatives; trimethoprim
Marketed
2004-07-30
0011 CCRF21029 PATIENT INFORMATION LEAFLET TRIMOPTIN TABLETS 100MG TRIMOPTIN TABLETS 200MG (Trimethoprim) READ ALL OF THIS LEAFLET CAREFULLY 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. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. • IF ANY OF THESE SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET: 1. What Trimoptin Tablets are and what they are used for 2. What you need to know before you take Trimoptin Tablets 3. How to take Trimoptin Tablets 4. Possible side effects 5. How to store Trimoptin Tablets 6. Contents of the pack and other information 1. WHAT TRIMOPTIN TABLETS ARE AND WHAT THEY ARE USED FOR Trimoptin Tablets belong to a group of medicines known as antibacterials and they contain Trimethoprim as the antibiotic. They are used to treat infections in your body, primarily urinary and respiratory tract infections and for the prevention of recurrent urinary tract infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMOPTIN TABLETS DO NOT TAKE TRIMOPTIN TABLETS IF YOU: • are allergic to trimethoprim, or to any of the other ingredients mentioned in Section 6 (consult your doctor if you think you might be) • suffer from severe kidney or liver impairment • suffer with fragile X chromosome (an inherited physical and intellectual impairment) • suffer with porphyria (a disorder that may cause skin sensitivity to the sun, pain attacks and muscle weakness) • suffer from anaemia or other blood disorders • are pregnant Trimethoprim is not suitable for babies less than 6 weeks old. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Trimoptin Tablets: • if you suffer from kidney or liver impairment or are having dialysis treatment • if you are receiving long-term tre 阅读完整的文件
Health Products Regulatory Authority 15 June 2021 CRN009S1J Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimoptin Tablets 100 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Trimethoprim 100 mg. Also contains 10mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Flat, white, bevelled-edge tablets embossed ‘TR 100’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of infections caused by trimethoprim-sensitive organisms including urinary and respiratory tract infections and prophylaxis of recurrent urinary tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Trimoptin 100mg tablets are not recommended for use in children under 12 years of age. Other suitable dosage forms are available for this patient population. 1. Treatment of respiratory and urinary tract infections Adults: 200mg twice daily for 7 – 10 days The first dosage on the first day can be doubled. Children Over 12 years: same as adult dose Not recommended for use in children under 12 years 2. Prophylaxis of recurrent urinary tract infection: Adults: The usual dose is 100mg at night. An extra 100mg may be taken in the morning if necessary. Children Over 12 years: same as adult dose Not recommended for use in children under 12 years 3. Dosage in renal impairment Creatinine Clearance (ml/sec) Plasma creatinine (micromole/l) Dosage advised Over 0.45 Men <250 Normal Health Products Regulatory Authority 15 June 2021 CRN009S1J Page 2 of 7 Women <175 0.25 - 0.45 Men 250-600 Women 175-400 Normal for 3 days then half dose Under 0.25 Men ˃600 Women >400 Half the normal dose Trimethoprim is removed by dialysis. However, it should not be administered to dialysis patients unless plasma concentrations can be estimated regularly. Route of administration: Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to Trimethoprim or any of the excipients. Severe hepatic insufficiency. Severe renal insufficiency unless 阅读完整的文件