Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium
Kent Pharma (UK) Ltd
C09CA01
Losartan potassium
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5015201007500
PATIENT INFORMATION LEAFLET LOSARTAN POTASSIUM 25MG, 50MG AND 100MG FILM-COATED TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, EVEN IF YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE INFORMATION I N YOUR PREVIOUS LEAFLET MAY HAVE CHANGED. • KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. • IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. • THIS MEDICATION HAS BEEN PRESCRIBED FOR YOU. YOU SHOULD NOT PASS IT ON TO ANYONE ELSE. 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 THAT ARE NOT LISTED IN THE LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET 1. What your medicine is and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Further information The name of your medicine is Losartan potassium 25mg, 50mg or 100mg film-coated tablets. Your medication is referred to as Losartan potassium tablets or Losartan throughout this leaflet. 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a chemical in your body, which tightens your blood vessels making it harder for the blood to pass through them and causes your blood pressure to increase. Losartan blocks this effect, causing the blood vessels to relax and so lowers your blood pressure. Your doctor has prescribed Losartan to: • TREAT HYPERTENSION (high blood pressure) in adults and in children and adolescents 6- 18 years of age • PROTECT THE KIDNEY IN HYPERTENSIVE TYPE 2 DIABETIC PATIENTS WITH LABORATORY EVIDENCE OF IMPAIRED RENAL FUNCTION AND PROTEINURIA ≥ 0.5MG PER DAY (a condition in which urine contains an abnormal amount of protein) • REDUCE THE RISK OF STROKE IN HYPERTENSION WITH LEFT VENTRICULAR HYPERTROPHY (thickening of the heart muscle) • TREAT CHRONIC HEART FAILURE when treatment with Read the complete document
OBJECT 1 LOSARTAN POTASSIUM 25MG FILM-COATED TABLETS Summary of Product Characteristics Updated 27-Jan-2015 | Kent Pharmaceuticals Ltd 1. Name of the medicinal product Losartan potassium 25mg film- coated tablets losartan potassium 2. Qualitative and quantitative composition Each tablet contains 25mg of losartan potassium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Losartan potassium 25mg film- coated tablet is supplied as a white, oblong, biconvex, non- scored film- coated tablet. 4. Clinical particulars 4.1 Therapeutic indications Losartan is indicated in: - Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. - Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment - Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of chronic heart failure. - Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (See section 5.1) 4.2 Posology and method of administration METHOD OF ADMINISTRATION Losartan should be swallowed with a glass of water. Losartan may be administered with or without food. POSOLOGY _Hypertension_ The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide). _Hypertensive ty Read the complete document