Losartan Potassium 50mg Film-Coated Tablets
Package leaflet: Information for the user
Losartan Potassium 25mg, 50mg and 100mg Film-coated Tablets
Losartan potassium
Read all of this leaflet carefully before you start taking this medicine 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Losartan potassium Film-coated Tablets are what they are used for
2. What you need to know before you take Losartan Potassium Film-Coated Tablets
3. How to take Losartan potassium Film-Coated Tablets
4. Possible side effects
5. How to store Losartan potassium Film-Coated Tablets
6. Contents of the pack and other information
1. What Losartan potassium Film-coated Tablets are 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 Potassium Tablets are used
• to treat patients with high blood pressure (hypertension) in adults and in children 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 by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
• in patients with high blood pressure and a thickening of the left ventricle, losartan potassium has been shown to decrease the risk of stroke ("LIFE indication”).
2. What you need to know before you take Losartan potassium Film-Coated Tablets
Do NOT take Losartan potassium Film-Coated Tablets
• if you are allergic (hypersensitive) to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also better to avoid these tablets in early pregnancy see "Pregnancy”.),
• 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 Film-coated Tablets.
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).
It is important to tell your doctor before taking Losartan potassium Film-Coated Tablets:
• if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 'Possible side effects'),
• if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• if you 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'),
• if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• if your liver function is impaired (see sections 2 "Do not take Losartan potassium Film-Coated Tablets” and 3 "Dosage in special patient groups”),
• if you 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 B-blocker concomitantly,
• if you have problems with your heart valves or heart muscle,
• if you 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),
• if you 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).
• 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 Film-coated Tablets”
Children and adolescents
Losartan potassium has been studied in children. For more information, talk to your doctor.
Losartan potassium is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. Losartan potassium 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 potassium Film-Coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take particular care if you are taking the following medicines while under treatment with losartan potassium:
• 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,
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium- sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indometacin, including C0X-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.
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
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 film-coated Tablets” and "warnings and precautions”) 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 potassium Film-Coated Tablets with food, drink and alcohol
The tablets can be taken with or without food.
Pregnancy, breast-feeding and fertility 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 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.
Losartan potassium is 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 potassium is not recommended for mothers who are breast feeding, and your doctor may choose another treatment for you if you wish to breast feed. Especially if your baby is a newborn or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Losartan is 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.
3. How to take Losartan potassium Film-coated 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 potassium film-coated tablets, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium film-coated 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
Treatment usually starts with 50 mg losartan (one 50mg tablet ) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (two 50 mg tablets or one 100mg tablet) 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.
Use in children or adolescents
Children below 6 years of age
Losartan potassium film-coated tablets is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.
Children aged 6 - 18 years old g
The recommended starting dose in patients who weigh between 20 and 50 kg is
SAME SIZE ARTWORK 420 x 150 mm Back
0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of losartan potassium). The doctor may increase the dose if blood pressure is not controlled.
Adult Patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one 50mg tablet) once a day. The dose may later be increased to 100 mg losartan (two 50mg tablets or one 100mg tablet) once daily depending on your blood pressure response.
Losartan tablets 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
Treatment usually starts with 12.5 mg losartan (half a 25mg tablet) once a day. Generally, the dose should be increased weekly 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 50 mg or one tablet each of Losartan 100 mg and Losartan 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.
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 film-coated tablets").
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 film-coated tablets until your doctor tells you otherwise.
If you take more Losartan potassium Film-coated Tablets than you should
If you accidentally take too many tablets, contact your doctor immediately.
Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
If you forget to take Losartan potassium Film-coated Tablets
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Losartan potassium Film-coated Tablets can cause side effects, although not everybody gets them.
If you experience the following, stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
This is a serious but rare side effect, which may affect up to 1 in 1,000 people. You may need urgent medical attention or hospitalisation.
The following side effects have been reported with losartan:
Common: may affect up to 1 in 10 people:
• dizziness,
• 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,
• debility,
• fatigue,
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia)
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increase in blood urea, serum creatinine and serum potassium in patients with heart failure.
Uncommon: may affect up to 1 in 100 people:
• somnolence,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema)
• cough.
Rare: may affect up to 1 in 1,000 people:
• hypersensitivity
• angiooedema
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation)
• brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Not known: frequency cannot be estimated from the available data:
• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears (tinnitus),
Side effects in children are similar to those seen in adults.
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Losartan potassium Film-coated Tablets
• Keep out of the sight and reach of children.
• Do not use Losartan Potassium after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package.
• Do not throw away any medicines via wastewater or household. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. Contents of the pack and other information What Losartan potassium Film-coated tablets contains
The active substance is losartan potassium.
Each Losartan potassium 25mg Film-coated tablet contains 25 mg of losartan potassium. Each Losartan potassium 50 mg Film-coated tablet contains 50 mg of losartan potassium Each Losartan potassium 100 mg Film-coated tablet contains 100 mg of losartan potassium
The other ingredients are maize starch, microcrystalline cellulose, purified talc, colloidal anhydrous silica, sodium starch glycollate, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide El71.
What Losartan potassium looks like and contents of the pack
25 mg Film-coated Tablet is white to off white, oval shaped, biconvex, film coated tablet embossed with "25" on one side and ”BL" on the other side.
50 mg Film-coated Tablet is white to off white, oval shaped, biconvex, film coated tablet embossed with ”50" on one side and ”BL" on the other side.
100 mg Film-coated Tablet is white to off white, oval shaped, biconvex, film coated tablet embossed with ”100" on one side and ”BL" on the other side.
The tablets are packed in packs of 28, 56 and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG, UK Telephone: 01442200922 Fax: 01442873717
e-mail: info@bristol-labs.co.uk
Losartan potassium 25mg Film-coated Tablet, PL 17907/0242 Losartan potassium 50 mg Film-coated Tablet, PL 17907/0243 Losartan potassium 100 mg Film-coated Tablet, PL 17907/0244
To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
This leaflet was last revised in November 2014.
V3 13-11-14 DO