The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00025/0324.
COZAAR 12.5mg, 50 mg and 100 mg Film-Coated Tablets
Cozaar® 12.5 mg film-coated tablets
Cozaar® 50 mg film-coated tablets
Cozaar® 100 mg film-coated tablets
1. What COZAAR is and what it is used for
2. What you need to know before you take COZAAR
3. How to take COZAAR
4. Possible side effects
5. How to store COZAAR
6. Contents of the pack and other information
Losartan (COZAAR) 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.
COZAAR is used
Talk to your doctor, pharmacist, or nurse before taking COZAAR.
You must tell your doctor if you think you are (or might become) pregnant. COZAAR 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 COZAAR:
COZAAR has been studied in children. For more information, talk to your doctor.
COZAAR is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. COZAAR is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.
Tell your doctor or pharmacist if you are taking, 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 COZAAR is not advisable.
Take particular care if you are taking the following medicines while under treatment with COZAAR:
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 COZAAR” and “Warnings and precautions”).
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.
COZAAR may be taken with or without food.
Grapefruit juice should be avoided while taking COZAAR.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking COZAAR before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of COZAAR. COZAAR is 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. COZAAR 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 new-born, or born prematurely.
Ask your doctor or pharmacist for advice before taking this medicine.
No studies on the effects on the ability to drive and use machines have been performed.
COZAAR is 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.
COZAAR contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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 COZAAR, depending on your condition and whether you are taking other medicines. It is important to continue taking COZAAR for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Adult patients with High Blood Pressure
Treatment usually starts with 50 mg losartan (one tablet COZAAR 50 mg) 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 (two tablets COZAAR 50 mg or one tablet of COZAAR 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.
Children below 6 years of age
COZAAR 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 - 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 COZAAR). 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 (one tablet COZAAR 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets COZAAR 50 mg or one tablet of COZAAR 100 mg) 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
Treatment usually starts with 12.5 mg losartan (one tablet COZAAR 12.5 mg) once a day. Generally, the dose should be increased weekly 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 (for example, three tablets of COZAAR 50 mg or one tablet each of COZAAR 100 mg and COZAAR 50 mg) 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.
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 COZAAR").
The tablets should be swallowed whole 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 COZAAR until your doctor tells you otherwise.
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
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 medicine, ask your doctor, pharmacist, or nurse.
Like all medicines, this medicine can cause side effects, although not everybody 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 COZAAR:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
Side effects in children are similar to those seen in adults.
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: www.mhra.gov.uk/yellowcard 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.
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 carton or the bottle label. The expiry date refers to the last day of that month.
Store COZAAR in the original package in order to protect from light and moisture.
Do not open the blister pack until you are ready to take the medicine.
Store COZAAR in the original container in order to protect from light.
Do not store above 25oC. Keep the bottle tightly closed 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.
The active substance is losartan potassium.
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinised maize starch, magnesium stearate (E572), hyprolose (E463), hypromellose (E464).
COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
The COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171) and indigo carmine (E132) aluminium lake.
The COZAAR 50 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).
The COZAAR 100 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).
COZAAR 12.5 mg is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
COZAAR 50 mg is supplied as scored film-coated tablets containing 50 mg of losartan potassium. The score line is not intended for breaking the tablet.
COZAAR 100 mg is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
COZAAR is supplied in the following pack sizes:
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Member State Invented name
Austria Cosaar 12,5 mg - Filmtabletten
Austria Cosaar 50 mg - Filmtabletten
Austria Cosaar 100 mg - Filmtabletten
Belgium COZAAR 12,5 mg
Belgium COZAAR 50 mg
Belgium COZAAR 100 mg
Bulgaria COZAAR 12,5 mg film-coated tablets
Czech Republic COZAAR 50 mg
Czech Republic COZAAR 100 mg
Finland Cozaar 12,5 mg kalvopäällysteiset tabletit
Finland Cozaar 50 mg kalvopäällysteiset tabletit
Finland Cozaar 100 mg kalvopäällysteiset tabletit
France COZAAR 50 mg scored coated tablets
France COZAAR 100 mg film-coated tablets
Germany LORZAAR PROTECT 100 mg Filmtabletten
Germany LORZAAR PROTECT 50 mg Filmtabletten
Germany LORZAAR START 12,5 mg Filmtabletten
Ireland COZAAR 12.5mg film-coated tablets
Ireland COZAAR 50 mg film-coated tablets
Ireland COZAAR 100 mg film-coated tablets
Italy LORTAAN 12,5 mg compresse rivestite con film
Italy LORTAAN 50 mg compresse rivestite con film
Italy LORTAAN 100 mg compresse rivestite con film
Luxembourg COZAAR 12,5 mg
Luxembourg COZAAR 50 mg
Luxembourg COZAAR 100 mg
Malta COZAAR 12,5 mg film-coated tablets
Malta COZAAR 50 mg film-coated tablets
Malta COZAAR 100 mg film-coated tablets
Netherlands COZAAR 12,5 mg
Netherlands COZAAR 50 mg
Netherlands COZAAR 100 mg
Portugal Cozaar 100 mg
Portugal Cozaar IC
Spain COZAAR 12,5 mg Inicio comprimidos recubiertos con película
Spain COZAAR 50 mg comprimidos recubiertos con película
Spain COZAAR 100 mg comprimidos recubiertos con película
Sweden COZAAR 12,5 mg filmdragerade tabletter
Sweden COZAAR 50 mg filmdragerade tabletter
Member State Invented name
Sweden COZAAR 100 mg filmdragerade tabletter
United Kingdom (Northern Ireland) COZAAR 12,5 mg film-coated tablets
United Kingdom (Northern Ireland) COZAAR 50 mg film-coated tablets
United Kingdom (Northern Ireland) COZAAR 100 mg film-coated tablets
This leaflet was last revised in December 2022.
© 2022 Organon group of companies. All rights reserved.