ENALAPRIL Maleate 5/10/20 mg Tablets – patient leaflet, side effects, dosage

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

Enalapril Tablets contain an active ingredient called enalapril maleate. This belongs to a group of medicines called Angiotensin converting enzyme inhibitors (ACE inhibitors). It works by causing blood vessels to relax, lowering blood pressure and increasing the supply of blood and oxygen to the heart.

Enalapril 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 Tablets

Do not take Enalapril Tablets:

• if you are allergic (hypersensitive) to enalapril maleate or any of the other ingredients of

  Enalapril tablets (listed in Section 6).

• if you have ever had an allergic reaction to a type of medicine similar to Enalapril tablets 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 unknown 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)
• asthma - associated tightness in chest
• slow movement of food through your intestine (ileus), inflammation of your pancreas
• being sick (vomitting), indigestion, constipation, anorexia
• irritated stomach (gastric irritations), dry mouth, ulcer
• increased sweating
• itching or nettle rash
• hair loss
• impaired kidney function, kidney failure
• impotence
• high level of proteins in your urine (measured in a test)
• muscle cramps
• flushing
• generally feeling unwell (malaise), high temperature, fever
• ringing in your ears (tinnitus)

Rare (may affect up to 1 in 1000 people)

• strange dreams or sleep problems

• Raynaud’s phenomenon, where your hands and feet may become very cold and white

  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
• 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
• 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, blisterings or raw sores), exfoliative dermatitis/erythroderma (severe skin rash with flaking or peeling of the skin), pemphigus (small fluid-filled bumps on the skin)

• reduced amount of urine

• 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.

  • 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 applies to you, talk to your doctor or pharmacist before taking Enalapril maleate Tablets.

Enalapril Tablets with food, drink and alcohol

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

Do not drink alcohol whilst taking Enalapril Tablets. It may cause your blood sugar levels to drop too much and you may experience dizziness, light- headedness or fainting.

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. Enalapril 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.

Breast-feeding:

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding new born babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Enalapril Tablets. In the case of older infants, your doctor should advise you on the benefits and risks of taking Enalapril Tablets whilst breast-feeding, compared to other treatments.

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 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 Tablets

Always take your medicine exactly as directed by your doctor. 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.

  LENA02/03

If you stop taking Enalapril Tablets

Do not stop taking your medicines, unless your doctor has told you to. 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. 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 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)

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)

• blurred vision
• feeling dizzy, weak or sick
• cough

Common (may affect up to1 in 10 people)

• headache, depression, fainting (syncope), change in sense of taste
• light-headedness due to low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain
• shortness of breath
• diarrhoea, abdominal pain
• rash, allergic reactions with swelling of the hands, lips, tongue or throat with difficulty in swallowing or breathing
• tiredness (fatigue)

• 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)

• 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)
• low level of blood sugar or sodium, high level of blood urea (all measured in blood tests)
• confusion, sleeplessness or sleepiness, or nervousness
• feeling your skin prickling or being numb
• vertigo (spinning sensation)

• runny nose, sore throat or hoarseness

  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 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 Tablets

• Keep this medicine out of sight and reach of children.
• Do not store above 25 ºC.

• 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.

• 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 dibehenate.

What Enalapril Tablets look like and contents of the pack

Enalapril tablets are white circular biplanar uncoated with 5, 10 or 20 embossed on one face and a score line on the other. They are supplied in blister packs of 28 tablets

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 020 33998960 (UK only)

Please be ready to give the following information:

Product name Reference number

Enalapril Maleate 5mg tablets PL 44041/0012

Enalapril Maleate 10mg tablets PL 44041/0013

Enalapril Maleate 20mg tablets PL 44041/0014

This leaflet was last revised in March 2025

Marketing Authorisation Holder and Manufacturer:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road

Maidenhead, Berkshire, SL6 2RB, United Kingdom

1 8 7 6

LENA01/03 • 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 5mg to 20mg taken once daily.
• Some patients may need lower starting dose
• The usual long term dose is 20mg taken once daily
• The maximal long term dose is 40mg once daily

Heart Failure

• The usual starting dose is 2.5mg taken once daily
• 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 20mg daily, taken in one or two doses
• The maximal long term dose is 40mg once daily, divided in two doses

Patients with kidney failure

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

• Moderate kidney problems – 5mg to 10mg daily
• Severe kidney problems – 2.5mg daily

• If you are having dialysis – 2.5mg daily.

  On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

Elderly patients

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

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 20kg to 50kg – 2.5mg each day
• More than 50kg – 5mg each day

The dose can be changed according to the needs of the child:

• a maximum of 20mg daily can be used in children who are between 20kg-50kg
• a maximum of 40mg daily can be used in children who are more than 50kg Enalapril maleate Tablets are not recommended in new born babies (first few weeks after birth) and in children with kidney problems

If you take more Enalapril 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 casualty 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 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.

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 or have recently taken, or might take any other medicines. This included 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 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’

• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-inhibitors medicine

  that reduce inflammation, and can be used to help relieve pain

• certain pain or arthritis medicine including gold therapy

• certain cough and cold medicines and weight reducing medicines which contain

  substances called sympathomimetic agents

• aspirin (acetyl salicylic acid)
• 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 Enalapril Tablets if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Enalapril 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 low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• if you have a liver problem

• if you have a blood problems 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 kidney problem (including kidney transplantation), are on 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 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 been very sick (excessive vomiting) or had bad diarrhoea recently.

• 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