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COZAAR-COMP 50/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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Package leaflet: Information for the patient
®

COZAAR -COMP 50/12.5 FILM-COATED TABLETS
(losartan potassium and hydrochlorothiazide)
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.
The name of your medicine is COZAAR-COMP 50/12.5 FILM-COATED
TABLETS but will be referred to as Cozaar Comp throughout this leaflet.
Please note that the leaflet also contains information about other
strengths COZAAR COMP 100mg/25mg and 100mg/12.5mg TABLETS.
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 you are treated
with a blood pressure lowering medicine containing aliskiren.
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 any of the following medicines used to treat high
blood pressure:
◦ an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in
particular if you have diabetes-related kidney problems.
◦ aliskiren
Your doctor may check your kidney function, blood pressure, and the
amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading ‘Do not take COZAAR COMP’.
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.
Your doctor may need to change your dose and/or to take other
precautions: If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings ‘Do not take Cozaar Comp’ and
‘Warnings and precautions’)
Please also inform your doctor you are taking Cozaar Comp if 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 50mg/12.5mg per day to control
blood pressure over the 24-hour period. This can be increased to 2
tablets once daily of Losartan / Hydrochlorothiazide 50mg/12.5mg FilmCoated Tablets or changed to 1 tablet daily of Losartan /
Hydrochlorothiazide 100mg/25mg Film-Coated Tablets (a stronger
strength) per day. The maximum daily dose is 2 tablets per day of
Losartan / Hydrochlorothiazide 50mg/12.5mg Film-Coated Tablets or 1
tablet daily of Losartan / Hydrochlorothiazide 100mg/25mg 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)
Disturbed taste (dysgeusia)
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
Keep 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 until you are ready to take
the medicine.
Do not take your tablets after the expiry date which is stated on the
carton/blister label after ‘Exp’. The expiry date refers to the last day of
that month.
REMEMBER: This medicine is for you. Do not share it with anyone else.
It may not suit them.
If your tablets become discoloured or show any signs of deterioration,
seek the advice of your pharmacist
REMEMBER: if your doctor tells you to stop taking this medicine, return
any unused tablets to your pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.

6. Contents of the pack and other information
What Cozaar Comp contains
Each film-coated tablet contains 50mg Losartan Potassium (equivalent to
45.8mg Losartan) and 12.5mg hydrochlorothiazide.
Also contains hyprolose; hypromellose; lactose monohydrate;
magnesium stearate; microcrystalline cellulose; pregelatinised maize
starch; titanium dioxide (E171); quinoline yellow aluminum lake (E104);
carnauba wax.
What Cozaar Comp looks like and contents of the pack
Cozaar Comp Tablets are available as yellow, oval, film-coated tablets
marked ‘717’ on one side with a breakline on the other side.
Cozaar Comp Tablets are supplied in calender packs of 28 tablets.
Manufactured by: Merck Sharp & Dohme Limited, Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK.
Procured from within the EU and repackaged by the Product
Licence Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
COZAAR®-COMP 50/12.5 FILM-COATED TABLETS
PL No: 18799/1664
POM
Leaflet date: 17.08.2015
Cozaar is a registered trademark of Merck Sharp & Dohme

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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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