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INNOVACE 5MG TABLETS

Active substance(s): ENALAPRIL MALEATE

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- liver or gallbladder problems such as lower liver function,
inflammation of your liver, jaundice (yellowing of the
skin or eyes), high levels of liver enzymes or bilirubin
(measured in a blood test)
- enlargement of breasts in males (gynaecomastia).
Very Rare (may affect up to 1 in 10,000 people)
- swelling in your intestine (intestinal angioedema).
Not known (frequency cannot be estimated from the
available data)
- overproduction of antidiuretic hormone, which causes fluid
retention, resulting in weakness, tiredness or confusion
- A symptom complex has been reported which may
include some or all of the following: fever, inflammation
of the blood vessels (serositis/vasculitis), muscle pain
(myalgia/myositis), joint pain (arthralgia/arthritis). Rash,
photosensitivity or other skin manifestations may occur.

5. How to store Innovace
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 blister and the carton after ‘EXP’. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original package in
order to protect from moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Innovace contains
- The active substance is enalapril maleate (either 2.5 mg,
5 mg, 10 mg, or 20 mg).
- The other ingredients are lactose monohydrate, sodium
hydrogen carbonate, maize starch, pregelatinised starch,
magnesium stearate. The 10 mg tablet also contains iron
oxide red (E172) and the 20 mg tablet also contains iron
oxide red (E172) and iron oxide yellow (E172).
What Innovace looks like and contents of the pack
Innovace tablets are available in 4 strengths.
The white round shaped tablet, one side marked ‘MSD 14’,
the other side plain, contain 2.5 mg of enalapril maleate.
The white, rounded triangle shaped tablet, one side scored*
and the other side marked ‘MSD 712’ contain 5 mg enalapril
maleate.
8242, 9890X, 9686X, 9850X

Innovace® 2.5 mg, 5 mg, 10 mg
or 20 mg tablets
enalapril maleate

*The scoreline is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.

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 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.

Innovace is supplied in the following pack sizes:
Innovace 2.5 mg – All-aluminium blister packages
containing 2, 11, 20, 28, 30, 40, 49 x 1, 50, or 100 tablets.
Innovace 5 mg - All-aluminium blister packages containing 2,
14, 20, 28, 28 x 1, 30, 49 x 1, 50, 60, 98, or 100 tablets.
Innovace 10 mg - All-aluminium blister packages containing 28,
49 x 1, 30, 50, 98 or 100 tablets.
Innovace 20 mg - All-aluminium blister packages containing
10, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 60, 84, 90, 98, 100 or
500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
MAH (UK)
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK
MAH (Ireland)
Merck Sharp & Dohme Ireland (Human Health) Limited,
Red Oak North, South County Business Park, Leopardstown,
Dublin 18, Ireland
The product is manufactured by Merck Manufacturing
Division, Merck Sharp & Dohme Limited, Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Belgium, Finland, France, Greece, Luxembourg,
Netherlands, Portugal, Spain, Sweden:
RENITEC
Germany:
XANEF
Italy:
ENAPREN
UK, Ireland:
INNOVACE
This leaflet was last revised in April 2016.
© Merck Sharp & Dohme Limited 2016. All rights reserved.
PIL.RNT.15.UK.4693.II-036

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For Position Only

Reporting of side effects
If you get any 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
(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
e-mail: medsafety@hpra.ie.

Package leaflet: Information for the user

The rust-red, rounded triangle shaped tablet, one side scored*,
the other side marked ‘MSD 713’ contain 10 mg enalapril
maleate.
The peach, rounded triangle shaped tablet, one side scored*,
the other marked ‘MSD 714’ contain 20 mg enalapril maleate.

What is in this leaflet
1. What Innovace is and what it is used for
2. What you need to know before you take Innovace
3. How to take Innovace
4. Possible side effects
5. How to store Innovace
6. Contents of the pack and other information
1. What Innovace is and what it is used for
Innovace contains an active substance called enalapril
maleate. This belongs to the group of medicines called ACE
inhibitors (angiotensin converting enzyme inhibitors).
Innovace is used:
- to treat high blood pressure (hypertension)
- to treat heart failure (weakening of heart function). It can
lower the need to go to hospital and can help some patients
live longer
- to prevent the signs of heart failure. The signs include:
shortness of breath, tiredness after light physical activity
such as walking, or swelling of the ankles and feet.
This medicine works by widening your blood vessels. This
lowers your blood pressure. The medicine usually starts to
work within an hour, and the effect lasts for at least 24 hours.
Some people will require several weeks of treatment until
the best effect on your blood pressure is seen.
2. What you need to know before you take Innovace
Do not take Innovace
- if you are allergic to enalapril maleate or any of the other
ingredients of this medicine (listed in section 6)
- if you have ever had an allergic reaction to a type of
medicine similar to this medicine called an ACE inhibitor
- if you have ever had swelling of your face, lips, mouth,
tongue or throat which caused difficulty in swallowing
or breathing (angioedema) when the reason why was
not known or it was inherited
- 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 Innovace in early pregnancy – see Pregnancy section).
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Innovace:
- if you have a heart problem
- if you have a condition involving the blood vessels in the brain
- if you have a blood problem such as low or lack of white
blood cells (neutropenia/agranulocytosis), low blood
platelet count (thrombocytopenia) or a decreased
number of red blood cells (anaemia)
- if you have a liver problem
- if you have a kidney problem (including kidney
transplantation). These may lead to higher levels of
potassium in your blood which can be serious. Your
doctor may need to adjust your dose of Innovace or
monitor your blood level of potassium
- if you are having dialysis
- if you have been very sick (excessive vomiting) or had
bad diarrhoea recently
- if you are on a salt-restricted diet, are taking potassium
supplements, potassium-sparing agents, or potassiumcontaining salt substitutes
- if you are over 70 years of age
- if you have diabetes. You should monitor your blood for
low blood glucose levels, especially during the first month
of treatment. The level of potassium in your blood can also
be higher
- if you have ever had an allergic reaction with swelling
of the face, lips, tongue or throat with difficulty in
swallowing or breathing. You should be aware that black
patients are at increased risk of these types of reactions
to ACE inhibitors
- if you have low blood pressure (you may notice this as
faintness or dizziness, especially when standing)
- if you have collagen vascular disease (e.g., lupus
erythematosus, rheumatoid arthritis or scleroderma),
are on therapy that suppresses your immune system,
are taking the drugs allopurinol or procainamide, or any
combinations of these
- if you are taking an mTOR inhibitor (e.g., temsirolimus,
sirolimus, everolimus: medicines used to treat certain
types of cancer or to prevent the body’s immune system
from rejecting a transplanted organ). You may be at
increased risk for an allergic reaction called angioedema.
- if you are taking any 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 diabetesrelated 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 Innovace.”
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You must tell your doctor 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).
You should be aware that this medicine lowers the blood
pressure in black patients less effectively than in non-black
patients.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
If you are about to have a procedure
If you are about to have any of the following, tell your doctor
that you are taking Innovace:
- any surgery or receive anaesthetics (even at the dentist).
- a treatment to remove cholesterol from your blood
called ‘LDL apheresis’.
- a desensitisation treatment, to lower the effect of an allergy
to bee or wasp stings.
If any of the above applies to you, talk to your doctor or dentist
before the procedure.
Other medicines and Innovace
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes herbal
medicines. This is because Innovace can affect the way some
medicines work. Also some other medicines can affect the
way Innovace works. Your doctor may need to change your
dose and/or to take other precautions.
In particular tell your doctor or pharmacist if 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
Innovace” and “Warnings and precautions”)
- other medicines to lower blood pressure, such as
beta-blockers or water tablets (diuretics)
- medicines containing potassium (including dietary salt
substitutes)
- medicines for diabetes (including oral antidiabetic
medicines and insulin)
- lithium (a medicine used to treat a certain kind of
depression)
- medicines for depression called ‘tricyclic antidepressants’
- medicines for mental problems called ‘antipsychotics’
- certain cough and cold medicines and weight
reducing medicines which contain something called
a ‘sympathomimetic agent’
- certain pain or arthritis medicines including gold therapy
- an mTOR inhibitor (e.g., temsirolimus, sirolimus,
everolimus; medicines used to treat certain types of
cancer or to prevent the body’s immune system from
rejecting a transplanted organ). See also information
under the heading “Warnings and precautions”
- non-steroidal anti-inflammatory drugs, including
COX-2-inhibitors (medicines that reduce inflammation,
and can be used to help relieve pain)
- aspirin (acetylsalicylic acid)
- medicines used to dissolve blood clots (thrombolytics)
- alcohol.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Innovace.

Innovace with food and drink
Innovace can be taken with or without food. Most people
take Innovace with a drink of water.
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 Innovace before
you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine
instead of Innovace. This medicine 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. Breast-feeding newborn babies (first few
weeks after birth), and especially premature babies, is not
recommended whilst taking this medicine. In the case of an
older baby your doctor should advise you on the benefits
and risks of taking this medicine whilst breast-feeding,
compared to other treatments.
Driving and using machines
You may feel dizzy or sleepy while taking this medicine.
If this happens, do not drive or use any tools or machines.
Innovace contains lactose
Innovace contains lactose, which is a type of sugar. If you
have been told by your doctor that you have intolerance to
some sugars, talk to your doctor before taking this medicine.
3. How to take Innovace
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
- It is very important to continue taking this medicine for
as long as your doctor prescribes it.
- Do not take more tablets than prescribed.
High Blood Pressure
- The usual starting dose ranges from 5 to 20 mg taken
once a day.
- Some patients may need a lower starting dose.
- The usual long term dose is 20 mg taken once a day.
- The maximal long term dose is 40 mg taken once a day.
Heart Failure
- The usual starting dose is 2.5 mg taken once a day.
- Your doctor will raise this amount step by step until the
dose that is right for you has been achieved.
- The usual long term dose is 20 mg each day, taken in
one or two doses.
- The maximal long term dose is 40 mg each day, divided
in two doses.
Patients with kidney problems
Your dose of medicine will be changed depending on how
well your kidneys are working:
- moderate kidney problems - 5 mg to 10 mg each day
- severe kidney problems - 2.5 mg each day
- if you are having dialysis - 2.5 mg each day. On days
you are not having dialysis, your dose may be changed
depending on how low your blood pressure is.
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Elderly patients
Your dose will be decided by your doctor and will be based
on how well your kidneys are working.
Use in children
Experience in the use of Innovace in children with high blood
pressure is limited. If the child can swallow tablets, the dose
will be worked out using the child’s weight and blood pressure.
The usual starting doses are:
- between 20 kg and 50 kg – 2.5 mg each day
- more than 50 kg – 5 mg each day.
The dose can be changed according to the needs of the child:
- a maximum of 20 mg daily can be used in children who
are between 20 kg and 50 kg
- a maximum of 40 mg daily can be used in children who
are more than 50 kg.
This medicine is not recommended in newborn babies (first
few weeks after birth) and in children with kidney problems.
If you take more Innovace than you should
If you take more Innovace than you should, talk to your
doctor or go to a hospital straight away. Take the medicine
pack with you. The following effects may happen: feeling
of light‑headedness or dizziness. This is due to a sudden or
excessive drop in blood pressure.
If you forget to take Innovace
- 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 you stop taking Innovace
Do not stop taking your medicine unless your doctor tells
you to.
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. The following side effects may happen
with this medicine:
Stop taking Innovace and talk to a doctor straight away,
if you notice any of the following:
- swelling of your face, lips, tongue or throat which may
cause difficulty in breathing or swallowing
- swelling of your hands, feet or ankles
- if you develop a raised red skin rash (hives).
You should be aware that black patients are at increased
risk of these types of reactions. If any of the above happen,
stop taking Innovace and talk to a doctor straight away.
When you start taking this medicine you may feel faint or
dizzy. If this happens, it will help to lie down. This is caused
by your blood pressure lowering. It should improve as you
continue to take the medicine. If you are worried, please
talk to your doctor.
Other side effects include:
Very Common (may affect more than 1 in 10 people)
- feeling dizzy, weak or sick
- blurred vision
- cough.
Common (may affect up to 1 in 10 people)
- light-headedness due to low blood pressure, changes in
heart rhythm, fast heartbeat, angina or chest pain
- headache, depression, fainting (syncope), change in
sense of taste

-
-
-
-

shortness of breath
diarrhoea, abdominal pain
tiredness (fatigue)
rash, allergic reactions with swelling of the face, lips, tongue
or throat with difficulty in swallowing or breathing
- high levels of potassium in the blood, increased levels of
creatinine in your blood (both are usually detected by a test).
Uncommon (may affect up to 1 in 100 people)
- flushing
- sudden fall in blood pressure
- fast or uneven heart beats (palpitations)
- heart attack (possibly due to very low blood pressure in
certain high-risk patients, including those with blood
flow problems of the heart or brain)
- stroke (possibly due to very low blood pressure in
high-risk patients)
- anaemia (including aplastic and haemolytic)
- confusion, sleeplessness or sleepiness, nervousness
- feeling your skin prickling or being numb
- vertigo (spinning sensation)
- ringing in your ears (tinnitus)
- runny nose, sore throat or hoarseness
- asthma-associated tightness in chest
- slow movement of food through your intestine (ileus),
inflammation of your pancreas
- being sick (vomiting), indigestion, constipation, anorexia
- irritated stomach (gastric irritations), dry mouth, ulcer
- muscle cramps
- impaired kidney function, kidney failure
- increased sweating
- itching or nettle rash
- hair loss
- generally feeling unwell (malaise), high temperature (fever)
- impotence
- high level of proteins in your urine (measured in a test)
- low level of blood sugar or sodium, high level of blood
urea (all measured in a blood test).
Rare (may affect up to 1 in 1,000 people)
- ‘Raynaud’s phenomenon’ where your hands and feet may
become very cold and white due to low blood flow
- changes in blood values such as a lower number of white
and red blood cells, lower haemoglobin, lower number
of blood platelets
- bone marrow depression
- swollen glands in neck, armpit or groin
- autoimmune diseases
- strange dreams or sleep problems
- accumulation of fluid or other substances in the lungs
(as seen on X‑rays)
- inflammation of your nose
- inflammation of the lungs causing difficulty breathing
(pneumonia)
- inflammation of the cheeks, gums, tongue, lips, throat
- reduced amount of urine
- rash that looks like targets (erythema multiforme)
- ‘Stevens-Johnson syndrome’ and ‘toxic epidermal
necrolysis’ (serious skin conditions where you have
reddening and scaling of your skin, blistering or raw
sores), exfoliative dermatitis/erythroderma (severe skin
rash with flaking or peeling of the skin), pemphigus
(small fluid-filled bumps on the skin)
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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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