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COZAAR COMP 100 MG/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / 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 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.
1

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

2

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

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
4

















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 (see details below). By
reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:
+353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.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
5

Store Cozaar Comp in the original package in order to protect from light and moisture. Do not store
the package above 30oC.
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 oC.
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.

6

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:
50 mg/12.5 mg strength: Merck Manufacturing Division, Shotton Lane, Cramlington,
Northumberland, NE23 3JU, UK.
100 mg/12.5 mg and 100 mg/25 mg 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

COSAAR Plus – Filmtabletten, FORTZAAR-Filmtabletten
COZAAR PLUS FORTE 100 mg/25 mg, COZAAR PLUS 50 mg/12.5 mg,
LOORTAN PLUS FORTE 100 mg/25 mg, LOORTAN PLUS
50 mg/12.5 mg
FORTZAAR, HYZAAR
COZAAR Comp, COZAAR Comp Forte, FORTZAAR, COZAAR Comp
100 mg/12.5 mg
HYZAAR, FORTZAAR
COZAAR Comp Forte, COZAAR Comp
FORTZAAR 100 mg/25 mg film-coated tablets, HYZAAR 100 mg/25 mg
film-coated tablets, FORTZAAR 50 mg/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/ 12.5mg
COZAAR Comp 50 mg/12.5 mg film-coated tablets, COZAAR Comp
100mg/25 mg film-coated tablets, COZAAR Comp 100mg/12.5 mg filmcoated 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/12.5mg plėvele dengtos tabletės, FORTZAAR
100 mg/25 mg plėvele dengtos tabletės, FORTZAAR 100 mg/12.5 mg
plėvele dengtos tabletės
7

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

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 50 mg/12.5 mg filmdragerade tabletter, COZAAR Comp
100 mg/12.5 mg filmdragerade tabletter, COZAAR Comp Forte
100 mg/25 mg filmdragerade tabletter,
COZAAR-COMP 50/12.5 MG Film-coated Tablets, COZAAR-COMP
100/25 MG Film-coated Tablets, COZAAR-COMP 100/12.5 mg Film-coated
Tablets
COZAAR-COMP 50/12.5 MG, COZAAR COMP Forte, COZAAR-COMP
100/12.5 MG
COZAAR Comp, COZAAR Comp Forte

This leaflet was last revised in September 2014
PIL.HYZ.14.UK.4122.WS-094.IB
© Merck Sharp & Dohme Limited 2014. 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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