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
(Referred to as Losartan Potassium Tablets in the remainder of the leaflet)
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 prescrbed for you. 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.
In this leaflet:
1. What Losartan Potassium Tablets are and what they are used for
2. What you need to know before you take Losartan Potassium Tablets
3. How to take Losartan Potassium Tablets
4. Possible side effects
5. How to store Losartan Potassium Tablets
6. Contents of the pack and other information
1. What Losartan Potassium 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 blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidneys 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 between 6 and 18 years of age
• to protect the kidneys in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria > 0.5g per day (a condition in which the 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, medicines 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 Potassium Tablets
• in patients with high blood pressure and a thickening of the left ventricle, Losartan Potassium Tablets have been shown to decrease the risk of stroke (“LIFE indication”).
2. What you need to know before you take Losartan Potassium Tablets
Do not take Losartan Potassium Tablets:
• if you are allergic (hypersensitive) to losartan or to any other ingredients in this medicine (see section 6. Contents of the pack and other information)
• if your liver function is severely impaired
• if you are more than three months pregnant. (It is also better to avoid taking Losartan Potassium Tablets in early pregnancy - see also ‘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 Tablets are not recommended in early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used at that stage (see ‘Pregnancy and breastfeeding')
It is important to tell your doctor before taking Losartan Potassium Tablets:
• if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue (see also section 4 ‘Possible side effects').
• if you suffer from excessive vomiting and/or diarrhoea leading to an extreme loss of fluid and/or salt in your body
• if you take diuretics (water pills), medicines used to increase the amount of urine produced (see also section 3. How to take Losartan Potassium tablets) 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 your liver function is impaired (see also section above “Do not take Losartan Potassium tablets if you” and 3 ‘Dosage in special patient groups')
• if you are known to have a narrowing or blockage of the blood vessels leading to your kidneys, or if you have had a kidney transplant recently
• if you suffer from heart failure with or without kidney problems or concomitant severe life threatening irregular heartbeat. 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 have 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-inh bitor (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 Tablets:”.
Other medicines and Losartan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those 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 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 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, [including amiloride, triamterene or spironolactone] or heparin)
• non-steroidal anti-inflammatory drugs such as indometacin, 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
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.
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”).
Losartan Potassium Tablets with food and drink
Losartan Potassium Tablets should be taken with a glass of water with or without food.
Pregnancy and Breast Feeding Pregnancy
You must tell your doctor if you are or think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Losartan Potassium 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 Potassium Tablets. Losartan Potassium Tablets are not recommended in early pregnancy and must not be taken when more than three 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 breastfeeding or about to start breastfeeding. Losartan Potassium Tablets are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn, or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children and adolescents
Losartan Potassium Tablets have been studied in children. For more information, ta k to your doctor.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. Losartan Potassium Tablets are unl kely to affect your ability to drive or operate machines. However, as with many other medicines used to treat high blood pressure, Losartan Potassium Tablets may make you feel dizzy or drowsy. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Losartan Potassium Tablets contain lactose
This medicine contains 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 Potassium 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 Tablets, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium Tablets as long as your doctor prescribes them in order to maintain smooth control of your blood pressure.
Adult Patients with high blood pressure
The usual starting dose is one 50 mg tablet once a day. The maximal blood pressure lowering effect should be reached three to six weeks after beginning treatment. In some patients the dose may later be increased to 100mg losartan (two 50mg tablets) once daily. If you have the impression that the effect of losartan is too strong or weak, please talk to your doctor or pharmacist.
Use in Children or adolescents (6 to 18 years old)
The usual starting dose in patients who weigh between 20 and 50kg is 0.7mg of losartan per kg of body weight administered once a day (up to 25mg of losartan). Your doctor may increase the dose if blood pressure is not controlled.
Adult patients with high blood pressure and type 2 diabetes
The usual starting dose is one 50 mg tablet once a day. The dose may later be increased to two 50 mg tablet or one 100 mg tablet) once a day 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. sulfonylurease, glitazones and glucosidase inhibitors).
Adult Patients with heart failure
The usual starting dose is 12.5mg losartan once a day. Generally, the dose should be increased weekly step-by-step (i.e., 12.5mg daily during the first week, 25mg daily during the second week, 50mg daily during the third week, 100mg daily during the fourth week, 150mg daily during the fifth week) up to the maintenance dose as determined by your physician. A maximum dose of 150mg losartan (for example, three tablets of Losartan Potassium 50mg Tablets or one tablet each of Losartan Potassium 100mg Tablets and Losartan Potassium 50mg Tablets) once daily may be used.
Doses smaller than 25 mg cannot be obtained with these Losartan Potassium Tablets. For a dose not achievable with this medicine, other medicinal products containing losartan potassium should 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 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 Tablets until your doctor tells you otherwise.
If you take more Losartan Potassium Tablets than you should
If you accidentally take too many tablets, contact your doctor or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor. Symptoms of overdose include low blood pressure (feeling dizzy or light headed, especially when standing up) and either increased or decreased heartbeat.
If you forget to take Losartan Potassium 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 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 Potassium 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 been reported with
Losartan Potassium Tablets:
Common (affects 1 to 10 users in 100):
• dizziness or a feeling of spinning (vertigo)
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• feeling weak or tired
• too little sugar in the blood (hypoglycaemia). Symptoms include feeling hungry, trembling or shakiness and sweating
• too much potassium in the blood (hyperkalaemia); shown in blood tests. Symptoms may include an abnormal heartbeat
• changes in kidney function including kidney failure
• reduced number of red blood cells (anaemia)
• increase in the blood urea, serum creatinine and serum potassium in patients with heart failure
Uncommon (affects 1 to 10 users in 1000):
• sleepiness
• headache
• problems sleeping
• feelings 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)
• stomach ache
• constipation
• diarrhoea
• feeling or being sick
• hives (urticaria)
• itchy skin with or without dark red lumps
• rash
• localised swelling (oedema)
• cough
Rare (affects 1 to 10 users in 10,000):
• hypersensitivity
• serious allergic reaction which causes swelling of the face or throat
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura)
• pins and needles (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (arterial f brillation)
• reduction of blood to the brain (stroke)
• inflammation of the liver (hepatitis). Symptoms include jaundice, itching, feeling sick or being sick, loss of appetite, weight loss, abdominal pain.
• increases in a protein in your blood called alanine aminotransferase (ALT); shown in blood tests; usually resolved upon discontinuation of treatment.
Frequency not known:
• changes in blood cells including reduced numbers of red blood cells (anaemia) and platelets; shown in blood tests
• migraine
• liver function abnormalities
• muscle and joint pain
• changes in kidney function (may be revers ble upon discontinuation of treatment) including kidney failure
• flu-like symptoms
• increase in blood urea, serum creatinine and
serum potassium in patients with heart failure
• back pain with bladder and kidney infections
• increased sensitivity to the sun (photosensitivity)
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)
• failure to achieve an erection (impotence)
• severe abdominal and back pain (pancreatitis)
• low levels of sodium in the blood (hyponatraemia)
• feeling depressed
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517; Website: www.hpra.ie: e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Losartan Potassium 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 outer carton and blister. 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 moisture.
Do not throw away any medicines via wastewater or household waste. 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 Tablets contain
The active substance is losartan potassium. Each Losartan Potassium 25 mg tablet contains 25 mg of losartan potassium equivalent to 22.9mg of losartan. Each Losartan Potassium 50 mg tablet contains 50 mg of losartan potassium equivalent to 45.8mg of losartan. Each Losartan Potassium 100 mg tablet contains 100 mg of losartan potassium equivalent to 91.6mg of losartan.
The other ingredients are:
• Tablet core: microcrystalline cellulose (E460), lactose (anhydrous), pregelatinised maize starch, magnesium stearate (E572)
• Film-Coating: Hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171).
What Losartan Potassium Tablets look like and contents of the pack
Losartan Potassium Tablets are available in white, opaque blister packs (Alu/PVC Aclar) with outer cardboard cartons in the following pack sizes: Losartan Potassium 25mg Film-Coated Tablets - 7 or 28
Losartan Potassium 50mg Film-Coated Tablets - 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and-unit dose packages of 28, 56 and 98 tablets for hospital use.
Losartan Potassium 100mg Film-Coated Tablets -7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56, and 98 tablets for hospital use.
Not all pack sizes may be marketed.
Losartan Potassium 25 mg Film-Coated Tablets are white, oval-shaped, film-coated tablets, plain on both sides.
Losartan Potassium 50 mg Film-Coated Tablets are white, oval-shaped, film-coated tablets with a central break line on one side and plain on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Losartan Potassium 100 mg Film-Coated Tablets are white, almond-shaped, film-coated tablets, plain on both sides.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Losartan Potassium 25/50/100mg Film-Coated Tablets
Cyprus: Losartan Potassium Wockhardt 25/50/100mg Film-Coated Tablets Germany: Losartan-Kalium Wockhardt 25/50/100mg Filmtabletten Ireland: Losartan Potassium 25/50/100mg Film-Coated Tablets
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
|
Product name |
Reference number |
|
Losartan Potassium 25mg Film-Coated Tablets |
PL 29831/0378 |
|
Losartan Potassium 50mg Film-Coated Tablets |
PL 29831/0379 |
|
Losartan Potassium 100mg Film-Coated Tablets |
PL 29831/0380 |
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This leaflet was last revised in 04/2016
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