Cozaar 12.5 mg film-coated tablets
Cozaar 25 mg film-coated tablets
Cozaar 50 mg film-coated tablets
Cozaar 100 mg film-coated tablets
Losartan potassium
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.
In this leaflet:
- 1. What Cozaar is and what it is used for
- 2. Before you take Cozaar
- 3. How to take Cozaar
- 4. Possible side effects
- 5. How to store Cozaar
- 6. Further information
What Cozaar Is And What It Is 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.
Cozaar 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, COZAAR has been shown to decrease the risk of stroke (“LIFE indication”).
Before You Take Cozaar
Do not take Cozaar
- if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
- if your liver function is severely impaired,
- if you are more than 3 months pregnant. (It is also better to avoid Cozaar in early pregnancy-see "Pregnancy".).
Take special care with 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:
- if you have had a history of angiooedema (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 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 Cozaar" and 3 "Dosage in 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 ß-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).
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.
Take particular care if you are taking the following medicines while under treatment with Cozaar:
- 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 Cozaar with food and drink
Cozaar 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 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.
Breast Feeding
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 newborn, or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children and adolescents
Cozaar has 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.
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.
Important information about some of the ingredients of Cozaar
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.
How To Take Cozaar
Always take Cozaar exactly as your doctor has instructed you. 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) 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.
Use in children or adolescents (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 Cozaar). The doctor may increase the dose if blood pressure is not controlled.
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) 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 (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) up to the usual maintenance dose of 50 mg losartan (one tablet Cozaar 50 mg) once daily, according to your condition.
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 is not recommended in patients with severe hepatic impairment (see section "Do not take Cozaar").
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 Cozaar until your doctor tells you otherwise.
If you take more Cozaar than you should
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 forget to take Cozaar
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, Cozaar 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 side effects of medicines are classified as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon affects 1 to 10 users in 1,000
rare: affects 1 to in 10 users in 10,000
very rare: affects less than 1 user in 10,000 patients
not known: frequency cannot be estimated from the available data
The following side effects have been reported with Cozaar:
Common:
- dizziness,
- low blood pressure,
- debility,
- fatigue,
- too little sugar in the blood (hypoglycaemia),
- too much potassium in the blood (hyperkalaemia).
Uncommon:
- somnolence,
- headache,
- sleep disorders,
- feeling of increased heart rate (palpitations),
- severe chest pain (angina pectoris),
- 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,
- shortness of breath (dyspnoea),
- abdominal pain,
- obstipation,
- diarrhoea,
- nausea,
- vomiting,
- hives (urticaria),
- itching (pruritus),
- rash,
- localised swelling (oedema).
Rare:
- inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
- numbness or tingling sensation (paraesthesia),
- fainting (syncope),
- very rapid and irregular heartbeat (atrial fibrillation)
- brain attack (stroke),
- inflammation of the liver (hepatitis),
- elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Not known:
- reduced number of red blood cells (anaemia),
- reduced number of thrombocytes,
- migraine,
- cough,
- liver function abnormalities,
- muscle and joint pain,
- changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
- flu-like symptoms,
- increase in blood urea, serum creatinine and serum potassium in patients with heart failure,
- 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).
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 listed in this leaflet, please tell your doctor or pharmacist.
How To Store Cozaar
Keep out of the reach and sight of children.
Do not use Cozaar 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.
Blisters
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.
Bottles
Store Cozaar in the original package. Store the bottle below 25°C. Keep the bottle tightly closed in order to protect from light and moisture.
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 Cozaar contains
The active substance is losartan potassium.
Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each Cozaar 25 mg tablet contains 25 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, pregelatinized maize starch, magnesium stearate (E572), hyprolose (E463), hypromellose (E464).
Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 2.12 mg (0.054 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), indigo carmine (E132) aluminum lake.
The Cozaar 25 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).
The Cozaar 50 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).
The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
What Cozaar looks like and contents of the pack
Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium. The tablets can be divided into equal halves.
Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Cozaar is supplied in the following pack sizes:
Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets.
Cozaar 25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets.
Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
12.5 mg:
25mg, 50mg and 100mg:
This medicinal product is authorised in the Member States of the EEA under the following names:
Member State : Invented name
Austria: COSAAR 12,5 mg, 50mg or 100mg Filmtabletten
Belgium: COZAAR 12.5 mg, 50 mg or 100 mg
Belgium: COZAAR 12.5 mg, 50 mg or 100 mg
LOORTAN 12.5 mg, 50 mg or 100 mg
Bulgaria: COZAAR
Cyprus: COZAAR
Denmark: COZAAR, COZAAR STARTPAKKE
Estonia: COZAAR, COZAAR 12,5 mg
Finland: COZAAR 50 or 100 mg
France: COZAAR 50 scored coated or 100 mg film-coated tablets
Germany: CARDOPAL START 12.5 mg Filmtabletten
Germany: LORZAAR 50 mg or 100 mg Filmtabletten
Germany: LORZAAR PROTECT 50 mg or 100 mg Filmtabletten
Germany: LORZAAR START 12,5 mg Filmtabletten
Germany: PINZAAR 50 mg or 100 mg Filmtabletten
Germany: LORZAAR VARIPHARMSTART 12,5 mg Filmtabletten
Greece: COZAAR
Hungary: COZAAR
Ireland: COZAAR 12.5 mg, 50 mg or 100 mg Film-coated Tablets
Italy: LORTAAN 12.5 mg, 50 mg or 100 mg compresse rivestite con film
Italy: NEO-LOTAN 12.5 mg, 50 mg or 100 mg compresse rivestite con film
Italy: LOSAPREX 12.5 mg, 50 mg, or 100 mg compresse rivestite con film
Latvia: COZAAR 50 mg or 100 mg film-coated tablets
Lithuania: COZAAR
(Losartan)
Luxembourg: COZAAR 12.5mg, 50 mg or 100 mg
Luxembourg: LOORTAN 12.5 mg, 50 mg or 100 mg
Malta: COZAAR 12.5 mg, 50mg or 100 mgfilm-coated tablets
Netherlands: COZAAR 50 or 100
Poland: COZAAR
Portugal: COZAAR, COZAAR 100 mg, COZAAR IC
Portugal: LORTAAN , LORTAAN 100mg , LORTAAN IC
Romania: COZAAR, comprimate filmate, 50 mg
Slovenia: COZAAR 12,5 , 50 mg or 100 mg filmsko obložene tablete
Spain: COZAAR 12,5 mg Inicio, COZAAR 50 or 100 mg
Sweden: COZAAR 50 or 100 mg 12,5 mg, 50 mg, or 100 mg filmdragerade tabletter
United Kingdom: COZAAR 12.5 mg, 25 mg, 50 mg or 100 mg FILM-COATED TABLETS
Iceland: COZAAR
Norway: COZAAR
This leaflet was last approved (11/2009)
PIL.CZR.09.UK.3197 REN
LOGO MSD
Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UK
Registered trademark of
EI du Pont de Nemours and Company
Wilmington
Delaware
USA
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