Active substance: ENALAPRIL MALEATE

View full screen / Print PDF » Download PDF ⇩

Enalapril maleate 2.5mg Tablets
Enalapril maleate 5mg Tablets
Enalapril maleate 10mg Tablets
Enalapril maleate 20mg Tablets
(Enalapril maleate)
Read all of this leaflet carefully before you start taking this medicine.
· leaflet. You may need to read it again.
Keep this
· any further questions, ask your doctor or pharmacist.
If you have
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.
·the side effects gets serious, or if you notice any side effects not listed in this leaflet,
If any of
please tell your doctor or pharmacist.
In this leaflet:
1. What is Enalapril maleate Tablet and what is it used for.
2. Before you take Enalapril maleate Tablet
3. How to take Enalapril maleate Tablet
4. Possible side effects
5. How to store Enalapril maleate Tablet
6. Further information


Enalapril maleate belongs to the class of medicines called Angiotensin converting enzyme inhibitors
(ACE inhibitors). Tin works by causing blood vessels to relax, lowering blood pressure and increasing
the supply of blood and oxygen to the heart.
Enalapril maleate Tablets are used
To treat high blood pressure (hypertension)
To treat heart failure (weakening of heart function)
· signs of heart failure. The signs include shortness of breath, tiredness after light
To prevent
physical activity such as walking, or swelling of the ankles and feet.


Do not take Enalapril maleate Tablets
· allergic (hypersensitive) to enalapril maleate, any of the other ingredients in these
If you are
tablets or other ACE inhibitors (see Section 6 and end of Section 2)
· previously developed swelling especially over the face, lips or mouth, rashes or
If you have
difficulty breathing after taking any medicines
· more than 3 months pregnant. (It is also better to avoid Enalapril maleate tablets in
If you are
early pregnancy – see Pregnancy section)
Do not take Enalapril Maleate if any of the above applies to you. If you are not sure, talk to your doctor
or pharmacist before taking Enalapril maleate Tablets.
Take special care with Enalapril maleate Tablets
You should let your doctor know:
· 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
If you have
(neutropenia/agranulocytosis), low blood pallet count (thrombocytopenia) or a decreased
number of red blood cells (anaemia)
· ever had allergic reaction with swelling of the face, lips, tongue or throat with
If you have
difficulty swallowing pr breathing.
· kidney problem (including kidney transplantation). These may lead to higher levels
If you have
of potassium in your blood which can be serious. Your doctor may need to adjust your dose of
Enalapril maleate Tablets or monitor you blood level of potassium
· on a salt restriction diet, are taking potassium containing medicines or supplements,
If you are
potassium-sparing agents, salt substitutes or low-salt milk.
· been very sick (excessive vomiting) or had bad diarrhoea recently
If you have
· diabetes. You should monitor your blood for low blood glucose levels, especially
If you have
during the first month of treatment. The level of potassium in your blood can also be higher
· a liver problem or develop jaundice (yellowing of the skin and white of the eye)
If you have
· having dialysis
If you are
· over 70 years of age
If you are
· low blood pressure (you may notice this as faintness or dizziness, especially when
If you have
If you have collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or
scleroderma), are on therapy that suppresses immune system, are taking drugs allopurinol or
procainamide, or any combinations of these
· you are (or might become) pregnant. Enalapril maleate Tablets are not
If you think
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
· breast-feeding or about to start breast feeding (see Breast-feeding section)
If you are
You should be aware that Enalapril maleate Tablets lowers blood pressure in black people less
effectively than in non-black patients
If you are not sure of any of the above apply to you, talk to your doctor or pharmacist before taking
Enalapril maleate Tablets.
If you are about to have a procedure:
If you are bout to receive any of the following, tell your doctor that you are taking Enalapril maleate
any surgery or receive anesthetics (even at dentist)



Enalapril maleate


Enalapril maleate


desensitisation treatment with hymenoptera venom (e.g. bee or wasp venom)
· called LDL apheresis to remove cholesterol form your blood machine
If any of the above applies to you, talk to your doctor or dentist before procedure
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. This includes herbal medicines. Some medicines
can affect the way Enalapril maleate Tablets works.
It is especially important to tell your doctor if you are taking any of the following:
Other medicines that lower blood pressure, such as beta blockers, vasodilators or water tablets
· containing potassium (including dietary salt substitutes)
·used for the treatment of certain kind of depression
·antidepressants such as amitriptyline used for treating depression
· for mental problems called 'antipsychotics'
Certain cough and cold medicines and weight reducing medicines which contain substances called
'sympathomimetic agents'
Certain pain or arthritis medicines including gold
Barbiturates (sedatives used for sleeplessness or epilepsy)
Cholestyramine (used to help control cholesterol levels)
· for the treatment of cancer
Antidiabetic drugs including oral agents to lower blood sugar and insulin
· (used to treat gout)
· (immunosuppressive agents for autoimmune disorders)
Procainamide used to treat abnormal heart rhythms
Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-inhibitors (medicines that reduce
inflammation, and can be used to help relieve pain)
Aspirin (acetylsalicylic acid)
· used to dissolve blood clots (thrombolytics)
Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions,
asthma or certain blood disorders
· (used for the relief of indigestion)
If you are not sure of any of the above apply to you, talk to your doctor or pharmacist before taking
Enalapril maleate Tablets.
Taking Enalapril maleate Tablets with food and drink
Enalapril maleate tablets can be taken with or without food. Do not drink alcohol while taking Enalapril
maleate tablets. It may cause your blood sugar levels to drop too much and you may experience
dizziness, light-headedness or faintness.
Pregnancy and breast-feeding
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 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
Tablets. Enalapril maleate tablets are 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.
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
Enalapril maleate Tablets. In the case of an older baby your doctor should advise you on the benefits
and risks of taking Enalapril maleate Tablets whilst breast-feeding, compared to other treatments.
Driving and using machines
As this medicine may make you feel dizzy, you should not drive or operate machinery until you know
how the drug affects you.
Important information about some of the ingredients of Enalapril maleate Tablets
This product contains lactose - if you know you have intolerance to some sugars, contact your doctor
before use.


Always take your medicine exactly as your doctor told you. If you are unsure about how to take your
tablets, ask your doctor or pharmacist.
· important to continue taking Enalapril maleate Tablets for as long your doctor
It is very
prescribes it.
Do not take more tablets than prescribed.
You should take your tablet at the same time each day unless your doctor tells you otherwise. If you are
taking your medicine twice daily (2 tablets a day), take one tablet in the morning and one in the evening,
unless your doctor has told you otherwise.
Usual dose to be swallowed with a glass of water:
High blood pressure:
· starting dose is form 5mg to 20mg taken once a day
The usual
Some patients may need lower starting dose
· long term dose is 20mg taken once daily
The usual
The maximal long term dose is 40mg once a day
Heart failure:
· starting dose is 2.5mg taken once a day
The usual
· will raise this amount step by step until the dose that us right for you has been
Your doctor
· long term dose is 20mg taken in one or two doses
The usual
The maximal long term dose is 40mg 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:
· kidney problems – 5mg to 10mg each day
Severe kidney problems – 2.5mg each day
· having dialysis – 2.5mg each day. On days you are not having dialysis, your dose
If you are
may be changed depending on how low your blood pressure is.
Children: Not for use in children
If you take more Enalapril maleate Tablets than you should
Do not take more medicine than your doctor tells you to. If you or anyone else has swallowed more
tablets than doctor have prescribed, contact your nearest hospital causality department or doctor
immediately. Take the medicine pack with you.
If you forget to take Enalapril maleate Tablets
If you forget to take a dose, 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 Enalapril Tablets
Do not stop taking your medicine, unless your doctor has told you to.
If you have any further questions on the use of this product ask your doctor or pharmacist.


Like all medicines Enalapril maleate Tablets can cause side effects, although not everybody gets them.
If you develop any of the following reactions stop taking these tablets and contact your doctor
If you develop severe dizziness or lightheadedness (especially at the start of the treatment or
when the dose is increased)
· of the face, lips, tongue or throat which may cause difficulty in breathing or
· of your hands, feet or ankles
· unexpected rash or burning, red or peeling skin
A sudden,
· or fever
Sore throat
You should be aware that black patients are at increased risk of these types of reactions. If any of the
above happens, stop taking Innovance and talk to doctor straight away.
You may feel dizzy when you start taking Enalapril maleate Tablets. 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 possible side effects include:
Very common (affects more than 1 in 10 people)
Feeling dizzy, weak or sick
Blurred vision
Common side effects (affecting between 1 in 10 and 1 in 100 people)
· or abdominal pain, rash
· fainting (syncope)
· pressure, changes in heart rhythm, fast heartbeat, angina or chest pain
Low blood
· or fatigue, depression
Allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or
· potassium level, increased levels of creatinine in your blood (both are detected by a
·in sense of taste, shortness of breath
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)
Indigestion, ,vomiting, constipation, anorexia (loss of appetite)
Slow movement of food through your intestine, inflammation of your pancreas
Irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure
Runny nose, sore throat or hoarseness
·fall in blood pressure (you may experience dizziness, fainting or light-headedness)
Fast or uneven heart beats (palpatations)
Heart attack (possibly due to very low blood pressure in certain high-risk patients, including
those with blood flow problems of heart or brain)
· (including aplastic and haemolytic)
Stroke (possibly due to very low blood pressure in certain high-risk patients)
· difficulty sleeping, sleepiness, nervousness
Feeling your skin prickling or being numb
· your ears (tinnitus)
Ringing in
· perspiration
· nettle rash
Itching or
Loss of hair
Muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever),
· of proteins in your urine (measured in a test)
High level
· of blood sugar or sodium, high level of blood urea (all measured in blood tests)
Low level
Rare side effects (affecting between 1 in 1000 and 1 in 10000 people)
· phenomenon' where your hands and feet may become very cold and pale due to
low blood flow
Bone marrow depression
Autoimmune diseases

·dreams or sleep problems
· infiltrates
Inflammation of your nose
Inflammation of the cheeks, gums, tongue, lips, throat
Lower amount of urine produced
Skin disorder due to an allergic reaction or infection called Erythema multiforme
Inflammation of the liver, liver disease, increase in liver enzymes or bilirubin (measured in
tests), jaundice (yellowing of the skin and/or eyes)
Stevens-Johnson syndrome' a serious skin condition where you have reddening or scaling of
your skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers
Blood disorders including changes in blood values such as lower number of white and red
blood cells, lower haemoglobin, lower number of blood platelets
· breasts in men
Very rare side effects (affecting less than 1 in 10000 people)
· in your intestine (intestinal angioedema)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.


Keep out of the reach and sight of children.
Do not take Enalapril maleate tablets after the expiry date on the carton; the expiry date refers to the
last day of the month.
Do not store above 25°C.
Store in the original packaging.
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.


What Enalapril maleate Tablets contain
The active substance is Enalapril maleate 2.5mg, 5mg, 10mg or 20mg per tablet.
The other ingredients are Lactose monohydrate, Maize starch and Glycerol palmitostearate.
What Enalapril maleate Tablets looks like and contents of the pack
Enalapril maleate Tablets are white to off-white round flat beveled edged tablets marked with '2.5'
(2.5mg), '5' (5mg), '10' (10mg) or '20' (20mg), on one side and break line on the other.
They are supplied in blister packs of 28 tablets and bottles containing 50 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
United Kingdom
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
United Kingdom
APL Swift Services (Malta) Ltd.,
Hf26, Hal Far Industrial Estate,
Hal Farm Bizebbugia, BBG 3000
The leaflet was last revised in (06/2012)


Elderly (65 years and over)
Your dose will be decided by your doctor and will be based on how well your kidneys are working.

Expand view ⇕

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.