Enalapril Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril Zentiva 5 mg tablets, 20 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Enalapril Zentiva is and what it is used for

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

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of heart function). It may reduce the need for hospitalisation and help some patients live longer
• to prevent the signs of heart failure. These signs include: shortness of breath, tiredness after mild physical activity such as walking, or swelling in the ankles and feet. This medicine works by dilating blood vessels. This action reduces blood pressure. The medicine usually starts to work within 1 hour and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the full effect on blood pressure becomes apparent.

2. What you should know before taking Enalapril Zentiva

Do not take Enalapril Zentiva:

• if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction to a type of medicine similar to this called an ACE inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioedema), when the cause was unknown or hereditary;
• 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 this increases the risk of angioedema (rapid swelling under the skin, such as in the throat);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are more than 3 months pregnant (it is best to avoid use of Enalapril Zentiva even in the early stages of pregnancy – see section Pregnancy).

Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have heart problems;
• if you have a condition affecting the blood vessels in the brain;
• if you have a blood disorder such as low number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia);
• if you have liver problems;
• if you have kidney problems (including kidney transplant). These may lead to increased levels of potassium in the blood, sometimes severe. In such cases, your doctor may need to adjust your dose of Enalapril Zentiva or monitor your blood potassium levels;
• if you are on dialysis;
• if you have recently been severely ill (excessive vomiting) or had severe diarrhoea;
• if you are on a low-salt diet, taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium;
• if you are over 70 years of age;
• if you have diabetes. In this case, monitoring for low blood glucose levels is necessary, especially during the first month of treatment. Blood potassium levels may also be elevated;
• if you have had an allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors;
• if you have low blood pressure (you may feel weak or dizzy, especially when standing);
• if you have a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), and are undergoing immunosuppressive therapy, taking allopurinol or procainamide, or any combination thereof;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) is higher:
• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other drugs belonging to the class of mTOR inhibitors – 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 antagonist" (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Enalapril Zentiva". You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Enalapril Zentiva is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as the medicine may cause serious harm to your baby if taken during this period (see section Pregnancy).

Please note that this medicine lowers blood pressure less effectively in black patients than in non-black patients.

If you are unsure whether any of these conditions apply to you, discuss them with your doctor or pharmacist before taking this medicine.

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 Zentiva:

• surgery or anaesthesia (including dental procedures);
• a treatment to remove cholesterol from the blood called "LDL apheresis";
• a desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.

If any of the above conditions apply to you, discuss them with your doctor or dentist before undergoing the procedure.

Other medicines and Enalapril Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Enalapril Zentiva can affect how some medicines work. Other medicines can also affect how Enalapril Zentiva works. Your doctor may need to adjust your dose and/or take other precautions.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• sacubitril / valsartan – a medicine used to treat a type of long-term (chronic) heart failure in adults (see also information under the heading "Do not take Enalapril Zentiva");
• other medicines to lower blood pressure, such as beta-blockers or tablets that increase urine production (diuretics);
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under "Do not take Enalapril Zentiva" and "Warnings and precautions");
• potassium supplements (including 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 (including oral antidiabetics such as vildagliptin and insulin);
• lithium (a medicine used to treat a certain type of depression);
• medicines for depression called "tricyclic antidepressants";
• medicines for mental disorders called "antipsychotics";
• some medicines for cough and cold or weight-reduction medicines containing a so-called "sympathomimetic agent";
• some medicines for pain or arthritis, including gold salt therapy;
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain);
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• racecadotril (a medicine used to treat diarrhoea) and other medicines belonging to the neprilysin inhibitor (NEP) class;
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the mTOR inhibitor class). See section "Warnings and precautions".

If you are unsure whether any of these conditions apply to you, talk to your doctor or pharmacist before taking Enalapril Zentiva.

Enalapril Zentiva with food, drinks and alcohol

If you drink alcohol while taking enalapril, you may feel dizzy, lightheaded or faint. Be cautious about the amount of alcohol you consume.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will usually advise you to stop taking Enalapril Zentiva before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Enalapril Zentiva is not recommended during 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 after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding of newborns (the first weeks after birth), and especially premature infants, is not recommended while taking Enalapril Zentiva. For older infants, your doctor will advise you on the benefits and risks of taking Enalapril Zentiva during breastfeeding compared to other treatments.

Driving and using machines

You may experience dizziness or drowsiness while being treated with this medicine. If this occurs, do not drive or operate tools or machinery.

Enalapril Zentiva contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Enalapril Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist.
Consult your doctor or pharmacist if you are unsure.

• It is very important to keep taking this medicine for as long as your doctor tells you to.
• Do not take more tablets than prescribed.
• Swallow the tablets with water. You may take this medicine with or without food.
• Take the tablet at approximately the same time each day.

High blood pressure

• The usual starting dose ranges from 5 mg to 20 mg once daily.
• Some patients may require a lower starting dose.
• The usual long-term dose is 20 mg once daily.
• The maximum long-term dose is 40 mg once daily.

