LOSARTAN POTASSIUM LICONSA 50 MG FILM-COATED TABLETS
Active substance: LOSARTAN POTASSIUM
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PACKAGE LEAFLET: INFORMATION FOR THE USER Losartan potassium Liconsa 25 mg / 50 mg / 100 mg film-coated tablets Losartan potassium Read all of this leaflet carefully before taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet: 1. 2. 3. 4. 5. 6. What Losartan potassium Liconsa is and what it is used for Before you take Losartan potassium Liconsa How to take Losartan potassium Liconsa Possible side effects How to store Losartan potassium Liconsa Further information
1.
WHAT Losartan potassium Liconsa IS AND WHAT IT IS 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 Liconsa is used to treat patients with high blood pressure (hypertension) 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 Liconsa has been shown to decrease the risk of stroke (LIFE indication).
2.
BEFORE YOU TAKE Losartan potassium Liconsa
Do not take Losartan potassium Liconsa
if you are allergic (hypersensitive) to losartan or to any of its other ingredients, if your liver function is severely impaired, if you are, think you may be or are planning to become pregnant (see also Pregnancy and breast-feeding), If you are more than 3 months pregnant. (It is also better to avoid Losartan potassium Liconsa in early pregnancy see pregnancy section.)
Take special care with Losartan potassium Liconsa You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium Liconsa is not recommended in early pregnancy, and must not be taken if you are more than 3months 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 Liconsa : 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" 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 -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). Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products. Take particular care if you are taking the following medicines while under treatment with Losartan potassium Liconsa : 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, baclofene, 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, triamteren, spironolactone] or heparine), 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 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. 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. Taking Losartan potassium Liconsa with food and drink Losartan potassium Liconsa 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 Liconsa 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 Liconsa . Losartan potassium Liconsa 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. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium Liconsa 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. Use in children and adolescents Losartan potassium Liconsa has been studied in children. For more information, talk to your doctor. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Losartan potassium Liconsa 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. Important information about some of the ingredients of Losartan potassium Liconsa Losartan potassium Liconsa 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 Liconsa
Always take Losartan potassium Liconsa exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Losartan potassium Liconsa , depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium Liconsa 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 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 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 adolescent (6 to 18 years old) The recommended dose in patients who weigh between 20 and 50kg is 25mg administered once a day. The doctor may increase the dose if blood pressure is not controlled The recommended dose in patients who weigh above 50 kg is 50 mg administered once a day. The doctor may increase the dose if blood pressure is not controlled Adults patients with high blood pressure and type 2 diabetes Treatment usually starts with 50 mg losartan once a day. The dose may later be increased to 100 mg losartan 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). 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) up to the usual maintenance dose of 50 mg losartan once daily, according to your condition. This medicine does not allow to take the 12.5 mg dose. In those cases in which losartan 12.5 mg is prescribed your doctor will have to choose another product. 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 Liconsa ").
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 Liconsa until your doctor tells you otherwise. If you take more Losartan potassium Liconsa 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 potassium Liconsa 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 product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Losartan potassium Liconsa 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 side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common: happening in 1 in 100 to 1 in 10 patients uncommon: happening in 1 in 1,000 to 1 in 100 patients rare: happening in 1 in 10,000 to 1 in 1,000 patients very rare: happening in less than 1 in 10,000 patients not known: (cannot be estimated from the available data) The following side effects have been reported with Losartan potassium Liconsa : Common: dizziness, low blood pressure, debility, fatigue, too less sugar in the blood (hypoglycaemia), too much potassium in the blood (hyperkalaemia).
