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S1629 LEAFLET Cozaar comp 20151014


COZAAR COMP 100mg/25mg

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

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

if you are taking any of the following medicines used to treat
high blood pressure:

(losartan potassium and hydrochlorothiazide)
The name of your medicine is Cozaar Comp 100mg/ 25mg
Film‑coated Tablets but will be referred to as Cozaar Comp
throughout the following leaflet.
Please note that information regarding other strengths of Cozaar
Comp Tablets (50mg/ 12.5mg & 100mg/25mg) may also be present
in the below leaflet.
Read all of this leaflet carefully before taking this medicine
because it contains important information for you.


an ACE-inhibitor (for example enalapril, lisinopril, ramipril),
in particular if you have diabetes-related kidney problems.



Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist
or nurse.

Your doctor may check your kidney function, blood pressure,
and the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.

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.

See also information under the heading “Do not take COZAAR

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
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).
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

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

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
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
Dietary salt in excessive quantities may counteract the effect of
Cozaar Comp tablets.
Cozaar Comp tablets may be taken with or without food.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cozaar

Pregnancy and breast-feeding

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).

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.

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

Tell your doctor if you are breast-feeding or about to start breastfeeding. 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.

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

Use in elderly patients

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

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.

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

Driving and using machines

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)

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

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.

Rare (may affect up to 1 in 1,000 people):

Hepatitis (inflammation of the liver), abnormal liver function

Not known (frequency cannot be estimated from the available data):

Flu-like symptoms

Unexplained muscle pain with dark (tea-colored) urine

High Blood Pressure

Low levels of sodium in the blood (hyponatraemia)

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

Generally feeling unwell (malaise)

Disturbed taste (dysgeusia)

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

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 (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:


Do not store above 30°C.

Store in the original package to protect from light and moisture.

Do not open the blister pack until you are ready to take the

Do not use the Cozaar Comp after the expiry date (EXP) stated
on the packaging. The term validity refers to the last day of the

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.

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
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.

What Cozaar Comp contains

Cozaar Comp 100mg/ 25mg contains 100 mg of losartan
potassium and 25 mg of hydrochlorothiazide as the active

The other ingredients are: microcrystalline cellulose, lactose
monohydrate, pregelatinised maize starch, magnesium
stearate, hydroxypropyl cellulose, hypromellose, titanium
dioxide (E171), quinoline yellow aluminum lake (E104) and
carnauba wax (E903).

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

What Cozaar Comp looks like and contents of the pack

Insomnia, headache, dizziness

Weakness, tiredness, chest pain

Cozaar Comp 100mg/ 25mg is available as light yellow, oval
film-coated tablets marked 747 on one side and plain on the

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

Cozaar Comp is available as blister packs containing 28 tablets.

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,

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

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

Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
This product is manufactured by Merck Sharp & Dohme BV,
Waardeweg 39, 2031 BN Haarlem, The Netherlands.

PL 19488/1629

Leaflet revision date: 14 October 2015
Cozaar Comp is a registered trademark of EI du Pont de Nemours
and Company, Wilmington, Delaware, USA.
S1629 LEAFLET Cozaar comp 20151014

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