Losartan Potassium 25mg Film-Coated Tablets
Package leaflet: Information for the user
Losartan potassium 25 mg film-coated tablets Losartan potassium 50 mg film-coated tablets Losartan potassium 100 mg 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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 tablets are and what they are used for
2. What you need to know before you take Losartan tablets
3. How to take Losartan tablets
4. Possible side effects
5. How to store Losartan tablets
6. Contents of the pack and other information
1. What Losartan tablets are and what they are used for
Losartan tablet contains the active substance losartan which 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 tablets are used:
• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 618 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 angiotensinconverting-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 has been shown to decrease the risk of stroke (“LIFE indication”).
• Losartan can be used alone or in combination with other antihypertensive agents especially with diuretics e. g. hydrochlorothiazide.
You must talk to a doctor if after taking the tablets you do not feel better or if you feel worse.
2. What you need to know before you take Losartan tablets Do not take Losartan tablets:
• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver problems,
• if you are more than 3 months pregnant. (It is also better to avoid Losartan tablets in early pregnancy-see pregnancy section.),
• 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 tablets.
You must tell your doctor if you think you are (or might become) pregnant. Losartan tablets are 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).
• if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see 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 patients 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 you liver function is impaired (see section 2 “Do not take Losartan 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 primary hyper aldosteronism (a syndrome associated with increase secretion of hormone aldosterone by the adrenal gland, caused by an abnormality within the gland),
• 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 are taking any of the following medicines used to treat high blood pressure.
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Children
Losartan tablets have been studied in children. For more information, talk to your doctor.
Losartan tablets are not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups.
Losartan tablets are 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.
Take particular care if you are taking the following medicines while under treatment with Losartan tablets:
• 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 the 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 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.
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 tablets” 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
Losartan may be taken with or without food.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are 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 you to 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 tablet 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 newborn, or was born prematurely.
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
If you have been told by your 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.
The medicine is recommended in:
Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (two Losartan 25 mg tablets or one Losartan 50 mg 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 Losartan 50 mg tablets or one Losartan 100 mg 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
Children below 6 years of age
Losartan tablets are 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
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.
Adult patients with high blood pressure and Type 2 diabetes
Treatment usually starts with 50 mg losartan (two Losartan 25 mg tablets or one Losartan 50 mg tablet) once a day. The dose may later be increased to 100 mg losartan (two Losartan 50 mg tablets or one Losartan 100 mg tablet) 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
Treatment usually starts with 12.5 mg losartan 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 advice 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 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 tablets until your doctor tells you otherwise.
If you take more Losartan tablets than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
If you forget to take Losartan 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 tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 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.
The following side effects have also been reported with Losartan tablets:
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 easing 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)
• sleepiness or other sleep disturbance
• skin rash
• itching
• hives
• headache
• feeling of increased heart rate (palpitations)
• severe chest pain
• cough
• breathlessness or difficulty breathing
• abdominal pain
• diarrhoea
• nausea
• vomiting
• constipation,
• localized swelling (oedema)
Rare (may affect up to 1 in 1,000 people)
• numbness or tingling sensation in the skin,
• fainting,
• hypersensitivity,
• inflammation of the blood vessels (vasculitis including Henoch-Schonlein purpura),
• inflammation of the liver,
• angioedema,
• very rapid and irregular heartbeat (atrial fibrillation),
• brain attack (stroke),
• 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,
• back pain,
• urinary infection,
• flu-like symptoms,
• migraine,
• muscle pains,
• joint pains,
• liver function abnormalities,
• 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),
• disturbed taste (dysgeusia).
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 or pharmacist. 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 tablets
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Store in the original package in order to protect from light.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Losartan tablets contain
- The active substance is losartan potassium.
o 25 mg: Each film-coated tablet contains 25 mg of losartan potassium o 50 mg: Each film-coated tablet contains 50 mg of losartan potassium o 100 mg: Each film-coated tablet contains 100 mg of losartan potassium
- The other ingredients are microcrystalline cellulose (E460), dibasic calcium phosphate, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate
The film-coat contains hypromellose (E464), lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000 and sodium citrate dihydrate.
What Losartan tablets look like and contents of the pack
Losartan potassium 25 mg tablets are white, round shaped film-coated tablets, diameter 6.5 mm, debossed with L25 on one side and plain on other side.
Losartan potassium 50 mg tablets are white, oval shaped film-coated tablets with central break line on one side and L50 on the other side.
Length: 11.5 mm Breadth: 6mm
Losartan potassium 100 mg tablets are white, oval shaped film-coated tablets debossed with L100 on one side and plain on other side.
Length: 13.4 mm Breadth: 6.6 mm
Losartan tablets are supplied in the following pack sizes:
Losartan 25 mg tablets are presented in a blister pack of 7 or 28 tablets.
Losartan 50 mg tablets are presented in a blister pack of 7, 10, 14, 28, 30, 56, 84, 90, 98, 280 or 500 tablets.
Losartan 100 mg tablets are presented in a blister pack of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Cipla (EU) Ltd,
Hillbrow House,
Hillbrow Road,
Esher, Surrey,
KT10 9NW.
Manufacturer:
Cipla (EU) Limited,
4th Floor,
1 Kingdom Street,
London, W2 6BY,
United Kingdom