Enalapril Teva Italia

Package leaflet: Information for the user

Enalapril Teva Italia 5 mg tablets, 20 mg tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including any 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 taking 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 Enalapril Teva Italia is and what it is used for

Enalapril Teva Italia contains an active substance called enalapril maleate. It belongs to a group of medicines known as 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 for hospitalisation and may help some patients live longer
• preventing the symptoms of heart failure, such as shortness of breath, tiredness after light physical activity like walking, and swelling of the feet and ankles.

Enalapril Teva Italia works by widening the blood vessels, thereby reducing blood pressure. This medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. For some people, several weeks of treatment are needed to achieve 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 substance or to any of the other ingredients of this medicine (listed in section 6)
• you have had an allergic reaction to a similar medicine to Enalapril Teva Italia called an ACE-inhibitor
• you have had swelling of the face, lips, mouth, tongue or throat, causing difficulty swallowing or breathing (angioedema), of unknown cause or hereditary origin
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• you are more than three months pregnant (it is better to avoid taking Enalapril Teva Italia even in early pregnancy – see section Pregnancy)
• you are taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in 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 condition
• you have a disorder affecting the blood vessels in the brain
• you have a blood disorder, such as absence or low number of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)
• you have a liver problem
• you have a kidney problem (including kidney transplant). This may cause higher and potentially dangerous levels of potassium in the blood. Your doctor may need to adjust the dose of Enalapril Teva Italia or monitor potassium levels in your blood
• you are undergoing dialysis
• you have recently had severe vomiting or diarrhoea
• you are on a low-salt diet, using potassium supplements, potassium-sparing medicines, or potassium-containing salt substitutes
• you are over 70 years old
• you have diabetes. You should monitor your blood glucose to rule out hypoglycaemia, especially during the first month of treatment. Blood potassium levels may also be higher
• you have previously experienced an allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty swallowing or breathing (angioedema), see also information in the section above “Do not take Enalapril Teva Italia if”. Please note that black patients have a higher risk of developing this type of reaction to ACE inhibitors
• 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 diarrhoea), or vildagliptin (a medicine used to treat diabetes). The risk of an allergic reaction called angioedema is increased (for symptoms, see above)
• you have low blood pressure (you may feel faint or dizzy, especially when standing up)
• you have a collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are receiving immunosuppressive therapy, or are taking allopurinol or procainamide, or a combination of these
• you are taking one 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), particularly if you have kidney problems related to diabetes
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading "Do not take Enalapril Teva Italia".
Inform your doctor if you think you may be (or could become) pregnant. Enalapril Teva Italia is not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause severe harm to the unborn baby if used during this period (see section Pregnancy).
Please note that Enalapril Teva Italia is less effective in lowering blood pressure in black patients compared to non-black patients.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking Enalapril Teva Italia.
If you are about to undergo a procedure
If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril Teva Italia:

• surgery or administration of an anaesthetic (including from your dentist)
• a treatment to remove cholesterol from the blood called "LDL apheresis"
• a desensitisation 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 Italia Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Enalapril Teva Italia may affect how some medicines work. Other medicines may also affect how Enalapril Teva Italia works. Your doctor may need to adjust the dose and/or take other precautions. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information in sections “Do not take Enalapril Teva Italia if” and “Warnings and precautions”)
• other medicines that lower blood pressure, for example beta-blockers or water pills (diuretics; e.g. potassium-sparing diuretics such as spironolactone, triamterene and amiloride)
• medicines containing potassium (including salt substitutes)
• medicines that may increase potassium levels in the body, including heparin (to thin the blood), cyclosporine (an immunosuppressant medicine used to prevent rejection of transplanted organs), and cotrimoxazole also known as trimethoprim/sulfamethoxazole (for bacterial infections)
• 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 disorders called "antipsychotics"
• some cough and cold medicines and some weight-reduction medicines containing substances called "sympathomimetic agents"
• some medicines for pain or arthritis, including gold therapy
• racecadotril (a medicine used to treat diarrhoea)
• an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent rejection of transplanted organs). See also information in section “Warnings and precautions”
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain)
• acetylsalicylic acid
• medicines used to dissolve blood clots (thrombolytics).

If you are unsure whether any of the above situations 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 treatment with this medicine, alcohol intake should be kept to a minimum, as alcohol increases the blood pressure-lowering effect of Enalapril Teva Italia.
Pregnancy, breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, 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 recommend an alternative medicine instead of Enalapril Teva Italia.
Enalapril Teva Italia is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding (during the first weeks after birth), and particularly breastfeeding of premature infants, is not recommended during treatment with Enalapril Teva Italia. For older infants, your doctor will need to weigh the benefits and risks of taking Enalapril Teva Italia during breastfeeding against other treatments.
Driving and using machines
You may feel drowsy or dizzy when taking Enalapril Teva Italia. If this occurs, do not drive and do not operate tools or machinery.
Enalapril Teva Italia contains lactose and sodium
Enalapril Teva Italia contains a type of sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

• It is very important that you continue taking 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 you to split the tablet, this is the best way to do it:
Place the tablet with the score line facing upwards on a hard, flat surface (e.g. a table or flat surface). Place your index fingers (or thumbs) on either side of the score line and press down quickly and firmly at the same time.

