COZAAR COMP 100/25 FILM COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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XXXXX/XXXXXX-X

Package leaflet: Information for the patient

6596, 6729

COZAAR® COMP 50mg/12.5mg Film‑coated Tablets
COZAAR® COMP 100mg/12.5mg Film‑coated Tablets
COZAAR® COMP 100mg/25mg Film‑coated Tablets
losartan potassium and hydrochlorothiazide

For Position Only

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 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.
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 experince 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

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Dimensions (mm):

BG148x520_260
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148 x 520mm

For Position Only

For Position Only

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• 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)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
5. How to store COZAAR COMP
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the
last day of that month.
Blisters
Store Cozaar Comp in the original package in order to protect from light and moisture. Do not store the
package above 30°C.
Bottle
Store in the original container in order to protect from light. Keep the bottle tightly closed in order to protect
from moisture. Do not store the bottle above 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cozaar Comp contains
The active substances are losartan potassium and hydrochlorothiazide.
Cozaar Comp 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as
the active ingredients.
Cozaar Comp 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide
as the active ingredients.
Cozaar Comp 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as
the active ingredients.
Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain the
following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch,
magnesium stearate, hydroxypropyl cellulose, hypromellose.
Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline
yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp 100 mg/12.5 mg also contains:  titanium dioxide (E171) and carnauba wax (E903).
What Cozaar Comp looks like and contents of the pack
Cozaar Comp 50 mg/12.5 mg is supplied as yellow, oval film‑coated tablets marked 717 on one side and
plain or scored on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
Cozaar Comp 100 mg/12.5 mg is supplied as white, oval film‑coated tablets marked 745 on one side and
plain on the other.
Cozaar Comp 100 mg/25 mg is supplied as light yellow, oval film‑coated tablets marked 747 on one side and
plain on the other.
Cozaar Comp is supplied in the following pack sizes:
Cozaar Comp 50 mg/12.5 mg ‑ PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing
4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital
use. HDPE bottles of 100 tablets.
Cozaar Comp 100 mg/12.5 mg ‑ PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing
14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets. HDPE bottles of 100 tablets.
Cozaar Comp 100 mg/25 mg ‑ PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing
7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use.
HDPE bottles of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK and Malta is Merck Sharp & Dohme Ltd, Hertford Road,
Hoddesdon, Hertfordshire, EN11 9BU, UK.
The Marketing Authorisation Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health) Ltd, Pelham
House, South County Business Park, Leopardstown, Dublin 18, Ireland.
Manufacturers:
50mg/12.5mg strength: Merck Manufacturing Division, Shotton Lane, Cramlington, Northumberland,
NE23 3JU, UK.
100mg/12.5mg and 100mg/25mg strengths: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem,
Netherlands.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Belgium
Cyprus
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy

Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovenia
Spain
Sweden
United
Kingdom
Iceland
Norway

Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

BG148x520_260
7
050708
148 x 520mm

COSAAR Plus – Filmtabletten, FORTZAAR‑Filmtabletten
COZAAR PLUS FORTE 100 mg/25 mg, COZAAR PLUS 50mg/12.5mg, LOORTAN PLUS FORTE
100mg/25mg, LOORTAN PLUS 50mg/12.5mg
FORTZAAR, HYZAAR
COZAAR Comp, COZAAR Comp Forte, FORTZAAR, COZAAR Comp 100mg / 12.5mg
HYZAAR, FORTZAAR
COZAAR Comp Forte, COZAAR Comp
FORTZAAR 100 mg/25mg film-coated tablets, HYZAAR 100mg/25mg film-coated tablets,
FORTZAAR 50mg/12.5 mg film-coated tablets, HYZAAR 50 mg/12.5 mg film-coated tablets,
FORTZAAR 100 mg/12.5 mg film-coated tablets
LORZAAR PLUS 50/12.5 mg Filmtabletten, FORTZAAR 100/25 mg Filmtabletten, LORZAAR PLUS
forte 100/12.5 mg Filmtabletten
HYZAAR, HYZAAR Extra Forte, HYZAAR Forte
HYZAAR 50/12.5 mg, HYZAAR Forte 100/25 mg, HYZAAR 100/12.5 mg
COZAAR Comp 50mg/12.5mg film-coated tablets, COZAAR Comp 100mg/25mg film-coated
tablets, COZAAR Comp 100mg/12.5mg film-coated tablets
HIZAAR 50 mg + 12.5 mg compresse rivestite con film, HIZAAR 100 mg + 25 mg compresse
rivestite con film, FORZAAR 100 mg + 25 mg compresse rivestite con film, NEO-LOTAN PLUS
50 mg + 12.5 mg compresse rivestite con film, NEO-LOTAN PLUS 100 mg + 25 mg compresse
rivestite con film, LOSAZID 50 mg + 12.5 mg compresse rivestite con film, LOSAZID 100 mg +
25 mg compresse rivestite con film
HYZAAR 50 mg/12.5 mg plėvele dengtos tabletės, FORTZAAR 100 mg/25 mg plėvele
dengtos tabletės, FORTZAAR 100 mg/12.5 mg plėvele dengtos tabletės
COZAAR PLUS FORTE 100 MG/25 MG, COZAAR PLUS 50 MG/12.5 MG, LOORTAN PLUS
50 mg/12.5 mg, LOORTAN PLUS FORTE 100 mg/25 mg
COZAAR Comp 100/12.5 mg pilloli miksija b’rita, COZAAR Comp 100/25 mg pilloli miksija
b’rita, COZAAR Comp 50/12.5 mg pilloli miksija b’rita
COZAAR Plus 100/12.5, FORTZAAR 100/25, HYZAAR 50/12.5
HYZAAR, HYZAAR FORTE
COZAAR Plus, FORTZAAR, SIAARA, LORTAAN PLUS, Losartan + Hidrochlorotiazide Fross
HYZAAR 50 mg/12.5 mg comprimate filmate, FORTZAAR 100/ 25 mg
comprimate filmate
HYZAAR, FORTZAAR
COZAAR Plus, FORTZAAR
COZAAR Comp 50mg/12.5mg filmdragerade tabletter, COZAAR Comp 100mg/12.5mg
filmdragerade tabletter, COZAAR Comp Forte 100mg/25mg filmdragerade tabletter,
COZAAR-COMP 50/12.5mg FILM COATED TABLETS, COZAAR-COMP 100/25mg FILM COATED
TABLETS, COZAAR-COMP 100/12.5 mg Film-coated tablets
COZAAR‑COMP 50/12.5mg, COZAAR COMP FORTE, COZAAR‑COMP 100/12.5mg
COZAAR Comp, COZAAR Comp Forte

This leaflet was last revised in 08/2012
PIL.HYZ.12.UK.3682_WS-034

Merck Sharp & Dohme Limited.
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
© Merck Sharp & Dohme Limited 2012. All rights reserved.

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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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