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ENALAPRIL MALEATE & HYDROCHLOROTHIAZIDE 20MG/12.5MG 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 and hydrochlorothiazide

Read all of this leaflet carefully before you start using 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
tablets is and what it is used for
2. What you need to know before you take Enalapril
Maleate and Hydrochlorothiazide tablets
3. How to take Enalapril Maleate and
Hydrochlorothiazide tablets
4. Possible side effects
5. How to store Enalapril Maleate and
Hydrochlorothiazide tablets
6. Contents of the pack and other information

Children and adolescents
Do not give Enalapril Maleate and Hydrochlorothiazide
tablets to children under 18 years. There is limited
information on the safety and effectiveness of Enalapril
Maleate and Hydrochlorothiazide tablets in children.

1. WHAT ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLETS IS AND
WHAT IT IS USED FOR

Hydrochlorothiazide contained in this medicinal
product can produce a positive analytic result in an
anti-doping test.

Enalapril Maleate and Hydrochlorothiazide tablets
belongs to the group of combination medicines used
to treat high blood pressure (hypertension). It contains
two active ingredients, enalapril (an ACE inhibitor)
and hydrochlorothiazide (a diuretic). Enalapril prevents
the formation of substances in the body that cause a
rise in blood pressure, and hydrochlorothiazide
increases the removal of water and salts from the
body, which also lowers the blood pressure.
Enalapril Maleate and Hydrochlorothiazide tablets is
used in patients whose blood pressure is successfully
controlled by taking the same amounts of each
ingredient as a separate medicine.

2. BEFORE YOU TAKE ENALAPRIL MALEATE
AND HYDROCHLOROTHIAZIDE TABLETS
Do not take Enalapril Maleate and
Hydrochlorothiazide tablets
• if you are allergic (hypersensitive) to enalapril maleate,
other ACE-inhibitors, thiazides (medicines for
increasing urine output), sulfonamide derivatives
(certain antibiotics and medicines for diabetes) or any
of the other ingredients of Enalapril Maleate and
Hydrochlorothiazide tablets (see section 6)
• if you or anyone among your blood relatives have
previously suffered from swelling of the extremities,
face, lips, throat, mouth or tongue (angioedema)
under any circumstances
• if you are more than 3 months pregnant (It is also
better to avoid Enalapril Maleate and
Hydrochlorothiazide tablets in early pregnancy see pregnancy section)
• if you have severe kidney or liver problems
• if you are not passing urine
• if you have diabetes or kidney problems and are
taking a medicine called aliskiren to reduce blood
pressure.
Warnings and precautions
The doctor who has prescribed this medicine must be
aware of the following:
• if you are using diuretics (“water tablets”)
• if you are on a salt restricted diet or if you are
currently suffering or suffer during treatment from
severe diarrhoea or vomiting
• if you have abnormal levels of water and minerals
in your body (fluid/electrolyte imbalance)
• if you have heart failure
• if you have narrowing of the arteries (atherosclerosis)
or a cerebrovascular disease (such as a stroke)
• 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 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 have kidney problems or narrow arteries to
your kidneys (renal artery stenosis) or only have one
functioning kidney, or you are receiving dialysis
• if you have recently had a kidney transplant
• if you have diabetes
• if you have a collagen vascular disease such as
systemic lupus erythematosus (SLE) or
scleroderma or if you are treated with
immunosuppressants, allopurinol or procainamide,
or a combination of these
• if your liver is not working properly
• if you are receiving desensitization therapy against
insect toxins
• if you have allergy problems or asthma
• if you need to undergo surgery during the treatment,
because some anaesthetic agents used during
surgery may cause excessive drop in blood pressure
in combination with Enalapril Maleate and
Hydrochlorothiazide tablets
• if you have high levels of potassium in your blood.
You must tell your doctor if you think that you are (or
might become) pregnant. Enalapril Maleate and
Hydrochlorothiazide tablets 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).
Sudden swelling of the tongue, lips and face, neck,
possibly also hands and feet, or wheezing or
hoarseness may occur at any time during treatment.
This condition is called angioedema. If this happens,
stop taking Enalapril Maleate and
Hydrochlorothiazide tablets and tell your doctor. ACE
inhibitors cause a higher rate of angioedema in black
patients than in non-black patients.
If dry cough occurs during treatment, consult your
doctor, who will decide whether or not treatment
should be continued.

Kidney
If your kidneys are not working well, it is important
that you are not using potassium supplements or
potassium sparing diuretics during treatment with
enalapril/hydrochlorothiazide because they may
increase potassium levels in your body excessively.

