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COZAAR-COMP 100MG/12.5MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Cozaar®- Comp 100mg / 12.5mg Film-coated
Tablets



(losartan potassium and hydrochlorothiazide)
This product is called Cozaar-Comp 100mg /12.5mg Film-Coated
Tablets, but will be referred to as Cozaar-Comp throughout the
remainder of this leaflet.
Your medicine is also available in the following strengths 50mg /12.5mg
and 100mg /25mg 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
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 CozaarComp”)
• 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 CozaarComp 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 CozaarComp 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 CozaarComp before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of CozaarComp. 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 50mg/12.5mg per day to control
blood pressure over the 24-hour period. This can be increased to 2
tablets once daily of Losartan / Hydrochlorothiazide 50mg/12.5mg FilmCoated Tablets or changed to 1 tablet daily of Losartan /
Hydrochlorothiazide 100 mg/25mg Film-Coated Tablets (a stronger
strength) per day. The maximum daily dose is 2 tablets per day of
Losartan / Hydrochlorothiazide 50mg/12.5mg Film-Coated Tablets or 1
tablet daily of Losartan / Hydrochlorothiazide 100mg/25mg 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 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 use Cozaar-Comp after the expiry date which is stated on the
container. The expiry date refers to the last day of that month.
• Store Cozaar-Comp in the original package in order to protect from
moisture and light. Do not store the package above 30°C.
• 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
Cozaar-Comp 100mg /12.5mg are white, oval film-coated tablets marked
745 on one side and plain on the other.
Each tablet contains 100mg of losartan potassium and 12.5mg of
hydrochlorothiazide as the active ingredients.
Also contains: microcrystalline cellulose, lactose monohydrate,
pregelatinized maize starch, magnesium stearate, hydroxypropyl
cellulose, hypromellose, titanium dioxide (E171) and carnauba wax
(E903).
Cozaar-Comp 100mg /12.5mg Film-Coated Tablets are available in
blister packs of 28 tablets and 98 tablets.
Manufactured by Merck Sharp & Dohme Shotton Lane, Cramlington,
NE23 3JU. UK. Procured from within the EU. Product Licence Holder:
Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA.
Cozaar-Comp 100mg /12.5mg Film-Coated Tablets
st

Date of preparation 1 December 2014

PL 20774/1242

POM

Cozaar-Comp is a registered trademark of Merck Sharp & Dohme Corp.
PP3/1242/V1

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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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