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TEVA LISINOPRIL AND HYDROCHLOROTHIAZIDE 10MG/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE / HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE / HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE

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ZINC Ref:

EBNUK1090a LEA LISINOPRIL/HCTZ A/S TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
460 mm
160 mm
N/A
N/A

• Keep this leaflet. You may need to read it again.
• If you have further questions, please 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 the 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.
Lisinopril and Hydrochlorothiazide will be
referred to as “Lisinopril/HCTZ” throughout
this leaflet.
What is in this leaflet

1. What Lisinopril/HCTZ is and what it is used for
2. What you need to know before you take
Lisinopril and Hydrochlorothiazide
3. How to take Lisinopril and
Hydrochlorothiazide
4. Possible side effects
5. How to store Lisinopril and
Hydrochlorothiazide
6. Contents of the pack and other information

What Lisinopril/HCTZ is and what
it is used for

Lisinopril/HCTZ contains lisinopril and
hydrochlorothiazide.
Lisinopril belongs to a group of drugs called
angiotensin-converting enzyme (ACE) inhibitors.
ACE inhibitors are vasodilators (drugs which
widen the blood vessels making it easier for the
heart to pump blood around the body).
Hydrochlorothiazide belongs to a group of
drugs called diuretics or “water tablets”. Diuretic
medicines increase the amount of water you
lose in your urine and therefore reduce the
amount of fluid in your blood vessels.
Because each of these drugs reduces blood
pressure in a different way, Lisinopril/HCTZ may
be used together to treat high blood pressure
when taking either of these drugs alone did not
control your blood pressure sufficiently.

What you need to know before you
take Lisinopril/HCTZ

Do not take Lisinopril/HCTZ:
• if you are allergic to lisinopril or
hydrochlorothiazide or any of the other
ingredients of this medicine (listed in section 6)
• if you are allergic to sulphonamides (e.g.
trimethoprim)
• if you have suffered an unexplained allergic
reaction or an allergic reaction to any other
ACE inhibitors, e.g. captopril, enalapril, which
has led to swelling of the face, lips, tongue
and/or throat
• if you have been diagnosed with a condition
known as hereditary angioedema or have a
history of angioedema (a sudden, severe
swelling of the skin in a particular area which
commonly affects the eyes, lips, nose,
tongue, voice box (larynx), hands, or bowel)
• if you have severe liver or kidney problems.
• if you are more than 3 months pregnant. (It is
also better to avoid Lisinopril/HCTZ in early
pregnancy – see section 'Pregnancy and
breast-feeding').
• 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 or pharmacist before taking
Lisinopril/HCTZ:
• if you think you are (or might become)
pregnant. Lisinopril/HCTZ Tablets are not
recommended in early pregnancy and may
cause serious harm to your baby after three
months of pregnancy (see section
‘Pregnancy and breast-feeding’)
• if you are at risk of high levels of potassium
in your blood e.g. from taking
potassium-containing salt substitutes or
supplements
• if you have been on a low sodium diet
• if you are suffering from diarrhoea or
vomiting
• if you have an imbalance of salts in your
blood
• if you have heart (aortic or mitral) valve
disease or an enlarged heart
• if you have liver disease or liver problems
• if you have kidney problems, need dialysis
treatment or have had a kidney transplant
• if you have diabetes. As you may need a
different dose of your antidiabetic medicine
(including insulin)
• if you suffer from gout
• if you have a history of allergy, bronchial
asthma or SLE (system lupus
erythematosus is an allergic condition
causing joint pain, rashes and fever)
• if you need blood separation treatment
(apheresis) or desensitisation treatment
e.g. following a wasp or bee sting; your
doctor may wish to interrupt treatment
with this medicine to prevent a possible
allergic reaction
• if you need to have surgery or a general
anaesthetic. Tell the doctor, dentist or hospital
staff you are taking this medicine, as there
may be a sudden fall in blood pressure.
• if you take lithium (a medicine for mood
stabilisation)
• if you play competitive sports as
hydrochlorothiazide is a banned substance
and may give a positive result in
anti-doping tests
• if you are of black race or Afro-Caribbean
origin: ACE inhibitors may be less effective
in lowering blood pressure in this group of
patients and a higher dose of this medicine
may be needed
• if you are taking any of the following
medicines used to treat high blood pressure:

Version 1.2

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Template

Package leaflet: Information for the user

REG0141815

18 May 2017

PANTONE® GREEN C

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.

2

1

Colours Used:

Lisinopril and Hydrochlorothiazide
10 mg/12.5 mg & 20 mg/12.5 mg
Tablets
Lisinopril and Hydrochlorothiazide

1

Version:

• an angiotensin II receptor blocker (ARBs)
(also known as sartans – for example
valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related
kidney problems
• aliskiren.
• if you are taking any of the following
medicines, the risk of angioedema (rapid
swelling under the skin in area such as the
throat) is increased:
• sirolimus, everolimus and other
medicines belonging to the class of
mTOR inhibitors (used to avoid rejection
of transplanted organs)
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 Lisinopril/HCTZ’.
While taking Lisinopril/HCTZ Tablets
Your doctor will monitor your condition closely,
take blood tests, check your kidney function and
monitor the level of salts in your blood from
time to time.
If you experience sudden swelling of the lips,
face, neck, and possibly hands and feet, a rash,
difficulty swallowing or breathing, hoarseness,
these are signs of a serious allergic reaction
called angioedema. This may occur at any time
during treatment. There is a higher risk in
patients of black race or Afro-Caribbean origin.
If this occurs stop taking the tablets and tell
your doctor immediately or go to the casualty
department at your nearest hospital.
Children and adolescents
Lisinopril and Hydrochlorothiazide is not
recommended for use in children and
adolescents because safety and efficacy of
Lisinopril and Hydrochlorothiazide in children
has not been established.
Other medicines and Lisinopril/HCTZ
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, especially if you are taking any of
the following:
• diuretics ("water tablets") such as
furosemide, torasemide, amiloride
• non-steroidal anti-inflammatory drugs
(NSAIDs) which are a type of pain killer, e.g.
aspirin or ibuprofen
• gold preparations
• other drugs to reduce blood pressure as
your blood pressure may become too low
• your doctor may need to change your dose
and/or to take other precautions: if you are
taking an angiotensin II receptor blocker
(ARB) or aliskiren (see also information under
the headings ‘Do not take Lisinopril/HCTZ’
and ‘Warnings and precautions’)
• tricyclic antidepressants (e.g. amitriptyline),
as these will further reduced your blood
pressure
• anti-psychotics e.g. chlorpromazine (used
for the treatment of mental disorders)
which may cause low blood pressure
• sympathomimetic drugs e.g. adrenaline,
noradrenaline, or ephedrine as the
effectiveness of lisinopril may be reduced.
Ephedrine may be present in medicines for
colds and nasal stuffiness.
• ansulin or tablets for the treatment of
diabetes, as the risk of ‘hypos’ may be
increased
• allopurinol for the treatment of gout, as
there is an increased risk of blood disorder
called leucopenia (a reduction in the number
white blood cells) and of kidney failure
• ciclosporin (used following organ
transplant), as the risk of hyperkalaemia
(high levels of potassium in the blood) and
of kidney failure may be increased
• lovastatin (a drug that reduces fat levels in
your blood)
• procainamide used to treat abnormal heart
rhythms as there is an increased risk of
blood disorder called leucopenia (a
reduction in the number white blood cells)
• cytostatics (drugs for treatments of cancer)
and immunosuppressives
• amphotericin B (used for the treatment of
serious infections caused by fungi)
• carbenoxolone (used in the treatment of
stomach and duodenal ulcers)
• corticosteroids e.g. prednisolone
• hormone called corticotropine (ACTH)
• laxatives e.g. lactulose
• calcium supplements
• cardiac glycosides e.g. digoxin
• drugs that reduce the fat levels in your
blood such as colestyramine or colestipol,
as they may impair the absorption of
hydrochlorothiazide. Lisinopril/HCTZ must
be taken at least one hour before or four to
six hours after these drugs.
• sotalol (beta-blocker), as there is an increased
risk of abnormalities of the heart rhythm
• potassium supplements,
potassium-sparing agents or
potassium-containing salt substitutes, as
potassium levels may increase above
expected levels (such as heparin and
co-trimoxazole also known as
trimethoprim/sulfamethoxazole)
• lithium, as lithium levels may be increased
• trimethoprim (treatment of or urinary and
respiratory tract infections).
• medicines which are most often used to
avoid rejection of transplanted organs
(sirolimus, everolimus and other medicines
belonging to the class of mTOR inhibitors).
See section “Warnings and precautions”.
Lisinopril/HCTZ with alcohol:
Drinking alcohol when taking Lisinopril/HCTZ
can have addictive effects and cause dizziness
or light-headedness.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Pregnancy
You must tell your doctor if you think you are
(or might become) pregnant. Your doctor will
normally advise you to stop taking

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ZINC Ref:

EBNUK1090a LEA LISINOPRIL/HCTZ A/S TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
460 mm
160 mm
N/A
N/A

The maximum daily dose of 40 mg Lisinopril/25 mg
Hydrochlorothiazide should not be exceeded.
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole.
If you take more Lisinopril/HCTZ than you should
If you (or someone else) swallow a lot of the
tablets all together or if you think a child has
swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor
immediately. An overdose is likely to cause
faintness or dizziness (due to a drop in blood
pressure), rapid breathing, anxiety or cough.
Please take this leaflet, any remaining tablets, and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Lisinopril/HCTZ
Do not take a double dose to make up for a
forgotten dose. Take one as soon as you
remember, unless it is nearly time to take the
next one. Take the remaining doses at the
correct time.
If you stop taking Lisinopril/HCTZ
You should continue to take these tablets for as
long as your doctor tells you to. Do not stop
taking your medicine without talking to your
doctor first even if you feel better.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department
at your nearest hospital if any of the following
happen:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You may
need urgent medical attention or hospitalisation.
Tell your doctor immediately if you experience
any of the following effects:
• heart attack or stroke in susceptible patients
• symptoms including feeling or being sick,
abdominal and back pain; these may be signs
of pancreatitis (inflammation of the pancreas).
These are serious but uncommon (may affect
up to 1 in 100 people) side effects.
• a serious illness with blistering of the skin,
mouth eyes and genitals (Stevens-Johnson
Syndrome), or severe blistering and peeling
of large areas of the skin (toxic epidermal
necrolysis)
• jaundice (yellowing of the skin and whites of
the eyes); this may be a sign of inflammation
of the liver (hepatitis), liver failure.
These are serious but very rare (may affect up
to 1 in 10,000 people) side effects.
If you develop any of the following symptoms
let your doctor know if:
• you feel dizzy after your first dose. A few
people react to their first dose or when the
dose is increased by feeling dizzy, weak, faint
and sick. Lie down if your blood pressure drops
too low. This is a common (may affect up to 1
in 10 people) side effect.
• you develop a cough which is persistent and
dry. This is a common (may affect up to 1 in 10
people) side effect.
• you develop complaints such as a dry mouth,
thirst, lethargy, muscle pain or cramps, a racing
heart, dizziness, feeling or being sick, and
passing less urine. These are signs of a fluid or
mineral imbalance in the body. This is rare
(may affect up to 1 in 1,000 people) side effect.
• you develop a high temperature, sore throat
and mouth ulcers, which are signs of a low
white cell count in the blood. This is very rare
(may affect up to 1 in 10,000 people) side effect.
The following side effects have been reported
at the approximate frequencies shown:
Common (may affect up to 1 in 10 people)
• tiredness, lethargy (a feeling of tiredness,
drowsiness, or lack of energy)
• headache
• kidney problems
• diarrhoea or being sick.
Uncommon (may affect up to 1 in 100 people)
• feeling sick
• feeling weak
• a sensation that your surroundings are
spinning (vertigo)
• changes in your sensation of taste

Version 1.2

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How to take Lisinopril/HCTZ

REG0141815

18 May 2017

PANTONE® GREEN C

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
If you are already taking diuretics, your doctor
may reduce your dose of these, or even tell you
to stop taking them before you start to take
Lisinopril/HCTZ.
Your doctor will monitor you during treatment
and this may include blood or urine tests.
Adults (including older people):
Lisinopril/HCTZ should be taken once a day. The
tablets should be swallowed with a drink of
water. Your dose will be decided by your doctor,
depending on your response to treatment.

4

1

Colours Used:

Lisinopril/HCTZ before you become pregnant or
as soon as you know you are pregnant and will
advise you to take another medicine instead of
Lisinopril/HCTZ. Lisinopril/HCTZ 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. Lisinopril/HCTZ is
not recommended for mothers who are
breast-feeding, and your doctor may choose
another treatment for you if you wish to
breast-feed, especially if your baby is newborn,
or was born prematurely.
Driving and using machines
If you feel tired or dizzy do not drive or operate
machines, especially at the start of your
treatment or if you medicine has changed, of if
taken with alcohol.

3

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dry mouth
indigestion
abdominal pain
rash, itching
gout (sudden, unexpected, burning pain, as
well as swelling, redness, warmth, and
stiffness in the affected joint)
• chest pain, awareness of your heart beating
(palpitations), fast heart rate
• poor circulation, coldness in the fingers
and toes
• muscle spasms and/or weakness,
‘pins-and-needles’ or numbness (usually in
the hands arms, legs or feet)
• impotence (difficulty getting or maintaining
an erection)
• mood swings
• sleep difficulties
• runny and itchy nose
• change in colour in your fingers or toes
(Raynaud’s phenomenon)
• increased levels of some substance in your
blood (urea, creatinine, potassium, liver
enzymes).
Rare (may affect up to 1 in 1 000 people)
• a complex of symptoms including, fever,
muscle and joint pain, redness, pain and
inflammation of blood vessels, sensitivity to
light or other skin problems
• unusual bleeding, unexplained bruising,
sore throat, ulcers in the mouth or throat,
fever or chill; these may be signs of anaemia
• psoriasis (thick patches of inflamed, red skin
covered in silvery scales)
• enlargement of the male breasts
• mental confusion
• itchy rash of the skin (nettle rash)
• hair loss (alopecia)
• kidney failure.
Very rare (may affect up to 1 in 10 000 people)
• reduced number of platelets in your blood
• swollen glands (lymph nodes)
• increased immune response (autoimmune
disease)
• breathing difficulties
• blocked or stuffy nose with a headache
(sinusitis)
• inflammation of lungs (allergic alveolitis,
eosinophilic pneumonia)
• swelling of the lining of the gut
• difficulty in passing urine or not passing
any at all
• blistering, peeling and other problems of
the skin
• excessive sweating
• low levels of blood sugar (symptoms of
this may include headache, feeling faint,
mental confusion, aggressive or abnormal
behaviour, slurred speech).
Not known (frequency cannot be estimated
from the available data):
• loss of appetite
• restlessness, depression
• flushing
• blurred vision, or a yellow tint to your vision
• abnormality of the rhythm or rate of heart
beat
• constipation
• inflammation of the salivary glands
• damage to blood vessels causing red or
purple spots in the skin.
Results of tests may show:
• sugar in the urine
• high or low levels of potassium, low levels
of sodium, high levels of uric acid, high
levels of sugar, increase in cholesterol and
other fats in the blood, increased levels of
liver enzyme, bone marrow depression and
other blood disorders.
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.
By reporting side effects you can help provide
more information on the safety of this medicine.

5

How to store Lisinopril/HCTZ

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. The expiry date
refers to the last day of that month.
Do not store above 30 °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 Lisinopril/HCTZ contains:
• The active substances are either 10 mg of
lisinopril (as dihydrate) and 12.5 mg of
hydrochlorothiazide, or 20 mg of lisinopril (as
dihydrate) and 12.5 mg of hydrochlorothiazide.
• The other ingredients are pregelatinised
starch, maize starch, calcium hydrogen
phosphate anhydrous, mannitol and
magnesium stearate.
What Lisinopril/HCTZ looks like and contents
of the pack:
• Each Lisinopril/HCTZ 10 mg/12.5 mg tablet is
white oval shaped slightly arched, indented
“LZ10” on one side and a breakline on the other.
• Each Lisinopril Hydrochlorothiazide
20 mg/12.5 mg tablet is white oval shaped
slightly arched, indented “LZ20” on one side
and a breakline on the other.
• The product is available in packs of 28, 30, 50,
98, and 100 tablets and in hospital packs of 50
(EAV: unit dose hospital pack), and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is Teva UK
Limited, Eastbourne BN22 9AG. The company
responsible for manufacture batch release is
Teva Pharmaceutical Works Company Ltd,
Debrecen, Hungary.
This leaflet was last revised in May 2017.
PL 00289/0455-56

Approved

EBNUK1090a

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ZINC Ref:

EBNUK1090a LEA LISINOPRIL/HCTZ A/S TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

PL Number(s),
MA Holder & Packer:

No
460 mm
160 mm
N/A
N/A

Version:

1

Colours Used:

18 May 2017
BLACK
PANTONE® GREEN C
Template

PL 00289/0455-56.
TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Debrecen.

Trackwise Parent:

647833

Trackwise Child:

647903

Reason for revision: Type 1B PSUSA & QRD update. (EB item code: 50025-C)

SKU (s): 231-10-02322 80001530
231-10-02324 80002460
Perforated:
Shelf Ready:

No
No

Pharma Code:
Edge Code:
PIP Code:
ULM Code:
Packing Site Code:

TBC
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N/A
N/A
TBC

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For Eastbourne packed
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specification:

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REG0141815

Digitally signed
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Sole
Date: 2017.05.18
15:31:41 +01'00'

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Approved by Regulatory for submission to the
authorities / internal Approval / implementation;
Sign & Date:

Amol
Veer

Digitally signed by Amol Veer
DN: dc=Corp, dc=Teva, dc=UK,
ou=LON, ou=USR, cn=Amol
Veer,
email=Amol.Veer@tevauk.com
Date: 2017.05.18 16:56:51
+01'00'

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the MA holder confirming full approval for release of
components; Sign & Date:

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

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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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