ENALAPRIL 5 mg Tablet

Зміст інструкції

1. ENALAPRIL DOC 5 mg, 20 mg tablets
   1. What is ENALAPRIL DOC and what is it used for
   2. What you need to know before taking ENALAPRIL DOC
   3. How to take ENALAPRIL DOC
   4. Possible side effects
   5. How to store ENALAPRIL DOC
   6. Contents of the pack and other information

ENALAPRIL DOC 5 mg, 20 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking 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 any side effect occurs, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ENALAPRIL DOC contains an active ingredient called enalapril maleate. This active ingredient
belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
ENALAPRIL DOC is used:

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of the heart function). It can reduce the need to go to hospital and can help some patients to live longer
• to prevent the signs of heart failure. The signs include: shortness of breath, fatigue after light activity such as walking, or swelling of the ankles and feet.

This medicine works by widening the blood vessels. This lowers blood pressure. The medicine
usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people will need
several weeks of treatment before the best effect on blood pressure can be seen.

2. What you need to know before taking ENALAPRIL DOC

Do not take ENALAPRIL DOC

• 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 medicine of a type similar to this medicine called an ACE inhibitor.
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) of unknown or hereditary origin.
• 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 three months. It is best to avoid ENALAPRIL DOC even in the early stages of pregnancy (see section Pregnancy).
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

If you are taking any of the following medicines, the risk of angioedema may be increased.

• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Do not take this medicine if you have any of the problems mentioned above. If you are unsure, 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 blood vessels in 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 a reduction in the number of red blood cells (anaemia).
• if you have a liver problem.
• 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.
• if you have a kidney problem (including 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 DOC or monitor your blood potassium levels.
• if you are on dialysis.
• if you have recently had episodes of excessive vomiting or severe diarrhoea.
• 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. Blood glucose levels need to be carefully monitored if a drop occurs, especially during the first month of treatment. Potassium levels in the blood may also be higher.
• if you have had an allergic reaction in the past with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing. You should know that black patients are at higher risk for these types of reactions to ACE inhibitors. - if you suffer from low blood pressure (you notice this when you feel faint or dizzy, especially when standing up).
• if you have a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing immunosuppressive therapy, are taking allopurinol or procainamide, or combinations thereof. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant).
This medicine is not recommended in early pregnancy, and should not be taken if you are pregnant for more
than three months, as it can cause serious harm to the baby if taken during this
period (see section Pregnancy).
You should know that in black patients this medicine reduces blood pressure less effectively
compared to non-black patients.
If you are not sure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before taking this medicine.
See also what is stated under "Do not take ENALAPRIL DOC".

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 DOC:

• any type of surgery or anaesthesia (including from the dentist).
• treatment that removes cholesterol from the blood called "LDL apheresis".
• desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

If any of the above conditions apply to you, talk to your doctor or dentist before the
procedure.

Other medicines and ENALAPRIL DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes herbal medicines. This is because ENALAPRIL DOC can
interfere with the mechanism of action of some medicines. Also, some other medicines can
interfere with the mechanism of action of ENALAPRIL DOC.
Your doctor may need to change the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
"Do not take ENALAPRIL DOC" and "Warnings and 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, diuretics.
• medicines for diabetes (including oral antidiabetics 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 coughs and colds and weight-reducing medicines that contain a so-called "sympathomimetic agent".
• some medicines for pain or arthritis including gold 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).
• alcohol.
• 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 co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent the formation of clots)

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist
before taking ENALAPRIL DOC.

ENALAPRIL DOC with food, drinks and alcohol
ENALAPRIL DOC tablets can be taken independently of meals, but should be taken with
sufficient liquid.
Alcohol enhances the effect of ENALAPRIL DOC on high blood pressure.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Usually, your doctor will advise you to stop taking ENALAPRIL DOC before starting to become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine
instead of ENALAPRIL DOC.
ENALAPRIL DOC is not recommended in early pregnancy, and should not be taken if you are pregnant for more
than three months, as it can cause serious harm to the baby if taken after the third
month of pregnancy.

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

Driving and using machines
When driving vehicles or using machines, consider the possibility of occasional dizziness or weakness. If this occurs, do not drive vehicles and do not use any
tool or machinery.

ENALAPRIL DOC contains lactose
Lactose is a type of sugar. If you have been diagnosed with an intolerance to certain sugars, contact
your doctor before taking this medicine.

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

3. How to take ENALAPRIL DOC

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your

doctor or pharmacist.
The daily dose is usually taken as a single dose, in the morning, however it is also possible
to divide it into two doses, in the morning and in the evening.

• It is very important to continue taking this medicine as long as it is prescribed by your doctor.
• Do not take more tablets than prescribed.

For the treatment of high blood pressure

• The usual starting dose ranges from 5 to 20 mg in a single daily dose.
• Some patients may need to start treatment with a lower dose.
• The usual maintenance dose is 20 mg in a single daily dose.
• The maximum maintenance dose is 40 mg in a single daily dose.

Patients with heart failure

• The usual starting dose is 2.5 mg in a single daily dose.
• The doctor will gradually increase the dose until reaching the appropriate dose for you.
• The usual maintenance dose is 20 mg per day, taken in one or two doses.
• The maximum maintenance dose is 40 mg per day, divided into two doses.

Patients with kidney problems
The dose of the medicine will vary according to the function of your kidneys:

• moderate kidney problems - 5 to 10 mg per day.
• severe kidney problems - 2.5 mg per day.
• if you are on dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, the dose may be varied depending on your blood pressure.

Elderly patients
The dose will be decided by the doctor and will be based on the degree of kidney function.

