LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 100 MG/12.5 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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Package leaflet: Information for the user

Losartan Potassium/
Hydrochlorothiazide
100 mg/12.5 mg
Film-coated Tablets

(Losartan potassium and hydrochlorothiazide)
Read all of this leaflet carefully before you
start 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
or pharmacist.
- 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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4
What is in this leaflet
1. What Losartan Potassium/Hydrochlorothiazide is
and what it is used for
2. What you need to know before you take
Losartan Potassium/Hydrochlorothiazide
3. How to take Losartan Potassium/Hydrochlorothiazide
4. Possible side effects
5. How to store Losartan Potassium/Hydrochlorothiazide
6. Contents of the pack and other information
1. What Losartan Potassium/Hydrochlorothiazide
is and what it is used for
Losartan Potassium/Hydrochlorothiazide
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.
Losartan/Hydrochlorothiazide is indicated for the
treatment of essential hypertension (high blood
pressure).
2. What you need to know before you take
Losartan Potassium/Hydrochlorothiazide
Do not take Losartan Potassium/Hydrochlorothiazide
• 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 sulfonamidederived 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 Losartan Potassium/
Hydrochlorothiazide 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
You must tell your doctor if you think you are
(or might become) pregnant. Losartan Potassium/
Hydrochlorothiazide 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
Losartan Potassium/Hydrochlorothiazide
• 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 Losartan Potassium/
Hydrochlorothiazide")
• 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
Losartan Potassium/Hydrochlorothiazide
in children. Therefore, Losartan Potassium/
Hydrochlorothiazide should not be given to
children.
Other medicines and Losartan Potassium/
Hydrochlorothiazide
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 Losartan Potassium/
Hydrochlorothiazide may interact with other
medicines.
Preparations containing lithium should
not be taken with Losartan Potassium/
Hydrochlorothiazide 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,
glycyrrhizin (found in liquorice), 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
Losartan Potassium/Hydrochlorothiazide and you
will be undergoing a radiographic procedure and
will be given iodine contrast media.
Losartan Potassium/Hydrochlorothiazide with
food, drink and alcohol
You are advised not to drink alcohol whilst taking
these tablets: alcohol and Losartan Potassium/
Hydrochlorothiazide tablets may increase each
other's effects.
Dietary salt in excessive quantities may
counteract the effect of Losartan Potassium/
Hydrochlorothiazide tablets.
Losartan Potassium/Hydrochlorothiazide 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 Losartan Potassium/
Hydrochlorothiazide before you become pregnant
or as soon as you know you are pregnant and
will advise you to take another medicine instead
of Losartan Potassium/Hydrochlorothiazide.
Losartan Potassium/Hydrochlorothiazide 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. Losartan Potassium/
Hydrochlorothiazide is not recommended for
mothers who are breast-feeding, and your doctor
may choose another treatment for you if you wish
to breast-feed.
Ask your doctor or pharmacist for advice before
taking any medicine.
Use in older people
Losartan Potassium/Hydrochlorothiazide 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.
Losartan Potassium/Hydrochlorothiazide
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 Losartan Potassium/
Hydrochlorothiazide
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 Losartan
Potassium/Hydrochlorothiazide depending on
your condition and whether you are taking other
medicines. It is important to continue taking
Losartan Potassium/Hydrochlorothiazide for
as long as your doctor prescribes it in order to

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maintain smooth control of your blood pressure.
High Blood Pressure
The recommended dose of Losartan Potassium/
Hydrochlorothiazide for most patients with high
blood pressure is 1 tablet of Losartan Potassium/
Hydrochlorothiazide 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 Potassium/Hydrochlorothiazide
50 mg/12.5 mg film-coated tablets or changed
to 1 tablet daily of Losartan Potassium/
Hydrochlorothiazide 100 mg/25 mg film-coated
tablets (a stronger strength) per day. The maximum
daily dose is 2 tablets per day of Losartan
Potassium/Hydrochlorothiazide
50 mg/12.5 mg film-coated tablets or 1 tablet daily
of Losartan Potassium/Hydrochlorothiazide
100 mg/25 mg film-coated tablets.
If you take more Losartan Potassium/
Hydrochlorothiazide 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 Losartan Potassium/
Hydrochlorothiazide
Try to take Losartan Potassium/
Hydrochlorothiazide daily as prescribed. However,
if you miss a dose, do not take an extra dose. Just
resume your usual schedule.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following serious
side effects, stop taking Losartan Potassium/
Hydrochlorothiazide tablets and tell your doctor
immediately or go to the casualty department of
your nearest hospital:
• A severe rare (may affect up to 1 in 1,000
people) allergic reaction (rash, itching, swelling
of the face, lips, mouth or throat that may
cause difficulty in swallowing or breathing)
(anaphylactic reaction).
• A severe uncommon (may affect up to 1 in 100
people) skin reaction associated with painful
red areas, large blisters, peeling of layers of skin.
This is accompanied by fevers and chills, aching
muscles and generally feeling unwell (toxic
epidermal necrolysis).
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
• Difficulty sleeping (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, destruction
of red blood cells (haemolysis), reduction in
white blood cells, 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 sensation, numbness or
weakness of the arms and legs, tremor, 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,
dizziness and spinning sensation (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,
changes in the rhythm or rate of the heart beat
(arrhythmias)
• Inflammation of blood vessels, which is often
associated with a skin rash or bruising
• Sore throat and discomfort when swallowing
(pharyngitis), swelling and irritation of the voice
box associated with loss of voice (laryngitis),
breathlessness, bronchitis, swelling of the lungs
(pneumonitis) , water on the lungs (which causes
difficulty breathing), nosebleed, runny nose,
congestion
• Constipation, severe constipation (obstipation),
wind, swelling and inflammation of the stomach
lining (gastritis), 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
or cramps

• Frequent urination including at night, abnormal
kidney function including inflammation of the
kidneys, urinary tract infection, sugar in the
urine, kidney failure
• Decreased sexual appetite, impotence
• Swelling of the face, localised swelling (oedema),
fever
Rare (may affect up to 1 in 1,000 people):
• Inflammation of the liver (hepatitis), 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)
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist . This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via Yellow Card Scheme
Website: 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 Losartan Potassium/
Hydrochlorothiazide
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 carton, blister and bottle
after EXP. The expiry date refers to the last day of
that month.
Losartan Potassium/Hydrochlorothiazide does not
require any special storage conditions.
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 Losartan Potassium/Hydrochlorothiazide
film-coated tablets contain
The active substances are losartan potassium and
hydrochlorothiazide
Each tablet contains 100 mg of losartan potassium
and 12.5 mg of hydrochlorothiazide.
Losartan Potassium/Hydrochlorothiazide 100
mg/12.5 mg contains the following other
ingredients: cellulose microcrystalline, lactose
monohydrate, starch pregelatinized (maize),
magnesium stearate, hydroxypropyl cellulose and
titanium dioxide.
Losartan Potassium/Hydrochlorothiazide 100
mg/12.5 mg also contains: Hypromellose 6cP,
What Losartan Potassium/Hydrochlorothiazide
film-coated tablets look like and contents of the
pack
Losartan Potassium/Hydrochlorothiazide 100
mg/12.5 mg is supplied as white to off white, oval,
biconvex film-coated tablets, debossed with 'M' on
one side of the tablet and 'LH5' on the other side.
Losartan Potassium/Hydrochlorothiazide filmcoated tablets are supplied in white, opaque
blisters in pack sizes of 7, 10, 14, 20, 28, 30, 50,
56, 60, 84, 90, 98, 100, 112, 280 and 500 tablets,
calendar pack of 28 tablets and in white, opaque
plastic bottles in pack sizes of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Jenson Pharmaceutical Service Limited, Carradine
House, 237 Regents Park Road, London, N3 3LF
Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft., H-2900, Komárom,
Mylan utca 1, Hungary.
This leaflet was last revised in 02/2014.

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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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