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COZAAR COMP 50 MG/12.5 MG TABLETS

Active substance: LOSARTAN POTASSIUM

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CUSTOMER: Waymade

CODE:

PRE-PRESS NO.:

Cozaar Comp 50mg tabs
6464/0596E

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

23/04/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 23/04/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

6. Contents of the pack and other information
What Cozaar Comp contains
Each tablet contains 50mg of the active ingredient losartan potassium (equivalent to 45.8mg Losartan base)
and 12.5mg of the active ingredient, hydrochlorothiazide.
Cozaar Comp 50 mg/12.5 mg Tablets/Losazid 50 mg/12.5 mg Tablets also contain the following inactive
ingredients:
hydroxypropylmethylcellulose, microcrystalline cellulose, magnesium stearate, lactose, hydroxypropyl
cellulose, carnauba wax, titanium dioxide (E171), quinoline yellow aluminium lake (E104) and pregelatinised
maize starch.
What Cozaar Comp looks like and the contents of the pack
Each yellow oval film-coated tablet is marked ‘717’ on one side with a breakline on the reverse.
Cozaar Comp 50 mg/12.5 mg Tablets/Losazid 50 mg/12.5 mg Tablets are available as blister packs of 14 and
28 tablets.
POM

PL No: 6464/0596

This product is manufactured by Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington, Northumberland,
England and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 23.04.2014
Cozaar® is a registered trademark of Merck Sharp & Dohme Ltd.

COZAAR COMP 50 mg/12.5 mg TABLETS/
LOSAZID 50 mg/12.5 mg TABLETS

(losartan potassium and hydrochlorothiazide)
Patient Information Leaflet
This product is known as either of the above names but will usually be called Cozaar Comp in this leaflet.
Please note that the leaflet also contains information about other strengths of the medicine, Cozaar Comp
100mg/12.5mg and Cozaar Comp 100mg/25mg film-coated tablets.
Read all of this leaflet carefully before 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, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Cozaar Comp is and what it is used for
2. What you need to know before you take Cozaar Comp
3. How to take Cozaar Comp
4. Possible side effects
5. How to store Cozaar Comp
6. Contents of the pack and other information

1. What Cozaar Comp is and what it is used for
Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide). 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.
Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood
pressure.
Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before you take Cozaar Comp
Do not take Cozaar Comp

if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine
(listed in section 6)

if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial
drugs such as co-trimoxazole, ask your doctor if you are not sure)

if you have severely impaired liver function

if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment

if you are suffering from gout

if you are more than 3 months pregnant. (It is also better to avoid Cozaar Comp in early pregnancy –
see Pregnancy section)

if you have severely impaired kidney function or your kidneys are not producing any urine,

if you have diabetes or impaired kidney function and are taking a medicine called aliskiren to reduce
blood pressure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cozaar Comp.
You must tell your doctor if you think you are (or might become) pregnant. Cozaar Comp 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 Comp:

if you have previously suffered from swelling of the face, lips, throat or tongue

if you take diuretics (water pills)

if you are on a salt-restricted diet

if you have or have had severe vomiting and/or diarrhoea

if you have heart failure

if your liver function is impaired (see section 2 “Do not take Cozaar Comp”)

if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning
kidney, or you have recently had a kidney transplant

if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart
function)

if you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic
cardiomyopathy’ (a disease causing thickening of heart muscle)

if you are diabetic

if you have had gout

if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin
rashes and fever (systemic lupus erythematosus)

if you have high calcium or low potassium levels or you are on a low potassium diet

if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have
tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking
losartan potassium and hydrochlorothiazide tablets

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 a medicine called aliskiren to reduce blood pressure.
Children and adolescents
There is no experience with the use of Cozaar Comp in children. Therefore, Cozaar Comp should not be given
to children.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

CODE:

PRE-PRESS NO.:

Cozaar Comp 50mg tabs
6464/0596E

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

23/04/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 23/04/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Other medicines and Cozaar Comp
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained in Cozaar Comp may interact with other medicines.
Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your
doctor.
Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements,
potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some
laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or
insulins).
It is also important for your doctor to know if you are taking

other medicines to reduce your blood pressure

steroids

medicines to treat cancer

pain killers

drugs for treatment of fungal infections

arthritis medicines

resins used for high cholesterol, such as cholestyramine

medicines which relax your muscles

sleeping tablets

opioid medicines such as morphine

'pressor amines' such as adrenaline or other drugs from the same group

oral agents for diabetes or insulins.

