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ENALAPRIL 5MG TABLETS

Active substance: 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. hat you need to know before you take Enalapril Tablets
W
3. ow to take Enalapril Tablets
H
4. ossible side effects
P
5. ow to store Enalapril Tablets
H
6. ontents of the pack and other information
C
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.
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
Do not take Enalapril Tablets:
• if you are hypersensitive (allergic) to Enalapril or any of the other ingredients of Enalapril
Tablets. The symptoms of an allergic reaction include itching, nettle rash, wheezing or
swelling of the hands, throat, mouth or eyelids. You can find a list of the ingredients of this
medicine in Section 6 of this leaflet
• if you are more than 3 months pregnant. (It is also better to avoid Enalapril in early pregnancy
- see pregnancy section)
• if you have a heart condition called ‘aortic stenosis’ or ‘outflow obstruction’ (narrowing of a
valve in your major artery (aorta) causing restricted blood flow around your body)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.
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.
Warnings and precautions
Tell your doctor before taking these tablets if any of the following points apply to you:
• if you have kidney disease or are a dialysis patient
• if you suffer from excessive vomiting or diarrhoea
• if you are on a low salt diet (sometimes called a low sodium diet)
• 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 this stage (see pregnancy section)
• if you are Afro-Caribbean as Enalapril may not work as well as expected.
• if you are taking any of the following medicines used to treat high blood pressure:
- an “angiotensin II receptor blocker” (ARBs) (also known as sartans - for example
valsartan, telmisartan, irbesartan, etc.), in particular if you have diabetes-related 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 Enalapril tablets”.
If you are due to undergo any of the following procedures you must tell the doctor who is
treating you 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.
Tests before and while taking this medicine
Your doctor will monitor your blood pressure before and during your treatment with this medicine.
You may also be required 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.
Taking other medicines
Tell your doctor before taking this medicine if you are already taking any of the following:
• Other medicines to lower your blood pressure such as beta blockers (e.g. Propranolol).
methyldopa, calcium antagonists and diuretics (water tablets).
• Potassium supplements or salt substitutes containing potassium.
• Allopurinol (used to treat gout).
• Procainamide (used to treat abnormal heart rhythms).
• Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. diclofenac, ibuprofen.
• Antacids used to treat heartburn or digestive discomfort.
• Immunosuppressive drugs e.g. cyclosporine or corticosteroids.
• Medicines used to treat diabetes e.g. insulin.
• Medicines to treat pain or to help you sleep e.g. morphine.
• Medicines to treat some psychiatric illnesses e.g. antipsychotics and lithium.
• Medicines to treat cancer.
• Medicines such as ephedrine, noradrenaline and adrenaline.
Tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information
under the headings “Do not take Enalapril tablets” and “Take Special care with Enalapril
tablets”).
Taking Enalapril Tablets with food and drink
The absorption of Enalapril Tablets is not affected by food intake.
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
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 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
These tablets contain Lactose which is a type of sugar. Contact your doctor before taking these
tablets if you are Lactose intolerant.

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. The dose you take will depend on your condition and whether you
are taking any other treatment.
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.
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, these tablets can cause side effects, although not everybody gets them.
Serious side effects - If you get any of the side effects shown in the list below STOP TAKING
the tablets and seek medical attention IMMEDIATELY:









severe dizziness or light-headedness
itching
blistering of the skin, mouth, eyes or
genitals
swelling of the hands, feet, mouth,
throat or face (Afro-Caribbean patients
may have a higher risk of this side
effect)










shortness of breath or wheezing
pain or tightness in the chest, neck,
shoulders or arms
numbness or weakness on one side of the
body (e.g. a drooping arm, leg or lower
eyelid, or a dribbling mouth)
slurred speech and/or blurred vision
confusion or unsteadiness.

These could be the sign of kidney failure, heart attack, stroke or a serious allergic reaction (such
as Stevens-Johnson syndrome or toxic epidermal necrolysis).
Other serious side effects - If you get any of the side effects shown in the list below STOP
TAKING the tablets and seek medical attention IMMEDIATELY:






Pancreatitis - symptoms include abdominal pain, nausea.
Liver problems including hepatitis and jaundice (yellowing of the skin or eyes).
Build up of fluid in the lungs causing difficulty breathing.
Light-headedness when you stand up (especially at the start of treatment or when the dose is
increased).

Other side effects - If you experience any of the side effects listed below and you are worried,
tell your doctor:

















Asthma or Cough.
Chest pain.
Palpitations or Irregular heartbeat.
Indigestion.
Constipation.
Diarrhoea.
Digestive problems.
Loss of appetite.
Urinating less.
Sore mouth and tongue.
Dizziness or Headaches.
Tiredness or Weakness.
Fainting.
Feeling sick or being sick.
Muscle cramps.
Feeling generally unwell.


















Depression or Confusion.
Difficulty in sleeping.
Nervousness.
Pins and needles.
Vertigo.
Sore throat and hoarseness.
Sexual inability in men.
Fever or Flushing.
Increased sensitivity to sunlight.
Runny nose.
Ringing in the ears.
Blurred vision.
Taste alteration.
Hair loss.
Excessive sweating.
Swollen or painful muscles or joints.

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.
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.
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. 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.
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.
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 April 2015.

POM
A003/UK/Y

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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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