Skip to Content

UK Edition. Click here for US version.

ENALAPRIL/HYDROCHLOROTHIAZIDE 20/12.5 MG TABLETS

Active substance(s): ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Enalapril maleate/Hydrochlorothiazide
20 mg/12.5 mg Tablets
Enalapril maleate / Hydrochlorothiazide (HCT)
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Enalapril maleate/Hydrochlorothiazide is and
what it is used for
2. Before you take Enalapril maleate/Hydrochlorothiazide
3. How to take Enalapril maleate/Hydrochlorothiazide
4. Possible side effects
5. How to store Enalapril maleate/Hydrochlorothiazide
6. Further information

1

What Enalapril maleate/Hydrochlorothiazide
is and what it is used for

Enalapril belongs to a group of medicines called
angiotensin converting enzyme inhibitors (ACE inhibitors)
and lowers blood pressure by widening the blood vessels.
Hydrochlorothiazide belongs to a group of drugs called
diuretics (“water tablets”) and lowers blood pressure by
increasing urine output.
Enalapril maleate/Hydrochlorothiazide tablets contain a
combination of enalapril and hydrochlorothiazide and are
used as a treatment for high blood pressure when treatment
with enalapril as a single agent on its own has proven
insufficient.
Your doctor may also prescribe Enalapril maleate/
Hydrochlorothiazide tablets instead of separate tablets of
the same doses of enalapril and hydrochlorothiazide.
This fixed dose combination is not suitable for initial therapy.



you take Enalapril Maleate/
2 Before
Hydrochlorothiazide

Do not take Enalapril maleate/Hydrochlorothiazide:
• if you are allergic (hypersensitive) to enalapril maleate,
hydrochlorothiazide or any of the other ingredients of this
medicine.
• if you are allergic (hypersensitive) to sulphonamide derived medicines (mostly antibiotics e.g.
sulphamethoxazole)
• if you have previously suffered from swelling of
the extremities, face, lips, throat, mouth or tongue
(angioedema) when treated with other medicines
belonging to a group of drugs called ACE inhibitors
(angiotensin-converting enzyme inhibitors)
• if you have previously suffered from swelling of
the extremities, face, lips, throat, mouth or tongue
(angioedema) under any other circumstances
• if anyone among your blood relatives has previously
suffered from swelling of the extremities, face, lips, throat,
mouth or tongue (angioedema)
• if you have severe kidney problems
• if you are not passing urine
• if you have diabetes or impaired kidney function and
you are treated with a blood pressure lowering medicine
containing aliskiren
• if you have severe liver problems or a neurological
disorder as a result of severe liver problems (hepatic
encephalopathy)
• if you are more than 3 months pregnant. (It is also better
to avoid Enalapril maleate/ Hydrochlorothiazide in early
pregnancy - see pregnancy section.)
Warnings and precautions
Talk to your doctor before taking Enalapril maleate/
Hydrochlorothiazide:
