ENALAPRIL 5 mg Coated Tablet

Зміст інструкції

1. Enalapril EG 5 mg or 20 mg tablets

Enalapril EG 5 mg or 20 mg tablets

Generic medicine

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 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 is Enalapril EG and what it is used for
• 2. What you need to know before you take 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

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL EG
Do not take Enalapril EG:

• 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 another medicine similar to Enalapril EG, called an ACE inhibitor
• if you have a history of swelling of the face, lips, mouth, tongue or throat with difficulty breathing or swallowing (angioedema) of unknown origin or if it is a hereditary condition
• if you are pregnant for more than 3 months (It is best to avoid the use of Enalapril EG even during the early stages of pregnancy - see the section Pregnancy).
• 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 think any of these apply to you, do not take Enalapril EG. If in doubt, consult your
doctor or pharmacist before taking Enalapril EG.

Warnings and precautions
Before taking the medicine, tell your doctor or pharmacist if:

• you suffer from a heart problem
• you have problems with the blood vessels in your brain
• you have a blood problem such as a reduction or lack of white blood cells (neutropenia/agranulocytosis), a reduction in the number of platelets (thrombocytopenia) or a reduced number of red blood cells (anemia)
• you have liver problems
• you have kidney problems (even if you have had a kidney transplant). This can lead to an increase in 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 very ill (excessive vomiting) or have recently suffered from diarrhoea
• you are following a low-sodium diet, taking potassium supplements, potassium-sparing diuretics or potassium-based salt substitutes
• you are over 70 years of age
• you suffer from diabetes. It will be necessary to monitor blood glucose levels, especially during the first month of treatment. It is also possible that potassium levels in the blood may be higher
• you have ever had an allergic reaction associated with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing. Be aware that people of color are more at risk of developing this type of reaction to ACE inhibitors
• your blood pressure is low (this condition can manifest with weakness or dizziness, especially when getting up from sitting)
• you suffer from a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing treatment with immunosuppressant medicines, are taking allopurinol or procainamide, or any combination thereof
• you are breastfeeding or intend to do so (see the section Breastfeeding)
• you are taking any of the following medicines used to treat high blood pressure: an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. aliskiren

The doctor may need to 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 in the section "Do not take Enalapril EG”
You should tell your doctor if you think you might be pregnant (or if there is a possibility of becoming
pregnant). Enalapril EG is not recommended in early pregnancy and the
medicine should not be taken if you are more than 3 months pregnant because, if
taken during that period of pregnancy, it can seriously harm your baby (see the
section Pregnancy).
Be aware that Enalapril EG may be less effective in lowering blood pressure in
black patients compared to non-black patients.
If you are not sure if any of the above applies to you, ask your doctor or pharmacist
before taking Enalapril EG.

If you are going to have surgery
If you are going to have any of the following procedures, tell your doctor that you
are taking Enalapril EG:

• any surgery or if you are to be given anaesthetics (even from the dentist).
• a procedure to remove cholesterol from your blood, the so-called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bee and wasp stings. If any of the above applies to you, consult your doctor or dentist before undergoing 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 can
influence the mechanism of action of some medicines. Likewise, other medicines can
influence the mechanism of action of Enalapril EG. 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 diuretics (water tablets)
• medicines containing potassium (including salt substitutes)
• medicines for diabetes (oral antidiabetics and insulin)
• lithium (a medicine for the treatment of a certain type of depression)
• medicines for the treatment of depression known as “tricyclic antidepressants”
• medicines for the treatment of mental problems called “antipsychotics”
• some remedies for cough and cold and weight loss medicines that contain a substance known as “sympathomimetic agent”
• some medicines for the treatment of pain or arthritis, including therapy with gold salts
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol.

The doctor may need to adjust the dose and / or take other precautions:
If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see
also what is stated in the section "Do not take Enalapril EG "and "Warnings and precautions“).
If you are not sure if any of the above applies 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, suspect you may be pregnant, or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
As a rule, your doctor will advise you to stop taking Enalapril EG before you
become pregnant or as soon as pregnancy is confirmed and will prescribe another medicine
to use instead of Enalapril EG. Enalapril EG is not recommended in early
pregnancy and the medicine should not be taken if you are more than 3 months pregnant because, if
taken after the third month of pregnancy, it could seriously harm your baby.

Breastfeeding
Breastfeeding of newborns (in the first weeks after birth) and especially premature babies is not recommended during treatment with Enalapril EG. Regarding older children, your doctor will explain the benefits and risks associated with the use of Enalapril EG during
breastfeeding compared to other treatments.

Driving and using machines
During treatment with Enalapril EG you may feel dizzy or drowsy. If these
effects occur, do not drive and do not use any tools or machinery.

Enalapril EG contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor
before taking this medicine.
Take this medicine exactly as your doctor has told you. If you have 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.

If the prescription provides for the administration of half a tablet, it can be divided 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 divisible tablet will break into two equal parts.

High blood pressure

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

Heart failure

• The recommended starting dose is 2.5 mg to be administered once a day.
• The doctor will gradually increase this dose until the dose suitable for you is reached.
• The recommended maintenance dose is 20 mg daily, to be taken in one or two administrations.
• The maximum maintenance dose is 40 mg daily, to be taken in two administrations.

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

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

Elderly
Your dose will be decided by your doctor and will vary depending on how your kidneys are functioning.

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 developed based on the child's weight and blood pressure. The
recommended starting doses are:

• for a weight between 20 and 50 kg - 2.5 mg daily
• for a weight over 50 kg - 5 mg daily. The dose may be modified according to the child's needs:
• In children weighing between 20 and 50 kg, a maximum dose of 20 mg/day may be used.
• In children weighing over 50 kg, a maximum dose of 40 mg/day may be used.

Do not recommend the administration of Enalapril EG to newborns (in the first weeks after
birth) and to children with kidney problems.
Like all medicines, this medicine can cause side effects, although not everyone
experiences them. The following side effects may occur with this medicine:

If any of the following occur, stop taking Enalapril EG and consult
your doctor immediately:

• swelling of the face, lips, tongue or throat that can cause difficulty breathing or swallowing.
• swelling of hands, feet or ankles
• red bumps on the skin (urticaria). Be aware that people of color are more at risk of developing this type of reaction. If any of the above occurs, stop taking Enalapril EG and consult your doctor immediately.

At the beginning of treatment with Enalapril EG you may feel weak or dizzy. If this
happens, you should lie down. These manifestations depend on a lowering of
your blood pressure. They should subside as therapy continues. If you are concerned, talk to
your doctor.
Other side effects include:

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

• feeling of dizziness, weakness or discomfort
• blurred vision
• cough

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• sudden drop in blood pressure
• fast or irregular heartbeat (palpitations)
• heart attack (probably caused by a drop in blood pressure in some high-risk patients, including those with blood flow problems to the heart or brain)
• anemia (both aplastic and hemolytic)
• stroke (probably resulting from a severe drop in blood pressure in high-risk patients)
• confusion, insomnia or drowsiness, nervousness
• sensation of tingling or numbness in 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
• discomfort (vomiting), indigestion, constipation, anorexia
• irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure
• excessive sweating
• itching or hives
• hair loss
• muscle cramps, hot flashes, general feeling of discomfort (malaise), increased temperature (fever), impotence
• high levels of protein in the urine (verified by a test)
• low levels of glucose or sodium in the blood, high urea concentrations in the blood (verified by blood tests)

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

• “Raynaud’s phenomenon” characterized by extreme cooling of hands and feet which take on a white coloration due to a reduction in blood flow.
• alteration of blood values such as deficiency of red and white blood cells, low hemoglobin, reduction in the number of platelets
• bone marrow depression
• autoimmune diseases
• abnormal dreams or sleep problems
• lung infiltrates
• inflammation of the nose
• pneumonia
• inflammation of the cheeks, gums, tongue, lips, throat
• decreased urine output
• erythema multiforme
• “Stevens-Johnson syndrome” a serious condition affecting the skin characterized by redness and skin peeling, formation of blisters or sores, or detachment of the upper layer of skin from the lower layers.
• liver disorders such as reduced liver function, liver inflammation, jaundice (yellowing of skin or eyes), increased levels of liver enzymes or bilirubin (verified by blood tests).
• enlargement of the mammary glands 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 effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing more information on the safety of this medicine.
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 at a temperature above 30°C. Store in the original
packaging to protect from moisture.
Do not dispose of any medicine via water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help to protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION