COZAAR COMP 50 MG/12.5 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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Cozaar® Comp 50 mg/12.5 mg
Film-Coated Tablets
Cozaar® Comp 100 mg/25 mg
Film-Coated Tablets

2311, 2312
08.01.13[4]

(losartan potassium/ hydrochlorothiazide)
PATIENT INFORMATION LEAFLET
Your medicine is available using any one of the above name but will be
referred to as Cozaar Comp throughout this leaflet.
Cozaar Comp is also available in other strength.
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.
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 sulphonamide-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.
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 erythematodus)
- 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).
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.

- 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

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

Rare (may affect up to 1 in 1,000 people):
- Hepatitis (inflammation of the liver), abnormal liver function tests

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.

5. HOW TO STORE COZAAR COMP
- Keep out of the sight and reach of children.
o
- Do not store above 30 C. Store in the original package.
- Do not use Cozaar Comp after the expiry date, which is stated on the
package. The expiry date refers to the last day of that month
- If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
- 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 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

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)
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cozaar Comp contains
There are two active ingredients in Cozaar Comp. These are losartan
potassium and hydrochlorothiazide.
Each Cozaar Comp 50 mg/12.5 mg Film-Coated Tablet contains 50 mg
losartan potassium and 12.5 mg of hydrochlorothiazide
Each Cozaar Comp 100 mg/25 mg Film-Coated Tablet contains 100 mg
losartan potassium and 25 mg of hydrochlorothiazide
Other ingredients: hyprolose, hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, pregelatinised maize
starch, titanium dioxide E171, quinoline yellow aluminium lake E104 and
carnauba wax E903.
What Cozaar Comp looks like and contents of the pack
Cozaar Comp 50 mg/12.5 mg Film-Coated Tablets are yellow, oval filmcoated tablets marked '717'on one side and scored on the other.
Cozaar Comp 100 mg/25 mg Film-Coated Tablets are light yellow, oval
film-coated tablets marked '747' on one side and plain on the other.
Pack Size: 28 Tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Merck Sharp and Dohme B.V., Waarderweg 39, NL-2031
BN, Haarlem, The Netherlands and procured from the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM
Cozaar Comp 50 mg/12.5 mg Film-Coated Tablets
Cozaar Comp 100 mg/25 mg Film-Coated Tablets

PL 20636/2311
PL 20636/2312

Leaflet revision and issue date (Ref.) 08.01.13[4]
Cozaar is a trademark of E. I. du Pont de Nemours and Company

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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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