Consumer medicine information

Cozaar 50 mg Tablets

Losartan potassium

BRAND INFORMATION

Brand name

Cozaar

Active ingredient

Losartan potassium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cozaar 50 mg Tablets.

1. Why am I using COZAAR?


COZAAR contains the active ingredient losartan. COZAAR is used to lower high blood pressure, which doctors call hypertension.
For more information, see Section 1. Why am I using COZAAR? in the full CMI.

2. What should I know before I use COZAAR?


Do not use if you have ever had an allergic reaction to COZAAR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use COZAAR? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with COZAAR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use COZAAR?

  • Your doctor will tell you how many tablets you need to take each day. This depends on your condition and whether you are taking other medicines.

More instructions can be found in Section 4. How do I use COZAAR? in the full CMI.

5. What should I know while using COZAAR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using COZAAR.
  • Go to your doctor regularly for a check-up. Have your blood pressure checked when your doctor says, to make sure COZAAR is working.
  • If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up
  • Make sure you drink enough water during exercise and hot weather when you are taking COZAAR, especially if you sweat a lot.
  • If you have excessive vomiting and/or diarrhoea while taking COZAAR, tell your doctor.
  • If your doctor has prescribed potassium tablets for you, continue taking them.
Things you should not do
  • Do not give COZAAR to anyone else, even if they have the same condition as you.
Driving or using machines
  • COZAAR may cause dizziness or light-headedness in some people. Make sure you know how you react to COZAAR before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
Drinking alcohol
  • If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
  • Keep it in a cool dry place where the temperature stays below 30°C.
  • Keep your tablets in the blister pack until it is time to take them.

For more information, see Section 5. What should I know while using COZAAR? in the full CMI.

6. Are there any side effects?


Common side effects include dizziness, lightheadedness, tiredness or weakness, spinning sensation, generally feeling unwell, increased sensitivity of the skin to the sun and an inability to get or maintain an erection. Serious side effects include skin rash, shortness of breath, sore muscles not caused by exercise, bleeding or bruising more easily than normal or symptoms of an allergic reaction.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Cozaar

Active ingredient

Losartan potassium

Schedule

S4

 

1 Name of Medicine

Losartan potassium.

2 Qualitative and Quantitative Composition

Cozaar (losartan potassium) 50 mg tablets.
Losartan potassium is a white to off-white free-flowing crystalline powder. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone.
List of excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cozaar (losartan potassium) 50 mg tablet: White, oval scored tablet, marked "952".

4 Clinical Particulars

4.9 Overdose

Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither losartan nor the active metabolite can be removed by haemodialysis. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No evidence of genotoxic activity was observed in assays for DNA damage, gene mutations and chromosomal damage.
Carcinogenicity. In animal studies, there was no evidence of carcinogenic activity when losartan potassium was administered orally to mice at doses up to 200 mg/kg/day for 92 weeks, or to rats at doses up to 270 mg/kg/day for 105 weeks.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1- [[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl] methyl]-1H-imidazole-5-methanol monopotassium salt.
Its empirical formula is C22H22ClKN6O. It has a molecular weight of 461.01.
Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLOSPOT.gif CAS number. The CAS Registry Number is 124750-99-8.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/COZAARST.gif