The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above. The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14017/0030. ENALAPRIL MALEATE TABLETS 2.5 mg ENALAPRIL MALEATE TABLETS 5 mg ENALAPRIL MALEATE TABLETS 10 mg ENALAPRIL MALEATE TABLETS 20 mg (enalapril maleate)
1. What ENALAPRIL MALEATE TABLETS are and what they are used for 2. What you need to know before you take ENALAPRIL MALEATE TABLETS 3. How to take ENALAPRIL MALEATE TABLETS 4. Possible side effects 5. How to store ENALAPRIL MALEATE TABLETS 6. Contents of the pack and other information ENALAPRIL MALEATE TABLETS (referred to as ‘ENALAPRIL’ throughout this leaflet) contains the active substance enalapril maleate. ‘ENALAPRIL’ belongs to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). ‘ENALAPRIL’ works by causing your blood vessels to widen. This helps your blood pressure to fall. It also makes it easier for your heart to pump blood around your body. 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 their blood pressure is seen.
Do not take ‘ENALAPRIL’ if any of the above applies to you. If you are not sure about taking ‘ENALAPRIL’, talk to your doctor. Talk to your doctor or pharmacist before taking ‘ENALAPRIL’ if:
You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
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 if" 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 ‘ENALAPRIL’ 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 ‘ENALAPRIL’. If you are about to have any of the following, tell your doctor that you are taking ‘ENALAPRIL’:
If any of the above applies to you, talk to your doctor or dentist before the procedure. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because ‘ENALAPRIL’ can affect the way some medicines work. Also, some other medicines can affect the way ‘ENALAPRIL’ works. 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:
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking ‘ENALAPRIL’. If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking ‘ENALAPRIL’.
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’ 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: ‘ENALAPRIL’ may make you feel tired or dizzy. If this happens, do not drive or use any tools or machines. ‘ENALAPRIL’ contains lactose: Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose of ‘ENALAPRIL’ will depend on the condition being treated and any other medicines you are taking.
The first ‘ENALAPRIL’ tablets you take may make your blood pressure fall by more than doses you take after that. The first tablets may make you feel dizzy or light-headed. It may help to lie down until you feel better. This effect becomes less likely with future doses. If you are concerned, talk to your doctor or pharmacist. The doctor will check how you respond to taking ‘ENALAPRIL’ by taking your blood pressure and doing some blood tests.
The actual dose, decided by your doctor, will depend on your blood pressure and other medical conditions. If you are taking a high dose of water tablets (diuretics), your doctor may ask you to stop taking them for 2 to 3 days before you start taking ‘ENALAPRIL’.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole. Contact your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any remaining tablets and the pack, so the doctor knows what you have taken. The most common signs and symptoms of overdose are fall in blood pressure and stupor (a state of almost complete lack of consciousness). Other symptoms may include dizziness or lightheadedness due to a fall in blood pressure, forceful and rapid heartbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing. If you forget to take ‘ENALAPRIL’: If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet. If you stop taking ‘ENALAPRIL’: If you stop taking your medication, your blood pressure may increase. If your blood pressure becomes too high it may affect the function of your heart and kidneys. Do not stop taking your medicine, unless your doctor has advised you to do so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
This may mean you are having an allergic reaction to ‘ENALAPRIL’. You should be aware that black patients are at increased risk of these types of reactions.
When you start taking ‘ENALAPRIL’ 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. A complex side effect has also been reported which may include some or all of the following signs:
Other side effects include: Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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 the Yellow Card Scheme at: 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. Blood tests: Taking ‘ENALAPRIL’ may affect the results of some blood tests. These include tests on: the blood cells or other parts of it, potassium levels, creatinine or urea, sodium, liver enzymes or bilirubin. If you are going to have a blood test, it is important to tell your doctor that you are taking ‘ENALAPRIL’.
The active substance is enalapril maleate Each tablet contains 2.5mg, 5mg, 10mg or 20mg of enalapril maleate. The other ingredients are lactose monohydrate, maize starch, sodium bicarbonate, pregelatinised maize starch, and magnesium stearate. The 10 mg and 20 mg tablets also contain iron oxide (E172). ENALAPRIL MALEATE TABLETS 2.5mg and ENALAPRIL MALEATE TABLETS 5mg are white, round, biconvex tablets, bisected on one side. The 2.5mg tablets are of smaller size than the 5mg tablets. ENALAPRIL MALEATE TABLETS 10mg and ENALAPRIL MALEATE TABLETS 20mg are pink, round, biconvex tablets, quadrisected on one side. The 10mg tablets are of smaller size than the 20mg tablets. All strengths of tablets are available in packs of 28 tablets in foil blister strips. Dexcel®-Pharma Ltd.7 Sopwith WayDrayton FieldsDaventryNorthamptonshireNN11 8PBUK This leaflet was last revised in: October 2021 |