COZAAR COMP 100/25 FILM COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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Package leaflet: Information for the patient

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
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 are taking a medicine
called aliskiren to reduce blood pressure.
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 a medicine called aliskiren to reduce blood pressure.
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.

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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 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)

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Technical Info

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6517

Profile: 170x313.27x2
Profile Revision:
G
Profile Revision Date: 161008
Dimensions (mm):
170 x 313.27

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, Red Oak North, 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

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
Cyprus
FORTZAAR, HYZAAR
Denmark
COZAAR Comp, COZAAR Comp Forte, FORTZAAR,
COZAAR Comp 100mg/12.5mg
Estonia
HYZAAR, FORTZAAR
Finland
COZAAR Comp Forte, COZAAR Comp
France
FORTZAAR 100mg/25mg film-coated tablets,
HYZAAR 100mg/25mg film-coated tablets, FORTZAAR
50mg/12.5 mg film-coated tablets, HYZAAR 50mg/12.5mg
film-coated tablets, FORTZAAR 100mg/12.5mg film-coated
tablets
Germany
LORZAAR PLUS 50/12.5mg Filmtabletten, FORTZAAR
100/25mg Filmtabletten, LORZAAR PLUS forte 100/12.5mg
Filmtabletten
Greece
HYZAAR, HYZAAR Extra Forte, HYZAAR Forte
Hungary
HYZAAR 50/12.5mg, HYZAAR Forte 100/25mg, HYZAAR
100/12.5mg
Ireland
COZAAR Comp 50mg/12.5mg film-coated tablets,
COZAAR Comp 100mg/25mg film-coated tablets, COZAAR
Comp 100mg/12.5mg film-coated tablets
Italy
HIZAAR 50 mg + 12.5 mg compresse rivestite con film,
HIZAAR 100mg + 25mg compresse rivestite con film,
FORZAAR 100mg + 25mg compresse rivestite con film,
NEO-LOTAN PLUS 50mg + 12.5mg compresse rivestite con
film, NEO-LOTAN PLUS 100mg + 25mg compresse rivestite
con film, LOSAZID 50mg + 12.5mg compresse rivestite con
film, LOSAZID 100mg + 25mg compresse rivestite con film
Lithuania
HYZAAR 50mg/12.5mg plėvele dengtos tabletės,
FORTZAAR 100 mg/25mg plėvele dengtos tabletės,
FORTZAAR 100 mg/12.5 mg plėvele dengtos tabletės
Luxembourg
COZAAR PLUS FORTE 100MG/25 MG, COZAAR PLUS
50MG/12.5 MG, LOORTAN PLUS 50mg/12.5mg, LOORTAN
PLUS FORTE 100mg/25 mg
Malta
COZAAR Comp 100/12.5mg pilloli miksija b’rita, COZAAR
Comp 100/25 mg pilloli miksija b’rita, COZAAR Comp
50/12.5mg pilloli miksija b’rita
Netherlands
COZAAR Plus 100/12.5, FORTZAAR 100/25, HYZAAR 50/12.5
Poland
HYZAAR, HYZAAR FORTE
Portugal
COZAAR Plus, FORTZAAR, SIAARA, LORTAAN PLUS,
Losartan + Hidrochlorotiazide Fross
Romania
HYZAAR 50mg/12.5mg comprimate filmate, FORTZAAR
100/ 25 mg
comprimate filmate
Slovenia
HYZAAR, FORTZAAR
Spain
COZAAR Plus, FORTZAAR
Sweden
COZAAR Comp 50mg/12.5mg filmdragerade tabletter,
COZAAR Comp 100mg/12.5mg filmdragerade tabletter,
COZAAR Comp Forte 100mg/25mg filmdragerade tabletter,
United Kingdom COZAAR-COMP 50/12.5mg Film-coated Tablets,
COZAAR-COMP 100/25mg Film-coated Tablets,
COZAAR-COMP 100/12.5 mg Film-coated Tablets
Iceland
COZAAR‑COMP 50/12.5mg, COZAAR COMP FORTE,
COZAAR‑COMP 100/12.5mg
Norway
COZAAR Comp, COZAAR Comp Forte
This leaflet was last revised in January 2014
PIL.HYZ.14.UK.4041.IA-282-G

Merck Sharp & Dohme Limited.
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
© Merck Sharp & Dohme Limited 2014. All rights reserved.
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For Position Only

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 tase (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 (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: www.mhra.gov.uk/yellowcard
Ireland: IMB Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.ie
Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate,
203 Level 3, Rue D’Argens, GŻR-1368 Gżira Website: www.medicinesauthority.
gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt
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.

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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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