ENALAPRIL 10 mg/10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets
   1. What is Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets and
   2. What you need to know before you take Enalapril and Lercanidipina Teva 10 mg/10 mg,
   3. How to take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets
   4. What you need to know before taking Enalapril and Lercanidipina Teva 10 mg/10 mg,
   5. How to take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets
   6. Possible side effects
   7. How to store Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets
   8. Package contents and other information
2. Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets
   1. What is Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets and
   2. What you need to know before you take Enalapril and Lercanidipina Teva 20 mg/10 mg,
   3. How to take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets with
   4. What you need to know before taking Enalapril and Lercanidipina Teva 20 mg/10 mg,
   5. How to take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets
   6. Possible side effects
   7. How to store Enalapril and Lercanidipina Teva 20 mg/10 mg, coated tablets
   8. Package Contents and Other Information
3. Enalapril and Lercanidipina Teva 20 mg/20 mg film-coated tablets
   1. What you need to know before taking Enalapril and Lercanidipina Teva
   2. How to take Enalapril and Lercanidipina Teva
   3. Possible side effects
   4. How to store Enalapril and Lercanidipina Teva
   5. Contents of the pack and other information

Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets

Enalapril maleate and lercanidipine hydrochloride

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 is Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets and

what it is used for

2. What you need to know before you take Enalapril and Lercanidipina Teva 10 mg/10 mg,

film-coated tablets

3. How to take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets

with

4. Possible side effects

5. How to store Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets

with film

6. Contents of the pack and other information

1. What is Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets and

what it is used for
Enalapril and Lercanidipina Teva is the fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipina), two drugs that reduce blood pressure.
Enalapril and Lercanidipina Teva is indicated for the treatment of high blood pressure (hypertension) in
adult patients who are currently taking enalapril and lercanidipina as separate tablets.

2. What you need to know before taking Enalapril and Lercanidipina Teva 10 mg/10 mg,

film-coated tablets
DO NOT take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets

• 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 medicine similar to those contained in Enalapril and Lercanidipina Teva, e.g., medicines called ACE inhibitors or calcium channel blockers.
• If you have previously experienced swelling of the face, lips, mouth, tongue or throat that caused difficulty swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitor, or without a known cause or due to hereditary reasons.
• If you suffer from diabetes or kidney problems and are taking medicines to reduce blood pressure containing aliskiren.
• If you are more than three months pregnant (it is also better to avoid Enalapril and Lercanidipina Teva in the first months of pregnancy - see section relating to pregnancy).
• If you suffer from certain heart conditions:
• 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 that progressively worsens or that is felt more frequently (unstable angina);
• if you have had a heart attack less than a month ago.
• If you have severe kidney problems, or if you are undergoing dialysis.
• If you have severe liver problems.
• If you are taking medicines 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 cyclosporine at the same time (used after transplants to prevent organ rejection).
• Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipina Teva 10 mg/10 mg,
film-coated tablets:

• If you have low blood pressure (you may feel unwell or dizzy, especially when standing up)
• If you have been very ill (excessive vomiting) or have recently suffered from diarrhea
• If you are following a low-salt diet
• If you have heart problems
• If you have a condition involving blood vessels in the brain
• If you suffer from kidney problems (including kidney transplant)
• If you suffer from liver problems
• If you suffer from blood disorders, such as a reduction or absence of white blood cells (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia) or a reduced number of red blood cells (anemia).
• If you suffer from collagen vascular diseases (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma).
• If you are a patient of color, you should be aware that patients of color have a higher risk of allergic reactions with swelling of the face, lips, tongue and throat with difficulty swallowing and breathing when taking ACE inhibitors.
• If you suffer from diabetes.
• If you develop a persistent dry cough.
• If you are taking potassium supplements, potassium-sparing agents or salt substitutes containing potassium.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (ARAII) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation).

The doctor may check your kidney function, blood pressure and the amount of electrolytes in your
blood (e.g., potassium) at regular intervals.
See also what is stated in the section "Do not take Enalapril and Lercanidipina Teva 10 mg/10 mg,
film-coated tablets".
Tell your doctor if you are going to undergo treatment
Tell your doctor that you are taking Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated
tablets, if you are going to undergo any of the following conditions:

• surgery or anesthesia (including dental anesthesia)
• a treatment to remove cholesterol from the blood, called “LDL-apheresis”
• a desensitization therapy to reduce the effect of allergies from bee or wasp stings.

Tell your doctor if you think you are pregnant (or if you are planning to become pregnant) or if you are
breastfeeding (see the section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is
no information on its effectiveness and safety.

Other medicines and Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets
Enalapril and Lercanidipina Teva must not be taken with some medicines.
Tell 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
Lercanidipina Teva is taken with certain medicines, the effect of Enalapril and Lercanidipina Teva or
that of the other medicines may be altered, or some side effects may occur more
frequently.
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 angiotensin II receptor blockers, diuretics (medicines that increase the need to urinate) or a medicine called aliskiren
• other medicines that can increase potassium levels in the body (including heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental disorders called “antipsychotics”
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines 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 rapid heartbeat)
• phenytoin or 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 usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (ARAII) or aliskiren(see also what is stated in the section "Do not take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets" and "Warnings and precautions”).

Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets, with food, drinks
and alcohol

• Enalapril and Lercanidipina Teva must be taken at least 15 minutes before a meal.
• Drinking alcohol may increase the effects of Enalapril and Lercanidipina Teva. For this reason, it is advisable not to drink alcohol or to minimize its consumption.
• Enalapril and Lercanidipina Teva must NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you are pregnant (or if you are planning to become pregnant). Enalapril and
Lercanidipina Teva should be avoided in women who may become pregnant and in the early
stages of pregnancy and must not be taken if you are more than 3 months pregnant, as the
medicine may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Breastfeeding of
newborns (in the first weeks after birth), and especially premature babies, should be avoided if you
are taking Enalapril and Lercanidipina Teva. In the case of an older newborn, your doctor must
inform you about the benefits and risks of taking Enalapril and Lercanidipina Teva while breastfeeding,
compared to other treatments.

Driving and using machines
You must not drive a vehicle or use machines if you experience
dizziness, weakness, fatigue or drowsiness while taking the medicine.

3. How to take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets

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

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

Patients with kidney problems/elderly:your doctor will decide the dose of medicine to take based
on how well your kidneys are functioning.

If you take more Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated tablets than
you should
If you take more medicine than you should, consult your doctor or go to hospital immediately.
Bring the product packaging with you.
Taking an excessive dose of the medicine can cause an excessive drop in blood
pressure and the appearance of irregularities or an acceleration of the heart rate.

If you forget to take Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated
tablets

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

If you stop takingEnalapril and Lercanidipina Teva10 mg/10 mg, film-coated
tablets

• Do not stop taking the medicine until 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, Enalapril and Lercanidipina Teva can cause side effects, although not everyone gets them.
The following side effects may occur with the use of this medicine:

Certain side effects can be serious.
If any of the following occur, tell your doctor immediately:

• Allergic reaction with swelling of the face, lips, tongue or throat, which can cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipina Teva you may feel faint or
dizzy, or have blurred vision; this is caused by a sudden drop in blood
pressure, and if this happens, lying down will help. If this causes you concern, talk
to your doctor.

Side effects observed with Enalapril and Lercanidipina Teva 10 mg/10 mg, film-coated
tablets
Common (may affect up to 1 in 10 people)
Cough, feeling of dizziness, headache.
Uncommon (may affect up to 1 in 100 people)
Changes in blood values such as reduced number of platelets, increased potassium level,
nervousness (anxiety), feeling dizzy when getting up, vertigo, tachycardia, fast or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper
chest (redness), low blood pressure, abdominal pain, constipation, feeling unwell
(nausea), high liver enzyme levels, skin redness, joint pain, increased
frequency of urination, feeling of weakness, fatigue, feeling of warmth, swelling
of the ankles.
Rare (may affect up to 1 in 1,000)
Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat,
indigestion, salty taste on the tongue, diarrhea, dry mouth, gum swelling, allergic reaction with swelling of face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, hives, need to get up at night to urinate, producing a high amount of urine,
impotence.

Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people)
Blurred vision.
Common (affects less than 1 in 10 people)
Depression, chest pain, changes in heart rate, angina, shortness of breath, change in
sense of taste, increased creatinine levels in the blood (usually detected by a test).
Uncommon (affects less than 1 in 100 people)
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure,
confusion, insomnia or drowsiness, feeling of tingling or numbness in the skin, heart attack
(probably caused by very low blood pressure in some high-risk patients,
including those with problems with blood flow to the heart or brain), stroke (probably caused by
very low blood pressure in high-risk patients), runny nose, sore throat and
hoarseness, asthma, reduced motility of food in the intestine, inflammation of the pancreas, feeling of
malbeing, irritated stomach (gastric irritation), ulcer, anorexia, increased sweating,
feeling of itching or hives, hair loss, reduced kidney function, kidney failure, high
levels of protein in the urine (measured with a test), muscle cramps, general feeling of not
being well (malaise), high temperature (fever), low level of sugar or sodium in the blood,
elevated urea levels in the blood (all detected with a blood test).
Rare (affects less than 1 in 1,000)
Changes in laboratory values such as reduced number of white blood cells, bone marrow depression,
autoimmune diseases, abnormal dreams or sleep problems, 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, liver problems such as reduced 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), erythema multiforme (red spots
on the skin, of various shapes), Stevens-Johnson syndrome (a serious skin condition with redness and peeling of the skin, formation of blisters or sores, or detachment of the outermost layer of the skin), reduced urine production, increased volume of the
male mammary gland.
Very rare (affects less than 1 in 10,000)
Intestinal swelling (intestinal angioedema).

