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LISINOPRIL AND HYDROCHLOROTHIAZIDE 20MG/12.5MG TABLETS

Active substance: LISINOPRIL DIHYDRATE

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

What is in this leaflet:

Version:

1

29 June 2015

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.
Lisinopril and Hydrochlorothiazide will be
referred to as “Lisinopril/HCTZ” throughout
this leaflet.

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

TEVA UK Ref:

231-30-63238-Z LEA LISINOPRIL/HCTZ 10/12.5mg TAB 28 TUK
1

What Lisinopril/HCTZ is and what it is
used for

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 and
Hydrochlorothiazide may be used together to
treat high blood pressure when taking either of
these drugs alone did not control your blood
pressure sufficiently.

2

What you need to know before you
take Lisinopril/HCTZ

Do not take Lisinopril/HCTZ:
• if you are allergic to lisinopril or
hydrochlorothiazide, any other ACE-inhibitors
or any of the other ingredients of this
medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is
also better to avoid Lisinopril/HCTZ in early
pregnancy – see section 2: Pregnancy and
breast-feeding.)
• if you are allergic to sulphonamide derived
drugs, 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.
• take the drug aliskiren (to treat hypertension).
• 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
this medicine:
• if you have diabetes (as your insulin
requirements may change)
• if you have severe high blood pressure
• if you have hypertrophic cardiomyopathy
(disorder of the heart muscle)
• if you have heart failure
• if you have narrowing of the aortic or mitral
valve
• if you have insufficient blood supply to your
heart (ischaemic heart disease)
• if you have insufficient blood supply to your
brain (cerebrovascular disease)
• if you have narrowing of the arteries leading
to the kidneys, any other kidney problems,
are undergoing dialysis or have had a kidney
transplant
• if you have impaired liver function
• if you have a collagen vascular disease (a
problem with the immune system that can
affect the structure of tendons, bones, and
connective tissues) such as: rheumatoid
arthritis, systemic lupus erythematosus or
scleroderma
• 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 suffer from gout
• if you have a history of allergy or bronchial
asthma
• if you are up to 3 months of pregnant
• if you are undergoing haemodialysis or
having LDL apheresis (removal of cholesterol
from the blood by machine).
• if you are of black race or Afro-Carribean
origin as Lisinopril/HCTZ may be less
effective in lowering blood pressure
• if you are taking any of the following
medicines used to treat high blood pressure:
• 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.
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’.
If any of the above applies to you, or if you are
not sure, please talk to your doctor or
pharmacist before taking this medicine.
You must tell your doctor if you think you are (or
might become) pregnant. Lisinopril/HCTZ 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 section 2: Pregnancy and
breast-feeding).
Tell your doctor you are taking Lisinopril/HCTZ
if you:
• have to undergo a desensitisation treatment
for an allergy e.g. bee or wasp stings
• are to have an operation and/or anaesthetic
(including at the dentist): tell the doctor or
dentist that you are taking Lisinopril/HCTZ
Tablets
• are to have a liver function test or other blood
tests, as Lisinopril/HCTZ may affect the results
• are to take an anti-doping test, as
Lisinopril/HCTZ may produce a positive result.
While taking Lisinopril and Hydrochlorothiazide
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.
Children and adolescents
Lisinopril/HCTZ is not recommended for use in
children and adolescents because safety and
efficacy of Lisinopril/HCTZ in children has not
been established.
Other medicines and Lisinopril/HCTZ
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, especially if you are taking any of
the following:
• other drugs to reduce blood pressure such as
diuretics (“water tablets”) e.g. amiloride,
vasodilators or nitrates
• anti-psychotics e.g. chlorpromazine (for the
treatment of mental disorders)
• tricyclic antidepressants (e.g. amitriptyline)
• lithium
• insulin, or tablets for the treatment of
diabetes such as metformin or gliclazide
• muscle-relaxing drugs such as tubocurarine
(given sometimes during a general anaesthetic)
• laxatives e.g. lactulose
• carbenoxolone (used to treat stomach and
duodenal ulcers)
• Amphotericin B (used in the treatment of
fungal infections)
• calcium salts
• cardiac glycosides e.g. digoxin
• medicines used to treat abnormal heart
rhythms such as sotalol (a beta-blocker),
procainamide
• non-steroidal anti-inflammatory drugs
(NSAIDs) which are a type of pain killer, e.g.
diflunisal or ibuprofen
• gold preparations
• sympathomimetic drugs e.g. adrenaline,
noradrenaline, or ephedrine. Ephedrine may
be present in medicines for colds and nasal
stuffiness.
• drugs that reduce fat levels in your blood
such as lovastatin (a cholesterol lowering
agent), colestyramine or colestipol
• potassium supplements, potassium-sparing
agents or potassium-containing salt
substitutes
• ciclosporin (used following organ transplant)
• trimethoprim (used to treat urinary and
respiratory tract infections)
• allopurinol for the treatment of gout
• medicines to treat cancer, or
immunosuppressive drugs (used following
an organ transplant)
• corticosteroids, e.g. prednisolone and ACTH
(to treat inflammation in diseases such as
rheumatoid arthritis).
• 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’).
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
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.
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.

Driving and using machines
• Lisinopril/HCTZ may reduce your ability to
drive and use machines at the start of
treatment or when the dose is modified,
especially when taken in combination with
alcohol. If you are affected, DO NOT drive or
operate machinery.

TEVA UK Ref:

231-30-63238-Z LEA LISINOPRIL/HCTZ 10/12.5mg TAB 28 TUK
Version:

1

29 June 2015

3

How to take Lisinopril/HCTZ

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 elderly):
Lisinopril/HCTZ should be taken once a day.
The tablets should be swallowed preferably
with a glass of water.
Your dose will be decided by your doctor,
depending on your response to treatment.
The maximum daily dose of 40 mg lisinopril/
25 mg hydrochlorothiazide should not be
exceeded.
• Children and adolescents under
18 years of age.
Lisinopril/HCTZ is not recommended in
children and adolescents under 18 years of age.
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 and a 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.

4

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 are taking Lisinopril/HCTZ tablets for the
first time, you may feel dizzy or light-headed for
a short time afterwards. This is unlikely to
happen when you are taking the tablets
regularly. Tell your doctor if you continue to
experience these effects and are worried about
them.
The following side effects have been reported
at the approximate frequencies shown:
Common (may affect up to 1 in 10 people ):
• dizziness or light-headedness (including
feeling faint on standing)
• low blood pressure (which may make you
feel dizzy or faint)
• dry cough
• 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
• 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).
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
• hair loss
• 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).
• kidney failure.
• Syndrome of inappropriate antidiuretic
hormone secretion (SIADH).
Very rare (may affect up to 1 in10,000 people):
• swollen glands (lymph nodes)
• increased immune response (autoimmune
disease)
• breathing difficulties
• blocked or stuffy nose with a headache
• difficulty in passing urine or not passing any
at all
• inflammation of lungs (allergic alveoltis,
eosinophilic pneumonia)
• swelling of the lining of the gut
• 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 outer packaging. The
expiry date refers to the last day of that month.
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/HCTZ 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
Marketing Authorisation holder: TEVA UK
Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/0453-0454

63238-Z

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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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