Other medicines and Enalapril Maleate and
Hydrochlorothiazide tablets
Taking Enalapril Maleate and Hydrochlorothiazide
tablets with other medicines may affect the efficacy
and safety of this medicine. On the other hand,
Enalapril Maleate and Hydrochlorothiazide tablets
may affect the efficacy and safety of other medicines.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription, herbal
products or natural remedies. Remember to tell your
doctor about Enalapril Maleate and Hydrochlorothiazide
tablets if he/she prescribes you another medicine
during the therapy or soon after it.
It is especially important to tell your doctor if you
are using any of the following:
• potassium-sparing diuretics (”water tablets”), such
as spironolactone, triamterene or amiloride
potassium or calcium supplements, or dietary or
salt supplements containing potassium or calcium.
The combination could lead to dangerously high
potassium or calcium levels in your blood
• other antihypertensive agents of high-dosed
diuretics (“water tablets”). This combination could
cause your blood pressure to fall dangerously low
• allopurinol (gout medicine), procainamide (medicine
to treat problems with heart rhythm), cytostatic
agents (cancer medicines) or medicines affecting the
body's immune system (such as cyclosporine)
• lithium (medicine used to treat mental health
problems). The combination could cause your body
to accumulate too much lithium and therefore
increase the risk of side effects
• antipsychotic medicines, certain medicines used to
treat depression (tricyclic antidepressants) or
medicines stimulating the central nervous system
• certain anaesthetic medicinal products, barbiturates
or strong pain killers. The combination may cause
you to feel dizzy when you stand up
• trimethoprim (an antibiotic for urinary tract infections)
• anti-inflammatory medicines (NSAIDs)
• carbenoxolone (used to sooth ulcers),
corticosteroids, corticotroptin (ACTH, used to treat
epilepsy) or stimulant laxatives. The combination
could lead to abnormal levels of water and minerals
in your body, particularly lack of potassium
• cardiac glycosides (like digitoxin) or tubocarin
(muscle relaxant). The effect of these medicinal
products may be enhanced
• insulin or oral diabetes medicines
• cholestyramine or colestipol (cholesterol binding
medicines).
Enalapril Maleate and Hydrochlorothiazide tablets
with food and drink
Enalapril Maleate and Hydrochlorothiazide tablets may
be taken with fluid on an empty stomach or with food.
You should be aware that drinking alcohol can
enhance the effect of this medicine.
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 tablets 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 tablets.
Enalapril Maleate and Hydrochlorothiazide tablets 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 and
Hydrochlorothiazide tablets is not recommended for
mothers who are breast-feeding.
Driving and using machines
Enalapril Maleate and Hydrochlorothiazide tablets
may make you feel tired or dizzy, which may affect
your ability to drive or use machinery requiring
special care.
Enalapril Maleate and Hydrochlorothiazide tablets
contain lactose
This product contains lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.

3. HOW TO TAKE ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLETS
Always take Enalapril Maleate and Hydrochlorothiazide
tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you
are not sure.
The usual dose is 1 tablet once daily.
Use in Children and adolescents
Children should not take this medicine, as it has not
been tested for children.
Older People
Your dose will be decided by your doctor. It will
depend on how well your kidneys are working.
Dosage in patients with kidney problems
The dosage depends on how well your kidneys are
working. Follow the instructions of your doctor.
Prior diuretic therapy
Treatment with diuretics other than hydrochlorothiazide
should be discontinued 2 to 3 days before the start of
the treatment with Enalapril Maleate and
Hydrochlorothiazide tablets.
Follow the instructions of your doctor.
Do not change the dosage or stop taking the
medicine without discussing it first with your doctor.
If you take more Enalapril Maleate and
Hydrochlorothiazide tablets than you should
Always contact your doctor or nearest hospital
immediately if you have taken more than you should
(overdose). 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.
If you forget to take Enalapril Maleate and
Hydrochlorothiazide tablets
Take the next dose when it is the normal time to take it.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Enalapril Maleate and
Hydrochlorothiazide tablets
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 and
Hydrochlorothiazide tablets can cause side effects,
although not everybody gets them.
Stop taking this medicine and see a doctor or go to
a hospital straightaway if:
• you get swelling of the hands, feet, ankle, face, lips
or throat which may cause difficulty in swallowing
or breathing, itching of the skin and nettle rash. This
is a serious and common side effect called
angioedema (affects 1 to 10 patients in 100)
• you get red, swollen or scalded skin with blisters on
the lips, eyes, mouth, nose and/or genitals. You may
also have a high temperature, swollen glands or
joint pain. This could be a rare condition called
Stevens-Johnson syndrome (affects less than 1
patient in 1,000).
This may mean you are having an allergic reaction to
Enalapril Maleate and Hydrochlorothiazide tablets.
Talk to your doctor straight away if you notice any of
the following serious side-effects.
These are uncommon or rare (affect less than 1
patient in 100):
• You may get a bloating feeling and cramping pain
in the stomach (abdomen), be sick (vomiting), have
indigestion, heartburn, upset stomach, constipation,
loss of appetite, dry mouth. This could be caused by
an obstruction or blockage of the bowel (ileus)
• Severe stomach pains which may reach through to
your back. This could be a sign of pancreatitis
• Blood disorders including bone marrow problems
and anaemia. Symptoms include bruising more
easily, bleeding longer after injury, bleeding from
the gums or elsewhere, purple spots or blotching
on the skin (caused by damage to small blood
vessels), a greater chance of infection
• Lung problems including inflammation of the
lungs. You may feel unwell or less hungry, or get
high temperature (fever) lasting 2 to 3 days,
difficulty breathing, shortness of breath, cough
• High temperature, tiredness, loss of appetite, stomach
pain, feeling sick, yellowing of the skin or eyes
(jaundice). These are symptoms of Hepatitis
(inflammation of the liver) that may lead to liver
failure
• A condition which may include some or all of the
following: high temperature, inflamed blood
vessels, painful inflamed muscles and joints, blood
problems detected by a blood test, rash, being very
sensitive to sunlight, other effects of the skin.
Other possible side effects:
Very common (in more than 1 of 10 patients)
• Dizziness
• Blurred vision
• Feeling sick
• Cough
• Weakness.
Common (in 1 to 10 of 100 patients):
• Headache
• Tiredness
• Chest pain
• Fainting
• Altered and/or irregular heartbeat
• Low blood pressure, including postural hypotension
with associated symptoms (dizziness, weakness,
blurred vision)
• Diarrhoea
• Distortion or decrease of the sense of taste
• Abdominal pain
• Exanthema (rash)
• Muscle spasms
• Changes in blood levels of potassium
• Increase in blood levels of creatinine and fat
• Excessive blood urine acid levels
• Depression
• Difficulty in breathing.

Uncommon (in 1 to 10 of 1,000 patients):
• Vomiting, indigestion, constipation, loss of appetite,
stomach irritation, dry mouth, peptic ulcer,
flatulence
• Kidney problems, protein in the urine
• Impotence
• Reduction in the number of red blood cells, which
can make the skin pale and cause weakness or
breathlessness (anaemia)
• 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)
• Confusion, drowsiness, sleeplessness, nervousness,
sensations of tingling, pricking or numbness
(paraesthesia)
• Vertigo (dizziness)
• Joint pain, feeling unwell, fever
• Red face, ringing in the ears (tinnitus)
• Itch, hives, hair loss
• Runny nose, sore throat and hoarseness, wheezing
• Excessive sweating
• Gout
• Low blood sodium and/or magnesium levels,
decreased blood glucose levels
• Inflammation of the gallbladder, especially in
patients with gallstones.
Rare (in 1 to 10 of 10,000 patients):
• Changes in blood count, disease of the lymph
nodes, autoimmune disease, in which the body
attacks itself
• Stomatitis, glossitis
• Allergic skin reactions (e.g. erythema multiforme,
redness, scaling or blistering of the skin, epidermal
necrolysis [serious condition with detachment of
the top layer of the skin], purpura), skin conditions
with red scaly patches over the nose and cheeks
(lupus erythematosus)
• Inflammation of the lining of the nose causing the
nose to run (rhinitis)
• Reduced urine production
• Inflammation in the kidneys (interstitial nephritis)
• Breast enlargement including in men
• Dream abnormality, disturbed sleep
• Impaired muscle movement (due to low blood
potassium levels)
• Raynaud´s phenomenon. (Symptoms include fingers
that change colour when exposed to the cold or
when pressure is put on them, pain in the fingers or
toes when cold, tingling or pain on warming.)
• Increase in the amount of enzymes and waste
products produced by the liver.
Very rare (in less than 1 of 10,000 patients)
• A condition called “intestinal angioedema”.
Symptoms are stomach pain with or without feeling
sick or being sick
• Increase in blood calcium.
Not known (cannot be determined based on the
available data)
• Inflammation of a salivary gland
• Increased blood sugar, glucose in the urine
• Restlessness
• Light-headedness
• Vision disturbances
• Inflammation of the blood vessels
• Anaphylactic reactions (allergic hypersensitivity
which develops rapidly, with generalised symptoms)
• Syndrome of inappropriate antidiuretic hormone
secretion (symptoms include headache, nausea,
vomiting, agitation or confusion and may progress
to convulsions and coma if left untreated).
Reporting of side effects
If any of the 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 ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLETS
Keep out of the reach and sight of children.
Do not use Enalapril Maleate and Hydrochlorothiazide
tablets after the expiry date which is stated on the
carton. The expiry date refers to the last day of that
month.
This medicinal product does not require any special
storage conditions.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Enalapril Maleate and Hydrochlorothiazide
tablets contain
The active substances are enalapril maleate and
hydrochlorothiazide. Each tablet contains 20 mg
enalapril maleate and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate,
maize starch, sodium hydrogen carbonate, starch
pregelatinised, talc and magnesium stearate.
What Enalapril Maleate and Hydrochlorothiazide
tablets look like and contents of the pack
Round, white, flat tablet, scored on one side and with
bevelled edge. Diameter 8mm.
The tablets can be divided into equal halves.
They are available in blister packs of 14, 20, 28, 28 x 1,
30, 30 x 1, 56, 60, 98, 98 x 1, 100, 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm,
Germany.
Manufacturer
Merckle GmbH, Graf-Arco-Str.3, D-89079 Ulm,
Germany.
This leaflet was last revised in October 2013.
PL 15773/0059
20179-C
112502.03-GB

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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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