Heart failure

• The usual starting dose is 2.5 mg once daily.
• Your doctor will gradually increase the dose until the right dose for you is reached.
• The usual long-term dose is 20 mg daily, taken in one or two doses.
• The maximum long-term dose is 40 mg daily, divided into two doses.

Patients with kidney problems
The dose of the medicine will be adjusted depending on how well the kidneys are working:

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

Elderly
The dose will be determined by the doctor and will be based on how well the kidneys are functioning.

Use in children
Experience with enalapril in children with high blood pressure is limited. If the child is able to swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual starting dose is:

• between 20 kg and 50 kg - 2.5 mg daily;
• over 50 kg - 5 mg daily.

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

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

This medicine is not recommended for newborns (the first weeks after birth) and in children with kidney problems.

If you take more Enalapril Zentiva than you should
If you take more Enalapril Zentiva than prescribed, contact your doctor or go to hospital immediately. Take the medicine pack with you. The following effects may occur:
feeling lightheaded or dizzy. This is due to a sudden or excessive drop in blood pressure.

If you forget to take Enalapril Zentiva

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

If you stop taking Enalapril Zentiva
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions about 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 everyone experiences them. The following side effects may occur with this medicine:
Stop taking Enalapril Zentiva and consult a doctor immediately if you notice any of the
following side effects:

• swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing;
• swelling of the hands, feet or ankles;
• if you develop a rash with raised red patches (urticaria). It should be noted that patients of black race have an increased risk of these types of reactions. If any of the above side effects occur, discontinue use of Enalapril Zentiva and consult a doctor immediately.

When you start taking this medicine, you may feel weak or dizzy. If this happens, lying down may help. This is caused by a drop in blood pressure. The condition should improve as you continue taking the medicine. If you are concerned, consult 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):

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

Uncommon (may affect up to 1 in 100 people):

• flushing;
• sudden drop in blood pressure;
• rapid or irregular heartbeat (palpitations);
• heart attack (possibly due to very low blood pressure in some high-risk patients, including those with circulatory problems affecting the heart or brain);
• stroke (possibly due to very low blood pressure in high-risk patients);
• anaemia (including aplastic and haemolytic anaemia);
• confusion, insomnia or drowsiness, nervousness;
• tingling sensation or numbness of the skin;
• vertigo (dizziness);
• ringing in the ears (tinnitus);
• runny nose, sore throat or hoarseness;
• asthma associated with chest tightness;
• slowed passage of food through the intestine (ileus), inflammation of the pancreas;
• feeling unwell (nausea), indigestion, constipation, loss of appetite;
• irritated stomach (gastric irritation), dry mouth, ulcer, impaired kidney function, kidney failure;
• muscle cramps;
• increased sweating;
• itching or hives;
• hair loss;
• general feeling of being unwell, high body temperature (fever), impotence;
• high levels of protein in the urine (detected by a test);
• low blood sugar or sodium levels, high blood urea levels (all detected by a blood test).

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

• Raynaud's phenomenon, in which hands and feet may become very cold and white due to reduced blood flow;
• changes in blood values such as reduced numbers of white and red blood cells, reduced haemoglobin, reduced platelet count;
• bone marrow depression;
• swelling of the glands in the neck, armpits or groin;
• autoimmune diseases;
• unusual dreams or sleep problems;
• fluid or other substance accumulation in the lungs (detected by X-ray);
• inflammation of the nose;
• lung inflammation causing breathing difficulties (pneumonitis);
• inflammation of the cheeks, gums, tongue, lips or throat;
• decreased urine output;
• target-like skin rash (erythema multiforme);
• Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin conditions involving redness, peeling of the skin, small cuts or sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin surface), pemphigus (small fluid-filled blisters on the skin);
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected by blood test);
• breast enlargement in men (gynaecomastia).

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

• intestinal swelling (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 the website 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 Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the medicine 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 Zentiva contains
The active substance is enalapril maleate.
Each tablet contains 5 mg of enalapril maleate.
Each tablet contains 20 mg of enalapril maleate.
The other components are:
monohydrate lactose, maize starch, crospovidone, pregelatinized starch, maleic acid, magnesium stearate.
Enalapril Zentiva 20 mg additionally contains: yellow iron oxide (E172).

Description of the appearance of Enalapril Zentiva and package contents
Enalapril Zentiva 5 mg: White or almost white, oblong, biconvex tablet with bevelled edges, with a break line engraved on one side. The tablet can be divided into two equal doses.
Enalapril Zentiva 20 mg: Mottled mustard-coloured, oblong, biconvex tablet with bevelled edges, with a break line engraved on one side.
This medicine is available in tablet form in packs containing 28, 30, 50 or 90 tablets.
Enalapril Zentiva 20 mg additionally available in packs of 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy

Manufacturer
S.C. ZENTIVA S.A
B-dul Theodor Pallady nr. 50, sector 3, Bucuresti, 032266, Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
France, Italy: Enalapril Zentiva