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

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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TEVA UK Ref:

231-30-18761-E LEA LOSARTAN HCTZ 100mg/12.5mg F/C TABS TUK

Version:

1

30 September 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

0HARMACODE

s IFYOUHAVE@AORTICORMITRALVALVESTENOSISNARROWING
OFTHEVALVESOFTHEHEART OR@HYPERTROPHIC
CARDIOMYOPATHYADISEASECAUSINGTHICKENINGOF
heart muscle)
s IFYOUAREDIABETIC
0!#+!'%,%!&,%4).&/2-!4)/.
s IFYOUHAVEHADGOUT
&/24(%53%2
s IFYOUHAVEORHAVEHADANALLERGICCONDITION ASTHMA
Read all of this leaflet carefully before you start taking
or a condition that causes joint pain, skin rashes and
this medicine because it contains important information
fever (systemic lupus erythematosus)
for you.
s IFYOUHAVEHIGHCALCIUMORLOWPOTASSIUMLEVELSOR
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
you are on a low potassium diet
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOROR
s IFYOUNEEDTOHAVEANANAESTHETICEVENATTHEDENTIST
pharmacist.
or before surgery, or if you are going to have tests to
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY$O
check your parathyroid function, you must tell the
not pass it on to others. It may harm them, even if
doctor or medical staff that you are taking losartan
their signs of illness are the same as yours.
potassium and hydrochlorothiazide tablets
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOROR
s IFYOUSUFFERFROMPRIMARYHYPERALDOSTERONISMA
pharmacist. This includes any possible side effects not
syndrome associated with increased secretion of the
listed in this leaflet. See section 4.
hormone aldesterone by the adrenal gland, caused by
an abnormality within the gland)
7(!4)3).4()3,%!&,%4
s IFYOURLIVERFUNCTIONISIMPAIREDSEE$ONOTTAKE
1. What Losartan potassium and Hydrochlorothiazide
Losartan potassium and Hydrochlorothiazide
100 mg/12.5 mg Film-coated Tablets are and what
MGMG&ILM COATED4ABLETS
they are used for
s IFYOUARETAKINGANYOFTHEFOLLOWINGMEDICINESUSED
2. What you need to know before you take Losartan
to treat high blood pressure:
potassium and Hydrochlorothiazide 100 mg/12.5 mg
s AN!#% INHIBITORFOREXAMPLEENALAPRIL LISINOPRIL
Film-coated Tablets
ramipril), in particular if you have diabetes-related
3. How to take Losartan potassium and
kidney problems
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
s ALISKIREN
Tablets
Your doctor may check your kidney function, blood
4. Possible side effects
pressure, and the amount of electrolytes (e.g. potassium)
5. How to store Losartan potassium and
in your blood at regular intervals.
Hydrochlorothiazide 100 mg/12.5 mg Film-coated
3EEALSOINFORMATIONUNDERTHEHEADING@$ONOTTAKE
Tablets
,OSARTANPOTASSIUM(YDROCHLOROTHIAZIDE
6. Contents of the pack and other information
Children and adolescents
WHAT LOSARTAN POTASSIUM AND
There is no experience with the use of Losartan
HYDROCHLOROTHIAZIDE 100 mg/12.5 mg
Potassium and Hydrochlorothiazide 100 mg/12.5 mg
FILM-COATED TABLETS ARE AND WHAT THEY
Film-coated Tablets in children. Therefore, it should not
ARE USED FOR
be given to children.
Losartan Potassium and Hydrochlorothiazide is a
Other medicines and Losartan Potassium and
combination of an angiotensin II receptor antagonist
Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
(losartan) and a diuretic (hydrochlorothiazide).
Tell your doctor or pharmacist if you are taking or have
Angiotensin II is a substance produced in the body which recently taken or might take any other medicines.
binds to receptors in blood vessels, causing them to
Diuretic agents such as the hydrochlorothiazide
tighten. This results in an increase in blood pressure.
contained in Losartan Potassium and
Losartan prevents the binding of angiotensin II to these
Hydrochlorothiazide may interact with other medicines.
receptors, causing the blood vessels to relax which in
Preparations containing lithium should not be taken with
turn lowers the blood pressure. Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide without
works by making the kidneys pass more water and salt.
close supervision by your doctor.
This also helps to reduce blood pressure.
It is indicated for the treatment of essential hypertension Special precautionary measures (e.g. blood tests) may be
appropriate if you take potassium supplements,
(high blood pressure).
potassium containing salt substitutes or potassium
WHAT YOU NEED TO KNOW BEFORE YOU TAKE sparing medicines, other diuretics (“water tablets”),
some laxatives, glycyrrhizin (found in liquorice),
LOSARTAN POTASSIUM AND
medicines for the treatment of gout, medicines to control
HYDROCHLOROTHIAZIDE 100 mg/12.5 mg
heart rhythm or for diabetes (oral agents or insulins).
FILM-COATED TABLETS
It is also important for your doctor to know if you are
Do NOT take Losartan potassium and
taking
Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets s OTHERMEDICINESTOREDUCEYOURBLOODPRESSURE
s IFYOUAREALLERGICTOLOSARTAN HYDROCHLOROTHIAZIDEOR
s STEROIDS
any of the other ingredients of this medicine (listed in
s MEDICINESTOTREATCANCER
SECTION
s PAINKILLERS
s IFYOUAREALLERGICHYPERSENSITIVE TOOTHER
s DRUGSFORTREATMENTOFFUNGALINFECTIONS
sulfonamide derived substances (e.g. other thiazides,
s ARTHRITISMEDICINES
some antibacterial drugs such as
s RESINSUSEDFORHIGHCHOLESTEROL SUCHASCOLESTYRAMINE
co-trimoxazole, ask your doctor if you are not sure)
s MEDICINESWHICHRELAXYOURMUSCLES
s IFYOUAREMORETHANMONTHSPREGNANT)TISALSO
s SLEEPINGTABLETS
better to avoid Losartan Potassium and
s OPIOIDMEDICINESSUCHASMORPHINE
Hydrochlorothiazide in early pregnancy - see
s gPRESSORAMINESgSUCHASADRENALINEOROTHERDRUGS
“Pregnancy and breast-feeding”)
from the same group.
s IFYOUHAVESEVERELYIMPAIREDLIVERFUNCTION
Your doctor may need to change your dose and/or to
s IFYOUHAVESEVERELYIMPAIREDKIDNEYFUNCTIONORYOUR take other precautions:
kidneys are not producing any urine
)FYOUARETAKINGAN!#% INHIBITORORALISKIRENSEEALSO
s IFYOUHAVELOWPOTASSIUM LOWSODIUMORHIGH
INFORMATIONUNDERTHEHEADINGS@$ONOTTAKE,OSARTAN
calcium levels which cannot be corrected by treatment POTASSIUM(YDROCHLOROTHIAZIDEAND@7ARNINGSAND
s IFYOUARESUFFERINGFROMGOUT
PRECAUTIONS 
s IFYOUHAVEDIABETESORIMPAIREDKIDNEYFUNCTIONAND
Please also inform your doctor you are taking Losartan
you are treated with a blood pressure lowering
Potassium and Hydrochlorothiazide if you will be
medicine containing aliskiren.
undergoing a radiographic procedure and will be given
Warnings and precautions
iodine contrast media.
You must tell your doctor if you think you are (or might
Losartan potassium and Hydrochlorothiazide
become) pregnant. Losartan Potassium and
100 mg/12.5 mg Film-coated Tablets with food and drink
Hydrochlorothiazide is not recommended in early
You are advised not to drink alcohol whilst taking these
pregnancy, and must not be taken if you are more than 3 tablets: alcohol and Losartan Potassium and
months pregnant, as it may cause serious harm to your
(YDROCHLOROTHIAZIDEMAYINCREASEEACHOTHERSEFFECTS
baby if used at that stage (see “Pregnancy and
Dietary salt in excessive quantities may counteract the
breast-feeding”).
effect of Losartan Potassium and Hydrochlorothiazide.
Talk to your doctor or pharmacist before taking Losartan
Losartan Potassium and Hydrochlorothiazide may be
Potassium and Hydrochlorothiazide 100 mg/12.5 mg
taken with or without food.
Film-coated Tablets
Pregnancy and breast-feeding
s IFYOUHAVEPREVIOUSLYSUFFEREDFROMSWELLINGOFTHE
If you are pregnant or breast-feeding, think you may be
face, lips, throat or tongue
pregnant or are planning to have a baby, ask your doctor
s IFYOUTAKEDIURETICSWATERPILLS
or pharmacist for advice before taking this medicine.
s IFYOUAREONASALT RESTRICTEDDIET
s IFYOUHAVEORHAVEHADSEVEREVOMITINGANDOR
You must tell your doctor if you think you are (or might
diarrhoea
become) pregnant. Your doctor will normally advise you
s IFYOUHAVEHEARTFAILURE
to stop taking Losartan Potassium and
s IFYOUHAVENARROWARTERIESTOYOURKIDNEYSRENAL
Hydrochlorothiazide before you become pregnant or as
artery stenosis) or only have one functioning kidney,
soon as you know you are pregnant and will advise you
or you have recently had a kidney transplant
to take another medicine instead of Losartan Potassium
s IFYOUHAVENARROWINGOFTHEARTERIESATHEROSCLEROSIS and Hydrochlorothiazide. Losartan Potassium and
angina pectoris (chest pain due to poor heart function) Hydrochlorothiazide is not recommended in early
pregnancy, and must not be taken when more than

1

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

TEVA UK Ref:

231-30-18761-E LEA LOSARTAN HCTZ 100mg/12.5mg F/C TABS TUK

Version:

1

30 September 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3 months pregnant, as it may cause serious harm to your
baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Losartan Potassium and
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.
Elderly people
Losartan Potassium and 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 and Hydrochlorothiazide
100 mg/12.5 mg Film-coated Tablets contains lactose
Losartan Potassium and Hydrochlorothiazide contains
lactose monohydrate. 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 AND
HYDROCHLOROTHIAZIDE 100 mg/12.5 mg
FILM-COATED TABLETS

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 and Hydrochlorothiazide depending
on your condition and whether you are taking other
medicines. It is important to continue taking Losartan
Potassium and Hydrochlorothiazide for as long as your
doctor prescribes it in order to maintain smooth control
of your blood pressure.
High blood pressure
The recommended dose of Losartan Potassium and
Hydrochlorothiazide for most patients with high blood
pressure is 1 tablet of Losartan Potassium and
Hydrochlorothiazide 50 mg/12.5 mg per day to control
blood pressure over the 24-hour period. This can be
increased to 1 tablet once daily of Losartan Potassium
and Hydrochlorothiazide 100 mg/12.5 mg or 2 tablets
once daily of Losartan Potassium and
hydrochlorothiazide 50 mg/12.5 mg or changed to
1 tablet daily of Losartan Potassium and
Hydrochlorothiazide 100 mg/25 mg (a stronger strength)
per day. The maximum daily dose is
2 tablets per day of Losartan Potassium and
Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily of
Losartan Potassium and Hydrochlorothiazide
100 mg/25 mg film-coated tablets.
For doses not realisable/practicable with this strength,
other strengths are available.
For oral administration
If you take more Losartan potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
than you should
In case of an overdose, contact your doctor immediately
so that medical attention may be given promptly.
Overdosage can cause a drop in blood pressure,
palpitations, slow pulse, changes in blood composition,
and dehydration.
If you forget to take Losartan potassium and
Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
Try to take Losartan Potassium and Hydrochlorothiazide
daily as prescribed. Do not take a double dose to make
up for a forgotten dose. Just resume your usual schedule.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

s )NCREASEDPOTASSIUMLEVELSWHICHCANCAUSEAN
abnormal heart rhythm), decreased haemoglobin
levels.
Uncommon (may affect up to 1 in 100 people):
s !NAEMIA REDORBROWNISHSPOTSONTHESKIN
(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 and bruising
s ,OSSOFAPPETITE INCREASEDURICACIDLEVELSORFRANK
gout, increased blood sugar levels, abnormal blood
electrolyte levels
s !NXIETY NERVOUSNESS PANICDISORDERRECURRINGPANIC
attacks), confusion, depression, abnormal dreams,
sleep disorders, sleepiness, memory impairment
s 0INSANDNEEDLESORSIMILARSENSATIONS PAININTHE
extremities, trembling, migraine, fainting
s "LURREDVISION BURNINGORSTINGINGINTHEEYES
conjunctivitis, worsening eyesight, seeing things in
yellow
s 2INGING BUZZING ROARINGORCLICKINGINTHEEARS
s ,OWBLOODPRESSURE WHICHMAYBEASSOCIATEDWITH
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
s )NFLAMMATIONOFBLOODVESSELS WHICHISOFTEN
associated with a skin rash or bruising
s 3ORETHROAT BREATHLESSNESS BRONCHITIS PNEUMONIA
water on the lungs (which causes difficulty breathing),
nosebleed, runny nose, congestion
s #ONSTIPATION WIND STOMACHUPSETS STOMACHSPASMS
vomiting, dry mouth, inflammation of a salivary gland,
toothache
s *AUNDICEYELLOWINGOFTHEEYESANDSKIN
inflammation of the pancreas
s (IVES ITCHING INFLAMMATIONOFTHESKIN RASH REDNESS
of the skin, sensitivity to light, dry skin, flushing,
sweating, hair loss
s 0AININTHEARMS SHOULDERS HIPS KNEESOROTHER
joints, joint swelling, stiffness, muscle weakness
s &REQUENTURINATIONINCLUDINGATNIGHT ABNORMALKIDNEY
function including inflammation of the kidneys,
urinary infection, sugar in the urine
s $ECREASEDSEXUALAPPETITE IMPOTENCE
s 3WELLINGOFTHEFACE FEVER
Rare (may affect up to 1 in 1,000 people)
s (EPATITISINFLAMMATIONOFTHELIVER ABNORMALLIVER
function tests.
Not known (frequency cannot be estimated from the
available data)
s -USCLEWASTINGRHABDOMYOLYSIS
s $ISTURBEDTASTEDYSGEUSIA 
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 via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMORE
information on the safety of this medicine.

5

HOW TO STORE LOSARTAN AND
HYDROCHLOROTHIAZIDE 100 mg/12.5 mg
FILM-COATED TABLETS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
STATEDONTHECARTONANDBLISTERAFTER%804HEEXPIRYDATE
refers to the last day of that month.
Do not store above 25°C. Store in the original package in
order to protect from moisture.
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 to protect the environment.

6

FURTHER INFORMATION

What Losartan potassium and Hydrochlorothiazide 100
mg/12.5 mg Film-coated Tablets contain
POSSIBLE SIDE EFFECTS
s 4HEACTIVESUBSTANCESARELOSARTANPOTASSIUMAND
HYDROCHLOROTHIAZIDE%ACHFILM COATEDTABLETCONTAINS
Like all medicines, this medicine can cause side effects,
100 mg of losartan potassium and
although not everybody gets them.
12.5 mg of hydrochlorothiazide.
s 4HEOTHERINGREDIENTSARELACTOSEMONOHYDRATE STARCH
If you experience the following, stop taking Losartan
pregelatinised, cellulose microcrystalline and
potassium and Hydrochlorothiazide 100 mg/12.5 mg
magnesium stearate in the tablet core and poly(vinyl
Film-coated Tablets, and tell your doctor immediately or
ALCOHOL PART HYDROLYZED TITANIUMDIOXIDE%
go to the casualty department of your nearest hospital:
macrogol 3350 and talc in the film-coating.
s !SEVEREALLERGICREACTIONRASH ITCHING SWELLINGOFTHE
face, lips, mouth or throat that may cause difficulty in
What Losartan potassium and Hydrochlorothiazide 100
swallowing or breathing).
mg/12.5 mg Film-coated Tablets look like and contents of
This is a serious but rare side effect, which affects more
the pack
than 1 out of 10,000 patients but fewer than
s &ILM COATEDTABLET
1 out of 1,000 patients. You may need urgent medical
s 7HITE BICONVEX OVAL SHAPEDFILM COATEDTABLET
attention or hospitalisation.
DEBOSSED,(ONONESIDEANDPLAINONTHEOTHER
The following side effects have been reported:
s !VAILABLEINBLISTERS      
Film-coated tablets. 50x1 unit dose (hospital pack)
Common (may affect up to 1 in 10 people):
film-coated tablets.
s #OUGH UPPERAIRWAYINFECTION CONGESTIONINTHENOSE
Not all pack sizes may be marketed.
sinusitis, sinus disorder
s $IARRHOEA ABDOMINALPAIN NAUSEA INDIGESTION
Marketing Authorisation Holder and Manufacturer
s -USCLEPAINORCRAMPS LEGPAIN BACKPAIN
4EVA5+,IMITED %ASTBOURNE ".!' 5NITED+INGDOM
s )NSOMNIA HEADACHE DIZZINESS
This leaflet was last revised in 09/2014
s 7EAKNESS TIREDNESS CHESTPAIN
 %
0,
X

4

REG0073620

Version 1.9

Approved

Page 2 of 3

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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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