Enalapril EG

Package leaflet: Information for the user

Enalapril EG 5 mg or 20 mg tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Enalapril EG is and what it is used for
2. What you need to know before taking Enalapril EG
3. How to take Enalapril EG
4. Possible side effects
5. How to store Enalapril EG
6. Contents of the pack and other information

1. What ENALAPRIL EG is and what it is used for

Enalapril EG contains the active substance enalapril maleate. It belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
Enalapril EG is used:

• to treat high blood pressure (hypertension);
• in the treatment of heart failure (weakening of heart function). It may reduce the need for hospitalization and can help some patients live longer;
• to prevent signs of heart failure, including: shortness of breath, fatigue after mild physical activity such as walking, or swelling in the ankles and feet. Enalapril EG works by widening your blood vessels, resulting in a lowering of blood pressure. The antihypertensive effect usually occurs within one hour and is maintained for at least 24 hours. For some people, several weeks of treatment may be needed before the optimal blood pressure effect is achieved.

2. What you should know before taking ENALAPRIL EG

DO NOT take Enalapril EG:

• if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction to another medicine similar to Enalapril EG, called an ACE-inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat accompanied by breathing or swallowing difficulties (angioedema) of unknown origin, or if this condition is hereditary;
• if you are taking or have taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat);
• if you are more than 3 months pregnant (It is advisable to avoid using Enalapril EG even during early pregnancy – see Pregnancy section);
• if you have diabetes or impaired kidney function and are being treated with aliskiren, a medicine that lowers blood pressure.

If you think any of these apply to you, do not take Enalapril EG. In case of doubt, consult your doctor or pharmacist before taking Enalapril EG.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• you have a heart condition;
• you have problems with blood vessels in the brain;
• you have a blood disorder such as low or absent white blood cells (neutropenia/agranulocytosis), reduced platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia);
• you have liver problems;
• you have kidney problems (including if you have had a kidney transplant). This may lead to increased potassium levels in the blood, which can be serious. Your doctor may need to adjust the dose of Enalapril EG or monitor your blood potassium levels;
• you are undergoing dialysis;
• you have been severely ill (excessive vomiting) or have recently had diarrhoea;
• you are on a low-sodium diet, or are taking potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes;
• you are over 70 years old;
• you have diabetes. Your blood glucose levels will need to be monitored, especially during the first month of treatment. Your blood potassium levels may also be higher;
• you have ever had an allergic reaction with swelling of the face, lips, tongue or throat, accompanied by difficulty in swallowing or breathing. Please note that people of black African or Afro-Caribbean origin are at greater risk of developing this type of reaction to ACE inhibitors;
• your blood pressure is low (this may cause weakness or dizziness, especially when standing up);
• you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are receiving immunosuppressive therapy, or are taking allopurinol, procainamide, or any combination of these medicines;
• you are breastfeeding or planning to breastfeed (see section Breastfeeding);
• you are taking any of the following medicines for high blood pressure: an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes, or aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also section "Do not take Enalapril EG";
• you are taking any of the following medicines, as they may increase the risk of angioedema (rapid swelling under the skin, for example in the throat): racecadotril, a medicine used to treat diarrhoea; medicines used to prevent rejection of transplanted organs or to treat cancer (such as temsirolimus, sirolimus, everolimus); vildagliptin, a medicine used to treat diabetes.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Enalapril EG is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may seriously harm your unborn baby (see section Pregnancy).

Please note that Enalapril EG may be less effective in lowering blood pressure in black patients compared to non-black patients.

If you are unsure whether any of the above apply to you, ask your doctor or pharmacist before taking Enalapril EG.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril EG:

• any surgical procedure or if you are to be given anaesthetics (including by your dentist);
• a procedure to remove cholesterol from your blood, known as "LDL apheresis";
• desensitisation treatment to reduce the effect of an allergy to bee or wasp stings. If any of the above apply to you, consult your doctor or dentist before undergoing the treatment.

Other medicines and Enalapril EG

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies. This is because Enalapril EG may affect how some medicines work. Likewise, other medicines may affect how Enalapril EG works.

In particular, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• other medicines that lower blood pressure, such as beta-blockers;
• potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
• medicines for diabetes (oral antidiabetics and insulin);
• lithium (a medicine used to treat certain types of depression);
• medicines for depression known as "tricyclic antidepressants";
• medicines for mental disorders known as "antipsychotics";
• some cough and cold remedies and weight-reducing medicines containing a substance known as a "sympathomimetic agent";
• certain medicines used to treat pain or arthritis, including gold salts therapy;
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• alcohol;
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Your doctor may decide it is necessary to adjust the dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Enalapril EG" and "Warnings and precautions").

If you are unsure whether any of the above apply to you, ask your doctor or pharmacist before taking Enalapril EG.

Enalapril EG with food and drink

Enalapril EG can be taken with or without food. Most patients take Enalapril EG with a glass of water.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Your doctor will usually advise you to stop treatment with Enalapril EG before you become pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine to replace Enalapril EG. Use of Enalapril EG is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may seriously harm your unborn baby if taken after the third month of pregnancy.

Breastfeeding

Breastfeeding is not recommended for newborn infants (in the first few weeks after birth), especially for premature babies, during treatment with Enalapril EG. For older infants, your doctor will discuss with you the benefits and risks of using Enalapril EG during breastfeeding compared to other treatments.

Driving and using machines

During treatment with Enalapril EG, you may feel dizzy or drowsy. If you experience these effects, do not drive or operate tools or machinery.

Enalapril EG contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ENALAPRIL EG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• It is very important that you continue to take Enalapril EG for as long as your doctor has prescribed it.
• Do not take more tablets than prescribed.

Enalapril EG 5 mg tablets
The tablet may be divided into equal doses.
If the prescription calls for half a tablet, it can be split into two halves by placing it on a hard surface with the central groove facing upwards. Apply pressure from above with your thumb, and the score tablet will break into two equal parts.

Enalapril EG 20 mg tablets
The tablet may be divided into equal doses.
If the prescription calls for half a tablet, it can be split into two halves by placing it on a hard surface with the central groove facing upwards. Apply pressure from above with your thumb, and the score tablet will break into two equal parts.

High blood pressure

• The recommended starting dose ranges from 5 to 20 mg once daily.
• Some patients may require a lower starting dose.
• The recommended maintenance dose is 20 mg once daily.
• The maximum maintenance dose is 40 mg once daily.

Heart failure

• The recommended starting dose is 2.5 mg once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The recommended maintenance dose is 20 mg daily, taken in one or two doses.
• The maximum maintenance dose is 40 mg daily, taken in two divided doses.

Patients with kidney problems
The dose of the medicine will depend on how well your kidneys are functioning.

• moderate kidney problems - 5 to 10 mg daily;
• severe kidney problems - 2.5 mg daily;
• if undergoing dialysis - 2.5 mg daily. On days when dialysis is not performed, the dose may be adjusted depending on how much your blood pressure drops.

Elderly patients
Your dose will be determined by your doctor and will depend on how well your kidneys are functioning.

Use in children
Experience with the use of Enalapril EG in hypertensive children is limited. If the child is able to swallow the tablet, the dose will be calculated based on the child's weight and blood pressure. The recommended starting doses are:

• for a body weight between 20 and 50 kg - 2.5 mg daily;
• for a body weight above 50 kg - 5 mg daily.

The dose may be adjusted according to the child's needs:

• in children weighing between 20 and 50 kg, a maximum daily dose of 20 mg may be used;
• in children weighing more than 50 kg, a maximum daily dose of 40 mg may be used.

Enalapril EG is not recommended for administration to neonates (during the first weeks after birth) and to children with kidney problems.

If you take more Enalapril EG than you should
If you take more Enalapril EG than prescribed, contact your doctor immediately or go to the hospital. Take the packaging with you. The following symptoms may occur: feeling of light-headedness or dizziness due to a sudden or excessive drop in blood pressure.

If you forget to take Enalapril EG

• If you forget to take a tablet, skip it.
• Take the next dose as usual.
• Do not take a double dose to make up for the missed dose.

If you stop taking Enalapril EG
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult 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 occur with this medicine:
If you experience any of the following, stop taking Enalapril EG and consult a doctor immediately:

• swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing;
• swelling of the hands, feet or ankles;
• appearance of red, raised skin rashes (urticaria).

Please note that people of African or Caribbean origin are at higher risk of developing these types of reactions. If any of the above conditions occur, stop taking Enalapril EG and consult a doctor immediately.
At the beginning of treatment with Enalapril EG, you may feel weak or dizzy. If this happens, you should lie down. These symptoms are due to a drop in your blood pressure and should lessen as treatment continues. If you are concerned, speak to your doctor.
Other side effects include:
Very common (may affect more than 1 in 10 people):

• dizziness, weakness or feeling unwell;
• blurred vision;
• cough.

Common (may affect up to 1 in 10 people)

• low blood pressure, changes in heart rhythm, rapid heartbeat, angina or chest pain;
• headache, loss of consciousness (syncope);
• changes in taste sensation, shortness of breath;
• diarrhoea or abdominal pain, skin rash;
• fatigue (tiredness), depression;
• allergic reactions associated with swelling of the face, lips, tongue or throat, with difficulty swallowing or breathing;
• increased potassium levels in the blood, increased creatinine levels in the blood (both increases are usually detected by a blood test).

Uncommon (may affect up to 1 in 100 people)

• sudden drop in blood pressure;
• fast or irregular heartbeat (palpitations);
• heart attack (likely due to low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain);
• anaemia (both aplastic and haemolytic);
• stroke (likely due to severe drop in blood pressure in high-risk patients);
• confusion, insomnia or drowsiness, nervousness;
• tingling or numbness of the skin;
• dizziness;
• ringing in the ears (tinnitus);
• runny nose, sore throat or hoarseness;
• asthma;
• slow movement of food through the intestine, inflammation of the pancreas;
• feeling unwell (vomiting), indigestion, constipation, loss of appetite;
• irritated stomach (gastric irritation), dry mouth, ulcer, impaired kidney function, kidney failure;
• excessive sweating;
• itching or hives;
• hair loss;
• muscle cramps, hot flushes, general feeling of being unwell (malaise), increased body temperature (fever), impotence;
• high levels of protein in the urine (detected by a test);
• low levels of glucose or sodium in the blood, high levels of urea in the blood (detected by blood tests).

Rare (may affect up to 1 in 1,000 people)

• “Raynaud’s phenomenon”, characterized by extreme coldness of the hands and feet, which turn white due to reduced blood flow;
• changes in blood test values such as deficiency of red and white blood cells, low haemoglobin, reduced platelet count;
• bone marrow depression;
• autoimmune diseases;
• abnormal dreams or sleep problems;
• lung infiltrates;
• inflammation of the nose;
• pneumonia;
• inflammation of the cheeks, gums, tongue, lips or throat;
• decreased urine output;
• erythema multiforme;
• “Stevens-Johnson syndrome”, a serious skin condition characterized by redness and skin peeling, blistering or sores, or detachment of the top layer of skin from underlying layers;
• liver disorders such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin levels (detected by blood tests);
• breast enlargement in men.

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

• swelling of the intestine (intestinal angioedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENALAPRIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of that month.
Do not store this medicine above 30°C. Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enalapril EG contains

• The active substance is enalapril maleate. One tablet contains 5 mg or 20 mg of enalapril maleate.
• The other components are:

Enalapril EG 5 mg tablets contain: sodium bicarbonate, monohydrate lactose, maize starch, hypromellose,
talc, magnesium stearate
Enalapril EG 20 mg tablets contain: sodium bicarbonate, monohydrate lactose, maize starch, talc,
magnesium stearate, red iron oxide (E172), yellow iron oxide (E172)

Description of the appearance of Enalapril EG and contents of the pack
Enalapril EG 5 mg tablets: white, round, biconvex tablets, divisible with a score line on one side.
The tablet can be divided into equal doses.
Enalapril EG 20 mg tablets: light orange, round, biconvex tablets, divisible with a score line on one side, with white specks.
The tablet can be divided into equal doses.
The tablets are packed in blisters (aluminum/OPA-Al-PVC) in the following pack sizes:
Original packs of
Enalapril EG 5 mg tablets: 10, 20, 28, 30, 50, 56, 60, 98, 100, 105, 120, 150, 200, 250, 300, 400, 500,
1000 tablets
Enalapril EG 20 mg tablets: 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 105, 120, 150, 200, 250, 300, 400,
500, 1000 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturers responsible for batch release
STADA Arzneimittel AG, Stadastrasse, 2-18, 61118 Bad Vilbel (Germany)
Coripharma, Reykjavikurvegur 78, 220 Hafnarfjordur (Iceland)
STADA M&D SRL, Str. Trascăului, nr 10, RO-401135, Turda (Romania)

This medicinal product is authorized in the European Economic Area countries under the following names:
AT: Renistad 5,10,20 mg Tabletten
BE: Enalapril EG 5, 20 mg tabletten
DE: Enalapril STADA 2.5, 5,10,20 mg Tabletten
DK: Enacodan
IT: Enalapril EG 5 mg/20 mg compresse
LU: Enalapril EG 2.5, 5,10,20 mg
SE: Enalapril Stada