Losartan Potassium 50 Mg Film-Coated Tablets
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Losartan potassium 25 mg, 50 mg & 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 potassium is and what it is used for
2. What you need to know before you take Losartan potassium
3. How to take Losartan potassium
4. Possible side effects
5. How to store Losartan potassium
6. Contents of the pack and other information
1. What Losartan potassium is and what it is used for
Losartan potassium 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 potassium prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan potassium slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan potassium is used to
• treat high blood pressure (hypertension) 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 > 0.5 g per day (a condition in which urine contains an abnormal amount of protein)
• treat chronic heart failure when treatment with specific medicines called angiotensinconverting enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by the doctor. If your heart failure has been stabilized with an ACE inhibitor you should not be switched to losartan,
• decrease the risk of a stroke in patients with high blood pressure and a thickening of the left ventricle of the heart (“LIFE indication”).
2. What you need to know before you take Losartan potassium Do not take Losartan potassium:
• if you are allergic (hypersensitive) to losartan or 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 Losartan potassium in early pregnancy (see also Section 2. “Pregnancy and breast-feeding”)).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
If any of the above apply to you do not take Losartan potassium.
Warnings and precautions
Take special care with Losartan potassium
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 before taking Losartan potassium:-
• if you have a history of angioedema (swelling of the face, lips, throat, mouth and/or tongue) as you may be more likely to develop an allergic reaction (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 take diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are on a salt restricted diet (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” and 3. “Dosage in special patient groups”),
• if you suffer from heart failure with or without kidney problems or have serious disturbances in your heart rhythm. Special caution is necessary when you are treated with a beta-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 condition associated with increased secretion of the hormone aldosterone by the adrenal 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”.
Children and adolescents
Losartan potassium has been studied in children. For more information, talk to your doctor. Other medicines and Losartan potassium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
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” and “Warnings and precautions”)
Take particular care and tell your doctor 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 the following medicines: tricyclic antidepressants, antipsychotics, baclofen, and amifostine,
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indomethacin, high doses of aspirin and, 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.
Using these medicines together may also lead to a worsening in kidney function, especially in people with kidney problems
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 with food and drink
Losartan potassium 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 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 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 newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicines
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Losartan potassium 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.
Losartan potassium contains lactose monohydrate
Losartan potassium contains lactose monohydrate. 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 potassium
• Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• Your doctor will decide on the correct dose of Losartan potassium, depending on your condition and whether you are taking other medicines.
• It is important to continue taking Losartan potassium 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 potassium once a day. The maximum blood pressure lowering effect should be reached within 3 to 6 weeks after beginning treatment. The dose may be increased by your doctor up to 100 mg losartan once daily.
If you have the impression that the effect of losartan potassium is too strong or too weak, please talk to your doctor or pharmacist.
Use in children and adolescents (6 to 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 weigh administered once a day (up to 25 mg of losartan). 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 potassium once a day. The dose may later be increased to 100 mg losartan potassium once daily depending on your blood pressure response.
Losartan potassium 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 potassium once a day. Generally, the dose should be increased weekly step-by-step by your doctor (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 usual maintenance dose as determined by your physician. A maximum dose of 150 mg (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 potassium 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, those with liver impairment, or in those over the age of 75 years. The use of losartan potassium is not recommended in patients with severe liver impairment (see section 2. "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 potassium than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose are low blood pressure and changes in the heartbeat (increased heartbeat or possibly decreased heartbeat).
If you forget to take Losartan potassium
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 serious side effects, stop taking Losartan potassium tablets and tell your doctor immediately or go to the casualty department of your nearest hospital. You may need urgent medical attention or hospitalization.
• 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 potassium:
Common (may affect up to 1 in 10 people):
• Dizziness or a feeling of spinning,
• low blood pressure,
• weakness,
• tiredness (fatigue),
• low blood sugar (hypoglycaemia),
• high potassium levels 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):
• drowsiness (somnolence),
• headache,
• sleep disorders,
• feeling of pounding in the chest or increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• 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 causing dizziness or faintness when getting up from a lying or sitting position,
• shortness of breath (dyspnoea),
• stomach (abdominal) pain,
• severe constipation (obstipation),
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• swelling of areas on the body (oedema),
• cough.
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity
• angiooedma
• 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),
• increased liver enzymes which usually gets better on stopping treatment.
Not known (frequency cannot be estimated from the available data):
• reduced number of blood cells (thrombocytes), possibly causing bruising or bleeding,
• migraine,
• liver function abnormalities,
• muscle and j oint pain,
• flu-like symptoms,
• back pain and urinary tract infection
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-colored) 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).
Additional side effects in children and adolescents
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 potassium
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.
This medicinal product does not require any special storage conditions.
Do not throw away medicines via wastewater 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 potassium contains
• The active substance is losartan potassium.
Each film-coated tablet contains 25 mg losartan potassium.
Each film-coated tablet contains 50 mg losartan potassium.
Each film-coated tablet contains 100 mg losartan potassium.
• The other ingredients are cellulose microcrystalline, lactose monohydrate, pregelatinised starch (maize), hydroxypropyl cellulose, magnesium stearate, hypromellose and titanium dioxide (E171).
What Losartan potassium looks like and contents of the pack
Film-coated tablet.
Losartan potassium 25 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘45’ on other side.
Losartan potassium 50 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘4’ and ‘6’ separated by a score line on other side. The tablets can be divided into equal halves.
Losartan potassium 100 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘47’ on other side.
Losartan potassium tablets are available in
• Blister packs: 7, 10, 14, 15, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100, 210 and 280 film coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta