ENALAPRIL 10 mg/10 mg Film-Coated Tablets

Зміст інструкції

1. ENALAPRIL E LERCANIDIPINA EG 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets
   1. What is Enalapril and lercanidipina EG and what it is used for
   2. What you need to know before taking Enalapril and lercanidipine EG
   3. How to take Enalapril and lercanidipina EG
   4. Possible side effects
   5. How to store Enalapril and lercanidipina EG
   6. Contents of the pack and other information

ENALAPRIL E LERCANIDIPINA EG 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets

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

1. What is Enalapril and lercanidipina EG and what it is used for

Enalapril and lercanidipina EG is the fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipina), two drugs that reduce blood pressure.

[only for the 10 mg/10 mg dose]
Enalapril and lercanidipina EG is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate blood pressure control has not been achieved with the administration of 10 mg of lercanidipina alone.

[only for the 20 mg/10 mg dose]
Enalapril and lercanidipina EG is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate blood pressure control has not been achieved with the administration of 20 mg of enalapril alone.
Enalapril and lercanidipina EG should not be used for the initial treatment of hypertension.

2. What you need to know before taking Enalapril and lercanidipine EG

Do not take Enalapril and lercanidipine EG

• if you are allergic to enalapril or lercanidipine or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously had an allergic reaction to a type of drug similar to those contained in Enalapril and lercanidipine EG, e.g. drugs called ACE inhibitors or calcium channel blockers.
• If you have previously experienced swelling of the face, lips, mouth, tongue or larynx that caused difficulty in swallowing or breathing (angioedema) after taking a type of medicine called an ACE inhibitor, or without a known cause or due to hereditary reasons.
• If you have diabetes or kidney problems and are taking medicines that contain aliskiren to lower your blood pressure.
• If you are more than three months pregnant (it is also best to avoid Enalapril and lercanidipine EG in the first months of pregnancy - see section on pregnancy).
• If you suffer from certain heart conditions such as:
• obstruction of blood flow from the heart, including narrowing of the aortic valve of the heart;
• untreated heart failure;
• chest pain that occurs at rest or worsens or occurs frequently (unstable angina pectoris);
• heart attack (myocardial infarction) that occurred less than a month ago.
• If you suffer from a severe kidney disease or are undergoing dialysis.
• If you suffer from severe liver problems.
• If you are taking medications that inhibit hepatic metabolism, such as:
• antifungals (e.g. ketoconazole, itraconazole);
• macrolide antibiotics (e.g. erythromycin, troleandomycin);
• antivirals (e.g. ritonavir).
• If you are taking another drug called cyclosporine at the same time (used after transplants to prevent organ rejection).
• Together with grapefruit or grapefruit juice. Warnings and precautionsTalk to your doctor or pharmacist before taking Enalapril and lercanidipine EG:
• if you have low blood pressure (it will manifest with weakness or dizziness, especially when standing up);
• if you have been very ill (excessive vomiting) or have had diarrhea recently;
• if you are following a low-sodium diet, taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium;
• if you are over 70 years of age;
• if you suffer from heart problems;
• if you suffer from a condition affecting blood vessels in the brain;
• if you have kidney problems (including kidney transplant);
• if you are undergoing dialysis;
• if you suffer from liver problems;
• if you have blood problems, such as a decrease or lack of white blood cells (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia) or a reduced number of red blood cells (anemia);
• if you suffer from vascular collagen diseases (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are taking immunosuppressants, allopurinol or procainamide or any combination of these factors;
• if you are a patient of color, you should be aware that patients of color have a higher risk of allergic reaction with swelling of the face, lips, tongue and throat with difficulty swallowing and breathing following the intake of ACE inhibitors;
• if you suffer from diabetes;
• if you develop a persistent dry cough;
• if you suspect (or are planning) a pregnancy. The use of Enalapril and lercanidipine EG is not recommended during the early stages of pregnancy and the medicine should not be taken if you are pregnant for more than 3 months because, if taken at that time of pregnancy, it could seriously harm your baby (see section on pregnancy);
• 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 - e.g. valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren.
• if you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin, for example at the level of the throat) is increased:
• sirolimus, everolimus and other medicines that belong to the class of mTOR inhibitors (used to prevent organ rejection)

The doctor may check kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also what is indicated in the section “Do not take Enalapril and lercanidipine EG”.
You should be aware that this medicine is less effective in lowering blood
pressure in patients of color than in non-color patients.
If you are about to undergo a procedure/treatment
Tell your doctor that you are taking Enalapril and lercanidipine EG if you are about to:

• undergo surgery or anesthesia (including dental anesthesia);
• undergo a treatment to remove cholesterol from the blood called “LDL apheresis”;
• follow a desensitization therapy to reduce the effect of allergies to bee or wasp stings. If you develop any of the following signs or symptoms, seek immediate medical attention:
• yellowing of skin and mucous membranes (see section 4). In these cases, stop treatment with Enalapril and lercanidipine EG. The doctor will take appropriate measures. Children and adolescentsDo not give this medicine to children and adolescents under 18 years of age because there is no information on efficacy and safety. Other medicines and Enalapril and lercanidipine EGTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. This is because when Enalapril and lercanidipine EG is taken with certain medicines, its effect or that of other medicines may change or some undesirable effects may occur more frequently.

Enalapril and lercanidipine EG should not be taken with certain medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• medicines containing potassium (including salt substitutes in diets);
• other medicines indicated to lower blood pressure, such as diuretics (water pills), angiotensin II receptor blockers or a drug called aliskiren;
• lithium (a medicine used to treat a certain type of depression);
• medicines for the treatment of depression called “tricyclic antidepressants”;
• medicines for severe pain (narcotics, such as morphine);
• medicines for mental problems called “antipsychotics”;
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (drugs that reduce inflammation and can be used to help relieve pain);
• some medicines for pain or arthritis, including gold therapy;
• some medicines for cough and cold and weight loss medicines containing a substance called “sympathomimetic agent”;
• medicines for diabetes (including oral antidiabetic drugs and insulin);
• astemizole or terfenadine (medicines for allergies);
• amiodarone or quinidine (medicines for treating a fast heartbeat);
• phenytoin and carbamazepine (medicines for epilepsy);
• rifampicin (a medicine for the treatment of tuberculosis);
• digoxin (a medicine for the treatment of heart problems);
• midazolam (a medicine that helps you sleep);
• beta-blockers (medicines for the treatment of high blood pressure and heart problems);
• a medicine for ulcers and heartburn called cimetidine, taken in daily doses greater than 800 mg;
• medicines very often used to prevent organ rejection (sirolimus, everolimus and other medicines that belong to the class of mTOR inhibitors). See section “Warnings and precautions”;
• potassium supplements or salt substitutes containing potassium, diuretics (water pills, especially the so-called potassium-sparing diuretics), other medicines that can increase potassium levels in the body (such as heparin and cotrimoxazole also known as trimethoprim / sulfamethoxazole).

The doctor may consider it appropriate to modify the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the sections “Do not take Enalapril and lercanidipine EG” and “Warnings and precautions”). Enalapril and lercanidipine EG with food, drinks and alcoholDo not take Enalapril and lercanidipine EG with grapefruit or grapefruit juice. Alcohol can increase the effect of Enalapril and lercanidipine EG. For this reason, it is advisable not to drink alcohol or to minimize its consumption. Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect (or are planning) a pregnancy. As a rule, your doctor will advise
you to stop treatment with Enalapril and lercanidipine EG before you become pregnant or as
soon as pregnancy is confirmed and will prescribe another medicine to use instead of
Enalapril and lercanidipine EG. The use of Enalapril and lercanidipine EG is not recommended during the
early stages of pregnancy and the medicine should not be taken if you are pregnant for more than 3 months
because, if taken after the third month of pregnancy, it could seriously harm your
baby.
Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed your baby. Breastfeeding of
newborns (in the first weeks after birth), and especially premature infants, is not
recommended if you are taking Enalapril and lercanidipine EG. In the case of an older
newborn, the doctor should inform you about the benefits and risks of taking Enalapril and lercanidipine EG while
breastfeeding, compared to other treatments.

