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
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 of the side effects, talk to
your doctor or pharmacist. This includes
side effects not listed in this leaflet.
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/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

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 (hypersensitive) to lisinopril or
hydrochlorothiazide or any of the other
ingredients of this medicine (listed in
section 6)
• are more than 3 months pregnant. (It is
also better to avoid Lisinopril/HCTZ in
early pregnancy – see pregnancy section.)
• are allergic to sulphonamide derived
drugs, e.g. trimethoprim
• 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
• 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)
• have severe liver or kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before
taking this medicine if you:
• have diabetes (as your insulin
requirements may change)
• have severe high blood pressure
• have hypertrophic cardiomyopathy
(disorder of the heart muscle)
• have heart failure
• have narrowing of the aortic or mitral valve
• have insufficient blood supply to your
heart (ischaemic heart disease)
• have insufficient blood supply to your
brain (cerebrovascular disease)
• have narrowing of the arteries leading to
the kidneys, any other kidney problems,
are undergoing dialysis or have had a
kidney transplant
• have impaired liver function
• 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
• have been on a low sodium diet
• are suffering from diarrhoea or vomiting
• have an imbalance of salts in your blood
• are up to 3 months pregnant
• are undergoing haemodialysis or having
LDL apheresis (removal of cholesterol
from the blood by machine).
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
pregnancy section).
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.
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:
• 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
• 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).
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.
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.

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.
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 product, 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 (affecting
fewer than one in 100 patients) 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).
These are serious but very rare (affecting
fewer than one in 10,000 patients) 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
• 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.

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 or other blood disorders
• 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).
Very rare (may affect up to 1 in 10,000 people):
• breathing difficulties
• blocked or stuffy nose with a headache
• 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).
Other side effects that have been reported:
• loss of appetite
• restlessness, depression
• blurred vision, or a yellow tint to your
vision
• abnormality of the rhythm or rate of heart
beat
• constipation
• inflammation of the salivary glands.
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.
If you get any of the side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

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
to protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Lisinopril/HCTZ contains:
• The active ingredients 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: February 2012
PL 00289/0453-0454

63238-W

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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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