Pg 3

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following, stop taking Cozaar Comp 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:
Common (may affect up to 1 in 10 people):

Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder

Diarrhoea, abdominal pain, nausea, indigestion

Muscle pain or cramps, leg pain, back pain

Insomnia, headache, dizziness

Weakness, tiredness, chest pain

Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin
levels

Changes in kidney function including kidney failure

Too low sugar in the blood (hypoglycaemia)

Please also inform your doctor if you are taking Cozaar Comp and you will be undergoing a radiographic
procedure and will be given iodine contrast media.
Cozaar Comp with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may
increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.
Cozaar Comp tablets 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 Comp before you become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Cozaar Comp. Cozaar Comp is not recommended during
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 Comp is not recommended
for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to
breast-feed.
Use in elderly patients
Cozaar Comp works equally well in and is equally well tolerated by most older and younger adult patients.
Most older patients require the same dose as younger patients.
Driving and using machines
When you begin treatment with this medication, you should not perform tasks which may require special
attention (for example, driving an automobile or operating dangerous machinery) until you know how you
tolerate your medicine.
Cozaar Comp contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Cozaar Comp
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 Comp depending on
your condition and whether you are taking other medicines. It is important to continue taking Cozaar Comp for
as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
High Blood Pressure
The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50
mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once
daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of
Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day. The
maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated
Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets
If you take more Cozaar Comp than you should
In case of an overdose, contact your doctor immediately so that medical attention may be given promptly.
Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and
dehydration.
If you forget to take Cozaar Comp
Try to take Cozaar Comp daily as prescribed. However, if you miss a dose, do not take an extra dose. Just
resume your usual schedule.

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

Anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and
buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in
white blood cells, clotting problems, reduced number of platelets

Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal
blood electrolyte levels

Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal
dreams, sleep disorders, sleepiness, memory impairment

Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting

Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in
yellow

Ringing, buzzing, roaring or clicking in the ears, vertigo

Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak
when you stand up), angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA,
“mini-stroke”), heart attack, palpitations

Inflammation of blood vessels, which is often associated with a skin rash or bruising

Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty
breathing), nosebleed, runny nose, congestion

Constipation, obstipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation
of a salivary gland, toothache

Jaundice (yellowing of the eyes and skin), inflammation of the pancreas

Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin,
flushing, sweating, hair loss

Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness

Frequent urination including at night, abnormal kidney function including inflammation of the kidneys,
urinary tract infection, sugar in the urine

Decreased sexual appetite, impotence

Swelling of the face, localised swelling (oedema), fever
Rare (may affect up to 1 in 1,000 people):

Hepatitis (inflammation of the liver), abnormal liver function tests
Not known (frequency cannot be estimated from the available data):

Flu-like symptoms

Unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)

Low levels of sodium in the blood (hyponatraemia)

Generally feeling unwell (malaise)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in
this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort
Terrace, IRL Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail:
imbpharmacovigilance@imb.ie

5. How to store Cozaar Comp
Keep all medicines out of the sight and reach of children.
Do not use Cozaar Comp after the expiry date which is stated on the container. The expiry date refers to the
last day of that month.
Store in a dry place in the original packaging.
Do not store above 30°C.
Do not remove the tablets from the blister strip until you are ready to take your medicine.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal.
Only keep the tablets if your doctor tells you to.
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.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell
you what to do.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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