Driving and using machines
Avoid driving a vehicle or using machines if you experience
dizziness, weakness, fatigue or drowsiness while taking the medicine.

Enalapril and lercanidipine EG contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Enalapril and lercanidipina EG

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

Adults:The recommended dose is one tablet a day, taken at the same time each
day, unless otherwise prescribed by your doctor. The tablet should be taken
preferably in the morning, at least 15 minutes before breakfast. The tablets must be
swallowed whole with water.

Patients with kidney problems/elderly: the doctor will decide the dose of medication to be taken based
on how your kidneys are functioning.

If you take more Enalapril and lercanidipina EG than you should
If you take more medicine than you should, consult your doctor or go to hospital immediately.
Bring the package with you. Taking an excessive dose of the medication may determine
an excessive drop in blood pressure and the appearance of irregularities in heart rate or
tachycardia. You may experience restlessness or drowsiness, or pain in the side and back.

If you forget to take Enalapril and lercanidipina EG
If you forget to take a tablet, skip the missed dose.
Take the next dose as usual.
Do not take a double dose to compensate for forgetting the dose.

If you stop taking Enalapril and lercanidipina EG
Do not stop taking the medicine unless your doctor has decided to do so.
If you have any doubts about the use of 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.
It is possible that the following side effects may occur with the use of this medicine:

Stop taking Enalapril and lercanidipine EG and contact your doctor immediately if you
notice the appearance of any of the following conditions:

• Allergic reaction manifesting with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing.
• Severe skin reactions, including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

At the beginning of treatment with Enalapril and lercanidipine EG you may feel weakness or dizziness or have
blurred vision; this is caused by a sudden drop in blood pressure and if this happens it would be helpful to lie down. If this worries you, talk to your doctor.

Side effects observed with Enalapril and lercanidipine EG
Common (may affect up to 1 in 10 people):
Cough, dizziness, headache.
Uncommon (may affect up to 1 in 100 people):
Changes in blood values such as a reduction in the number of blood platelets, increased
potassium level in the blood, nervousness (anxiety), feeling dizzy when getting up,
vertigo, tachycardia, fast or irregular heartbeat (palpitations), sudden flushing of the
face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), high levels of liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of
weakness, fatigue, hot flushes, swelling of the ankles.
Rare (may affect up to 1 in 1,000):
Anemia, allergic reactions, ringing in the ears (tinnitus), fainting due to a severe drop in
blood pressure, dry throat, sore throat, indigestion, salty taste on the tongue,
diarrhea, dry mouth, swelling of the gums and lips, rash, hives, waking up
at night to urinate, increased urine production, impotence.

Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, feeling dizzy, cough, feeling unwell (nausea), feeling of
weakness.
Common (may affect up to 1 in 10 people):
Depression, fainting, chest pain, changes in heart rhythm, angina, shortness of breath,
diarrhea, abdominal pain, altered sense of taste, rash, fatigue,
increased potassium levels in the blood, increased creatinine levels in the blood
(usually detected by a test).
Uncommon (may affect up to 1 in 100 people):
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure,
confusion, insomnia or drowsiness, sensation of tingling or numbness in the skin, heart attack (probably due to very low blood pressure in some high-risk patients, including those with problems with blood flow to the heart or brain), stroke
(probably due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, reduced intestinal motility, pancreatitis,
feeling unwell, indigestion, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia,
increased sweating, itching or hives, hair loss, reduced kidney function,
kidney failure, high protein levels in urine (measured with a test), impotence, muscle cramps,
general feeling of unwellness, high temperature (fever), low blood sugar
or sodium levels, elevated urea levels in the blood (all detected with a blood test).
Rare (may affect up to 1 in 1,000):
Changes in blood values such as a reduction in the number of white blood cells, reduced
bone marrow function, autoimmune diseases, abnormal dreams or sleep disturbances, Raynaud's phenomenon (where hands and feet can become very cold and white due to reduced
blood flow), lung infiltrates, inflammation of the nose, pneumonia, swelling of the
tongue, liver problems such as decreased liver function, inflammation of the liver, jaundice
(yellowing of the skin and/or whites of the eyes), increased levels of bilirubin
(measured with a blood test), decreased urine output, enlargement of the
male breast.
Very rare (may affect up to 1 in 10,000):
Intestinal swelling (intestinal angioedema).
Frequency not known (the frequency cannot be estimated on the basis of the available data)
Overproduction of the antidiuretic hormone, causing fluid retention, resulting in
weakness, fatigue or confusion
A complex symptom has been reported that may include some or all of the following symptoms: fever,
inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity or other
skin manifestations may occur.

Lercanidipine
Rare (may affect up to 1 in 1,000):
Angina pectoris (chest pain caused by insufficient blood flow to the heart), vomiting,
heartburn, muscle pain.
Very rare (may affect up to 1 in 10,000):
Chest pain.
Patients with pre-existing angina pectoris may experience an increase in the frequency,
duration or severity of attacks with the group of drugs to which lercanidipine
belongs. Isolated cases of heart attack may occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 and lercanidipina EG

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 or the packaging
after the wording “EXP.” The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from light and 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 Enalapril and lercanidipine EG contains

• The active ingredients are enalapril and lercanidipine. Each tablet contains 10 mg of enalapril maleate equivalent to 7.64 mg of enalapril and 10 mg of lercanidipine hydrochloride equivalent to 9.44 mg of lercanidipine.
• The active ingredients are enalapril and lercanidipine. Each tablet contains 20 mg of enalapril maleate equivalent to 15.29 mg of enalapril and 10 mg of lercanidipine hydrochloride equivalent to 9.44 mg of lercanidipine.
• Other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone K30, sodium carboxymethylstarch Type A, sodium bicarbonate. Tablet coating:[only for the 10 mg/10 mg dose]:Opadry II white 85F18422 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol PEG 3350, talc. [only for the 20 mg/10 mg dose]:Opadry II yellow 85F32645 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol PEG 3350, talc, yellow iron oxide (E172). Description of the appearance of Enalapril and lercanidipine EG and contents of the packEnalapril and lercanidipine EG 10 mg/10 mg film-coated tablets are oval, biconvex tablets, with a colour varying from white to off-white and with a diameter of 9.5 x 7.5 mm. Enalapril and lercanidipine EG 20 mg/10 mg film-coated tablets are round, biconvex tablets, of yellow colour and with a diameter of 9 mm.

Blister packs (Al/OPA/PVC/AL):
Packs: 10, 14, 28, 30, 50, 56, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan

Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str. Dupnitza 2600 – Bulgaria
STADA Arzneimittel AG, Stadastrasse 2 – 18 Bad Vilbel 61118 - Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Enalaprilmaleat/Lercanidipinhydrochlorid AL 10mg/10 mg Filmtabletten
Enalaprilmaleat/Lercanidipinhydrochlorid AL 20mg/10 mg Filmtabletten
France: Enalapril/Lercanidipine EG 10 mg/10 mg, coated tablet
Enalapril/Lercanidipine EG 20 mg/10 mg, coated tablet
Denmark: Enalapril/Lercanidipin STADA Arzneimittel AG
Enalapril/Lercanidipin STADA Arzneimittel AG
Italy: ENALAPRIL E LERCANIDIPINA EG