• if you have narrowing of the arteries (atherosclerosis),
cerebrovascular problems such as a stroke or transient
ischemic attack (TIA, a “mini-stroke”)
• if you suffer from a disease, distinguished by reduced
blood supply of the heart muscle, usually due to coronary
blood vessel diseases (ischemic heart disease)
• if you have heart failure
• if you have low blood pressure, are on a salt restricted
diet or are taking diuretics (“water tablets”)
• if you have abnormal levels of water and minerals in your
body (fluid/electrolyte imbalance) distinguished by
nausea, abdominal cramping, and/or vomiting, headache,
edema (swelling), muscle weakness and/or tremor
amongst others
• if you have heart muscle disease (hypertrophic
cardiomyopathy), a narrowing of the main artery carrying
blood away from the heart, the aorta (aortic stenosis), or
a narrow of the artery to the only functioning kidney, have
a kidney transplantation or other forms of a heart problem
called outflow obstruction
• if you undergo LDL apheresis (removal of cholesterol
from the blood by a machine)
• if you undergo desensitization therapy to some insect
venoms, such as bee or wasp stings
• if you have diabetes
• if you suffer from gout, have high levels of uric acid in
your blood or are being treated with allopurinol
• if you need to have an anesthetic
• if you have recently suffered from prolonged, violent
vomiting and/or serious diarrhoea
• if you are going to have tests to check your parathyroid
function
• if you have or have had liver or kidney problems, or you
have narrow arteries to your kidneys (renal artery
stenosis) or only have one functioning kidney, or you are
undergoing dialysis
• if you have collagen vascular disease such as systemic
lupus erythematosus (SLE) or scleroderma, which may
be associated with skin rashes, joint pain and fever
• if you take an agent capable of suppressing immune
responses (immunosuppressant) or procainamide, which
is used to treat heart rhythm disturbances amongst others
• if you have allergy problems or asthma.
• if you are taking lithium, used for the treatment of some
psychiatric illness
• 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
Enalapril maleate/Hydrochlorothiazide”.
You must tell your doctor if you think you are (or might
become) pregnant. Enalapril maleate/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). Breast-feeding is not recommended
when you take Enalapril maleate/Hydrochlorothiazide
Enalapril maleate/Hydrochlorothiazide is not generally
recommended if the following apply, so talk to your doctor
before starting to take this medicine:
- if you have recently had a kidney transplant
- if you have too much potassium in the blood, your
potassium values should be supervised during the
treatment. Risk factors for raised potassium values include
a reduced kidney function, age (> 70 years), dehydration,
acute heart failure, acidification of the blood (metabolic

acidose), diabetes (diabetes mellitus), concurrent taking
of potassium sparing water tablet (diuretic), a potassium
supplement or potassium-containing salt substitutes
or taking medicines that increase the concentration of
potassium in the blood. It is also possible that you can
develop low levels of potassium in your blood distinguished
by elevated blood pressure, disturbed heart rhythm etc.
(e.g. to be caused by drug interactions, excessive loss of
urine etc.).
Please refer also to “Other medicines and Enalapril
maleate/Hydrochlorothiazide ” below.
Talk to your doctor if you are an athlete taking a doping test,
as Enalapril maleate/Hydrochlorothiazide contains an active
ingredient that can cause positive results in a doping test.
Elderly (> 70 years) or malnourished patients should
be particularly careful when using Enalapril maleate/
Hydrochlorothiazide.
Enalapril maleate/Hydrochlorothiazide may be less effective
in Black people.
This medicine is not recommended for use in children.
While taking Enalapril maleate/Hydrochlorothiazide if you
develop any of the following symptoms you should let your
doctor know immediately:
• You feel dizzy after your first dose. A few people react to
their first dose or when their dose is increased by feeling
dizzy, weak faint and sick.
• Sudden swelling of the lips and face neck, possibly
also hands and feet, or wheezing or hoarseness. This
condition is called angioedema. This may occur at any
time during treatment. ACE inhibitors cause a higher rate
of angioedema in black patients than in non-black patients.
• High temperature, sore throat or mouth ulcers (these
may be symptoms of infection caused by the lowering of
the number of white blood cells).
• Yellowing of the skin and whites of eyes (jaundice) that
may be sign of liver disease.
• A dry cough which is persistent for a long time. Cough
has been reported with the use of ACE inhibitors but may
be also a symptom of other upper respiratory track disease.
Other medicines and Enalapril maleate/
Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Enalapril maleat/hydrochlorothiazide and other medicines
can influence each other’s effect and side effects:
• potassium supplements, or potassium-containing salt
substitutes
• diuretics (“water tablets”) which are used to treat high
blood pressure including potassium-sparing diuretics
such as spironolactone, triamterene or amiloride.
• other medicines used to treat high blood pressure.
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 Enalapril maleate/
Hydrochlorothiazide” and “Warnings and precautions”).
• anesthetics and medicines for mental disorders or
depressions, medicines to treat psychoses, tricyclic
antidepressants or sedatives
• lithium (medicine for treatment of psychic disorders)
• painkillers and anti-inflammatory medicines, such as
acetylsalicylic acid or indomethacin
• gold injections (sodium aurothiomalat), a medicine to
injection against rheumatic arthritis
• medicines such as ephedrine, used in some cough and
cold remedies, or noradrenaline and adrenaline used
for low blood pressure, shock, cardiac failure, asthma or
allergies.
• blood sugar lowering medicines, such as insulin or those
taken orally.
• colestyramine resin and colestipol, active substances for
lowering blood lipid values
• corticosteroids, anti-inflammatory hormone-like
substances
• corticotropin (ACTH), it is used mainly to test whether
your adrenal glands are working properly
• muscle relaxants (e.g. .tubocurarine chloride, medicines
for relaxing muscles that are used in operations)
• allopurinol, probenecide, sulfinpyrazone, medicinal
products used to treat gout
• medicines such as atropine or biperiden which are used
to treat a variety of disorders such as gastrointestinal
cramps, urinary bladder spasm, asthma, motion sickness,
muscular spasms and as an aid to anesthesia
• medicines to treat cancer, such as cyclophoshamide or
methotrexate
• medicines that inhibit your body’s immune system,
medicines to prevent rejection reactions after organ or
bone marrow transplants such as ciclosporin
• cardiac glycosides (e.g., digoxin, medicines for
strengthening the heart)
• medicines that as a side effect may cause abnormalities
in the stimulus conduction in the heart such as medicines
for disturbances for heart rhythm, some medicines for
psychosis and other medicines such as drugs used to
treat bacterial infections
• calcium salts and vitamin D, elevated calcium levels in
the blood (can lead to gastrointestinal disorders,
excessive thirst, excessive urination, tiredness, weakness
and decrease in weight)
• carbamazepine, drug used primarily in the treatment of
epilepsy and bipolar disorder
• amphotericin B, medicines against fungal infections
• laxatives, medicines to promote defection
• iodinated contrast media, enhances the visibility of
vascular structures and organs during radiographic
procedures
• barbiturates, medicines that act as central nervous
system depressant resulting in sedation
• opioid analgesics, strong pain killers with no anti-
inflammatory effect
• carbenoxolone, medicine to treat inflammation of the
intestinal tract
• salicylates, medicines to treat pain and/or inflammatory
diseases
Taking Enalapril maleate/Hydrochlorothiazide with food
and drink
Enalapril maleate/Hydrochlorothiazide can be taken without
regard to meals. Drinking alcohol together with this medicine
can increase the blood pressure-lowering effect (and can
then cause dizziness on standing up, among other things).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
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 Enalapril maleate/Hydrochlorothiazide before
you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine
instead of Enalapril maleate/Hydrochlorothiazide.
Continued on the next page >>

Enalapril maleate/Hydrochlorothiazide is not recommended
in early 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. Enalapril maleate/Hydrochlorothiazide is
not recommended for mothers who are breast-feeding.
Driving and using machines
Dizziness and tiredness have been reported by people
taking Enalapril maleate / Hydrochlorothiazide. If you
experience either of these do not drive a car and do not
operate machinery (see also “4. Possible side effects”).
Important information about some of the ingredients of
Enalapril maleate/Hydrochlorothiazide
Patients who are intolerant to lactose should note that
Enalapril maleate/Hydrochlorothiazide tablets contain a
small amount of 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.

to take Enalapril Maleate/
3 How
Hydrochlorothiazide
Always take Enalapril maleate/Hydrochlorothiazide exactly
as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Adults
The usual dose is one tablet taken once a day.
Elderly
Your doctor may adjust the dose of enalapril and
hydrochlorothiazide carefully.
Kidney problems
Your doctor will adjust the dose of enalapril and
hydrochlorothiazide carefully.
Method of administration
The tablets should be swallowed with a drink of water.
Enalapril maleate/Hydrochlorothiazide can be taken with
meal or to empty stomach.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
If you take more Enalapril maleate/Hydrochlorothiazide
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, seek medical advice immediately. An overdose is
likely to cause low blood pressure, an excessively fast or
slow heart beat, palpitations (a feeling of unduly rapid or
irregular heart beat), shock, rapid breathing, cough, feeling
and being sick, cramps, dizziness, feeling sleepy and
confused or anxious, excessive urination or not being able
to urinate. 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 Enalapril maleate/
Hydrochlorothiazide
Do not take a double dose to make up for a forgotten tablet,
take your next dose at the normal time.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
If you stop taking Enalapril maleate/Hydrochlorothiazide
The treatment of hypertension is a long term treatment and
interruption of treatment must be discussed with the doctor.
Interruption or stopping your treatment could cause your
blood pressure to increase.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Enalapril maleate/Hydrochlorothiazide
can cause side effects, although not everybody gets them.
If you experience the following, stop taking Enalapril
maleate/Hydrochlorothiazide and tell your doctor
immediately or go to the emergency department of your
nearest hospital:
• A severe allergic reaction called angioedema (rash,
itching, swelling of the extremities, face, lips, mouth or
throat that may cause difficulty in swallowing or breathing).
This is a serious and common (affecting more than 1 out of
100 patients and less than 1 out of 10 patients) side effect.
You may need urgent medical attention or hospitalization.
• Jaundice (yellowing of the skin and the whites of the
eyes). This is a potentially serious but rare (affecting more
than 1 out of 10000 patients and less than 1 out of 1000
patients) side effect indicative of inflammation of the liver.
You may need urgent medical attention or hospitalization.
Enalapril maleate/Hydrochlorothiazide commonly causes
low blood pressure which may be associated with feelings
of light-headedness and weakness. In some patients,
this may occur after the first dose or when the dose is
increased. If you experience these symptoms, you should
contact your doctor immediately.
Enalapril maleate/Hydrochlorothiazide rarely causes a
reduction in the number of white blood cells and your
resistance to infection may be decreased. If you experience
an infection with symptoms such as fever and serious
deterioration of your general condition, or fever with local
infection symptoms such as sore throat/pharynx/mouth or
urinary problems you should see your doctor immediately. A
blood test will be taken to check possible reduction of white
blood cells (agranulocytosis). It is important to inform your
doctor about your medicine.
A dry cough, which may persist for a long time, has been
reported very commonly (in more than 1 out of 10 patients)
with the use of Enalapril maleate/Hydrochlorothiazide and
other ACE inhibitors, but may be also a symptom of other
upper respiratory tract disease. You should contact your
doctor if you develop this symptom.
The following side effects have also been reported:
Very common (more than 1 out of 10 patients)
• blurred vision
• dizziness
• nausea
• weakness
Common (more than 1 out of 100 patients and less than
1 out of 10 patients)
• low level of potassium in the blood, which can cause
muscle weakness, twitching or abnormal heart rhythm
• high level of fat or uric acid in the blood
• headache, depression
• fainting, low blood pressure associated with changes in
posture (such as feeling light-headed or weak when
you stand up after lying down), chest pain, abnormal
heart rhythm, excessively fast heart beat (tachycardia)
• shortness of breath
• diarrhoea, abdominal pain
• a distorted sense of taste
• rash
• tiredness
• high level of potassium in the blood, which can cause an
abnormal heart rhythm; increase in the amount of
creatinine in the blood
• muscle cramps
Uncommon (more than 1 out of 1000 patients and less
than 1 out of 100 patients)
• reduction in the number of red blood cells, which can
make the skin pale and cause weakness or
breathlessness (anaemia)
• hypoglycaemia (low blood sugar levels)
(see “Take special care with Enalapril maleate /

Hydrochlorothiazide” in section 2)
• low level of magnesium in the blood
• uric acid crystals in the joints (gout)
• confusion, sleepiness, insomnia, nervousness, tingling
feeling or numbness, vertigo, decreased sexual desire
• palpitations (a sensation of a fast or particularly strong or
irregular heart beat)
• heart attack or cerebrovascular accident (“mini-stroke”)
(mainly in patients suffering from low blood pressure)
• runny nose, sore throat, hoarseness, difficulty breathing,
wheezing
• intestinal obstruction, inflammation of the pancreas
which causes severe pain in the abdomen and
back (pancreatitis), vomiting, indigestion, constipation,
loss of appetite, stomach irritation, dry mouth, peptic
ulcer, flatulence
• sweating, itching, hives, hair loss
• joint pain
• kidney problems, protein in the urine
• impotence
• hot flushes, ringing in the ears
• feeling unwell, fever
• low levels of sodium in the blood, which can cause
tiredness and confusion, muscle twitching, fits or coma,
also leading to dehydration and low blood pressure that
makes you feel dizzy when you stand up; increase in the
amount of urea in the blood
Rare (more than 1 out of 10000 patients and less than 1
out of 1000 patients)
• reduction in the number of white blood cells, which
makes infection more likely, reduction in the number
of other blood cells, changes in blood composition, poor
production of bone marrow, disease of the lymph nodes,
autoimmune disease, in which the body attacks itself.
• strange dreams, sleep disorders
• paresis
• Raynaud’s syndrome, a blood vessel disorder which may
cause your fingers and toes to tingle, and turn pale, then
bluish, then reddish.
• lung problems including pneumonia, inflammation of the
lining of the nose causing the nose to run (rhinitis)
• mouth ulcers, inflammation of the tongue
• liver problems, inflammation of the gallbladder
• skin rash, severe blisters, redness of the skin, Stevens
Johnson syndrome (blistering of the skin, mouth, eyes
and genitals), skin looking as if it were burnt and
peeling off, sensitivity of the skin to light, skin conditions
with red scaly patches over the nose and cheeks (lupus
erythematosus), pemphigus (a condition causing blisters
and lesions normally starting in the mouth, nettle rash,
hair loss and itching). Sometimes, skin problems may be
accompanied by fever, serious inflammation,
inflammation of blood vessels, muscle pain and/or joint
pain, changes in blood composition and an increased
sedimentation rate (a blood test used to detect
inflammation).
• reduced urine production
• inflammation in the kidneys (interstitial nephritis)
• breast enlargement including in men
• increase in the amount of enzymes and waste products
produced by the liver
• increased blood sugar levels
Very rare (less than 1 out of 10000 patients)
• swelling in the intestines
• high levels of calcium in the blood (see “Take special care
with Enalapril maleate / Hydrochlorothiazide” in section 2)
Not known (cannot be estimated from available data)
• inappropriate antidiuretic hormone secretion (known as
SIADH) causing amongst others the general symptoms
confusion, nausea, altered mood, seizures and loss of
consciousness
Further side effects:
• inflammation of a salivary gland
• excretion of glucose into the urine (glycosuria)
• decreased appetite, light-headedness
• predominance of yellow in vision due to a yellowing of the
optic media of the eye (xanthopsia)
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

to store Enalapril Maleate/
5 How
Hydrochlorothiazide
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original package.
Do not use Enalapril maleate/Hydrochlorothiazide after the
expiry date that is stated on the outer packaging.
Do not use after the expiry (EXP) date which is stated on
the label.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further information
What Enalapril maleate/Hydrochlorothiazide contains
• The active substances are enalapril maleate and
hydrochlorothiazide.
• Each tablet contains 20 mg of enalapril maleate and
12.5 mg of hydrochlorothiazide.
• The other ingredients are sodium hydrogen carbonate,
maize starch, lactose monohydrate, calcium
hydrogen phosphate dehydrate, talc, magnesium
stearate.
What Enalapril maleate/Hydrochlorothiazide looks like
and contents of the pack
Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg
tablets are white, oval, biconvex, with a break-line on one
side of the tablet and the stamp “E H” on the other side of
the tablet.
Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg
tablets are available in pack sizes of 10, 14, 20, 28, 30, 49,
50, 50x1, 56, 60, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Alle 1, 39179 Barleben
Germany
This leaflet was last revised in 08/2014.

SZ00000LT000

Expand view ⇕

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.

Hide