ENALAPRIL 10MG TABLETS

Active substance: ENALAPRIL MALEATE

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PROPOSED
PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL 5/10/20 mg TABLETS
Enalapril Maleate
Read all of this leaflet carefully before you start taking this medicine.
 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What ENALAPRIL 5, 10 and 20 mg Tablets (referred to as Enalapril Tablets in this leaflet) are and what they
are used for
2. Before you take Enalapril Tablets
3. How to take Enalapril Tablets
4. Possible side effects
5. How to store Enalapril Tablets
6. Further information
1. WHAT ENALAPRIL TABLETS ARE AND WHAT THEY ARE USED FOR
Enalapril Tablets belong to a group of medicines known as 'ACE inhibitors'. Your doctor has probably prescribed
Enalapril Tablets for one of the following reasons which will have been explained to you:
 Your blood pressure is too high.
 You have a heart condition sometimes referred to as 'heart failure'. This means that your heart is not working
as well as it used to, in order to pump blood around your body, leading to tiredness after light exercise,
breathlessness and swelling of you rankles and legs.
Enalapril tablets may prevent heart failure from getting worse in some patients who have symptoms.
These patients may be less likely to go into hospital for treatment of heart failure.
In many patients with early stage heart failure who have no symptoms, including those who have had a heart
attack, Enalapril may help to reduce the possibility of your heart from weakening further (that is, to help reduce
the possibility of you developing heart failure).
Enalapril tablets may slow down the development of the signs of heart failure such as tiredness after light
exercise, breathlessness and swelling of your ankles and feet. Such patients may be less likely to have to go into
hospital for treatment for heart failure.
By taking Enalapril tablets, some heart-failure patients (with or without symptoms) may lessen their risk of heart
attack.
2. BEFORE YOU TAKE ENALAPRIL TABLETS
Do not take Enalapril Tablets
 if you are allergic (hypersensitive) to enalapril or any of the other ingredients of Enalapril Tablets and have
experienced symptoms such as itching, nettle rash, wheezing or swelling of the hands, throat, mouth or
eyelids.
 if you are more than 3 months pregnant. (It is better to avoid Enalapril Tablets in early pregnancy – see
pregnancy section).
 if you are breast-feeding.
 if you have a condition called 'aortic stenosis' or 'outflow obstruction'.
If you think any of these apply to you do not take the tablets. Talk to your doctor first and follow the advice given.

PROPOSED
Take special care with Enalapril Tablets
 If you have kidney disease or are a dialysis patient, check with your doctor before taking Enalapril Tablets. In
addition you should tell your doctor if you suffer from excessive vomiting or diarrhoea.
 In addition to measuring your blood pressure your doctor may wish you to have a blood test to check that
your kidneys are working properly before you start taking the tablets and at intervals during your treatment.
 If you are about to have a treatment called LDL apheresis, which is removal of cholesterol from your blood by
a machine, you should tell the doctor who is treating you that you are taking Enalapril Tablets.
 If you undergo any surgery or receive anaesthetics (even at the dentist), you should make the doctor or
dentist treating you aware that you are taking Enalapril Tablets.
 If you think you are (or might become) pregnant. Enalapril 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 suffer from lactose intolerance it is important to tell your doctor. Lactose is one of the inactive
ingredients in Enalapril Tablets.
 If you are about to have desensitisation treatment, that is treatment to reduce the effects of an allergy to bee
or wasp stings, you should tell the doctor who is treating you that you are taking Enalapril Tablets.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
Taking Enalapril Tablets with food and drink
The absorption of Enalapril Tablets is not affected by food intake.
Enalapril Tablets and alcohol can have additive effects and may cause dizziness or light-headedness.
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.
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 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.
Enalapril 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
Enalapril. In the case of an older baby your doctor should advise you on the benefits and risks of taking Enalapril
whilst breast-feeding, compared to other treatments.
Driving and using machines
There is no indication that taking Enalapril Tablets affects the ability to drive and use machines. However, care
should be taken and, if affected, do not drive or operate machines.
Important Information about some of the Ingredients of Enalapril Tablets
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. You should check with your doctor or
pharmacist if you are not sure. The dose you take will depend on your condition and whether you are taking any
other treatment. The usual dose is:

PROPOSED
High blood pressure: treatment is usually started with 5 mg once a day, and increased gradually up to 10-20 mg
once daily. The maximum dose is 40 mg a day. Some patients may start on a lower dose of 2.5 mg once a day.
Heart failure: the usual recommended starting dose is 2.5 mg a day, which 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.
Taking Enalapril tablets with a diuretic: the recommended initial dose of Enalapril Tablets 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 your
Enalapril Tablets.
You should 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.
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.
lf 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, Enalapril Tablets can cause side effects, although not everybody gets them.
It is very important that you stop taking Enalapril Tablets immediately and see your doctor if you have severe
dizziness, light-headedness (especially at the start of treatment or when the dose is increased or when you stand
up). It is vital to stop taking Enalapril Tablets and seek medical attention immediately if you begin to itch, get
short of breath or wheezy and develop swelling of the hands, mouth, throat, face or eyes.
Other general side effects of Enalapril Tablets seen in a few patients are dizziness, headaches, tiredness,
weakness, fainting, mild tummy upsets, nausea, diarrhoea, muscle cramps, rash or a cough. Enalapril Tablets
may have an effect on the kidneys of a very small number of patients, usually with other conditions. This is
recognisable by feeling generally unwell, possible itching of the skin and swelling of the ankles, and a decrease
in the amount of urine passed.
There are, in addition, a few other very rare side effects seen only in a very small minority of patients. These
include effects on the heart such as chest pain (which may occur after exercise) and palpitations; effects on the
digestive system which can cause abdominal and back pain, vomiting, heartburn, constipation, loss of appetite,
sore mouth and tongue and taste alteration; effects on the skin such as blisters, hair loss and excessive
sweating.
Other very rare effects are jaundice (symptoms may be yellowing of the skin and/or whites of the eyes), stroke,
depression, confusion, difficulty in sleeping, nervousness, pins and needles, vertigo, abnormal accumulation of
substances in the lungs, sore throat and hoarseness, sexual inability in men, flushing, increased sensitivity to
sunlight, runny nose, ringing in the ears, blurred vision, fever, and inflamed and aching muscles and joints. If you
notice any of the above effects or if you have any other unusual symptoms or feelings, you should contact your
doctor as soon as possible.
Whilst you are taking this medicine it may affect tests your doctor may perform on blood or urine samples. Please
remind your doctor that you are taking Enalapril tablets if ever he/she wants to carry out such a test.
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.

PROPOSED

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.
Keep out of the reach and sight of children.
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. FURTHER INFORMATION
What Enalapril Tablets contains
 The active substance is enalapril maleate
 The other ingredients are lactose monohydrate; maize starch and glycerol distearate
What Enalapril Tablets look like and contents of the pack
Each tablet is white circular biplanar 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 the packs of 28.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited
11 Boumpoulinas, 3rd Floor
1060 Nicosia, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
This leaflet was last revised in 07/2013

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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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