Enalapril 20mg tablets

Main information

  • Trade name:
  • Enalapril 20mg tablets
  • Dosage:
  • 20mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enalapril 20mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02050501

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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.

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 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.

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

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.

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

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.

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 are not sure if any of the above applied to you, talk to your

doctor or pharmacist before taking 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

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 breast-

feeding. 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

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL 5, 10 and 20 mg Tablets

Enalapril Maleate

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:

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)

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.

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).

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

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.

Keep out of the sight and reach 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 May 2017.

A003/UK/Z/04