12.5 mg, 50 mg and 100 mg film-coated tablets
losartan potassium
1. What Cozaar is and what it is used for
Losartan belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a body-specific substance that binds to receptors in blood vessels and causes them to constrict. This causes the blood pressure to rise. Losartan prevents the binding of angiotensin II to these receptors, which causes the blood vessels to dilate and the blood pressure to drop. Losartan prevents further renal impairment in patients with high blood pressure and type 2 diabetes.
Cozaar is used:
- to treat high blood pressure ( hypertension ) in adults and children and adolescents aged 6-18 years.
- to protect the kidney in patients with high blood pressure and type 2 diabetes and who have laboratory values indicating renal impairment and proteinuria ≥0.5 g / day (a condition in which the urine contains abnormal amounts of protein).
- to treat chronic heart failure, when treatment with specific drugs called ACE inhibitors (antihypertensive drugs) is not considered appropriate by your doctor. If your heart failure is stabilized with an ACE inhibitor, you should not switch to losartan.
- to treat high blood pressure and a thickening of the heart wall. Cozaar has been shown to reduce the risk of stroke (“LIFE indication”).
What you need to know before you take Cozaar
Do not take Cozaar
- if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6)
- during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Cozaar, see Pregnancy and breast-feeding)
- if you have severe hepatic impairment
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Cozaar.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Cozaar is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see Pregnancy).
It is important to tell your doctor before starting treatment with Cozaar;
- if you have a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4; Possible side effects )
- if you have been sick with vomiting or diarrhea, which has caused severe salt and/or dehydration
- if you are being treated with diuretics (medicines that increase the excretion of urine from your kidneys) or are eating a low-salt diet which can lead to severe salt and fluid loss (see section 3; Dosage in special patient groups)
- if you have a narrowing or blockage in the blood vessels leading to your kidneys or if you have recently had a kidney transplant
- if you have impaired liver function (see section 2; Do not take Cozaar again, and section 3; Dosage in special patient groups)
- if you suffer from heart failure with or without impaired kidney function or at the same time severe life-threatening cardiac arrhythmia. Special care should be taken if you are being treated with a β-blocker at the same time
- if you have problems with your heart valves or your heart muscle
- if you suffer from coronary heart disease (caused by a decrease in blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a decrease in blood circulation in the brain)
- if you suffer from primary hyperaldosteronism (a syndrome in which your adrenal glands produce too much of the hormone et alaldosterone, caused by a disorder of the adrenal gland)
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems
- aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Cozaar”.
- if you are taking other medicines that may increase the concentration of potassium in your blood (see section 2 “Other medicines and Cozaar”).
Children and young people
Cozaar has been studied in children. For more information, talk to your doctor.
Cozaar is not recommended for use in children with kidney or liver problems, as limited data are available in these patient groups. Cozaar is not recommended for use in children below 6 years of age, as it has not been shown to work in this age group.
Other medicines and Cozaar
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, salt substitutes that contain potassium, potassium-sparing medicines such as certain diuretics(amiloride, triamterene, spironolactone ), or other medicines that may increase the concentration of potassium in your blood (eg heparin or medicines containing trimethoprim), as use of these together with Cozaar is not recommended.
Take special care with any of the following medicines while you are being treated with Cozaar:
- other antihypertensive drugs as they can lower your blood pressure further. Blood pressure can also be lowered with one of the following drugs/drug group: tricyclic antidepressants, antipsychotics, baclofen, amifostine
- non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2inhibitors (medicines for inflammation and pain) as they may reduce the blood pressure-lowering effect of losartan.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Cozaar” and “Warnings and precautions”).
If you have renal impairment, concomitant use of these drugs may lead to impaired renal function.
Medicines containing lithium should not be used in combination with losartan without close monitoring by your doctor. Special precautions (eg blood tests) may be appropriate.
Cozaar with food and drink
Cozaar can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually your doctor will suggest that you stop taking Cozaar before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Cozaar should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Cozaar is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies have been performed.
Cozaar is not expected to affect your ability to drive or use machines. However, keep in mind that, as with many other medicines used to treat high blood pressure, losartan can cause dizziness and drowsiness in some patients. If you experience dizziness or drowsiness, consult your doctor before performing any of these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cozaar contains lactose
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.
3. How to take Cozaar
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Cozaar, depending on your medical condition and whether you are taking other medicines. It is important that you continue to take Cozaar according to your doctor’s prescription to maintain even control of your blood pressure.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (one Cozaar 50 mg tablet) once daily. The maximum blood pressure-lowering effect is achieved within 3-6 weeks after starting treatment. In some patients, the dose may then be increased to 100 mg losartan (two Cozaar 50 mg tablets or one Cozaar 100 mg tablet) once daily.
If you have the impression that the effect of losartan is too strong or too weak, talk to your doctor or pharmacist.
Use for children and adolescents
Children under 6 years of age
Cozaar 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 to 18 years
The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg losartan per kg body weight once daily (up to 25 mg Cozaar). Your doctor may need to increase the dose in case of insufficient blood pressure control.
Another dosage form of this medicine may be more suitable for children, consult a doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment is usually started with 50 mg losartan (one Cozaar 50 mg tablet) once daily. Dose one can then be increased to 100 mg losartan (two Cozaar 50 mg tablets or one Cozaar 100 mg tablet) once daily depending on your blood pressure response.
Losartan tablets can be given with other antihypertensive drugs (eg diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting drugs) as well as with insulin and other commonly used drugs that lower blood glucose levels (eg sulphonylureas, glitazones, and glucosidase inhibitors).