Lercanidipine
Rare (affects less than 1 in 1,000)
Angina pectoris (chest pain caused by insufficient blood supply to the heart), vomiting,
heartburn, muscle pain.
Very rare (affects less than 1 in 10,000)
Chest pain.
Bearing in mind the group of drugs to which lercanidipine belongs, patients with pre-existing
angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated
cases of myocardial infarction have been observed.
If any of these side effects should worsen, or if you notice any not listed in this leaflet, tell your
doctor or pharmacist. They have a more complete list of side effects.

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.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 and Lercanidipina Teva 10 mg/10 mg, film-coated tablets

with film
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 Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipina Teva 10 mg/10 mg film-coated tablets contain
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 10 mg of enalapril maleate and 10 mg of lercanidipine
hydrochloride.
The other ingredients are:
Core: Microcrystalline cellulose, Sodium bicarbonate, Pregelatinized starch, Sodium starch glycolate (type
A), Anhydrous colloidal silica, Magnesium stearate
Film coating: Hypromellose, Macrogol 6000, Talc, Titanium dioxide (E171)

Description of the appearance of Enalapril and Lercanidipina Teva 10 mg/10 mg film-coated
tablets and package contents
Enalapril and Lercanidipina Teva 10 mg/10 mg tablets are film-coated tablets, round, biconvex, from
white to off-white in colour.
Enalapril and Lercanidipina Teva 10 mg/10 mg is available in packs of 14, 28, 30, 50, 56, 90 and 100
tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 – 20123 Milan - Italy

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg – 89143 Germany
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen – 4042 Hungary
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza – 50016 Spain

Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets

Enalapril maleate and lercanidipine hydrochloride

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 they have the same symptoms as you, as it may 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 is Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets and

what it is used for

2. What you need to know before you take Enalapril and Lercanidipina Teva 20 mg/10 mg,

film-coated tablets

3. How to take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets with

film

4. Possible side effects

5. How to store Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets

with film

6. Contents of the pack and other information

1. What is Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets and

what it is used for
Enalapril and Lercanidipina Teva is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two drugs that reduce blood pressure.
Enalapril and Lercanidipina Teva is indicated for the treatment of high blood pressure
(hypertension) in patients in whom adequate control has not been achieved with the sole
administration of enalapril 20 mg. Enalapril and Lercanidipina Teva is not indicated for the initial
treatment of hypertension.

2. What you need to know before taking Enalapril and Lercanidipina Teva 20 mg/10 mg,

film-coated tablets
DO NOT take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets

• 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 medicine similar to those contained in Enalapril and Lercanidipina Teva, e.g., medicines called ACE inhibitors or calcium channel blockers.
• If you have previously experienced swelling of the face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitor, or in the absence of a known cause or due to hereditary reasons.
• If you suffer from diabetes or kidney problems and are taking medicines to reduce blood pressure containing aliskiren.
• If you are more than three months pregnant (it is also best to avoid Enalapril and Lercanidipina Teva in the first months of pregnancy - see section on pregnancy).
• If you suffer from certain heart conditions:
• 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 progressively worsens or is experienced more frequently (unstable angina);
• if you have had a heart attack less than a month ago.
• If you have severe kidney problems, or if you are undergoing dialysis.
• If you have severe liver problems.
• If you are taking medicines 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 cyclosporine at the same time (used after transplants to prevent organ rejection).
• Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipina Teva 20 mg/10 mg,
film-coated tablets:

• If you have low blood pressure (you may feel unwell or dizzy, especially when standing up)
• If you have been very ill (excessive vomiting) or have recently suffered from diarrhea
• If you are following a low-salt diet
• If you have heart problems
• If you have a condition involving blood vessels in the brain
• If you suffer from kidney problems
• If you suffer from liver problems
• If you suffer from blood disorders, such as a reduction or absence of white blood cells (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia) or a reduced number of red blood cells (anemia).
• If you suffer from collagen vascular diseases (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma).
• If you are a patient of color, you should be aware that patients of color have a higher risk of allergic reactions with swelling of the face, lips, tongue and throat with difficulty swallowing and breathing when taking ACE inhibitors.
• If you suffer from diabetes.
• If you develop a persistent dry cough.
• If you are taking potassium supplements, potassium-sparing agents or salt substitutes containing potassium.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (ARAII) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation).

