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ENALAPRIL 10MG TABLETS

Active substance(s): ENALAPRIL MALEATE / ENALAPRIL MALEATE / ENALAPRIL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL 5, 10 and 20 mg Tablets
Enalapril Maleate
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 Tablets are and what they are used for
2. What you need to know before you take Enalapril Tablets
3. How to take Enalapril Tablets
4. Possible side effects
5. How to store Enalapril Tablets
6. Contents of the pack and other information
1. WHAT ENALAPRIL TABLETS ARE AND WHAT THEY ARE
USED FOR
These tablets contain enalapril maleate. Enalapril belongs to a group
of medicines known as ‘ACE inhibitors’, which work by widening your
blood vessels.

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 to have a procedure
If you are about to have any of the following, tell your doctor that you
are taking Enalapril Tablets:
• treatment called LDL apheresis to remove cholesterol from your
blood by a machine
• any surgery or anaesthetics (even at the dentist)
• desensitisation treatment to reduce the effects 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 Enalapril Tablets
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 Enalapril Tablets can affect the way some medicines
work. Also some other medicines can affect the way Enalapril Tablets
work. Your doctor may need to change your dose and/or take other
precautions.

Do not take Enalapril Tablets:
• if you are allergic to enalapril 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 are more than 3 months pregnant. (It is also better to avoid
Enalapril in early pregnancy - see pregnancy section)
• if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.

In particular tell you 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 heading “Do not take Enalapril Tablets” and
“Warnings and Precautions”)
• Other medicines to lower your blood pressure such as beta
blockers (e.g. Propranolol) and diuretics (water tablets)
• 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. tenmsirolimus, 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 (acetylsalicyclic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol.

If you think any of the above points apply to you, do not take the
tablets. Talk to your doctor first and follow the advice given.

If you are not sure if any of the above applied to you, talk to your
doctor or pharmacist before taking Enalapril Tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril Tablets:
• 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
enalapril 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 potassium-containing
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 supresses
your immune system, are taking the drugs allopurinol or
procainamide, or any combinations of these
• if you are taking mTOR inhibitors (e.g. temsirolimus, sirolimus,
everolimus: medicine 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, ibestartan, etc.)
- aliskiren.

Taking Enalapril Tablets with food and drink
The absorption of Enalapril Tablets is not affected by food intake.

They are used to treat:
• High blood pressure.
• Heart failure (symptoms of which include tiredness after light
exercise, breathlessness and swelling of your ankles and legs).
They are also used to prevent heart failure and heart attacks in
people who have heart problems but have no symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENALAPRIL TABLETS

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 Enalapril
tablets”.
You must tell your doctors if you think you are (or might become)
pregnant. This medicine if 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

Alcohol and Enalapril Tablets can have additive effects and may
cause dizziness or lightheadedness. Your doctor will have told you
that you should always keep your alcohol intake to a minimum. If you
are concerned about how much alcohol you can drink while you are
taking Enalapril Tablets, discuss this with your doctor.
If you are on a low salt diet (sometimes called a low sodium diet) tell
your doctor before taking these tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
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
before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of
Enalapril. 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 breastfeeding. Breast-feeding newborn babies (first few weeks after birth),
and especially premature babies, is not recommended whilst taking
this medicine.
In case of an older baby your doctor should advise you on the
benefits and risks of taking Enalapril whilst breast-feeding, compared
with other treatments.
Driving and using machines
Enalapril Tablets can cause side effects such as dizziness, light
headedness, headache, tiredness, confusion and blurred vision.
Do not drive or operate machines if you experience any of these side
effects.
Important information about some of the ingredients of Enalapril
Tablets
Enalapril Tablets contain 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 TABLETS
Always take Enalapril Tablets exactly as your doctor 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.
Usual dose for high blood pressure:
The normal starting dose is 5 mg once a day. This is gradually
increased up to 10-20 mg once a day. The maximum dose is 40 mg a
day. Some patients including the elderly (over 65 years of age) may

