Patient leaflet - Enalapril Maleate 10 mg tablets

1. What Enalapril maleate Tablets are and what they are used for

Enalapril maleate belongs to the class of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Enalapril maleate Tablets are used:

to treat high blood pressure (hypertension)
to treat heart failure (weakening of heart
function). It can lower the need to go to hospital and can help some patients live longer.
to prevent signs of heart failure. The signs
include shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen.

2. What you need to know before you take Enalapril maleate Tablets

Do not take Enalapril maleate Tablets

if you are allergic (hypersensitive) to enalapril
maleate 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 maleate tablets 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 have taken or are currently taking
sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril maleate Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril maleate 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), are on a salt- restricted diet, are taking potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections]). 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 maleate Tablets or monitor your blood level of potassium. See also information under the heading “Other medicines and Enalapril maleate Tablets”
if you are having dialysis
if you have 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 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 suppresses immune system, are taking drugs allopurinol or procainamide, or any combinations of these
if you are taking any of the following
medicines, the risk of angiodema may be increased:
- Racecadotril, a medicine used to treat
  diarrhoea;
- Medicines used to prevent organ
  transplant rejection or for cancer (e.g., temsirolimus, sirolimus, everlimus)
- Vildagliptin, a medicine used to treat
  diabetes.
  - 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), 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 maleate Tablets”.

You must tell your doctor if you think you are (or might become) pregnant. This medicine 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). 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 about to have a procedure:

If you are about to have any of the following, tell your doctor that you are taking Enalapril maleate Tablets:

any surgery or receive anesthetics (even at dentist)
a treatment to remove cholesterol from your blood called ‘LDL apheresis’
a desensitisation treatment, to lower the effect 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 maleate 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 maleate Tablets can affect the way some medicines work. Also, some other medicines can affect the way Enalapril maleate Tablets work. Your doctor may need to change your dose and/or to take other precautions. In particular tell your 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 headings “Do not take Enalapril maleate Tablets” and “Warnings and precautions”)
other medicines that lower blood pressure, such as beta blockers or water tablets (diuretics)
Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots). See also information under the heading “Warnings and precautions”.
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 substances called ‘sympathomimetic agents’
certain pain or arthritis medicines including gold therapy.
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)
medicines used to dissolve blood clots
(thrombolytics)
an mTOR inhibitor (e.g., temsirolimus, 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”
a medicine containing a neprilysin inhibitor such as sacubitril (available as fixed-dose combination with valsartan), racecadotril or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) may be increased. See also information under the headings “Do not take Enalapril maleate Tablets”.
alcohol

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

Enalapril maleate Tablets with food, drink and alcohol

Enalapril maleate tablets can be taken with or without food. Most people take Enalapril maleate Tablets with a drink of water.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 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. 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 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril maleate 2.5mg Tablets Enalapril maleate 5mg Tablets Enalapril maleate 10mg Tablets Enalapril maleate 20mg Tablets

enalapril maleate

Driving and using machines

You may feel dizzy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines.

Enalapril maleate Tablets contain lactose

This product contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Enalapril maleate Tablets

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. • It is very important to continue taking

Enalapril maleate Tablets for as long your doctor prescribes it.

Do not take more tablets than prescribed. • The score line is only there to help you break
the tablet if you have difficulty swallowing it whole.

High Blood Pressure

The usual starting dose ranges from 5 to 20 mg
taken once a day.
Some patients may need lower starting dose. • The usual long term dose is 20 mg taken once
daily.
The maximal long term dose is 40 mg once a
day.

Heart Failure

The usual starting dose is 2.5 mg taken once a
day.
Your doctor will raise this amount step by
step until the dose that is right for you has been achieved.
The usual long term dose is 20 mg each day
taken in one or two doses.
The maximal long term dose is 40 mg each
day, divided in two doses.

Elderly patients

Your dose will be decided by your doctor and will be based on how well your kidneys are working.

Patients with kidney problems

Your dose of medicine will be changed depending on how well your kidneys are working:

moderate kidney problems – 5 mg to 10 mg
each day
severe kidney problems – 2.5 mg each day • if you are having dialysis – 2.5 mg each day.
On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

Use in children

Experience in the use of this medicine in children with high blood pressure is limited. If the child can swallow tablets, the dose will be worked out using the child’s weight and blood pressure. The recommended starting doses are: • between 20 kg and 50 kg – 2.5 mg each day • more than 50 kg – 5 mg each day. The dose can be changed according to the needs of the child:

a maximum of 20 mg daily can be used in
children who are between 20 kg and 50 kg - a maximum of 40 mg daily can be used in
children who are more than 50 kg. This medicine is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.

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.

The following 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 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 medicine ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Enalapril maleate Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Enalapril maleate Tablets and talk to a doctor straight away, if you notice any of the following:

swelling of the face, lips, tongue or throat which
may cause difficulty in breathing or swallowing. This can occur at any time during treatment. • swelling of your hands, feet or ankles • if you develop a raised red skin rash (hives) You should be aware that black patients are at increased risk of these types of reactions. If any of the above happens, 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 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 side effects include:

Very common (may affect more than 1 in 10 people)

feeling 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), inflammation of your pancreas • 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 level of proteins in your urine (measured in a test)
- low level of blood sugar or sodium, high level of blood urea (all measured in blood tests)

Rare (may affect up to 1 in 1,000 people) • ‘Raynaud’s phenomenon’ where your hands and feet may become very cold and pale due to low blood flow

changes in blood values such as a 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 your nose
inflammation of the lungs causing difficulty in breathing (pneumonia)
inflammation of the cheeks, gums, tongue, lips, throat
reduced amount of urine
rash that looks like targets (erythema multiforme)
'Stevens-Johnson syndrome' and 'toxic epidermal necrolysis' (serious skin conditions where you have reddening and scaling of your skin, blistering or raw sores), 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), high levels of liver enzymes or bilirubin (measured in a blood test)
enlargement of breasts in males
(gynaecomastia).

Very Rare (may affect up to 1 in 10,000 people) • swelling in your intestine (intestinal angioedema)

Not known (frequency cannot be estimated from the available data)

overproduction 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/vasculitis), muscle pain (myalgia/ myositis), 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril maleate tablets

Keep this medicine out of the sight and reach 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Enalapril maleate Tablets contain

The active substance is enalapril maleate either 2.5 mg, 5 mg, 10 mg or 20 mg

The other ingredients are lactose monohydrate, maize starch and glycerol palmitostearate.

What Enalapril maleate Tablets look 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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Milpharm Limited

1 Roundwood Avenue,

Stockley Park,

Uxbridge,

UB11 1AF

United Kingdom

Manufacturers: