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ENALAPRIL MALEATE 20MG & HYDROCHLOROTHIAZIDE 12.5MG TABLETS

Active substance(s): ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOZIDE® 20/12.5mg Tablets
ENALAPRIL MALEATE 20mg and
HYDROCHLOROTHIAZIDE 12.5mg Tablets
(enalapril maleate / hydrochlorothiazide)
This product will be referred to as Innozide throughout the remainder of
this leaflet.
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 of pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Innozide is and what it is used for
2. What you need to know before you take Innozide
3. How to take Innozide
4. Possible side effects
5. How to store Innozide
6. Contents of the pack and other information
1.

What Innozide is and what it is used for

Innozide contains enalapril maleate and hydrochlorothiazide:
 enalapril belongs to a group of medicines called angiotensin
converting enzyme inhibitors (ACE inhibitors), which work by
widening your blood vessels
 hydrochlorothiazide belongs to a group of medicines known as water
tablets (diuretics), which increase the volume of urine you produce.
The effect of these medicines is to lower your blood pressure.
Innozide is used to treat high blood pressure (hypertension). Taking both
medicines that Innozide contains can increase their effect compared to
taking just one.
2.

What you need to know before you take Innozide

Do not take Innozide:
 if you are allergic to enalapril maleate, hydrochlorothiazide, or any of
the other ingredients of this medicine (listed in section 6).
 if you have previously been treated with a medication in the same
group of drugs as this medicine (ACE inhibitors) and have had
allergic reactions with swelling of the face, lips, tongue and/or throat
with difficulty in swallowing or breathing. You should not take this
medicine if you have had these types of reactions without a known
cause, or if you have been diagnosed with hereditary or idiopathic
angioedema.
 if you are allergic to any sulfonamide-derived drugs. (Ask your doctor
if you are not sure what sulfonamide-derived drugs are.)
 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 are more than 3 months pregnant. (It is also better to avoid
Innozide in early pregnancy – see pregnancy section.)
 if you have a condition known as renal artery stenosis (narrowing of
the arteries that supply the blood to your kidneys)
 if you have severe kidney or liver problems
Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking this medicine.
Warning and precautions
Talk to your doctor or pharmacist before taking Innozide
 if you have kidney problems, 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 are on a salt restricted diet, or have suffered from excessive
vomiting or diarrhoea recently
 if you have a heart condition called ‘aortic stenosis’, ‘hypertrophic
cardiomyopathy’ or ‘outflow obstruction’
 if you have collagen vascular disease, are taking
immunosuppressant therapy (used for the treatment of autoimmune
disorders such as rheumatoid arthritis or following transplant surgery)
 if you are taking allopurinol, (used for the treatment of gout), or
procainamide, (used to treat abnormal heart rhythms). If you develop
an infection (symptoms may be high temperature or fever), you
should let your doctor know immediately. Your doctor may take a
blood sample from time to time to check your white blood cell count
 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
 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 lithium, used for the treatment of some psychiatric
illnesses
 if you have been told by your doctor that you have an intolerance to
some sugars.
 if you think you are (or might become) pregnant. This medicine 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 if you are taking either of the following medicines
used to treat high blood pressure:
 an angiotensin II receptor blocker (ARB) (also known as sartans
– for example valsartan, telmisartan, irbesartan etc), 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 Innozide.”

If you are about to have any of the following procedures, you
should tell your doctor who is treating you that you are taking
Innozide:
 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 Innozide, 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 or will take an anti-doping test since this
medication can produce a positive result.
Children and adolescents
Innozide is not recommended for use in children.
Other medicines and Innozide
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicine.
Your doctor may need to change your dose and/or to take other
precautions.
In general, Innozide can be taken with other drugs. For prescribing the
correct dose of Innozide, it is especially important for your doctor to know
whether you are taking any of the following medicines:
 an angiotensin II-receptor blocker (ARB) or aliskiren (see also
information under the headings “Do not take Innozide” and
“Warnings and precautions”),
 potassium sparing water tablets (diuretics) such as spironolactone,
eplerenone, triamterene or amiloride, potassium supplements, or
potassium-containing salt substitutes. Innozide 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, and vasodilators,
 lithium, used for the treatment of some psychiatric illnesses.
Innozide should not be taken with this drug
 barbiturates (sedatives used for sleeplessness or epilepsy),
 tricyclic antidepressants such as amitriptyline, used for depression,
antipsychotics such as phenothiazines, used for severe anxiety,
 pain killers 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 which can lead to flushing of your face,
feeling sick (nausea), vomiting and low blood pressure, when
taken with Innozide, 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
Innozide these drugs may keep your blood pressure high,
 ACTH (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),
 allopurinol (used to treat gout),
 ciclosporins (immunosuppressive agents used for autoimmune
disorders),
 medicines for the treatment of cancer,
 antacids (used for indigestion relief),
 procainamide, amiodarone or sotalol (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. Innozide may cause your
blood sugar levels to drop even further if you take it with antidiabetics
 an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) as
coadministration could increase the risk for an allergic reaction called
angioedema.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Innozide.
Innozide with food, drink and alcohol
Most people take Innozide with a drink of water.
Innozide can be taken with or without food. However, if you drink alcohol
while taking Innozide, 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
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. Your doctor will normally advise you to stop taking Innozide
before you become pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead of Innozide. This
medicine 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.
This medicine 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 this medicine which may affect some patients’ ability to
drive or operate machinery (see Possible side effects).

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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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