ENAPREN 20 mg Таблетки

Содержание инструкции

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

Enapren 5 mg or 20 mg tablets

enalapril maleate
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 they have the same symptoms as you, 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 Enapren is and what it is used for
• 2. What you need to know before you take Enapren
• 3. How to take Enapren
• 4. Possible side effects
• 5. How to store Enapren
• 6. Contents of the pack and other information

1. What is Enapren and what is it used for

Enapren contains an active substance called enalapril maleate. This active substance
belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
Enapren 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 your blood vessels. This lowers your 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 Enapren

Do not take Enapren

• 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 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 that caused difficulty 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 3 months. (It is also preferable to avoid using Enapren in the early stages of pregnancy - see section Pregnancy.)
• 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 the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased. Do not take this medicine if you have any of the problems listed above. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enapren:

• 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 lack of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or a reduction in the number of red blood cells (anemia)
• if you have a liver problem
• if you have a kidney problem (including kidney transplant), are following a low-salt diet, are taking potassium supplements, potassium-sparing agents, salt substitutes containing potassium or other medicines that can increase potassium levels in the blood (e.g., heparin [a medicine used to prevent blood clots], products containing trimethoprim such as co-trimoxazole [medicines used to treat infections]). 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 Enapren or monitor your blood potassium levels. See also the information in the section “Other medicines and Enapren”.
• if you are on dialysis
• if you have recently experienced episodes of excessive vomiting or severe diarrhea
• if you have diabetes. You need to carefully monitor if a lowering of blood glucose levels occurs, especially during the first month of treatment. The potassium level 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 have a feeling of fainting or dizziness, 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 their combinations
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus)
• 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 blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan, etc.), especially if you suffer from kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also the information under “Do not take Enapren”. You should tell 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 3 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 than in non-black patients. If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before taking this medicine. If you are going to have a procedureIf you are going to have any of the following procedures, tell your doctor that you are taking Enapren:
• any type of surgery or anesthesia (including from the dentist)
• treatment that removes cholesterol from the blood called “LDL apheresis”
• desensitization 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 Enapren
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 Enapren can
interfere with the mechanism of action of some medicines. Also, some other medicines can
interfere with the mechanism of action of Enapren. Your 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:

• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the information under “Do not take Enapren” and “Warnings and precautions”)
• other medicines to lower blood pressure, such as beta-blockers or diuretics
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria
• cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection
• heparin, a medicine used to thin the blood to prevent the formation of clots). See also the information in the section “Warnings and precautions”
• 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 cough and cold and weight-reducing medicines that contain a so-called “sympathomimetic agent”
• some medicines for pain or arthritis including gold salt therapy
• an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat some types of cancer or to prevent an organ transplant from being rejected by the body’s immune system). See also the information in the section “Warnings and precautions”
• a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), racecadotril or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) may be increased. See also the information in the sections “Do not take Enapren” and “Warnings and precautions”
• 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. If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before taking Enapren.

Enapren with food and drink
Enapren can be taken with or without food. Most people take Enapren with
a glass of water.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine. As a rule, your doctor
will advise you to stop taking Enapren before planning a pregnancy or
as soon as you find out you are pregnant and will advise you to take another
medicine instead of Enapren. 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 after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Breastfeeding of newborns (first weeks after birth), especially premature babies, is not recommended
during the use of this medicine. In the case of older children, the doctor will inform you of the
benefits and risks associated with taking this medicine during breastfeeding, compared to
other treatments.

Driving and using machines
Dizziness or drowsiness may occur while taking this medicine. If this
happens, do not drive or use any tools or machinery.

Enapren contains lactose
Enapren contains lactose, which is a type of sugar. If your doctor has diagnosed you with
lactose intolerance, contact him/her before taking this medicine.

Enapren contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say, it is essentially
“sodium-free”.

3. How to take Enapren

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

• It is very important to continue taking this medicine for as long as prescribed by your doctor.
• Do not take more tablets than prescribed
• The score line is to facilitate breaking the tablet if you have difficulty swallowing it whole. High blood pressure
• The usual starting dose ranges from 5 to 20 mg as a single daily dose.
• Some patients may need to start treatment with a lower dose.
• The usual maintenance dose is 20 mg as a single daily dose.
• The maximum maintenance dose is 40 mg as a single daily dose. Heart failure
• The usual starting dose is 2.5 mg as a single daily dose.
• The doctor will gradually increase the dose until the appropriate dose for you is reached.
• The usual maintenance dose is 20 mg per day, taken as one or two doses.
• The maximum maintenance dose is 40 mg per day, divided into two doses. Patients with kidney problemsThe dose of the medicine will vary depending on your kidney function:
• 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 patientsThe dose will be decided by the doctor and will be based on the degree of your kidney function. Use in childrenExperience with the use of Enapren in children with high blood pressure is limited. If the child is able to swallow the tablets, the dose will be established based on 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 take more Enapren than you should
If you take more Enapren than you should, tell your doctor or go to hospital immediately.
Bring the medicine packaging with you. The following effects may occur: feeling of
lightness or dizziness. This is due to a sudden or excessive decrease in
blood pressure.

If you forget to take Enapren

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

If you stop taking Enapren
Do not stop taking the medicine unless your doctor tells you to.
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 gets them. The following side effects may occur with this medicine:

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

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

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

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

• feeling of dizziness, weakness or unwell
• 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), altered sense of taste
• shortness of breath
• diarrhoea, abdominal pain
• tiredness (fatigue)
• skin rash, allergic reactions with swelling of the face, lips, tongue or throat with difficulty breathing or swallowing
• high 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)
• flushing
• sudden decrease 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 in 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 pins and needles or numbness
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma associated with chest tightness
• slowed transit of food in the intestine (ileus), inflammation of the pancreas
• feeling unwell (vomiting), difficulty digesting, constipation, loss of appetite
• irritated stomach (gastric irritations), dry mouth, ulcer
• muscle cramps
• impaired kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of unwellness, high body temperature (fever)
• impotence
• high level of protein in the urine (measured with a laboratory 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” in which hands and feet can become very cold and white due to low blood flow
• changes in blood values such as decreased number of white blood cells and red blood cells, decreased haemoglobin, decreased number of platelets
• bone marrow suppression
• swelling of the glands in the neck, armpits or groin
• autoimmune diseases
• strange dreams or sleep disturbances
• accumulation of fluid or other substances in the lungs (visible on X-ray)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of cheeks, gums, tongue, lips, throat
• decreased amount of urine
• skin rash similar to a target (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin conditions in which there is redness and peeling of the skin, blistering or exposed ulcers), exfoliative dermatitis/erythroderma (severe rash with peeling or exfoliation of the superficial layer of the skin), pemphigus (small blisters filled with fluid on the skin)
• 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 (gynecomastia) Very Rare(may affect up to 1 in 10,000 people)
• swelling in the intestine (intestinal angioedema) Not known(frequency cannot be estimated based on available data)
• overproduction of antidiuretic hormone, which causes fluid retention, with consequent weakness, fatigue or confusion
• a complex of symptoms has been reported that may include some or all of the following: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin manifestations 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 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 Enapren

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 package after
the wording EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°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 Enapren contains

• The active ingredient is enalapril maleate (5 mg or 20 mg).
• The other ingredients are lactose monohydrate, sodium bicarbonate, corn starch, pregelatinized corn starch, magnesium stearate. The 20 mg tablets also contain red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Enapren and contents of the pack
Enapren is available in the following packs:
ENAPREN 5 mg – packs in aluminum blisters containing 2, 14, 20, 28, 28 x 1, 30, 49 x 1, 50,
56, 98 or 100 tablets.
ENAPREN 20 mg - packs in aluminum blisters containing 10, 14, 20, 28, 28 x 1, 30, 49 x 1,
50, 56, 60, 84, 90, 98, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, 2220, Belgium

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
Austria, Belgium, Finland, France, Greece, Luxembourg, Netherlands, Portugal, Spain, Sweden:
RENITEC
Germany:
XANEF
Italy:
ENAPREN
United Kingdom (Northern Ireland), Ireland:
INNOVACE