LOSARTAN POTASSIUM 100 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Potassium 100mg film-coated tablets

Losartan Potassium

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 prescribed for you only. Do not pass it on to others. It may harm them, evenif their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine will be referred to as “Losartan tablets” throughout the patient leaflet.

What is in this leaflet

• 1. What Losartan Tablets are and what they are used for

• 2. What you need to know before you take Losartan Tablets

• 3. How to take Losartan Tablets

• 4. Possible side effects

• 5. How to store Losartan Tablets

• 6. Contents of the 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 slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Tablets are 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 adult 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 adult 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 stabilized with an ACE inhibitor you should not be switched to losartan tablets.
• in adult patients with high blood pressure and a thickening of the left ventricle, losartan tablets 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 to losartan or any of the other ingredients of this medicine (listed in section 6)
• If your liver function is severely impaired
• If you are more than 3 months pregnant. (It is also better to avoid Losartan Tablets in early pregnancy – see pregnancy section)
• 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 or pharmacist before taking Losartan tablets:

You must tell your doctor if you think you are (or might become) pregnant. Losartan Tablets is 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).

It is important to tell your doctor before taking Losartan 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 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 taking the potassium sparing diuretics, potassium supplements and potassium containing salt substitutes
• 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 Tablets” and 3 “Dosagein 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 R-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)
• if you 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

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”

• if you are taking other medications that may increase serum potassium (see section 2 “Other medicines and Losartan Tablets).

Children and adolescents

Losartan Tablets has been studied in children. For more information, talk to your doctor.

Losartan Tablets is not recommended for use in children suffering from kidney or liver problems,as limited data are available in these patient groups. Losartan Tablet is not recommended for use in children under 6years 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 or have recently taken or might take any other medicines.

Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamteren, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, trimethoprim-containing medicines), as the combination with losartan tablets is not advisable.

Take particular care if you are taking the following medicines while under treatmentwith

Losartan 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,
• 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-pressure lowering effect of losartan.

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”)

If your kidney function is impaired, the concomitant use of these medicines may lead to a worseningof 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, drink and alcohol

Losartan Tablets may be taken with or without food.

Pregnancy, breast-feeding

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 is not recommended in early pregnancy, and must not be taken when more than3 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 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 a newborn, or born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Losartan Tablets isunlikely to affect your ability to drive or use machines. However, as with many other medicines usedto 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.

3. how to take losartan tablets

Always take this medicine exactly as your doctor or pharmacist has told you.

• 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.
• Always take Losartan Tablets exactly as your doctor has instructed you.
• Your doctor will decide on the appropriate dose 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.

For those indications in which a daily dose of less than 100mg Losartan Tablets is specified, other film-coated tablets containing 12.5mg, 25mg or 50mg of medically active ingredient have to be used.

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 (one tablet Losartan Potassium 100 mg tablets) once daily.

If you have the impression that the effect of losartan tablet is too strong or too weak, please talk to your doctor or pharmacist.

Use in Children and adolescents

Children below 6 years of age

Losartan Tablets is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.

Children aged (6 to 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 Potassium). 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.

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 (one tablet Losartan Potassium100mg) 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).

Adult 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., 12.5mg daily during the first week, 25mg daily during the second week, 50mg 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 150mg 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.

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 tablets is not recommended in patients with severe hepatic impairment (see section “Do nottake Losartan Tablets”).

If you take more Losartan Tablets than you should

In 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 Losartan Tablets, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although noteverybody 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 following side effects have been reported with Losartan Tablets.

Common (may affect up to 1 in 10 people):

• Dizziness
• vertigo
• 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)
• debility
• fatigue
• too little sugar in the blood (hypoglycaemia)
• too much potassium in the blood (hyperkalaemia)
• changes in kidney function including kidney failure
• reduced number of red blood cells (anaemia)
• increase in blood urea, serum creatinine and serum potassium in patients with heartfailure.
• dose-related orthostatic effects such as lowering of blood pressure when rising from a lying or sitting position

Uncommon (may affect up to 1 in 100 people):

• somnolence
• headache
• sleep disorders
• feeling of increased heart rate (palpitations)
• severe chest pain (angina pectoris)
• shortness of breath (dyspnoea)
• abdominal pain
• obstipation
• diarrhoea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• rash
• localized swelling (oedema)
• cough

Rare (may affect up to 1 in 1000 people):

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura)
• numbness or tingling sensation (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (atrial fibrillation)
• stroke
• inflammation of the liver (hepatitis)
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment

Not known (frequency cannot be estimated from the available data):

• reduced number of thrombocytes
• migraine
• liver function abnormalities
• muscle and joint pain
• flu-like symptoms
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• 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).
• alteration in the sense of taste (dysgeusia)

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, 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:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store losartan tablets

• Keep out of the sight and reach of children.
• Do not use Losartan Potassium after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions. Do not open the blister pack until you are ready to take the medicine.
• Do not throw away any medicines via waste water or house hold 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 potassium film-coated tablets contains

• The active substance is losartan potassium.

Each tablet contains 100 mg of losartan potassium

• The other ingredients for the tablet are: Maize Starch, Microcrystalline cellulose, Talc, Colloidal Anhydrous Silica, Sodium Starch Glycollate (type A), Magnesium stearate.

The ingredients for the coating are: Hypromellose, Titanium dioxide (E171), Talc, Macrogol 6000

What Losartan Tablets looks like and the contents of the pack

• 100 mg tablet: White to off-white, almond shaped, biconvex, film-coated tablet, with “100” debossed on one side and “BL” debossed on the other side.
• The tablets are packed in packs of 7, 14, 15, 28, 30, 50, 56, 84, 98 film-coated tablets.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom.

Telephone: 0044 (0) 1442 200922

Fax: 0044 (0) 1442 873717

Email: info@bristol-labs.co.uk

Manufacturer

Bristol Laboratories Limited

Laporte way

Luton

Bedfordshire

LU4 8WL

United Kingdom

Losartan Potassium 100mg film-coated tablets; PL 17907/0320

This leaflet was last revised in June 2020

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

9