Use in children
Experience with the use of ENALAPRIL DOC in children with high blood pressure is limited. If the
child is able to swallow the tablets, the dose will be established according to the child's weight and blood
pressure. The usual starting doses are:

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

This medicine is not recommended in newborns (first weeks of life) and in children with kidney
problems.
If you think that the effect of ENALAPRIL DOC is too strong or too weak, consult your doctor or
pharmacist.

If you take more ENALAPRIL DOC than you should

If you accidentally take too many tablets, contact your doctor immediately.
Limited data are available on overdose in humans. Symptoms of overdose may include
extremely low blood pressure and kidney failure.

If you forget to take ENALAPRIL DOC
If you accidentally miss a dose, skip the missed dose and take as usual the next dose.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking ENALAPRIL DOC
Do not stop treatment with the medicine unless your doctor tells you to. Usually there
is no rebound effect (reappearance or worsening of symptoms) when taking
ENALAPRIL DOC tablets is stopped.
If you have any doubts 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 everybody gets them.

Stop taking ENALAPRIL DOC and contact your doctor immediately if you notice any of the following:

• swelling of the face, lips, tongue or throat which may cause difficulty with breathing or swallowing.
• swelling of the hands, feet or ankles.
• development of a skin rash with raised, red patches (urticaria).

You should be aware that patients of Black ethnicity have a higher risk of developing this type of reaction. If you notice any of these manifestations, stop taking ENALAPRIL DOC and contact your doctor immediately.
When you start taking this medicine you may feel dizzy or lightheaded. If this happens, it may be helpful to lie down. This is caused by low blood pressure.
It should improve as you continue to take the medicine. If you are worried, please contact your doctor.
Other side effects

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

• feeling dizzy, weak or unwell.
• blurred vision.
• cough.

Common(may affect up to 1 in 10 people)

• low blood pressure, changes in heart rate, fast heartbeat, angina pectoris or chest pain.
• headache, fainting (syncope).
• altered sense of taste, shortness of breath.
• diarrhoea or abdominal pain, skin rash.
• tiredness (fatigue), depression.
• allergic reactions with swelling of the face, lips, tongue or throat with difficulty breathing or swallowing.
• increased levels of potassium in the blood, increased levels of creatinine in the blood (both are usually found with a laboratory test).

Uncommon(may affect up to 1 in 100 people)

• sudden drop in blood pressure.
• fast or irregular heartbeats (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).
• anaemia (including aplastic and haemolytic anaemia).
• stroke (possibly due to very low blood pressure in patients at high risk).
• confusion, insomnia or drowsiness, nervousness.
• tingling skin sensation or numbness.
• vertigo.
• ringing in the ears (tinnitus).
• nasal secretion, sore throat and hoarseness.
• asthma.
• slowed transit of food in the intestine (intestinal obstruction) which causes a feeling of bloating and painful abdominal cramps, inflammation of the pancreas.
• vomiting, difficulty digesting, constipation, loss of appetite.
• irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure.
• increased sweating.
• itching or urticaria.
• hair loss.
• muscle cramps, hot flushes, general feeling of being unwell, high body temperature (fever), impotence.
• high level of protein in the urine (measured with a laboratory test).
• low blood sugar level (with an increased state of consciousness or feeling of faintness), low sodium level in the blood, high urea level in the blood (all measured with a blood test).

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

• "Raynaud's phenomenon" in which hands and feet can become very cold and white due to low blood flow.
• changes in blood values such as a decrease in the number of white blood cells and red blood cells, decrease in haemoglobin, decrease in the number of platelets.
• bone marrow suppression.
• autoimmune diseases.
• altered dreams or sleep disturbances.
• lung infiltrates.
• inflammation of the nose.
• pneumonia.
• inflammation of cheeks, gums, tongue, lips, throat.
• decreased amount of urine produced.
• erythema multiforme.
• “Stevens-Johnson syndrome” a serious skin condition in which there is redness and peeling of the skin, blistering or exposed ulcers, or detachment of the superficial layer of the skin from the deeper layers.
• liver problems such as reduced liver function, inflammation of the liver, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin (measured with a blood test).
• enlargement of the mammary glands in men.

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

• swelling in the intestine (intestinal angioedema). Frequency not known(cannot be estimated from the available data)
• Syndrome of inappropriate secretion of the antidiuretic hormone (SIADH), a condition in which the body develops an excess of water and a decreased concentration of sodium (salt), as a result of incorrect chemical signals. Patients with SIADH may become seriously ill or may have no symptoms.
• A complex of symptoms has been described that may be associated with some or all of the following side effects: fever, inflammation of the serous surfaces, inflammation of the blood vessels, muscle and joint pains, inflammation of the muscles and joints and some changes in laboratory values; skin rash, sensitivity to light and other skin reactions may occur.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa..
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ENALAPRIL DOC

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 30ºC. Store in the original package.
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 DOC contains

• The active ingredient is 5 mg or 20 mg of enalapril maleate
• The other ingredients are anhydrous colloidal silica, magnesium stearate, sodium hydroxide, povidone, talc, crospovidone, microcrystalline cellulose and lactose monohydrate.

Description of the appearance of ENALAPRIL DOC and contents of the pack
The tablets are round, white or off-white, with the inscription ED 5 (5 mg tablets), ED 20 (20 mg
tablets) on one side and a fracture line on the other side.
The tablets are packaged in blisters (Alu/OPA-Alu-PVC).
Packs of ENALAPRIL DOC 5 mg tablets: 28, 30, 50 or 100 tablets.
Packs of ENALAPRIL DOC 20 mg tablets: 7, 14, 28, 30, 50 or 100 tablets.
However, not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l.
Via Turati 40,
20121 Milano,
Italy
Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: ENALAPRIL DOC 5 mg tablets
Italy: ENALAPRIL DOC 20 mg tablets