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Enalapril Maleate 2.5mg Tablets

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ENALAPRIL MALEATE 2.5MG, 5MG, 10MG AND 20MG TABLETS PATIENT INFORMATION LEAFLET

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 maleate is and what it is used for

2. What you need to know before you take enalapril maleate

3. How to take enalapril maleate

4. Possible side effects

5. How to store enalapril maleate

6. Contents of the pack and other information

1. WHAT ENALAPRIL MALEATE IS AND WHAT IT IS USED FOR

This medicine contains an active substance called enalapril maleate (referred to as enalapril throughout this leaflet). This belongs to the group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Enalapril is 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 the symptomss of heart failure. The symptoms 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 effects last 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 Do not take enalapril:

• if you are allergic 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 (angiooedma) when the reason why was not known or it was inherited;

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren;

• if you are more than 3 months pregnant. (It is also better to avoid enalapril in early pregnancy- see pregnancy section).

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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• 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 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 your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these;

• 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 you 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”.

• You must tell your doctor 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 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:

• any surgery or receive anaesthetics (even at the 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because enalapril can affect the way some medicines work. Also some other medicines can affect the way that 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:

• other medicines that lower blood pressure, such as beta-blockers or water tablets (diuretics);

• an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take enalapril” and “Warnings and precautions”);

• 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 “tri-cyclic 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;

• 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);

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking enalapril.

Enalapril with food, drink and alcohol

• If you drink alcohol while taking enalapril you may feel dizzy, light-headed or faint.

Take care with the amount of alcohol you drink.

Pregnancy, breast-feeding and fertility

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 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 with 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 contains lactoself 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

• Always take this medicine exactly as your doctor or pharmacist 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.

• Swallow the tablets with water. You can take enalapril with or without food.

• Take your tablet at about the same time each day.

High blood pressure

• The usual starting dose ranges from 5 to 20mg taken once a day.

• Some patients may need a lower starting dose.

• The usual long term dose is 20mg taken once a day.

• The maximal long term dose is 40mg taken once a day.

Heart failure

• The usual starting dose is 2.5mg 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 20mg each day, taken in one or two doses.

• The maximal long term dose is 40mg each day, divided in two doses.

Patients with kidney problems

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

• moderate kidney problems - 5mg to 10mg each day

• severe kidney problems - 2,5mg each day.

• if you are having dialysis - 2.5mg each day. On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

Older 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 enalapril 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 usual starting doses are:

• between 20kg and 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 and 50kg.

• a maximum of 40mg daily can be used in children who are more than 50kg.

This medicine is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.

If you take more enalapril than you should

If you take more enalapril than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling of light-headed or dizziness. This is due a sudden or excessive drop in blood pressure.

If you forget to take enalapril

• If you forget to take a tablet, skip the missed dose.

• Take the next dose as usual.

• Do not take a double dose to make up for a forgotten tablet.

If you stop taking enalapril

Do not stop taking your medicine unless the doctor tells 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, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking enalapril and talk to a doctor straightaway, if you notice any of the following:

• swelling of your face, lips, tongue or throat which may cause difficulty in breathing or swallowingswelling of the hands, feet or ankles if you develop a raised red skin rash (hives).

You should be aware that black patients are at an increased risk of these types of reactions. If any of the above happen, stop taking enalapril 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):

• low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain;

• headache, fainting (syncope);

• changes in sense of taste, shortness of breath;

• diarrhoea or abdominal pain, rash;

• tiredness (fatigue), depression;

• allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing;

• increased blood potassium level, 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);

• anaemia (including aplastic and haemolytic);

• stroke (possibly due to very low blood pressure in high-risk patients);

• confusion, sleeplessness or sleepiness, nervousness;

• feeling your skin prickling or being numb;

• vertigo;

• ringing in your ears (tinnitus);

• runny nose, sore throat or hoarseness;

• asthma;

• slow movement of food through your intestine, inflammation of your pancreas;

• being sick (vomiting), indigestion, constipation, anorexia;

• irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure;

• increased perspiration;

• itching or nettle rash;

• loss of hair;

• muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence;

• high levels of protein in your urine (measured in a test);

• low level of blood sugar or sodium, high level 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 very 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;

• autoimmune diseases;

• strange dreams or sleep problems;

• pulmonary infiltrates;

• inflammation of your nose;

• pneumonia;

• inflammation of the cheeks, gums, tongue, lips, throat;

• lower amount of urine produced;

• erythema multiforme;

• “Stevens-Johnson syndrome” - a serious skin condition where you have reddening and scaling of your skin, blistering or raw sores, or detachment of the top layer of skin from the bottom layers;

• liver problems such as lower liver function, inflammation of your liver, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin (measured in a blood test);

• enlargement of the mammary glands in males.

Very rare (may affect up to 1 in 10,000 people):

• swelling in your intestine (intestinal angioedema)

Frequency not known (cannot be estimated from available data)

• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called “syndrome of inappropriate anti-diuretic hormone secretion” (SIADH).

Reporting of side effects

If you get any side effects, talk to your doctor or 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/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ENALAPRIL

• Keep this medicine out of the sight and reach of children.

• Do not store above 30°C. Store in the original package.

• Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP’. The expiry date refers to the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What enalapril contains

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, crospovidone, pregelatinised starch, maleic acid and magnesium stearate. The 10mg and 20mg tablets also contain iron oxide (E172).

What enalapril looks like and contents of the pack

Enalapril Maleate 2.5mg: white, round, bevel edged tablets marked S105 on one side.

Enalapril Maleate 5mg: white or off-white, oblong, biconvex bevel edged tablets with a break-line on one side.

Enalapril Maleate 10mg: pink, round, bevel edged tablets marked S107 on one side.

Enalapril Maleate 20mg: mottled mustard, oblong, biconvex bevel edged tablets with a break-line engraved on one side.

Enalapril tablets are supplied in blister packs of 10, 14, 28, 30, 50, 56, 60, 98 and 100 tablets.

(Final printed leaflet to include only marketed pack sizes)

Marketing Authorisation Holder:

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer:

Chinoin Pharmaceutical and Chemical Works Co Ltd, H-2112 Veresegyhaz, Levai u. 5, Hungary