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ENALAPRIL MALEATE 20MG & HYDROCHLOROTHIAZIDE 12.5MG TABLETS

Active substance: 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.
 Keep this leaflet. You may want 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 get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Innozide is and what it is used for
2. Before you take Innozide
3. How to take Innozide
4. Possible side effects
5. How to store Innozide
6. Further information
1.

What Innozide is and what it is used for

Innozide contains enalapril maleate and hydrocholorothaizide:
 enalapril belongs to a group of medicines known as 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.

Before you take Innozide

Do not take Innozide if:
you have ever had an allergic reaction to Innozide, a similar
medicine or to any of the ingredients (listed in Section 6). The
signs may have been itching, nettle rash, wheezing or swelling of
your hands, throat, mouth or eyelids
 you are allergic to a type of medicine called ‘sulphonamides'
 you are more than 3 months pregnant. (It is also better to avoid
'Innozide' in early pregnancy – see pregnancy section.)
 you are not passing urine
 you have a condition know as renal artery stenosis (narrowing of
the arteries that supply the blood to your kidneys).
 you have severe kidney or liver problems
Do not take Innozide if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Innozide.


Take special care with Innozide
Check with your doctor or pharmacist before taking your medicine if:
 you have kidney problems, have had a recent kidney
transplantation, are a dialysis patient, or are taking water tablets
(diuretics)
 you have blood disorders or liver problems
 you are on a salt restricted diet, or have suffered from excessive
vomiting or diarrhoea recently
 you have a heart condition called ‘aortic stenosis', ‘hypertrophic
cardiomyopathy' or ‘outflow obstruction'
 you have collagen vascular disease, are taking
immunosuppressant therapy (used for the treatment of
autoimmune disorders such as rheumatoid arthritis or following
transplant surgery)
 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
 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
 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)
 you are taking potassium supplements or potassium containing
salt substitutes
 you are taking lithium, used for the treatment of some psychiatric
illnesses
 you have been told by your doctor that you have an intolerance
to some sugars.
 You must tell your doctor if you think you are (or might become)
pregnant. 'Innozide' 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).
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 you doctor if you have or will take an anti-doping test since this
medication can produce a positive result.
Children
Innozide is not recommended for use in children.
Taking 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 as some drugs may affect each other's action.
This includes herbal medicines. Also some other medicines can
affect the way Innozide works:
 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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Innozide.
Taking Innozide with food and drink
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
You must tell your doctor if you think you are (or might become)
pregnant. 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. Innozide 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. Innozide 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 Innozide which may affect some patients' ability to
drive or operate machinery.
Important information about some of the ingredients of Innozide
Innozide contains lactose, which is a type of sugar. It is important to
tell your doctor if you suffer from lactose intolerance.

3.

How to take Innozide

Taking this medicine
 You should take this medicine by mouth.
 Always take Innozide exactly as your doctor told you.
 The number of tablets you take each day will depend upon your
condition.
You should check with your doctor or pharmacist if you are not sure.
REMEMBER, this medicine is for you. Do not share it with anyone
else. It may not suit them.



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The usual dose for many people is:
 One tablet each day.
 Your doctor may increase the dose to two tablets each day.
 Do not take more or less than your doctor has prescribed.

pain, swelling or ulcers in your mouth, infection or pain and
swelling of your tongue, kidney problems such as lower back pain
and reduction in the volume of urine you pass
swollen nasal lining
difficulty breathing, respiratory distress
liver failure or hepatitis, this may cause yellowing of your skin
(jaundice)
excessive redness of your skin, blisters, skin peeling off in sheets
development of breasts in men
increased liver enzymes or blood ‘bilirubin' (usually detected by a
blood test), increases in blood sugar.
muscle weakness, sometimes due to low potassium (paresis)

Very rare (affects less than 1 in 10,000 people)
intestinal ‘angioedema'. Signs may include stomach pain, feeling
sick and vomiting, elevated calcium level in blood



If you take more Innozide than you should
Contact your doctor immediately if you think you have taken more of
your tablets than you should. The most common signs and symptoms of an overdose are a fall in blood pressure and stupor (a state
of almost complete lack of consciousness). Other symptoms may
include dizziness or light-headedness due to a fall in blood pressure,
forceful and rapid heartbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing.

Others (it is unknown how many people may be affected)
A complex side effect has also been reported which may include
some or all of the following signs:
 fever, inflammation of your blood vessels, pain and inflammation
of muscles or joints
 blood disorders affecting the components of your blood (usually
detected by a blood test)
 rash, hypersensitivity to sunlight and other effects on your skin.

If you forget to take Innozide
If you forget to take a tablet, skip the missed dose.
Take the next dose as usual.
Do not take a double dose to make up for a forgotten dose.

If any of these side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.


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

If you stop taking Innozide
Do not stop taking your medicine, unless your doctor has told you to.
If you do your blood pressure may increase. If your blood pressure
becomes too high it may affect your heart and kidneys.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4.

Possible side effects

5.

How to store Innozide

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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use after the expiry date printed on the packaging.
Store below 25°C in a dry place. Protect from direct sunlight.
Keep in the original container.
If the tablets become discoloured or show any other sign of
deterioration, ask your pharmacist for advice.
 If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep
the tablets if your doctor tells you to.

Like all medicines Innozide can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:

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.

It is vital to stop taking Innozide and seek medical attention
immediately if you begin to have the following symptom:
allergic reaction - you may get an itch, short of breath or wheezy
and develop swelling of your hands, mouth, throat, face or eyes.

6.

Stop taking Innozide immediately and see your doctor if you
have any of the following side effects
 severe dizziness, light-headedness, especially at the start of
treatment or when your dose is increased or when you stand up.
Other possible side effects
Very common (affects more than 1 in 10 people)
 blurred vision, cough, feeling sick (nausea), weakness
Common (affects less than 1 in 10 people)
headache, depression, low blood pressure, fainting
chest pain, heart rhythm changes, angina, fast heart beat,
shortness of breath
 diarrhoea, pain around your stomach area (abdomen), changes in
taste, fluid retention (oedema), feeling tired
 rash, hypersensitivity/angioneurotic oedema: angioneurotic
oedema of the face, extremities, lips, tongue, glottis and/or larynx
has been reported.
 increased blood potassium level, increases in serum creatinine
(both are usually detected by a test); low levels of potassium in
the blood, increased levels of cholesterol, increased levels of
triglycerides, increased levels of uric acid in the blood.
 muscle cramps
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Uncommon (affects less than 1 in100 people)
anaemia, anxiety, 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)
 low blood pressure (which may make you feel dizzy when you
stand up), racing or uneven heart beats, heart attack or stroke (in
high risk patients)
 runny nose, sore throat and hoarseness, difficulty breathing or
asthma
 a blockage in your intestine (ileus), pancreatitis, being sick,
indigestion, constipation, not feeling like eating properly
(anorexia), stomach irritation, dry mouth, flatulence, gout
 burning, aching pain with an empty feeling and hunger,
particularly when the stomach is empty (caused by a peptic ulcer),
excessive sweating, itching, hives (urticaria), hair loss, protein in
your urine (usually detected by a test)
 impotence, decreased libido, flushing, ringing in your ears, feeling
lethargic, high temperature
 increases in blood urea and decreases in blood sodium levels
(usually detected by a test), weakness (malaise)
 low level of magnesium in the blood (hypomagnesemia)
 kidney problems
 joint pain

Further information

What Innozide contains:
The active ingredients in Innozide Tablets are enalapril maleate and
hydrochlorothiazide. Each tablet contains 20 mg enalapril maleate
and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, sodium hydrogen
carbonate (E500), gluten-free maize starch, pregelitinized maize
starch, magnesium stearate (E572) and yellow iron oxide (e172).

What Innozide looks like and the contents of the pack
Innozide is available as yellow, six-sided tablet marked on one side
with ‘MSD 718’ and on the other side with a score line. Innozide
Tablets are available in blister packs containing 28 tablets.
PL NO. 16369/0088
Manufacturer
Merck Sharp & Dohme, B.V. Waarderweg 39, 2031 BN Haarlem,
Holland.
Procured from within the EU. Parallel Import Product Licence holder:
G Pharma Ltd, Dakota Avenue, Salford M50 2PU.
POM

Innozide 20/12.5mg Tablets

03/06/2014

This leaflet gives you some of the most important patient information
about Innozide. If you have any questions after you have read it, ask
your doctor or pharmacist, who will give you further information.



Rare (affects less than 1 in 1,000 people)
strange dreams, sleeping problems
decreases in your white blood cells, red blood cells, platelets,
bone marrow depression (all are usually detected by tests)
 swollen glands, autoimmune diseases, low blood flow to your
fingers and toes causing redness and pain (Raynaud's), fluid on
your lungs, runny or sore nose
 eosinophilic pneumonia (signs may be cough, high temperature
and difficulty breathing)



Innozide is a registered trademark of Merck & Co. Inc.

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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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