Losartan Potassium 50mg Film-Coated Tablets
The following side effects have also been reported but the frequency is not known:
- anaemia, reduced number of red blood cells and white blood cells
- migraine
- flu-like symptoms
- cough
- urinary infection
- changes in kidney function
- reduced number of thrombocytes (low blood platelet count, which may make you more prone to bleeding or bruising)
- pain in the joints and muscles, back pain
- high levels of blood urea or serum creatinine
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.
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: http://www. mhra.gov.uk/yellowcard"www.mhra.gov.uk/yellowcard.
5. HOW TO STORE
Keep this medicine out of the reach and sight of children.
Do not use Losartan tablets after the expiry date which is stated on the blister and carton after EXP The expiry date refers to the last day of that month.
Medicines should not be disposed of 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 PACK AND OTHER INFORMATION What Losartan tablets contain
The active substance is losartan potassium. Each Losartan tablet contains either 12.5 mg, 25 mg, 50 mg or 100 mg of losartan potassium.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), magnesium stearate (E572), lactose monohydrate, pregelatinised starch.
Tablet film coating: Hypromellose (E464), titanium dioxide (E171). Macrogol/PEG 4000 and Indigo carmine aluminum lake (E132) (only in Losartan potassium 25 mg film-coated tablets).
What Losartan tablets look like and contents of the pack
Losartan potassium 12.5 mg tablets are White, round film-coated tablets. Losartan potassium 25 mg tablets are Blue, round film-coated tablets, scored on one side.
Losartan potassium 50 mg tablets are White, round film-coated tablets scored on one side.
Losartan potassium 100 mg tablets are White, oblong film-coated tablets scored on one side.
They come in blisters of: 7, 10, 14, 28, 30, 50, 56, 98 film coated tablets.
The 12.5mg strength is also available in 21 tablet packs.
(Not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail: info@medrich.co.uk
Losartan potassium 12.5 mg: PL 21880/0139 Losartan potassium 25 mg: PL 21880/0140 Losartan potassium 50 mg: PL 21880/0141 Losartan potassium 100 mg: PL 21880/0142
This leaflet was last revised in 01/2014.
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Package leaflet: Information for the user
Losartan potassium
12.5 mg, 25 mg, 50 mg and 100 mg film-coated tablets
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 your 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.
In this leaflet:
1. What Losartan tablets are and what they are used for
2. What you need to know before you take these tablets
3. How to take these tablets
4. Possible side effects
5. How to store
6. Contents of pack and other information
1. WHAT LOSARTAN 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 the blood vessels to relax which in turn lowers the blood pressure.
Losartan is used
• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age.
• 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.
• patients taking losartan should have a left ventricula ejection fraction <40% and should be stabilised under the treatment of the chronic heart failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THESE TABLETS Do not take Losartan tablets if you:
- are allergic (hypersensitive) to losartan or to any of the other ingredients listed in section 6.
- have severely impaired liver function
- are more than 3 months pregnant. (It is also better to avoid Losartan tablets in early pregnancy - see ‘Pregnancy and Breastfeeding')
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan tablets if you:
- have, or have a history of, angio-oedema (swelling of the face, lips, throat, and/or tongue)
- are suffering from severe sickness (vomiting) or diarrhoea
- take or have recently taken diuretics (water tablets which make you urinate more frequently)
- are on a low salt diet
- have progressive liver disease (cirrhosis) or mild to moderate liver impairment
- suffer from reduced kidney function, kidney failure, have only one functioning kidney or have received a kidney transplant
- are known to have narrowing (stenosis) or blockage of the blood vessels leading to your kidneys
- have increased secretion of the hormone aldosterone by the adrenal gland (primary hyperaldosteronism)
- suffer from reduced blood supply to the heart (coronary heart disease) or reduced blood circulation in the brain (cerebrovascular disease)
- have an irregular heartbeat
- suffer from heart failure, with or without kidney problems
- have narrowing of the valves of the heart (aortic or mitral valve stenosis)
- have diabetes
- are of Afro-Caribbean origin then these tablets may not be suitable for you as they may not be as effective as they should be
If any of these points apply to you, do not take this medicine until you have talked to your doctor or pharmacist. You may need to be given a different medicine or the dose may need to be changed.
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 and Breastfeeding section).
Other medicines and Losartan tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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Take particular care if you are taking any of the following:
- other blood pressure lowering medicines as they may additionally reduce your blood pressure e.g. valsartan or telmisartan
- diuretics (water tablets), e.g. bendroflumethiazide, indapamide, sprinolactone
- medicines for high blood pressure called ACE inhibitors e.g. enalapril, lisinopril, ramipril
- other medicines to lower blood pressure, e.g. amlodipine, felodipine, lecanidipine, methyldopa
- medicines for heart conditions and high blood pressure called beta-blockers e.g. atenolol, bisoprolol, sotalol
- tricyclic antidepressants- e.g. amitriptyline, trazodone, lofepramine
- medicines to treat psychiatric conditions such as schizophrenia and bipolar disorder, e.g. flupentixol, chlorpromazine, olanzapine, risperidone, lithium
- medicines to relax your muscles, including baclofen
- cancer treatments, including amifostine
- medicines which can increase potassium levels e.g. potassium supplements, salt substitutes, heparin or potassium sparing medicines, e.g. spironolactone, amiloride
- medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that reduce inflammation, and pain e.g. aspirin, ibuprofen, indometacin, naproxen, celecoxib
- rifampicin (an antibiotic used to treat tuberculosis)
- medicines to treat fungal infections, including fluconazole
Taking Losartan tablets with food and drink
The tablets should be taken with a glass of water. They may be taken with or without food.
Do not drink alcohol whilst taking these tablets as alcohol and Losartan tablets may increase each other's effects.
High levels of salt in your diet may stop Losartan tablets from working properly so avoid eating too much salty food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan tablets are 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
Losartan tablets can cause dizziness or drowsiness in some people, particularly at the start of treatment or if your dose is increased. If you experience these symptoms, contact your doctor before driving or operating machinery.
Losartan tablets contain Lactose
Losartan tablets contain lactose monohydrate. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
3. HOW TO TAKE THE TABLETS
Always take this medicine exactly as your doctor 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.
Swallow this medicine with a glass of water. This medicine may be taken with or without food.
For treatment of high blood pressure
The recommended dose is 50 mg once daily. The maximum blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may be increased to 100 mg once daily.
For treatment of heart failure
The recommended initial dose of Losartan in patients with heart failure is 12.5 mg once daily. The dose should be increased at weekly intervals until the required dose is reached. The recommended required dose is 50 mg once daily.
Children and adolescents
This medicine is not recommended for use in children or adolescents suffering from kidney or liver problems, or children under 6 years of age.
The recommended dose for children and adolescents weighing between 20 -50 kg is 25 mg once daily. Your doctor may increase the dose to 50 mg once daily in certain circumstances.
The recommended dose for children and adolescents weighing more than 50 kg is 50 mg once daily. Your doctor may increase the dose to 100 mg once daily in certain circumstances.
Other dosage information
• Kidney Impairment - No change of dosage is required in patients with kidney impairment or patients having dialysis.
• Liver Impairment - A lower dose may be considered if you have mild to moderate liver impairment. This medicine should not be used if you have severe liver impairment.
• Reduced blood volume - Your doctor may prescribe a different starting dose of this medication if you have reduced blood volume.
• Elderly patients - This medicine is suitable for elderly patients, however the dose should be decreased in elderly patients over 75 years of age.
If you take more Losartan tablets than you should If you take more Losartan tablets than you should, contact your doctor or pharmacist immediately. If possible take the tablets or box with you. Symptoms of overdose are low blood pressure, heart palpitations or a slow pulse.
If you forget to take Losartan tablets
If you 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 stop taking Losartan tablets
It is important to continue taking Losartan tablets for as long as your doctor prescribes it in order to maintain control of you blood pressure.
If you have the impression that the effect of Losartan is too strong or too weak, please talk to your doctor or pharmacist.
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.
Serious side effects
Stop taking this medicine and contact your doctor or hospital emergency department IMMEDIATELY if you develop any of the following symptoms:
- swelling of the face, lips, mouth or throat difficulty breathing or swallowing, rash or itching. These could be a sign of a severe allergic reaction.
- yellowing of the eyes and skin (jaundice). This could be a sign of serious liver problems including hepatitis.
Stop taking the tablets and seek immediate medical advice if the above symptoms occur.
Other side effects
The following side effects may also occur:
Common side effects (affects 1 to 10 users in 100):
- dizziness (vertigo)
- low blood pressure
- weakness, tiredness, fatigue
- low blood sugar
- high levels of potassium in the blood
Uncommon side effects (affects 1 to 10 users in 1,000):
- sleep disorders, sleepiness
- headache
- angina (heaviness or tightness in the chest along with heart pain),
- fainting, feeling light headed or weak when you stand up
- breathlessness, shortness of breath
- abdominal pain, severe constipation, nausea, vomiting, diarrhoea
- hives, itchy rash
- inflammation or redness of the skin
- swelling of the hands or feet, aching, stiff joints
- feeling of increased heart rate (palpitations)
Rare (affects 1 to 10 users in 10,000):
- swelling of the skin or mucous membranes such as the eyes and mouth
- skin rash, bruising or red/purplish discolouration of the skin produced by small bleeding vessels near the surface
- pins and needles or similar sensations, pain or numbness in the extremities
- abnormal heartbeat, stroke, heart attack, change in heart rhythm
- hepatitis (inflammation of the liver), abnormal liver function tests
This section is continued overleaf ^
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