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COZAAR COMP 100MG/25MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
®

COZAAR COMP 100mg/25mg TABLETS
(losartan potassium/hydrochlorothiazide)
This product will be referred to as Cozaar Comp throughout the following leaflet. Please note that the leaflet also
contains information about other strengths (Cozaar Comp 50mg/12.5mg and 100mg/12.5mg 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 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:
ο an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney
problems.
ο 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, potassiumcontaining 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 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)
• 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 in order to protect from light and moisture.
• Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day
of that month.
• If the tablet has become discoloured or shows any other signs of deterioration, you should ask your doctor or
pharmacist for advice.
• 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cozaar Comp contains
Each tablet contains 100mg losartan potassium and 25mg hydrochlorothiazide.
Cozaar Comp contains the following inactive ingredients:
microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hyprolose,
hypromellose, quinoline yellow aluminium lake (E104), carnauba wax and titanium dioxide (E171).
What Cozaar Comp looks like and contents of the pack
Cozaar Comp are yellow, film-coated, oval and coded ‘747’ on one side and plain on the reverse.
Cozaar Comp are supplied as blister packs of 28 tablets.
PL: 15814/0789
Cozaar Comp 100mg/25mg Tablets
POM
This product is manufactured by Merck Sharp & Dohme Ltd, Shotton Lane, Cramlington, Northumberland, UK and
is procured from within the EU and repackaged by the product licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 01.02.2016.
Cozaar is a registered trade mark of Merck Sharp & Dohme Corp., USA.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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