Product Details

Product Information of Lozatan-H

What you need to know before you take Losartan Hydrochlorothiazide Tablets

Do not take Losartan potassium/Hydrochlorothiazide Tablets • if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6) • if you are allergic (hypersensitive) to other sulfonamidederived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure) • if you have severely impaired liver function • if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment, • if you are suffering from gout • if you are more than 3 months pregnant. It is also better to avoid Losartan/Hydrochlorothiazide in early pregnancy (see also pregnancy section) • if you have severely impaired kidney function or your kidneys are not producing any urine. • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren Warnings and precautions Talk to your doctor or pharmacist before taking Losartan potassium /Hydrochlorothiazide. – if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide. – if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Losartan/Hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. – If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Losartan potassium/Hydrochlorothiazide, seek medical attention immediately. You must tell your doctor if you think that you are (or might become) pregnant. Losartan potassium /Hydrochlorothiazide is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). It is important to tell your doctor before taking Losartan potassium /Hydrochlorothiazide: • if you have previously suffered from swelling of the face, lips, throat or tongue • if you take diuretics (water pills) • if you are on a salt-restricted diet • if you have or have had severe vomiting and/or diarrhoea • if you have heart failure • if your liver function is impaired (see section 2 “Do not take Losartan potassium /Hydrochlorothiazide”) • if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) • if you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle) • if you are diabetic • if you have had gout • if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus). • if you have high calcium or low potassium levels or you are on a low potassium diet • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets. • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldoesterone by the adrenal gland, caused by an abnormality within the gland). • if you are taking any of the following medicines used to treat high blood pressure. – an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. – aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Losartan potassium/Hydrochlorothiazide”. Children and adolescents There is no experience with the use of Losartan potassium/ Hydrochlorothiazide in children. Therefore, Losartan potassium/Hydrochlorothiazide should not be given to children. Other medicines and Losartan potassium / Hydrochlorothiazide Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines. Diuretic agents such as the hydrochlorothiazide contained in Losartan potassium/Hydrochlorothiazide may interact with other medicines. Preparations containing lithium should not be taken with Losartan potassium/Hydrochlorothiazide without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassiumcontaining salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins). It is also important for your doctor to know if you are taking: • other medicines to reduce your blood pressure • steroids • medicines to treat cancer • pain killers • drugs for treatment of fungal infections • arthritis medicines • resins used for high cholesterol, such as colestyramine • medicines which relax your muscles • sleeping tablets • opioid medicines such as morphine • ‘pressor amines’ such as adrenaline or other drugs from the same group • oral agents for diabetes or insulins • carbamazepine • calcium salts • antipsychotics, antidepressants • erythromycin IV, vincamine IV, halofantrine, pentamidine • mizolastin, terfenadine • ciclosporin • methyldopa • anticholinergic agents (e.g. atropine, biperiden) • ACTH • glycyrrhizin (found in liquorice) Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan potassium /Hydrochlorothiazide” and “Warnings and precautions”) Please also inform your doctor when it is planned to apply iodine contrast media about taking Losartan potassium/ Hydrochlorothiazide. Losartan potassium/Hydrochlorothiazide Tablets with food and drink and alcohol You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium/Hydrochlorothiazide tablets may increase each other’s effects. Dietary salt in excessive quantities may counteract the effect of Losartan potassium/Hydrochlorothiazide tablets. Losartan potassium/Hydrochlorothiazide tablets may be taken with or without food. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan potassium/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan potassium/Hydrochlorothiazide. Losartan potassium/Hydrochlorothiazide is not recommended in pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium/ Package leaflet: Information for the user Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg film-coated tablets Losartan potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets losartan potassium and hydrochlorothiazide N03757 Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed. Use in elderly patients Losartan potassium/Hydrochlorothiazide works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients. Driving and using machines When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine. Losartan potassium/Hydrochlorothiazide Tablets contains lactose Losartan potassium/Hydrochlorothiazide Tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugar