Losartan potassium 25mg,
50mg and 100mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
- 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. 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.
- The full name of this medicine is Losartan potassium 25mg, 50mg and 100mg Film-coated Tablets but within the leaflet it will be referred to as Losartan tablets.
In this leaflet:
1 What Losartan tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
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 tablets are used to treat patients with high blood pressure (hypertension).
Losartan tablets may also be prescribed to treat conditions not listed in this leaflet. If you have any questions, ask your doctor or pharmacist.
Before you take
Do not take Losartan tablets if you:
- are allergic (hypersensitive) to losartan or to any of its other ingredients
- have severe liver problems
- are more than 3 months pregnant (It is also better to avoid Losartan tablets in early pregnancy – see pregnancy section).
Take special care with Losartan tablets
It is important to tell your doctor before taking Losartan tablets if you:
- have had a history of angio-oedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects’)
- suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body
- take 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’)
- are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently
- have liver problems (see sections 2 “Do not take Losartan” and 3 ‘Dosage in special patient groups’)
- suffer from heart failure with or without kidney problems or severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a beta-blocker at the same time
- have problems with your heart valves or heart muscle
- suffer from coronary heart disease (reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (reduced blood circulation in the brain)
- suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, causing headaches, tiredness, night time urination and high blood pressure)
- 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 section).
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.
Especially:
- 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 [amiloride, triamterene, 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 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 tablets with food and drink
Losartan tablets 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 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 breastfeeding. 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.
Use in children and adolescents
Losartan tablets have 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 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.
How to take
Always take Losartan tablets exactly as your doctor has instructed you. 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.
Dose:
Treatment usually starts with 50mg once a day. The maximum blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100mg 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.
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”).
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 tablets until your doctor tells you otherwise.
If you take more Losartan tablets 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 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 any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Losartan tablets can cause side effects, although not everybody gets them.
Stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital if you experience the following signs of a severe allergic reaction:
a 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.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (less than 1 in 10 users)
- dizziness, weakness, tiredness
- low blood pressure
- low blood sugar (hypoglycaemia)
- high levels of potassium in the blood (hyperkalaemia).
Uncommon (less than 1 in 100 users)
- drowsiness, sleep disorders
- headache
- feeling of increased heart rate (palpitations)
- severe chest pain (angina pectoris)
- low blood pressure (especially after excessive loss of water from within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics)
- dizziness or fainting when standing up due to low blood pressure (orthostatic hypotension)
- shortness of breath
- abdominal pain, severe constipation, diarrhoea
- feeling or being sick
- hives, itching or rash
- localised swelling (oedema).
Rare: (less than 1 in 1000 users)
- inflammation of blood vessels (vasculitis including Henoch- Schonlein purpura)
- numbness or tingling sensation (paraesthesia)
- fainting
- very rapid and irregular heartbeat (artrial fibrillation) or stroke
- inflammation of the liver (hepatitis, causing tiredness or stomach, muscle or joint pain)
- elevated blood alanine aminotransferase (ALT) levels, usually resolved upon stopping treatment.
Not known: (cannot be estimated from the available data)
- reduced number of red blood cells (anaemia) or platelets (thrombocytopenia)
- migraine
- cough, flu-like symptoms
- liver function abnormalities (seen in blood tests)
- muscle and joint pain
- 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
- back pain and urinary track infection.
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.
How to store
Keep 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. The expiry date refers to the last day of that month.
25mg: Store in the original package in order to protect from light.
50/100mg: Do not store above 25 °C. Store in the original package in order to protect from light.
Tablet containers: Do not require any special storage requirements.
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.
Further information
What Losartan tablets contains
- The active substance is losartan. Each tablet contains either 25mg, 50mg or 100mg of losartan potassium.
- The other ingredients are:
Tablet core: mannitol, microcystalline cellulose, croscarmellose sodium, povidone K29/32, magnesium stearate.
Tablet film coating: Hypromellose 6, titanium dioxide (E171), talc, propylene glycol.
What Losartan tablets look like and contents of the pack
Appearance of the tablets:
25mg: White, round biconvex, coated tablets, no score, marked 2 L, size: 8mm
50mg: White, round biconvex, scored, coated tablets, marked 3 L, size: 10mm
100mg: White, oval biconvex, scored, coated tablets, marked 4 L, size: 18.3mm x 9.2mm
Pack sizes:
Blister packs: 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 98, 100, 210 film-coated tablets
Clinic pack: 280 film-coated tablets.
Tablet container: 100, 250 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Manufacturers
This leaflet was last revised in April 2010
If you would like a leaflet with larger text, please contact 01271 311257.
L18829CIP-30
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