Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fenofibrate micronised
Genus Pharmaceuticals Ltd
C10AB05
Fenofibrate micronised
160mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5030451003812
* Trademark _Please read the back of this leaflet._ PACKAGE LEAFLET: INFORMATION FOR THE USER FENOFIBRATE 160MG TABLETS (FENOFIBRATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 the 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 Fenofibrate Tablets are and what they are used for 2. Before you take Fenofibrate Tablets 3. How to take Fenofibrate Tablets 4. Possible side-effects 5. How to store Fenofibrate Tablets 6. Further information 1. WHAT FENOFIBRATE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Fenofibrate 160mg Tablets (hereafter referred to as Fenofibrate Tablets). Fenofibrate Tablets belong to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Fenofibrate Tablets are used, alongside a low fat diet and other non- medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Fenofibrate Tablets can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone. 2. BEFORE YOU TAKE FENOFIBRATE TABLETS DO NOT TAKE FENOFIBRATE TABLETS: • if you are allergic to fenofibrate or any of the other ingredients of Fenofibrate Tablets (see Section 6 'What Fenofibrate Tablets contain') • if you have a liver disorder • if you have a kidney disorder or severe kidney problems • if you have known allergic reactions to light during treatment with fenofibrate or ketoprofen (an anti-inflammatory drug) • if you have gallbladder disease • if you have inflammation of the pancre Prečítajte si celý dokument
OBJECT 1 FENOFIBRATE 160MG TABLETS Summary of Product Characteristics Updated 21-Nov-2016 | Genus Pharmaceuticals 1. Name of the medicinal product Fenofibrate 160 mg Tablets. 2. Qualitative and quantitative composition Fenofibrate 160mg Each Fenofibrate 160 mg tablet contains 238.45mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White to off-white oblong 15mm x 7mm tablet. 4. Clinical particulars 4.1 Therapeutic indications Fenofibrate 160 mg Tablets are indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled. 4.2 Posology and method of administration Posology: Adults: The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking one fenofibrate 200mg capsule can be changed to one fenofibrate 160 mg tablet without further dose adjustment. Elderly patients (≥ 65 years old): No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m2 (see _Patients with renal impairment_ _ _ _ _) _ _. Patients with renal impairment: Fenofibrate should not be used if severe renal impairment, defined as eGFR <30 mL/min per 1.73 m2, is present. If eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of Fenofibrate should not exceed 100mg standard or 67 mg micronized once daily. If, during follow-up, the eGFR decreases persistently to <30 mL/min per 1.73 m2, Fenofibrate should be discontinued. Paediatric population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. There Prečítajte si celý dokument