Patient leaflet - Losartan Potassium 25 mg film-coated tablets
1. What Losartan tablets are and what they are used for
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan is used
- to treat patients with high blood pressure (hypertension) in adults and inchildren and adolescents 6-18 years of age.
- to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
- to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable byyour doctor. If your heart failure has been stabilised with an ACE inhibitor youshould not be switched to losartan.
in patients with high blood pressure and a thickening of the left ventricle,
Losartan has been shown to decrease the risk of stroke (“LIFE indication”).
2. What you need to know before you take Losartan tablets
Do not take Losartan tablets if you:
- are allergic (hypersensitive) to losartan or to any of the other ingredients listed in section 6.
- have severely impaired liver function
- are more than 3 months pregnant. (It is also better to avoid Losartan tablets in early pregnancy – see ‘Pregnancy and breastfeeding’)
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium 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).
Talk to your doctor, pharmacist, or nurse before taking Losartan tablets if you:
- have, or have had a history of, angio-oedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects’)
- are suffering from severe sickness (vomiting) or diarrhoea leading to an extreme loss of fluid and/or salt in your body
- receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups’)
liver function is impaired (see sections 2 “Do not take Losartan potassium “
and 3 “Dosage in special patient groups”)
- are known to have narrowing (stenosis) or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently.
- suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker concomitantly
- suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland)
- suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain)
- have problems with your heart valves or heart muscle,
- 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
Talk to your doctor if you experience abdominal pain, nausea, vomiting or
diarrhoea after taking Losartan. Your doctor will decide on further treatment. Do not stop taking Losartan on your own.
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 tablets”. if you are taking other medications that may increase serum potassium (see section 2 “Other medicines and Losartan potassium”).
Children and adolescents: Losartan has been studied in children. For more information, talk to your doctor.
Losartan is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. Losartan is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.
Other medicines and Losartan tablets: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamteren, spironolactone), or other medicines that may increase serum potassi-um (e.g., heparin, trimethoprim-containing medicines), as the combination with Losartan potassium is not advisable.
Take particular care if you are taking any of the following:
- other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
- non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan
- an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan potassium” and “Warnings and precautions”) If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.
Losartan tablets with food and drink
The tablets should be taken with a glass of water. They may be taken with or without food.
Grapefruit juice should be avoided while taking Losartan tablets. Pregnancy and breast-feeding and fertility: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 tablets before you become pregnant or as soon as you know you are pregnant and will advise youto take another medicine instead of Losartan tablets. Losartan tablets are not recommended in early 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.
Breast-feeding: Tell your doctor if you are breast-feeding or about to start breast-feeding.Losartan tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish tobreast-feed, especially if your baby is newborn, or was born prematurely. Ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines: No studies on the effects on the ability to drive and use machines have been performed.
Losartan tablets are unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities. Losartan tablets contain Lactose: Losartan tablets contain lactose monohydrate. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
3. How to take Losartan tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of Losartan tablets depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Adult patients with high blood pressure: The recommended dose is 50 mg once daily. The maximum blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may be increased to 100 mg Losartan (two tablets Losartan potassium 50 mg or one tablet of Losartan potassium 100mg) once daily.
If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Adult patients with high blood pressure and Type 2 diabetes: Treatment usually starts with 50 mg losartan (one tablet Losartan potassium 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets Losartan potassium 50 mg or one tablet of Losartan potassium 100 mg) once daily depending on your blood pressure response.
Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors). Adult patients with heart failure: The recommended initial dose of Losartan in patients with heart failure is 12.5mg (one tablet Losartan 12.5mg) once daily. The dose should be increased at weekly intervals step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week) up to the maintenance dose as determined by your physician. A maximum dose of 150 mg losartan (for example, three tablets of Losartan potassium 50 mg or one tablet each of Losartan potassium 100 mg and Losartan potassium 50 mg) once daily may be used. In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker.
Use in children and adolescents
Children below 6 years of age: This medicine is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group. Children aged 6 - 18 years old: The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of Losartan). The doctor may increase the dose if blood pressure is not controlled.
