COZAAR COMP 50/12.5 TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® COMP 50/12.5 TABLETS
(losartan potassium and hydrochlorothiazide)
The name of your medicine is Cozaar Comp 50/12.5 Tablets but will
be referred to as Cozaar Comp throughout the remainder of this
leaflet. Other strengths100/12.5 and 100/25 are also available.
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.
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.
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.
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)
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-colored) 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 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. By reporting side effects, you can
help provide more information on the safety of this medicine.
5.

HOW TO STORE Cozaar Comp

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

Keep your tablets out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not put the tablets into another container, they might get mixed
up.
 Do not remove the tablets from the blister pack or open the blister
pack until you are ready to take the medicine. Do not take the
tablets past the expiry date, which is clearly marked on the pack.
 If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
6.

FURTHER INFORMATION

What Cozaar Comp contains
 There are two active ingredients in Cozaar-Comp. These are
losartan potassium and hydrochlorothiazide.
 Cozaar-Comp contains 45.8mg of losartan, present as 50mg of
losartan potassium and 12.5mg of hydrochlorothiazide.
 Other ingredients: Hyprolose; hypromellose; lactose
monohydrate; magnesium stearate; microcrystalline cellulose;
pregelatinised maize starch; titanium dioxide; quinoline yellow
aluminum lake E104; carnauba wax.
What Cozaar Comp looks like and contents of the pack
Cozaar-Comp is available as yellow, oval, film-coated tablets marked
‘717’ on one side and a score line on the other.
Your tablets are available in cartons of 28 tablets.
Manufacturer
Cozaar-Comp is manufactured by Merck Sharp & Dohme Ltd,
Shotton Lane, Cramlington, Northumberland. and is procured from
within the EU by the product licence holder: G. Pharma Ltd., Salford
M50 2PU

POM
PL NO 16369/1266 Cozaar-Comp 50/12.5 Tablets
Leaflet Revision: 28/03/2014
Cozaar registered trademark of E. I. du Pont de Nemours and
Company, Wilmington, Delaware, USA.

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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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