ENALAPRIL 5 мг Пленочные таблетки

Содержание инструкции

1. Enalapril Zentiva 5 mg tablets, 20 mg tablets
   1. What is Enalapril Zentiva and what is it 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

Enalapril Zentiva 5 mg tablets, 20 mg tablets

Generic medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Enalapril Zentiva and what is it used for

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

• for the treatment of high blood pressure (hypertension)
• for the treatment of heart failure (weakness of the heart function). It can reduce the need to go to hospital and help some patients to live longer
• to prevent the signs of heart failure. The signs include: shortness of breath, fatigue after slight activity such as walking, or swelling of the ankles and feet. This medicine works by widening the blood vessels. This action reduces blood pressure. The medicine usually starts to have an effect within 1 hour and the effect lasts for at least 24 hours. Some people will require several weeks of treatment before the best effect on blood pressure is visible.

2. What you need to know before taking Enalapril Zentiva

Do not take Enalapril Zentiva:

• if you are allergic to enalapril maleate or 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 medicine called an ACE inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary;
• if you have taken or are 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 in areas such as the throat)
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• if you are pregnant for more than 3 months (it is best to avoid the 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 not
sure, 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 suffer from a condition involving the blood vessels of the brain;
• if you have a blood problem such as a low number or absence of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or red blood cells (anemia);
• if you have liver problems;
• if you have kidney problems (including kidney transplant). These may cause a significant increase in potassium levels in the blood. In this case, your doctor may need to adjust your dose of Enalapril Zentiva or monitor your potassium levels in the blood;
• if you are on dialysis;
• if you have recently been very ill (excessive vomiting) or had severe diarrhea;
• if you are following 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, it is necessary to monitor for a decrease in blood glucose levels, especially during the first month of treatment. Potassium levels in the blood may also be higher;
• if you have had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing. It is good to know that people of black race have a higher risk of having this type of reaction to ACE inhibitors;
• if you have low blood pressure (you may feel weak or dizzy, especially when standing up);
• if you have a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), and are undergoing therapy that suppresses the immune system, are 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 in areas such as the throat) is greater:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection 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), especially if you suffer from kidney problems related to diabetes;
• aliskiren. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals .See also what is stated under "Do not take Enalapril Zentiva”. You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Enalapril Zentiva is not recommended in early pregnancy, and should not be taken if you are pregnant for more than 3 months, as the medicine can cause serious harm to your baby if taken during this period (see section Pregnancy).

It is good to know that this medicine lowers blood pressure in people of black race less effectively than in people of non-black race.
If you are not sure if any of these conditions apply to you, talk to your doctor or pharmacist before
taking this medicine.

If you are going to have a procedure
If you are going to have any of the following procedures, tell your doctor that you are taking Enalapril
Zentiva:

• surgery or anesthesia (even from the dentist);
• a treatment to remove cholesterol from the blood called “LDL apheresis”;
• a desensitization treatment, to reduce the effect of an allergy to bee or wasp stings. If any of the above conditions apply to you, talk to 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 the way some
medicines work. Other medicines can also affect the way Enalapril Zentiva works. The
doctor may need to change the 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 the 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 what is stated under "Do not take Enalapril Zentiva" and "Warnings and precautions“);
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent blood clots;
• 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 problems called “antipsychotics”;
• some medicines for cough and cold and weight-loss medicines that contain a so-called “sympathomimetic agent”;
• some medicines for pain or arthritis, including gold salt therapy;
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation, and which can be used to help relieve pain);
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• racecadotril (a medicine used against diarrhea) and other medicines that belong to the class of neprilysin (NEP) inhibitors;
• medicines usually used to prevent organ rejection (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See paragraph “Warnings and precautions”.

If you are not sure if 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 careful about the amount of alcohol you drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Your doctor will usually advise you to stop taking Enalapril Zentiva before starting
pregnancy or as soon as you find out you are pregnant and will advise you to
take another medicine instead of Enalapril Zentiva. Enalapril Zentiva is not recommended
in early pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Breastfeeding of newborns
(the first few weeks after birth), and especially premature babies, is not recommended while
taking Enalapril Zentiva. In the case of an older baby, the doctor should inform you about the benefits and risks associated with taking Enalapril Zentiva during breastfeeding, compared to
other treatments.

Driving and using machines
You may feel dizzy or sleepy while being treated with this medicine. If this
happens, do not drive or use tools or machines.

Enalapril Zentiva contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before
taking this medicine.

3. How to take Enalapril Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
Consult your doctor or pharmacist if you are not sure.

• It is very important to continue taking this medicine until your doctor tells you to stop.
• Do not take more tablets than prescribed.
• Swallow the tablets with water. You can take this medicine with or without food.
• Take the tablet at about the same time each day.