start on a lower dose of 2.5 mg once a day.
Usual dose for heart failure:
The normal starting dose is 2.5 mg a day. This is gradually increased
up to 20 mg a day, given either once daily or in 2 doses of 10 mg
according to your doctor’s advice.
If taking Enalapril tablets with a diuretic (water tablet):
The recommended initial dose is 2.5 mg a day. If possible, your
doctor will ask you to stop taking your diuretic tablets 2-3 days before
starting to take Enalapril Tablets.
Take your tablet at the same time each day unless your doctor tells
you otherwise. If you are taking 2 tablets a day, take one in the
morning and one in the evening, unless your doctor has told you
otherwise.
If you take more Enalapril Tablets than you should:
If you take too many tablets by mistake contact your doctor
IMMEDIATELY.
Take the medicine pack with you. The following side 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 Enalapril Tablets:
Do not take a double dose to make up for a forgotten tablet. If you
miss a dose just carry on with the next one as normal, but make sure
you tell your doctor.
If you stop taking Enalapril Tablets:
Your doctor will tell you when you should stop taking Enalapril Tablets.
If you have any further questions on the use of this product, 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 Enalapril Tablets and talk to a doctor straight away, if
you notice any of the following:

• changes in blood values such as 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 the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced amount of urine
• high levels of liver enzymes or bilirubin (measured in a blood test)
• enlargement of the breast in males (gynaecomastia).
Very rare (may affect up to 1 in 10,000 people)
• swelling in your intestinal (intestinal angioedema).
Not known (frequency cannot be estimated from the available data)
• over production 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/vasculitits), muscle pain (myalgia/mysitis), joint
pain (arthralgia/arthritis). Rash, photosensitivity or other skin
manifestations may occur.
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 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 TABLETS
Do not store above 25°C. Store in the original package. Do not put
them into another container as they might get mixed up.
Keep them in the pack in which they are supplied.

• 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).
• inflammation of your pancreas
• rash that looks like targets (erythema multiforme)
• ‘Stevens-Johnson syndrome’ and ‘toxic epidermal necrolysis’
(serious skin conditions where you have reddening and scaling of
the skin, blistering or raw sore), exfoliative dermatitis/ erythroderma
(severe skin rash with flaking or peeling of the skin), pemphigus
(small fluid-filled bumps on the skin)
• liver or gallbladder problems such as lower liver function,
inflammation of your liver, jaundice (yellowing of the skin or eyes)

Keep out of the sight and reach of children.

You should be aware that black patients are at increased risk of these
types of reactions. If any of the above happen, stop taking Enalapril
Tablets 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 cause by your blood pressure lowering. It should
improve as you continue to take the medicine. If you are worried,
please talk to your doctor.

What Enalapril Tablets look like and contents of the pack
Each tablet is white, circular, biplanar and uncoated with either 5, 10
or 20 embossed on one face and a score line on the other.
Enalapril 5 mg, 10 mg and 20 mg tablets are available in packs of 28.

Other side effects include:
Very Common (may affect more than 1 in 10 people)
• felling 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).

Do not use Enalapril Tablets after the expiry date which is stated on
the blister and the carton after EXP or EXP. DATE.
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 Tablets contains
The active substance is Enalapril Maleate. The other ingredients are
Lactose, Maize Starch and Glycerol Distearate.

Product Licence Holder and Manufacturer
The product licence holder for your tablets is PharmaDreams Ltd,
Old Police Station, Church Street, Swadlincote, DE11 8LN.
Your tablets are manufactured by IPG Pharma Ltd, Atrium Court,
The Ring, Bracknell, Berkshire, RG12 1BW.
PL 28395/0001, PL 28395/0002, PL 28395/0003
If you would like this leaflet in a different format please contact the
licence holder at the following address: Atrium Court, The Ring,
Bracknell, Berkshire, RG12 1BW.
This leaflet was last revised in May 2017.

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)
• 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 levels of proteins in your urine (measured in a test)
• low levels of blood sugar or sodium, high levels 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
cold and white due to low blood flow

A003/UK/Z/04

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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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