ENALAPRIL 5 mg Tabletki Powlekane

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1. Enalapril Teva Italia 5 mg tablets, 20 mg tablets
   1. What is Enalapril Teva Italia and what it is used for
   2. What you need to know before taking Enalapril Teva Italia
   3. How to take Enalapril Teva Italia
   4. Possible side effects
   5. How to store Enalapril Teva Italia
   6. Package Contents and Other Information

Enalapril Teva Italia 5 mg tablets, 20 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 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 Teva Italia is and what it is used for
• 2. What you need to know before you take Enalapril Teva Italia
• 3. How to take Enalapril Teva Italia
• 4. Possible side effects
• 5. How to store Enalapril Teva Italia
• 6. Contents of the pack and other information

1. What is Enalapril Teva Italia and what it is used for

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

• treating high blood pressure (hypertension)
• treating heart failure (weakening of the heart's function). It can reduce the need to be hospitalised and can help some patients to live longer
• preventing the signs of heart failure, such as shortness of breath, fatigue after light activities such as walking and swelling of feet and ankles.

Enalapril Teva Italia works by widening the blood vessels so as to reduce blood pressure.
This medicine generally starts to work within one hour and the effect lasts for at least 24 hours.
For some people, several weeks of treatment are necessary to obtain the maximum
effect on blood pressure.

2. What you need to know before taking Enalapril Teva Italia

Do not take Enalapril Teva Italia if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• you have had an allergic reaction to a type of medicine similar to Enalapril Teva Italia called ACE-inhibitor
• you have experienced swelling of the face, lips, mouth, tongue or throat, which has caused difficulty swallowing or breathing (angioedema), of unknown cause or hereditary origin
• you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren
• you are already more than three months pregnant (it is best to avoid taking Enalapril Teva Italia even at the beginning of pregnancy - see the section Pregnancy).
• 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).

Do not take Enalapril Teva Italia if you are in any of the above conditions. If you have any doubts, consult your
doctor or pharmacist before taking Enalapril Teva Italia.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

• you have a heart problem
• you have a disorder affecting the blood vessels of the brain
• you have a blood problem, such as an absence or a low number of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or a reduced number of red blood cells (anemia)
• you have a liver problem
• you have a kidney problem (including a kidney transplant). This could cause higher and potentially dangerous levels of potassium in the blood. Your doctor may need to correct the dose of Enalapril Teva Italia or monitor potassium levels in the blood
• you are undergoing dialysis
• you have recently had severe vomiting or diarrhea
• you are following a low-salt diet, use potassium supplements, potassium-sparing medicines or salt substitutes containing potassium
• you are over 70 years old
• you have diabetes. You should monitor your blood to rule out hypoglycemia, especially during the first month of treatment. Potassium levels in the blood may also be higher
• you have had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing (angioedema), see also the information in the section above “Do not take Enalapril Teva Italia if”. Please note that people of black skin have a greater risk of developing this type of reaction to ACE-inhibitors
• if you are taking an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent rejection of transplanted organs), racecadotril (a medicine used to treat diarrhea) or vildagliptin (a medicine used to treat diabetes). The risk of an allergic reaction called angioedema is higher (for symptoms, see the point above)
• you have low blood pressure (you may notice this because you feel faint or dizzy, especially when standing up)
• you have a collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma), are taking immunosuppressive therapy, are taking allopurinol or procainamide or a combination thereof
• 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.

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 what is stated under "Do not take Enalapril Teva Italia".
Tell your doctor if you think you may be (or become) pregnant. Enalapril Teva Italia is not
recommended at the beginning of pregnancy and should not be taken if you are already past the 3rd month of
pregnancy as it could cause serious harm to the fetus (see the
section Pregnancy).
Please note that Enalapril Teva Italia is less effective in lowering blood pressure in patients of
black skin compared to patients who are not of black skin.
If you are not sure whether the situations listed above apply to you, consult your doctor or
pharmacist before taking Enalapril Teva Italia.

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 Teva Italia:

• surgery or the administration of an anesthetic (even from the dentist)
• a treatment that removes cholesterol from the blood called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bee or wasp stings. If you are in any of the above conditions, consult your doctor or dentist before the procedure. Other medicines and Enalapril Teva ItaliaTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Enalapril Teva Italia can affect the way some medicines work. Also, other medicines can affect the way Enalapril Teva Italia works. Your doctor may need to change the dose and/or take other precautions. In particular, tell your doctor or pharmacist if you take any of the following medicines:
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the information in the sections “Do not take Enalapril Teva Italia if” and “Warnings and precautions”)
• other medicines that lower blood pressure, such as beta-blockers or diuretics (water pills; for example potassium-sparing diuretics such as spironolactone, triamterene and amiloride)
• medicines that contain potassium (including salt substitutes)
• medicines that can increase potassium levels in the body including heparin (to thin the blood), cyclosporine (an immunosuppressant used to prevent rejection of transplanted organs) and co-trimoxazole also known as trimethoprim/sulfamethoxazole (for infections caused by bacteria)
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat a particular type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental problems called “antipsychotics”
• some medicines for coughs and colds and some medicines for weight reduction that contain substances called “sympathomimetics”
• some medicines for pain or arthritis, including gold-based therapy
• racecadotril (a medicine used to treat diarrhea)
• an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or used to prevent rejection of transplanted organs). See also the information in the section “Warnings and precautions”
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and can be used to relieve pain)
• acetylsalicylic acid
• medicines used to dissolve blood clots (thrombolytics).

If you are not sure whether the situations listed above apply to you, consult your doctor or
pharmacist before taking Enalapril Teva Italia.

Enalapril Teva Italia with food, drinks and alcohol
Enalapril Teva Italia can be taken with or without food. Most people take
Enalapril Teva Italia with a glass of water.
During the intake of this medicine, alcohol intake should be minimized,
as alcohol increases the blood pressure lowering effects of Enalapril Teva Italia.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine.

Pregnancy
Your doctor will usually advise you to stop taking Enalapril Teva Italia before
becoming pregnant or as soon as you find out you are pregnant and will advise you to take
another medicine instead of Enalapril Teva Italia.
Enalapril Teva Italia is not recommended in early pregnancy and should not be taken beyond
the third month of pregnancy, as it could cause serious harm to the 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
(during the first weeks after delivery), and especially premature infants, is not
recommended during the use of Enalapril Teva Italia. In the case of older infants, the doctor
must assess the benefits and risks associated with taking Enalapril Teva Italia during
breastfeeding compared to other treatments.

Driving and using machines
You may feel sleepy or dizzy when taking Enalapril Teva Italia. If this
happens, do not drive and do not use tools or machines.

Enalapril Teva Italia contains lactose and sodium
Enalapril Teva Italia contains a type of sugar called lactose. If you have been
diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Enalapril Teva Italia

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 that you continue to take Enalapril Teva Italia for the duration prescribed by your doctor.
• Do not take more tablets than prescribed.

Enalapril Teva Italia 5 mg tablets, Enalapril Teva Italia 20 mg tablets
The tablet can be divided into equal doses.
If your treatment with Enalapril Teva Italia requires dividing the tablet, this is the
best way to do it:
place the tablet with the fracture line facing upwards on a hard, smooth surface (e.g.
a table or a flat surface). Position your index fingers (or thumbs) on either side of the fracture line and press
down simultaneously in a quick and decisive manner.

This is a schematic drawing of the tablet. Therefore, the format may be slightly
different from your tablet.

High blood pressure

• The usual starting dose is 5-20 mg once a day.
• Some patients may need a lower starting dose.
• The usual maintenance dose is 20 mg once a day.
• The maximum maintenance dose is 40 mg once a day.

Heart failure

• The usual starting dose is 2.5 mg once a day.
• The doctor will gradually increase this amount until they reach the right dose for you.
• The usual maintenance dose is 20 mg per day, divided into one or two doses.
• The maximum maintenance dose is 40 mg per day, divided into two doses.

Patients with kidney problems
The dose of medicine will change based on how well your kidneys are working:

• in the presence of moderate kidney problems: 5-10 mg per day
• in the presence of severe kidney problems: 2.5 mg per day
• if you are undergoing dialysis: 2.5 mg per day. On the days when you are not undergoing dialysis, the dose may be adjusted based on your low blood pressure.

Elderly patients
The dose will be determined by the doctor based on how well your kidneys are working.

Use in children and adolescents
Experience with the use of Enalapril Teva Italia in children with high blood pressure is limited. If the child
can swallow the tablets, the dose is determined based on body weight and blood pressure. The
usual starting doses are:

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

Enalapril Teva Italia is not recommended in newborns (during the first few weeks after birth) and
in children with kidney problems.

If you take more Enalapril Teva Italia than you should
If you take more Enalapril Teva Italia than you should, tell your doctor or go directly to
hospital. Bring the medicine packaging with you. The following effects may occur:
feeling of dizziness or lightheadedness. These effects are due to a rapid or excessive drop in
blood pressure.

If you forget to take Enalapril Teva Italia

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

If you stop taking Enalapril Teva Italia
Do not stop taking the medicine unless your doctor tells you to.
If you have any doubts about using 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 Enalapril Teva Italia and contact your doctor immediately if you notice the
appearance of any of the following symptoms:

• Swelling of the face, lips, tongue or throat, which can cause difficulty breathing or swallowing; swelling of hands, feet or ankles; hives. These are symptoms of a serious allergic reaction called angioedema (may affect up to 1 in 10 people). Please note that people of black skin have a higher risk of developing this type of reaction.
• Severe skin reactions with redness and peeling of the skin, blisters or sores (Stevens-Johnson syndrome, toxic epidermal necrolysis), severe rash with redness or peeling of the skin (exfoliative dermatitis/erythroderma), small blisters filled with fluid on the skin (pemphigus), rash characterized by lesions with a target-like appearance (erythema multiforme) (may affect up to 1 in 1,000).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice), dark urine. These can be signs of liver problems such as hepatitis (liver inflammation) or liver damage (may affect up to 1 in 1,000).

In rare cases, Enalapril Teva Italia may impair white blood cells, compromising the immune
system. If you develop an infection with symptoms such as fever accompanied by a severely
deteriorating general health condition or fever with symptoms of a local infection such as sore
throat/mouth or difficulty urinating, you should contact a doctor immediately so that a blood
test can be performed to rule out a possible lack of white blood cells
(agranulocytosis, may affect up to 1 in 1,000). It is important that you inform your
medical personnel about the medicines you are taking.
At the beginning of treatment with Enalapril Teva Italia you may feel faint or dizzy. In
this case, it is helpful to lie down. These symptoms are caused by a lowering of blood pressure and
should improve as treatment continues. If you feel worse, consult your doctor.
Other side effects include:

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

• dizziness, weakness or nausea
• blurred vision
• cough Common(may affect up to 1 in 10 people)
• dizziness due to low blood pressure, changes in heart rate, increased heart rate, angina or chest pain
• headache, depression, fainting (syncope)
• altered sense of taste
• shortness of breath
• diarrhea or abdominal pain
• fatigue (tiredness)
• skin rash
• high levels of potassium in the blood, increased creatinine levels in the blood (which can be detected by blood tests) Uncommon(may affect up to 1 in 100 people)
• hot flushes
• sudden drop in blood pressure
• fast or irregular heartbeat (palpitations)
• heart attack (potentially caused by very low blood pressure in some high-risk patients, including patients with problems with blood flow to the heart or brain)
• stroke (potentially caused by very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, insomnia or drowsiness, nervousness
• tingling sensation 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, ulcers, muscle cramps
• impaired kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• general feeling of malaise, fever
• impotence
• high levels 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” in which the hands and feet become very cold and white due to poor blood flow
• changes in blood values, such as low number of white blood cells and red blood cells, decreased hemoglobin, decreased platelets
• bone marrow suppression
• enlargement of the glands in the neck, armpit or groin
• autoimmune diseases
• abnormal dreams or sleep problems
• build-up of fluids or other substances in the lungs (visible on X-ray) inflammation of the nose
• inflammation of the lungs due to difficulty breathing (pneumonia)
• inflammation of cheeks, gums, tongue, lips, throat
• reduced urine volume
• high levels of liver enzymes or bilirubin (measured with a blood test)
• enlargement of the breasts in males (gynecomastia)

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

• swelling of the intestine (intestinal angioedema)

Not known(frequency cannot be estimated from the available data)

• excessive production of antidiuretic hormone, which causes fluid retention, resulting in weakness, fatigue or confusion
• a set 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 rashes, 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 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 Teva Italia

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 package after ”Expiry”. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Store in the original package 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. Package Contents and Other Information

What Enalapril Teva Italia contains

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients are: sodium bicarbonate, lactose monohydrate, corn starch, hydroxypropylcellulose, talc and magnesium stearate.
• The 10 mg tablet also contains red iron oxide (E 172), while the 20 mg tablet also contains red iron oxide (E 172) and yellow iron oxide (E172).

Description of the appearance of Enalapril Teva Italia and package contents
The 5 mg tablets of Enalapril Teva Italia are round, biconvex tablets, of
white color, with a beveled edge and a fracture line on one side.
The tablet can be divided into equal doses.
They are supplied in blister packs of 20, 28, 30, 50, 50 x 1, 60, 100, 250 and 500 tablets.
The 20 mg tablets of Enalapril Teva Italia are round, biconvex tablets, of
light orange color with individual spots, with a beveled edge and a fracture line on one side.
The tablet can be divided into equal doses.
They are supplied in blister packs of 14, 20, 28, 30, 50, 50 x 1, 100 and 250 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Teva Operations Poland Sp. z.o.o.
Ul. Mogilska 80, 31-546 Krakow - Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren - Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Enalapril Teva 2.5, 5, 10, 20 mg tablet
Italy: Enalapril Teva Italia
Sweden: Enalapril Teva 2.5, 5, 10, 20 mg tablet