High blood pressure

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

Heart failure

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

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

• moderate kidney problems - 5 mg to 10 mg per day;
• severe kidney problems - 2.5 mg per day;
• if you are on dialysis - 2.5 mg per day. On the days you are not on dialysis, the dose may be changed to

depending on how low your blood pressure is.

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

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

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

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

• a maximum of 20 mg per day may be used in children who are between 20 kg and 50 kg;
• a maximum of 40 mg per day may be used in children who are over 50 kg. This medicine is not recommended in newborns (the first few 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 you should, consult 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 as usual.
• Do not take a double dose to make up for the missed dose.

If you stop taking Enalapril Zentiva
Do not stop taking the medicine unless your doctor tells you to do so.
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
will experience 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 skin rash with raised red formations (urticaria). It is good to know that patients of Black race have an increased risk of this type of reactions. If any of the above side effects should occur, stop taking Enalapril Zentiva and consult a doctor immediately.

When you start taking this medicine you may feel weak or dizzy. If this
happens, lying down is helpful. This is caused by lowering of the blood pressure. The situation
should improve continuing to take the medicine. If you are worried, consult your doctor.
Other side effects include:

Very common(may affect more than 1 in 10 people):

• feeling of dizziness, weakness or unwellness;
• blurred vision;
• cough.

Common(may affect up to 1 in 10 people):

• confusion due to low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain;
• headache, depression, fainting (syncope);
• alteration of the sense of taste, shortness of breath;
• diarrhoea, abdominal pains;
• fatigue (tiredness);
• skin rash, allergic reactions with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing;
• high levels of potassium in the blood, increased levels of creatinine in the blood (both are usually recognised by a test). Uncommon(may affect up to 1 in 100 people):
• flushing;
• sudden drop in blood pressure;
• fast or irregular heartbeat (palpitations);
• heart attack (possibly due to very low blood pressure in some patients at high risk, including those with circulatory problems at the level of the heart or brain);
• stroke (possibly due to very low blood pressure in patients at high risk);
• anaemia (including aplastic and hemolytic anaemia);
• confusion, insomnia or drowsiness, nervousness;
• feeling of tingling on the skin or numbness;
• vertigo (sense of dizziness);
• ringing in the ears (tinnitus);
• runny nose, sore throat or hoarseness;
• asthma associated with chest tightness;
• slowed transit of food through the intestine (ileus), inflammation of the pancreas;
• feeling unwell (vomiting), indigestion, constipation, anorexia;
• irritated stomach (gastric irritations), dry mouth, ulcer, altered kidney function, kidney failure;
• muscle cramps;
• increased sweating;
• itching or urticaria;
• hair loss;
• feeling generally unwell, high temperature (fever), impotence;
• high level of protein in the urine (measured with a test);
• low level of sugar or sodium in the blood, high level of urea in the blood (all measured with a blood test).

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

• “Raynaud’s phenomenon” when hands and feet can 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, reduced haemoglobin, lower number of platelets;
• bone marrow suppression;
• swelling of the glands of the neck, armpits or groin;
• autoimmune diseases;
• strange dreams or problems sleeping;
• accumulation of fluid or other substances in the lungs (evident from an X-ray);
• inflammation of the nose;
• inflammation of the lungs causing difficulty breathing (pneumonia);
• inflammation of the cheeks, gums, tongue, lips, throat;
• decreased amount of urine;
• skin rash similar to a target (erythema multiforme);
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin condition where there is redness and peeling of the skin, formation of small cuts or sores), exfoliative dermatitis/erythroderma (severe rash with peeling or exfoliation of the superficial layer of the skin), pemphigus (small blisters filled with fluid);
• problems with the liver or gallbladder such as reduced liver function, inflammation of the liver, jaundice (yellowing of the skin or eyes), high levels of liver enzymes or bilirubin (measured with a blood test);
• enlargement of the breasts in men (gynaecomastia).

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

• swelling of the intestine (intestinal angioedema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverseReporting side effects 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 which is stated on the blister and the packaging after
"EXP". The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to protect
the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enalapril Zentiva contains
The active ingredient is enalapril maleate
Each tablet contains 5 mg of enalapril maleate.
Each tablet contains 20 mg of enalapril maleate.
The other ingredients are:
lactose monohydrate, corn 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 contents of the pack
Enalapril Zentiva 5 mg: White or almost white, oblong, biconvex tablet with bevelled
edges, with a fracture line engraved on one side. The tablet can be divided into two equal doses.
Enalapril Zentiva 20 mg: Mottled mustard yellow coloured, oblong, biconvex tablet with bevelled
edges, with a fracture line engraved on one side.
This medicine is available in packs of 28, 30, 50 or 90 tablets.
Enalapril Zentiva 20 mg additionally contains: 14 tablets
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
France, Italy: Enalapril Zentiva