Patient leaflet - Losartan Potassium 12.5 mg film-coated tablets
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 slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan is used
to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 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 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 has been shown to decrease the risk of stroke (“LIFE indication”).
2. What you need to know before you take Losartan 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 breast feeding’)
- 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, pharmacist, or nurse before taking Losartan tablets if you:
- have, or have had a history of, angio-oedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects’)
- are suffering from severe sickness (vomiting) or diarrhoea leading to an extreme loss of fluid and/or salt in your body
- 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’)
- 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
- 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 ß-blocker concomitantly
- 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)
- 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)
- have an irregular heartbeat
- have narrowing of the valves of the heart (aortic or mitral valve stenosis)
- 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
- 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
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Losartan tablets. Your doctor will decide on further treatment. Do not stop taking Losartan tablets on your own. 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 tablets”.
Package leaflet: Information for the user
Losartan potassium
12.5 mg, 25 mg, 50 mg and 100 mg film-coated tablets
POM
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail: info@medreich.co.uk
50 mm
19 mm
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. Children and adolescents: Losartan has been studied in children. For more information, talk to your doctor.
Losartan is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. Losartan is 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 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 calledbeta-blockers e.g. atenolol, bisoprolol, sotalol
- tricyclic antidepressants- e.g. amitriptyline, trazodone, lofepramine
- medicines to treat psychiatric conditions such as schizophrenia and bipolardisorder, 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, triamterene
- medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that reduce inflammation, and pain e.g. aspirin, ibuprofen, indomethacin, naproxen, celecoxib
- rifampicin (an antibiotic used to treat tuberculosis)
- medicines to treat fungal infections, including fluconazole
- an ACE-inhibitor or aliskiren
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 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. Breast-feeding: 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.
Ask your doctor or pharmacist for advice before taking this medicine. 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: 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 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. Adult patients with 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.
If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Adult 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 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: The recommended initial dose of Losartan in patients with heart failure is 12.5mg once daily. The dose should be increased at weekly intervals 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 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. Use in children and adolescents
Children below 6 years of age: This medicine is not recommended for use in children under 6 years of age, 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.
Dosage in special patient groups
- 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 tomoderate 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 tablet for as long as your doctor prescribes it in order to maintain control of your 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.
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.
- 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 (may affect up to 1 in 10 people):
- dizziness (vertigo) - weakness, tiredness, fatigue
- reduced number of red blood cells (anaemia),
- low blood sugar(hypoglycaemia),
- high levels of potassium in the blood(hyperkalaemia),
- changes in kidney function including kidney failure,
- increase in blood urea, serum creatinine and serum potassium in patients with heart failure.
- 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,
Uncommon side effects (may affect up to 1 in 100 people):
- sleep disorders, sleepiness - headache
- inflammation or redness of the skin - rash, hives, itching
- breathlessness, shortness of breath, cough
- angina (heaviness or tightness in the chest along with heart pain),
abdominal pain, severe constipation, nausea, vomiting, diarrhoea
Swiss 721 Condensed BT
Heading - 12 pts
Body - 8 pts
V-1
Red 032 C Colour:
Unit 7
Product Losartan 50 mg Tablets - S/L - English - PIL
(SAP Descr:
Customer
Reason
Specification:
CQA:
PDC: PDC: Regulatory:
MED/LOS/PIL/01
(AI Format)
MEDREICH PLC, UK
AWR No.: (Old Code: 1217915)
Printed on 40.5 (±3.5) GSM News Print Paper.
Internal Approval issued on CD issued on
- swelling of the hands or feet, aching, stiff joints
- feeling of increased heart rate (palpitations)
Rare (may affect up to 1 in 1,000 people):
- 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)
- elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
- fainting (syncope)
- Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea. Not known (frequency cannot be estimated from the available data):
- migraine - flu-like symptoms
- urinary infection - impotence,
- disturbed taste (dysgeusia) - generally feeling unwell (malaise),
- depression, - liver function abnormalities
- pain in the joints and muscles, back pain
- high levels of blood urea or serum creatinine
- ringing, buzzing, roaring, or clicking in the ears (tinnitus),
- inflammation of the pancreas (pancreatitis),
- increased sensitivity to the sun (photosensitivity),
- low levels of sodium in the blood (hyponatraemia),
- unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
- reduced number of thrombocytes (low blood platelet count, which may make you more prone to bleeding or bruising)
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 listedin this leaflet, please tell your doctor or pharmacist. Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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 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 the 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).
Macrogol/PEG 400(only in Losartan potassium 12.5 mg/50 mg/ 100mg 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 tablets pack. (Not all pack sizes may be marketed)
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 01/2025