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ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 20 MG/12.5 MG TABLETS

Active substance(s): ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril Maleate
and Hydrochlorothiazide
20 mg/12.5 mg Tablets
enalapril maleate/hydrochlorothiazide

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.
What is in this leaflet
1. What Enalapril Maleate and Hydrochlorothiazide is
and what it is used for
2. What you need to know before you take Enalapril
Maleate and Hydrochlorothiazide
3. How to take Enalapril Maleate and Hydrochlorothiazide
4. Possible side effects
5. How to store Enalapril Maleate and Hydrochlorothiazide
6. Contents of the pack and other information
1. What Enalapril Maleate and Hydrochlorothiazide is
and what it is used for
Enalapril Maleate and Hydrochlorothiazide contains a
combination of enalapril maleate and hydrochlorothiazide.
• Enalapril belongs to a group of medicines called angiotensin
converting enzyme inhibitors (ACE inhibitors), which lower
blood pressure by widening your blood vessels.
• Hydrochlorothiazide belongs to a group of drugs called
diuretics (‘water tablets’), which lower blood pressure by
increasing the volume of urine you produce.
Enalapril Maleate and Hydrochlorothiazide is used when
treatment with enalapril as a single agent on its own has
proven insufficient.
Your doctor may also prescribe Enalapril Maleate
and Hydrochlorothiazide instead of separate tablets of the
same doses of enalapril and hydrochlorothiazide.
This fixed dose combination is not suitable for initial therapy.
2. What you need to know before you take Enalapril
Maleate and Hydrochlorothiazide
Do not take Enalapril Maleate and Hydrochlorothiazide:
• if you are allergic to enalapril, hydrochlorothiazide or any of
the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• if you are not passing urine
• if you have previously suffered from swelling of
the extremities, face, lips, throat, mouth or tongue
(angioedema) when treated with other ACE inhibitors
such as ramipril or under any other circumstances
• if someone in your family has previously suffered from
swelling of the extremities, face, lips, throat, mouth or
tongue (angioedema)
• if you are allergic to a type of medicine called ‘sulphonamides’
• if you are more than 3 months pregnant. (It is also better
to avoid Enalapril Maleate and Hydrochlorothiazide in
early pregnancy - see pregnancy section)
• if you have severe liver problems
• if you are diabetic or have kidney problems and are
taking medicine containing aliskiren (used to treat high
blood pressure).
Do not take Enalapril Maleate and Hydrochlorothiazide if
any of the above applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Enalapril Maleate
and Hydrochlorothiazide.
Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril
Maleate and Hydrochlorothiazide:
• if you have kidney problems, such as ‘renal artery stenosis’
(reduced blood flow to the kidney), have had a recent
kidney transplantation, are a dialysis patient, or are taking
‘water tablets’ (diuretics)
• if you have blood disorders or liver problems
• if you have low blood pressure, are on a salt restricted diet, or
have suffered from excessive vomiting or diarrhoea recently
• if you have a heart condition called ‘ischaemic heart disease’
which reduces the blood supply to the heart muscles
• if you have a heart condition called ‘aortic stenosis’,
‘hypertrophic cardiomyopathy’ or ‘outflow obstruction’
• if you have a condition affecting the blood supply to your
brain (cerebrovascular disease)
• if you have heart failure
• 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 are taking immunosuppressant therapy (used
for the treatment of autoimmune disorders such as
rheumatoid arthritis or following transplant surgery)
• if you suffer from gout or are taking allopurinol (used for
the treatment of gout), or procainamide (used to treat
abnormal heart rhythms)
• if you have a history of ‘angioedema’ while taking other
medicines. The signs may have been itching, nettle rash,
wheezing or swelling of your hands, throat, mouth or
eyelids (see section 4)
• if you have diabetes and are taking antidiabetic medicines,
including insulin to control your diabetes (you should
monitor your blood for low blood glucose levels, especially
during the first month of treatment)
• if you are taking potassium supplements or potassium
containing salt substitutes
• if you are taking other medicines that can affect the level of
potassium in your blood, such as heparin (an anticoagulant)
• if you have high levels of potassium in the blood
• if you are taking lithium, used for the treatment of some
psychiatric illnesses
• if you have abnormal levels of water and minerals in your
body (fluid/electrolyte imbalance)
• if you are going to have tests to check your
parathyroid function
• if you have allergy problems or asthma.
You must tell your doctor if you think you are (or might
become) pregnant. Enalapril Maleate and 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).
You should be aware that this medicine may be less
effective at lowering the blood pressure in black patients
than in non-black patients.
If you are about to have any of the following procedures,
you should tell your doctor who is treating you that you
are taking Enalapril Maleate and Hydrochlorothiazide:
• any surgery or receive anaesthetics (even at the dentist)
• a treatment called LDL apheresis, to remove cholesterol
from your blood using a machine

• desensitisation treatment, to reduce the effect of an
allergy to bee or wasp stings.
Routine tests
When you first start to take Enalapril Maleate
and Hydrochlorothiazide, your doctor will monitor your
blood pressure frequently to ensure you have been given
the correct dose. In addition, for some patients the doctor
may want to do some tests to measure your potassium,
sodium, magnesium, creatinine and liver enzyme levels.
Tell your doctor if you have taken or will need to take an antidoping test, as this medicine can produce a positive result.
Children
Enalapril Maleate and Hydrochlorothiazide is not
recommended for use in children.
Other medicines and Enalapril Maleate
and Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription as some drugs may affect
each other's action. Also some other medicines can affect the
way Enalapril Maleate and Hydrochlorothiazide works:
• potassium sparing ‘water tablets’ (diuretics) such as
spironolactone, eplerenone, triamterene or amiloride,
potassium supplements, or potassium-containing salt
substitutes. Enalapril Maleate and Hydrochlorothiazide
may increase the levels of potassium in your blood leading
to high potassium levels. This causes few signs and is
usually seen by a test
• ‘water tablets’ (diuretics) such as thiazides,
furosemide, bumetanide
• other medicines that lower blood pressure, such as
nitroglycerine, nitrates, vasodilators, methyldopa
and angiotensin II receptor antagonists (e.g. candesartan,
irbesartan and losartan)
• lithium, used for the treatment of some psychiatric
illnesses. Enalapril Maleate and Hydrochlorothiazide
should not be taken with this drug
• barbiturates (sedatives used for sleeplessness or epilepsy)
• tricyclic antidepressants such as amitriptyline, used for
depression and antipsychotics such as phenothiazines,
used for severe anxiety
• painkillers such as morphine or anaesthetics, because your
blood pressure may become too low
• cholestyramine or colestipol (used to help control
cholesterol levels)
• medicines used for, stiffness and inflammation associated
with painful conditions, particularly those affecting your
muscles, bones and joints including:
- gold therapy (sodium aurothiomalate) which can lead
to flushing of your face, feeling sick (nausea), vomiting
and low blood pressure, when taken with Enalapril
Maleate and Hydrochlorothiazide, and
- non-steroidal anti-inflammatory drugs (NSAIDs), for
example diflunisal or diclofenac. They may prevent
your blood pressure from being well controlled
and may increase the level of potassium in your blood
• 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. If
used with Enalapril Maleate and Hydrochlorothiazide these
drugs may keep your blood pressure high
• corticotropin (ACTH), used to test whether your adrenal
glands are working properly
• corticosteroids (used to treat certain conditions such as
rheumatism, arthritis, allergic conditions, asthma or certain
blood disorders)
• probenecid, sulfinpyrazone and allopurinol (used to
treat gout)
• ciclosporin (immunosuppressive agents used for
autoimmune disorders)
• medicines for the treatment of cancer such as
cyclophosphamide or methotrexate
• antacids (used for indigestion relief)
• procainamide, amiodarone, sotalol, quinidine,
hydroquinidine, disopyramide, dofetilide or ibutilide
(used to treat abnormal heart rhythms)
• digitalis (used to treat heart rhythm problems)
• carbenoxalone (used to treat stomach ulcers)
• excessive use of laxatives
• antidiabetic medicines such as insulin and metformin.
Enalapril Maleate and Hydrochlorothiazide may cause
your blood sugar levels to drop even further if you take it
with antidiabetics
• anti-pain and anti-inflammatory drugs, such as
acetylsalicylic acid (more than 300 mg/day)
• muscle relaxants, e.g. tubocurarine chloride used to relax
the muscles during operations
• salts of calcium and vitamin D
• carbamazepine used to treat epilepsy or bipolar disorder
• amphoteracin B used to treat fungal infections
• iodinated contrast agents used in X-ray procedures
• medicines such as atropine or biperiden.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Enalapril Maleate
and Hydrochlorothiazide.
Enalapril Maleate and Hydrochlorothiazide with alcohol
If you drink alcohol while taking Enalapril Maleate
and Hydrochlorothiazide, it may cause your blood pressure
to drop too much and you may experience dizziness,
light-headedness or faintness. You should keep your
alcohol intake to a minimum.
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 Enalapril Maleate and 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 and Hydrochlorothiazide.
Enalapril Maleate and Hydrochlorothiazide 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. Enalapril Maleate and Hydrochlorothiazide
is not recommended for mothers who are breast-feeding.
Driving and using machines
Certain side effects, such as dizziness and weariness,
have been reported with Enalapril Maleate and
Hydrochlorothiazide, which may affect some patients’ ability
to drive or operate machinery. If you experience any of these
effects, do not drive and use machines (also see section 4).
Enalapril Maleate and Hydrochlorothiazide
contains 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.
3. How to take Enalapril Maleate and Hydrochlorothiazide
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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The recommended dose is one tablet taken once a day.
Elderly
Your doctor will adjust the dose of Enalapril Maleate
and Hydrochlorothiazide carefully.
Kidney problems
Your doctor will adjust the dose of Enalapril Maleate
and Hydrochlorothiazide carefully.
Use in children
Enalapril Maleate and Hydrochlorothiazide is not
recommended for use in children.
Method of administration
Enalapril Maleate and Hydrochlorothiazide can be used
with or without food.
The tablets should be swallowed with a drink of water.
The tablets can be divided into equal doses.
If you take more Enalapril Maleate
and Hydrochlorothiazide than you should
If you (or someone else) swallow a lot of the tablets at the
same time, 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.
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
and 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
and Hydrochlorothiazide
The treatment of hypertension is a long term treatment
and you should consult your doctor before stopping
treatment. Interruption or discontinuation of your treatment
could cause your blood pressure to increase.
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.
If you think you may have any of the following side effects,
stop taking Enalapril Maleate and Hydrochlorothiazide
and contact your doctor or go to your nearest hospital
emergency room immediately:
Common: may affect up to 1 in 10 people
• a severe allergic reaction with symptoms such as rash,
itching, shortness of breath or wheezing, swelling of your
hands, face, eyes, lips, tongue, mouth or throat, which may
cause difficulty in swallowing (called angioedema). You
should be aware that black patients are at an increased
risk of these types of reactions to ACE inhibitors
• pain with a feeling of tightness, pressure or heaviness in
the chest (angina)
• severe dizziness, light-headedness, especially at the start
of treatment or when you stand up.
Uncommon: may affect up to 1 in 100 people
• inflammation of the pancreas, which causes severe pain in
the abdomen and back (pancreatitis)
• heart attack or stroke (in high risk patients)
• persistent constipation with discomfort or bloating,
possibly with feeling or being sick. These may be signs of
a blockage in the gut
• burning, aching pain in the stomach with an empty feeling
and hunger, particularly when the stomach is empty.
These may be signs of an ulcer
• difficulty or pain when urinating, with blood in the urine or
changes in the colour or amount of urine passed. Pain in the
lower back, feeling or being sick, feeling generally unwell.
These may be signs of serious problems with your kidneys
• changes to the number of certain cells in your blood that
may cause you to feel more tired than usual, weak, short of
breath or have pale skin (fewer red blood cells), have more
frequent infections with fever, chills, sore throat of mouth
ulcers (fewer white blood cells), or to bleed or bruise more
easily or for longer than usual (fewer platelets).
Rare: may affect up to 1 in 1,000 people
• skin rash, which may blister and looks like small targets –
central dark spots surrounded by a paler area, with a dark
ring around the edge (erythema multiforme)
• blistering of the skin, mouth, eyes and genitals
(Stevens-Johnson syndrome)
• skin looks as if it were burnt and peeling off
(toxic epidermal necrolysis)
• a condition causing blisters and lesions normally starting
in the mouth (pemphigus), nettle rash, hair loss
and itching). Sometimes skin problems may be
accompanied by fever, serious inflammation, inflammation
of the blood vessels, muscle pain and/or joint pain,
changes in blood composition and an increase in
sedimentation rate (a blood test to detect inflammation)
• Severe breathing difficulties, including when resting,
generally feeling unwell with increased shivering, fever,
sweating, cough or wheezingfeeling sick (nausea) or being
sick (vomiting), loss of appetite, feeling generally unwell,
fever, itching, yellowing of the skin and whites of the eyes
(jaundice), light coloured bowel motions
and dark coloured urine which may be signed of
severe liver problems or hepatitis.
Not known: frequency cannot be estimated from the
available data
• swollen and sore saliva glands
• a lower than normal level of sodium in the blood, which
may make you feel weak and confused with aching of
muscles. This may be due to inappropriate ADH secretion,
a hormone that causes the body to retain water and dilute
the blood, reducing the amount of sodium.
Other possible side effects
A dry cough, which may persist for a long time, has
been reported very commonly (may affect more than
1 in10 people) with the use of enalapril/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.
Very common: may affect more than 1 in 10 people
• blurred vision
• dizziness
• feeling sick (nausea)
• weakness.
Common: may affect up to 1 in 10 people
• headache, depression, fainting
• low blood pressure (which may make you feel dizzy when
you stand up)
• chest pain
• heart rhythm changes, fast heart beat
• shortness of breath

• diarrhoea, pain around your stomach area (abdomen),
changes in taste, feeling tired
• rash
• increased blood potassium level, increases in serum
creatinine (both are usually detected by a test)
• low levels of potassium in the blood, which can cause
muscle weakness, twitching or abnormal heart rhythm,
increased levels of cholesterol, increased levels of
triglycerides, increased levels of uric acid in the blood
• muscle cramps.
Uncommon: may affect up to 1 in 100 people
• a sense of heightened awareness or a shaky feeling
(caused by low blood sugar)
• confusion, feeling sleepy, difficulty sleeping, feeling
nervous, tingling or numbness, feeling like you are
spinning (vertigo) flushing, racing or uneven heart beats
• runny nose, sore throat and hoarseness, difficulty
breathing or wheezing
• being sick, indigestion, constipation, loss of appetite,
stomach irritation, dry mouth, flatulence, excessive
sweating, itching, hives (urticaria), hair loss
• kidney problems, protein in your urine (usually detected
by a test)
• impotence, decreased libido
• high temperature, weakness (malaise)
• ringing in your ears
• increases in blood urea and decreases in blood sodium
levels (usually detected by a test)
• low level of magnesium in the blood (hypomagnesemia)
• joint pain, disease with painful swollen joints caused by
uric acid crystals (gout).
Rare: may affect up to 1 in 1,000 people
• strange dreams, sleeping problems, weakness causing loss
of movement
• swollen lymph glands in the throat, armpits or groin
• low blood flow to your fingers and toes causing redness
and pain (Raynaud’s)
• runny or sore nose pain, swelling or ulcers in your mouth,
infection or pain and swelling of your tongue
• passing less urine than usual
• swollen nasal lining
• difficulty breathing, respiratory distress
• flaking or peeling of the skin, excessive redness of your
skin, blisters, purple or red-brown spots visible through
the skin development of breasts in men
• increased liver enzymes or liver waste products (usually
detected by a blood test)
• increases in blood sugar or decreases in the amount of
haemoglobin in the blood (usually detected by a blood test)
• inflammation of the gallbladder.
Very rare: may affect up to 1 in 10,000 people
• swelling in the intestines. Signs may include stomach pain,
feeling sick and vomiting
• elevated calcium level in blood causing abdominal pain,
feeling and being sick, constipation, loss of appetite,
excessive thirst, excessive urination, tiredness, weakness
and weight loss.
Not known: frequency cannot be estimated from the
available data
• sugar (glucose) in the urine
• lightheadedness
In some patients, a group of side effects may be seen at
the same time. These can include fever, problems caused
by inflammation or changes to blood cells (some of which
may require urgent medical attention – see the start of this
section), painful or swollen joints and skin problems, which
may include unusual sensitivity to sunlight.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 Enalapril Maleate and Hydrochlorothiazide
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, bottle and blister after 'EXP'. The expiry
date refers to the last day of the month.
This medicine does not require any special temperature
storage conditions. Store in the original packaging.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
any medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Enalapril Maleate and Hydrochlorothiazide contains
• The active ingredients are enalapril maleate
and hydrochlorothiazide. Each tablet contains 20 mg of
enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other ingredients are cellulose, microcrystalline;
starch, pregelatinised; lactose; silica, colloidal anhydrous;
magnesium stearate; sodium laurilsulfate; maleic acid; iron
oxide yellow (E172).
What Enalapril Maleate and Hydrochlorothiazide looks
like and contents of the pack
Enalapril Maleate and Hydrochlorothiazide 20 mg/12.5 mg
Tablets are yellow coloured, capsule shaped biconvex tablets,
debossed with E on one side of the score line and H on the
other side on one side of the tablet, and M on the other side.
Enalapril Maleate and Hydrochlorothiazide 20 mg/12.5 mg
Tablets are available in blister packs of 10, 14, 20, 28, 30, 60,
90, and 100 tablets, calendar packs of 28 and perforated
unit dose blisters of 30 x 1 tablets.
Enalapril Maleate and Hydrochlorothiazide 20 mg/12.5 mg
Tablets are available in bottles of 500 tablets. The bottle also
contains a canister of desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland.
Mylan Hungary Kft, H-2900, Komarom, Mylan utca 1,
Hungary.

This leaflet was last revised
in August 2014

02 Sep 2014

486688
Code No.: MH/DRUGS/25/NKD/89

07:56
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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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