Adult patients with heart failure
Treatment is usually started with 12.5 mg losartan (a Cozaar 12.5 mg tablet) once daily.
Depending on your condition, the dose should be increased step by step, weekly (ie 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 for the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg losartan (eg three tablets Cozaar 50 mg or one tablet of both Cozaar 100 mg and Cozaar 50 mg) once daily can be used.
In the treatment of heart failure, losartan is often combined with a diuretic (a medicine that increases the excretion of urine from your kidneys) and/or digitalis (a medicine that helps the heart to function better and more efficiently) and/or a β-blocker.
Dosage in special patient groups
Your doctor may prescribe a lower dose, especially for initial treatment in some patients, such as in patients treated with high-dose diuretics, in patients with hepatic impairment, or in patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section: Do not take Cozaar).
Administration
Losartan tablets should be swallowed whole with a glass of water. Try to take your daily dose at the same time each day. It is important that you continue to take Cozaar according to your doctor’s prescription.
If you take more Cozaar then you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.
If you forget to take Cozaar
If you accidentally miss a daily dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking losartan tablets and talk to your doctor immediately or seek medical attention:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing and breathing).
This is a serious but rare side effect, occurring in more than 1 in 10,000 and less than 1 in 1,000 patients. You may need emergency medical care or hospitalization.
The following side effects have been reported with Cozaar:
Common (may affect up to 1 in 10 people):
- dizziness
- low blood pressure (especially after severe fluid loss from the body, eg in patients with severe heart failure or during treatment with high-dose diuretics)
- dose-related orthostatic effects such as a drop in blood pressure when rising rapidly from a supine or sitting position
- impotence
- fatigue
- low blood sugar (hypoglycemia)
- excess potassium in the blood (hyperkalemia)
- change in renal function including renal failure
- decreased number of red blood cells ( anemia )
- increase in urea in the blood and increase in serum creatinine and serum potassium in patients with heart failure
Uncommon (may affect up to 1 in 100 people):
- somnolence
- headache
- sleep disorders
- the feeling of the heart beating fast (palpitations)
- severe chest pain ( angina pectoris )
- shortness of breath ( dyspnoea )
- abdominal pain
- constipation
- diarrhea
- nausea
- vomiting
- hives ( urticaria )
- itching ( pruritus )
- rash
- local swelling ( edema )
- cough
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity
- angioedema
- inflammation of the blood vessels ( vasculitis including Henoch-Schönlein purpura)
- numbness or tingling ( paresthesias )
- fainting ( syncope )
- fast and irregular heartbeat ( atrial fibrillation )
- stroke
- inflammation of the liver ( hepatitis )
- elevated alanine aminotransferase (SALAT ) levels, usually reversible after discontinuation of treatment.
No known frequency (cannot be calculated from the available data):
- decreased platelet count
- migraine
- abnormal liver function
- muscle and joint pain
- flu-like symptoms
- back pain and urinary tract infection
- increased sensitivity to sunlight ( photosensitivity )
- unexplained muscle pain with dark (tea-colored) urine ( rhabdomyolysis )
- impotence
- inflammation of the pancreas ( pancreatitis )
- low levels of sodium in the blood ( hyponatremia )
- Depression
- general malaise
- ringing, buzzing, throbbing, or clicking in the ears ( tinnitus ).
- taste disorder ( dysgeusia ).
The side effects in children are similar to the side effects in adult patients.
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 to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Cozaar
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 jar after “EXP”. The expiration date is the last day of the specified month.
Blister: Store in the original package. Sensitive to light. Moisture sensitive. Do not open the blister pack until you are ready to take your medicine.
Plastic jar: Do not store above 25 ° C. Store in the original package. Sensitive to light. Close the jar tightly. Moisture sensitive.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is losartan potassium.
One Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
One Cozaar 50 mg tablet contains 50 mg of losartan potassium.
One 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), hypromellose (E463), and 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.
Cozaar 12.5 mg tablet also contains carnauba wax (E903), titanium dioxide (E171) and
indigo carmine (E132).
Cozaar 50 mg tablet also contains carnauba wax (E903) and titanium dioxide (E171).
Cozaar 100 mg tablet also contains carnauba wax (E903) and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Cozaar 12.5 mg tablets are supplied as uncut film-coated tablets and contain 12.5 mg of losartan potassium.
Cozaar 50 mg tablets are supplied as scored film-coated tablets and contain 50 mg of losartan potassium. The notch is not intended for splitting the tablet.
Cozaar 100 mg tablets are supplied as uncut film-coated tablets and contain 100 mg of losartan potassium.
Cozaar 12.5 mg: PVC / PE / PVDC blister pack with aluminum closure containing; 7, 14, 21, 28, 50, 98, 210 or 500 tablets and single-dose pack for hospital use containing 28 tablets. HDPE jar containing 100 tablets.
Cozaar 50 mg: PVC / PE / PVDC blister pack with aluminum closure containing; 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and single-dose packs for hospital use containing 28, 56 or 98 tablets. HDPE jar containing 100 or 300 tablets.
Cozaar 100 mg: PVC / PE / PVDC blister pack with aluminum closure containing; 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and single-dose packs for hospital use containing 28, 56 or 98 tablets. HDPE jar containing 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme BV
PO Box 581
2003 PC Haarlem
Netherlands
Manufacturer
Merck Sharp & Dohme BV
PO Box 581
2003 PC Haarlem
Netherlands
or
Merck Sharp & Dohme Ltd
Shotton Lane
NE23 3JU Cramlington
Northumberland
UK
or
Schering-Plow Labo NV
Industrial Park 30
Heist-op-den-Berg, 2220
Belgium
Information provided by:
Merck Sharp & Dohme