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
Dosage in special patient groups
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section “Do not take Losartan potassium“).
Administration
The tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan potassium until your doctor tells you otherwise.
If you take more Losartan tablets than you should: If you take more Losartan tablets than you should, contact your doctor orpharmacist immediately. If possible take the tablets or box with you. Symptoms of overdose are low blood pressure, heart palpitations or a slow pulse.
If you forget to take Losartan tablets: If you miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctoror pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: Stop taking this medicine and contact your doctor or hospital emergency department immediately if you develop any of the following symptoms:
- swelling of the face, lips, mouth or throat difficulty breathing or swallowing, rash or itching. These could be a sign of a severe allergic reaction. This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.
Other side effects
The following side effects may also occur:
Common side effects (may affect up to 1 in 10 people):
- dizziness (vertigo) - weakness, tiredness, fatigue
- reduced number of red blood cells (anaemia),
- low blood sugar (hypoglycaemia),
- high levels of potassium in the blood (hyperkalaemia),
- changes in kidney function including kidney failure,
- increase in blood urea, serum creatinine and serum potassium in patients with heart failure.
- low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics), dose related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position, Uncommon side effects (may affect up to 1 in 100 people):
- sleep disorders,
- sleepiness
- headache
- angina pectoris (heaviness or tightness in the chest along with heart pain),
- breathlessness, shortness of breath, cough
- abdominal pain, severe constipation, nausea, vomiting, diarrhoea
- rash, hives, itching
- swelling of the hands or feet, aching, stiff joints
- feeling of increased heart rate (palpitations)
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity
- Inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura)
- swelling of the skin or mucous membranes such as the eyes and mouth (angioedema)
- pins and needles or similar sensations, pain or numbness in the extremities
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- abnormal heartbeat, stroke, change in heart rhythm
- hepatitis (inflammation of the liver)
- elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
- fainting (syncope)
- swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea (Intestinal angioedema)
Not known (frequency cannot be estimated from the available data):
- migraine - flu-like symptoms
- urinary infection - impotence,
- disturbed taste (dysgeusia). - generally feeling unwell (malaise),
- depression, - liver function abnormalities
- pain in the joints and muscles, back pain
- ringing, buzzing, roaring, or clicking in the ears (tinnitus),
- inflammation of the pancreas (pancreatitis),
- increased sensitivity to the sun (photosensitivity),
- low levels of sodium in the blood (hyponatraemia),
- unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
- reduced number of thrombocytes (low blood platelet count, which maymake you more prone to bleeding or bruising)
Side effects in children are similar to those seen in adults
If any of the side effects get serious, or if you notice any side effects not listedin 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: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
5. How to store Losartan Tablets
Keep this medicine out of the sight and reach of children.
Do not use Losartan tablets after the expiry date which is stated on the blisterand carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Losartan tablets contain
The active substance is losartan potassium. Each Losartan tablet contains either 12.5 mg, 25 mg, 50 mg or 100 mg of losartan potassium.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), magnesium stearate (E572), lactose monohydrate, pre-gelatinised starch.
Tablet film coating: Hypromellose (E464), titanium dioxide (E171). Macrogol/PEG 4000 and Indigo carmine aluminum lake (E132) (only in Losartan potassium 25 mg film-coated tablets).
Macrogol/PEG 400 (only in Losartan potassium 12.5 mg/ 50 mg/ 100mg film-coated tablets).
What Losartan tablets look like and contents of the pack
Losartan Potassium 12.5 mg Film-coated Tablets are White, round film-coated tablets.
Losartan Potassium 25 mg Film-coated Tablets are Blue, round film-coated tablets, scored on one side.
Losartan Potassium 50 mg Film-coated Tablets are White, round film-coated tablets scored on one side.
Losartan Potassium 100 mg Film-coated Tablets are White, oblong film-coated tablets scored on one side.
They come in blisters of: 7, 10, 14, 28, 30, 50, 56, 98 film coated tablets.The 12.5mg strength is also available in 21 tablets pack.
Not all pack sizes may be marketed.