This is a schematic drawing of the tablet. Therefore, the actual appearance may differ slightly from your tablet.
High blood pressure

• The usual starting dose is 5–20 mg once daily.
• Some patients may require a lower starting dose.
• The usual maintenance dose is 20 mg once daily.
• The maximum maintenance dose is 40 mg once daily.

Heart failure

• The usual starting dose is 2.5 mg once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The usual maintenance dose is 20 mg daily, divided into one or two doses.
• The maximum maintenance dose is 40 mg daily, divided into two doses.

Patients with kidney problems
The dose of medicine will be adjusted depending on kidney function:

• in case of moderate kidney problems: 5–10 mg daily
• in case of severe kidney problems: 2.5 mg daily
• if you are undergoing dialysis: 2.5 mg daily. On days when you do not undergo dialysis, the dose may be adjusted based on your low blood pressure.

Elderly patients
The dose will be determined by your doctor based on kidney function.
Use in children and adolescents
Experience with the use of Enalapril Teva Italia in children with high blood pressure is limited. If the child is able to swallow tablets, the dose is based on body weight and blood pressure. Usual starting doses are:

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

Enalapril Teva Italia is not recommended in neonates (during the first 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, inform your doctor or go immediately to hospital. Take the medicine package with you. The following effects may occur:
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 usual 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 treatment with this medicine unless instructed by your doctor.
If you have any questions about how to use this medicine, consult 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 any of the following symptoms:

• Swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing; swelling of the 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 patients with 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 fluid-filled blisters on the skin (pemphigus), skin rash characterized by lesions resembling targets (erythema multiforme) (may affect up to 1 in 1,000 people).
• Fever, chills, fatigue, loss of appetite, stomach discomfort, feeling unwell, yellowing of the skin or eyes (jaundice), dark urine. These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage (may affect up to 1 in 1,000 people).

In rare cases, Enalapril Teva Italia may affect white blood cells and impair the immune system. If you develop an infection with symptoms such as fever associated with a severely deteriorated general condition or fever with signs of localized infection such as sore throat/mouth or difficulty urinating, contact your 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 people). It is important that you inform medical personnel about the medicines you are taking.
At the beginning of treatment with Enalapril Teva Italia, you may feel faint or dizzy. If this happens, it is helpful to lie down. These symptoms are caused by a drop in 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 rhythm, rapid heartbeat, angina or chest pain
• headache, depression, fainting (syncope)
• altered sense of taste
• shortness of breath
• diarrhoea or abdominal pain
• fatigue (tiredness)
• skin rash
• high levels of potassium in the blood, increased levels of creatinine 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
• rapid or irregular heartbeat (palpitations)
• heart attack (potentially caused by very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain)
• stroke (potentially caused by very low blood pressure in high-risk patients)
• anaemia (including aplastic and haemolytic anaemia)
• confusion, insomnia or drowsiness, nervousness
• tingling sensation or numbness of the skin
• vertigo (dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma associated with chest tightness
• slowed passage of food through the intestine (ileus), inflammation of the pancreas
• feeling unwell (vomiting), indigestion, constipation, loss of appetite
• irritated stomach (gastric irritation), dry mouth, ulcer, muscle cramps
• impaired kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• general feeling of being unwell, fever
• impotence
• high levels of protein in the urine (measured by a test)
• low levels of sugar or sodium in the blood, high levels of urea in the blood (all measured by blood tests)

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 test values, such as low numbers of white and red blood cells, decreased haemoglobin, decreased platelets
• bone marrow depression
• swelling of the glands in the neck, armpit or groin
• autoimmune diseases
• abnormal dreams or sleep problems
• accumulation of fluid or other substances in the lungs (visible on X-ray), inflammation of the nose
• inflammation of the lungs due to breathing difficulties (pneumonitis)
• inflammation of cheeks, gums, tongue, lips, throat
• reduced urine output
• high levels of liver enzymes or bilirubin (measured by blood test)
• breast enlargement in males (gynaecomastia)

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, causing fluid retention, leading to weakness, fatigue or confusion
• a group of symptoms has been reported which 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 also occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via 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 substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The active substance is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components are: sodium bicarbonate, monohydrate lactose, maize 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 (E 172).

Description of the Appearance of Enalapril Teva Italia and Contents of the Pack
The 5 mg tablets of Enalapril Teva Italia are white, round, biconvex tablets with bevelled edges and a score line on one side.
The tablet can be divided into equal doses.
They are supplied in blister packs containing 20, 28, 30, 50, 50 x 1, 60, 100, 250 and 500 tablets.
The 20 mg tablets of Enalapril Teva Italia are light orange, round, biconvex tablets with speckles, bevelled edges and a score line on one side.
The tablet can be divided into equal doses.
They are supplied in blister packs containing 14, 20, 28, 30, 50, 50 x 1, 100 and 250 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
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 authorized in the European Economic Area countries under the following names:
Denmark: Enalapril Teva 2.5, 5, 10, 20 mg tablet
Italy: Enalapril Teva Italia
Sweden: Enalapril Teva 2.5, 5, 10, 20 mg tablett