reduced number of red blood cells (anaemia), changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure increase in blood urea, serum creatinine and serum potassium in patients with heart failure vertigo
Uncommon: somnolence, headache, sleep disorders, feeling of 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 appearing when rising from a lying or sitting position, shortness of breath (dyspnoea), abdominal pain, constipation, diarrhoea, nausea, vomiting, hives (urticaria), itching (pruritus), rash, localised swelling (oedema). cough oedema (swelling) Rare:
inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura), numbness or tingling sensation (paraesthesia), fainting (syncope), very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke), inflammation of the liver (hepatitis), elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Not known.: reduced number of thrombocytes, migraine, liver function abnormalities, muscle and joint pain, flu-like symptoms, back pain and urinary track infection. increased sensitivity to the sun (photosensitivity)
unexplained muscle pain with dark (tea-coloured)urine (rhabdomyolisis) 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE Losartan potassium Liconsa
Keep out of the reach and sight of children. Do not use Losartan potassium Liconsa after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
No special storage conditions are requiredDo not open the blister pack until you are ready to
take the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Losartan potassium Liconsa contains The active substance is losartan potassium. Each Losartan potassium Liconsa 25 mg tablet contains 25 mg of losartan potassium. Each Losartan potassium Liconsa 50 mg tablet contains 50 mg of losartan potassium. Each Losartan potassium Liconsa 100 mg tablet contains 100 mg of losartan potassium. The other ingredients are: - Tablet core: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose and magnesium stearate. - Tablet coating: hyprolose, hypromellose and titanium dioxide.
What Losartan potassium Liconsa looks like and contents of the pack Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 25 mg of losartan potassium. Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 50 mg of losartan potassium.
Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 100 mg of losartan potassium. Losartan potassium Liconsa is supplied in the following pack sizes: Losartan potassium Liconsa 25 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28 25, 50, 56, 90, 98, 100, 210 or 280 tablets Losartan potassium Liconsa 50 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56,90, 98, 100, 210 or 280 tablets. Losartan potassium Liconsa 100 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90, 98, 100, 210 or 280 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder LABORATORIOS LICONSA, S.A. Gran Va Carlos III, 98, 7th floor, 08028 Barcelona
SPAIN
Manufacturer LABORATORIOS LICONSA, S.A. Avda. Miralcampo, N 7, Polgono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara) SPAIN This medicinal product is authorized in the Member States of the EEA under the following names: Member State Denmark: France: The Netherlands: United Kingdom: Invented name Losartankalium Liconsa 25 mg / 50 mg / 100 mg filmovertrukket tablet Losartan BGR 25 mg / 50 mg / 100 mg comprime pellicul Losanox 25 mg / 50 mg / 100 mg filmomhulde tablet Losartan potassium Liconsa 25 mg / 50 mg / 100 mg film-coated tablets
This leaflet was last approved in 01/2012.
In this leaflet: 1. 2. 3. 4. 5. 6. What Losartan potassium Liconsa is and what it is used for Before you take Losartan potassium Liconsa How to take Losartan potassium Liconsa Possible side effects How to store Losartan potassium Liconsa Further information
1.
WHAT Losartan potassium Liconsa IS AND WHAT IT IS 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 Liconsa is used to treat patients with high blood pressure (hypertension) 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 Liconsa has been shown to decrease the risk of stroke (LIFE indication).
2.
BEFORE YOU TAKE Losartan potassium Liconsa
Do not take Losartan potassium Liconsa
if you are allergic (hypersensitive) to losartan or to any of its other ingredients, if your liver function is severely impaired, if you are, think you may be or are planning to become pregnant (see also Pregnancy and breast-feeding), If you are more than 3 months pregnant. (It is also better to avoid Losartan potassium Liconsa in early pregnancy see pregnancy section.)
Take special care with Losartan potassium Liconsa You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium Liconsa is not recommended in early pregnancy, and must not be taken if you are more than 3months 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 Liconsa : 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" 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 -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). Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products. Take particular care if you are taking the following medicines while under treatment with Losartan potassium Liconsa : 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, baclofene, 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, triamteren, spironolactone] or heparine), 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 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. 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. Taking Losartan potassium Liconsa with food and drink Losartan potassium Liconsa 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 Liconsa 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 Liconsa . Losartan potassium Liconsa 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. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium Liconsa 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. Use in children and adolescents Losartan potassium Liconsa has been studied in children. For more information, talk to your doctor. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Losartan potassium Liconsa 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. Important information about some of the ingredients of Losartan potassium Liconsa Losartan potassium Liconsa 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 Liconsa
Always take Losartan potassium Liconsa exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Losartan potassium Liconsa , depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium Liconsa 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 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 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 adolescent (6 to 18 years old) The recommended dose in patients who weigh between 20 and 50kg is 25mg administered once a day. The doctor may increase the dose if blood pressure is not controlled The recommended dose in patients who weigh above 50 kg is 50 mg administered once a day. The doctor may increase the dose if blood pressure is not controlled Adults patients with high blood pressure and type 2 diabetes Treatment usually starts with 50 mg losartan once a day. The dose may later be increased to 100 mg losartan 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). 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) up to the usual maintenance dose of 50 mg losartan once daily, according to your condition. This medicine does not allow to take the 12.5 mg dose. In those cases in which losartan 12.5 mg is prescribed your doctor will have to choose another product. 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 Liconsa ").
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 Liconsa until your doctor tells you otherwise. If you take more Losartan potassium Liconsa 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 potassium Liconsa 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 product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Losartan potassium Liconsa 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 side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common: happening in 1 in 100 to 1 in 10 patients uncommon: happening in 1 in 1,000 to 1 in 100 patients rare: happening in 1 in 10,000 to 1 in 1,000 patients very rare: happening in less than 1 in 10,000 patients not known: (cannot be estimated from the available data) The following side effects have been reported with Losartan potassium Liconsa : Common: dizziness, low blood pressure, debility, fatigue, too less sugar in the blood (hypoglycaemia), too much potassium in the blood (hyperkalaemia).
reduced number of red blood cells (anaemia), changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure increase in blood urea, serum creatinine and serum potassium in patients with heart failure vertigo
Uncommon: somnolence, headache, sleep disorders, feeling of 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 appearing when rising from a lying or sitting position, shortness of breath (dyspnoea), abdominal pain, constipation, diarrhoea, nausea, vomiting, hives (urticaria), itching (pruritus), rash, localised swelling (oedema). cough oedema (swelling) Rare:
inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura), numbness or tingling sensation (paraesthesia), fainting (syncope), very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke), inflammation of the liver (hepatitis), elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Not known.: reduced number of thrombocytes, migraine, liver function abnormalities, muscle and joint pain, flu-like symptoms, back pain and urinary track infection. increased sensitivity to the sun (photosensitivity)
unexplained muscle pain with dark (tea-coloured)urine (rhabdomyolisis) 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE Losartan potassium Liconsa
Keep out of the reach and sight of children. Do not use Losartan potassium Liconsa after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
No special storage conditions are requiredDo not open the blister pack until you are ready to
take the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Losartan potassium Liconsa contains The active substance is losartan potassium. Each Losartan potassium Liconsa 25 mg tablet contains 25 mg of losartan potassium. Each Losartan potassium Liconsa 50 mg tablet contains 50 mg of losartan potassium. Each Losartan potassium Liconsa 100 mg tablet contains 100 mg of losartan potassium. The other ingredients are: - Tablet core: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose and magnesium stearate. - Tablet coating: hyprolose, hypromellose and titanium dioxide.
What Losartan potassium Liconsa looks like and contents of the pack Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 25 mg of losartan potassium. Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 50 mg of losartan potassium.
Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 100 mg of losartan potassium. Losartan potassium Liconsa is supplied in the following pack sizes: Losartan potassium Liconsa 25 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28 25, 50, 56, 90, 98, 100, 210 or 280 tablets Losartan potassium Liconsa 50 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56,90, 98, 100, 210 or 280 tablets. Losartan potassium Liconsa 100 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90, 98, 100, 210 or 280 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder LABORATORIOS LICONSA, S.A. Gran Va Carlos III, 98, 7th floor, 08028 Barcelona
SPAIN
Manufacturer LABORATORIOS LICONSA, S.A. Avda. Miralcampo, N 7, Polgono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara) SPAIN This medicinal product is authorized in the Member States of the EEA under the following names: Member State Denmark: France: The Netherlands: United Kingdom: Invented name Losartankalium Liconsa 25 mg / 50 mg / 100 mg filmovertrukket tablet Losartan BGR 25 mg / 50 mg / 100 mg comprime pellicul Losanox 25 mg / 50 mg / 100 mg filmomhulde tablet Losartan potassium Liconsa 25 mg / 50 mg / 100 mg film-coated tablets
This leaflet was last approved in 01/2012.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