The doctor may check your kidney function, blood pressure and the amount of electrolytes in your
blood (e.g., potassium) at regular intervals.
See also what is stated in the section "Do not take Enalapril and Lercanidipina Teva 20 mg/10 mg,
film-coated tablets".
Tell your doctor if you are going to undergo treatment
Tell your doctor that you are taking Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated
tablets, if you are going to undergo any of the following conditions:

• surgery or anesthesia (including dental anesthesia)
• a treatment to remove cholesterol from the blood, called “LDL-apheresis”
• a desensitization therapy to reduce the effect of allergies from bee or wasp stings.

Tell your doctor if you think you may be pregnant (or if you are planning to become pregnant) or if you
are breastfeeding (see the section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is no
information on its effectiveness and safety.

Other medicines and Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets
Enalapril and Lercanidipina Teva must not be taken with some medicines.
Tell 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
Lercanidipina Teva is taken together with certain medicines, the effect of Enalapril and
Lercanidipina Teva or that of the other medicines may be altered, or some side effects may occur more
frequently.
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 used to lower blood pressure, such as angiotensin II receptor blockers, diuretics (medicines that increase the need to urinate) or a medicine called aliskiren
• other medicines that can increase potassium levels in the body (including heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental problems called “antipsychotics”
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain)
• some medicines for pain or arthritis, including gold therapy
• some medicines for coughs and colds and weight loss medicines containing a substance called “sympathomimetic agent”
• medicines for diabetes (including oral antidiabetic medicines and insulin), astemizole or terfenadine (medicines for allergies)
• amiodarone or quinidine (medicines for treating a fast heartbeat)
• phenytoin or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• digoxin (a medicine for treating heart problems)
• midazolam (a medicine that helps you sleep)
• beta-blockers (medicines for treating high blood pressure and heart problems)
• a medicine for ulcers and heartburn called cimetidine, taken in daily doses greater than 800 mg
• medicines usually used to prevent organ rejection after transplantation (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (ARAII) or aliskiren(see also what is stated in the section "Do not take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets" and "Warnings and precautions”).

Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets, with food, drinks
and alcohol

• Enalapril and Lercanidipina Teva must be taken at least 15 minutes before a meal.
• Drinking alcohol can increase the effects of Enalapril and Lercanidipina Teva. For this reason, it is advisable not to drink alcohol or to minimize its consumption.
• Enalapril and Lercanidipina Teva MUST NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you may be pregnant (or if you are planning to become pregnant). Enalapril and
Lercanidipina Teva should be avoided in women who could be pregnant and in the early stages of
pregnancy and MUST NOT be taken if you are more than 3 months pregnant, as the
medicine may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Breastfeeding of
newborns (in the first weeks after birth), and especially premature infants, should be avoided if you
are taking Enalapril and Lercanidipina Teva. In the case of an older newborn, your doctor should
inform you about the benefits and risks of taking Enalapril and Lercanidipina Teva while breastfeeding,
compared to other treatments.

Driving and using machines
DO NOT drive a vehicle or use machines if you experience dizziness, weakness, fatigue or drowsiness
while taking the medicine.

3. How to take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets

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

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

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

If you take more Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated tablets than
you should
If you take more medicine than you should, consult your doctor or go to the hospital immediately.
Bring the product packaging with you.
Taking an excessive dose of the medicine may cause an excessive drop in blood
pressure and the appearance of irregularities or an acceleration of the heart rate.

If you forget to take Enalapril and Lercanidipina Teva 20 mg/10 mg, film-coated
tablets

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

If you stop takingEnalapril and Lercanidipina Teva20 mg/10 mg, film-coated
tablets

• Do not stop taking the medicine until 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, Enalapril and Lercanidipine Teva can cause side effects, although not everyone
will experience them. The following side effects may occur with the use of
this medicine:

Certain side effects can be serious.
If any of the following effects occur, tell your doctor immediately:

• Allergic reaction with swelling of the face, lips, tongue or throat, which can cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipine Teva you may experience a feeling of fainting or
dizziness, or have blurred vision; this is caused by a sudden drop in blood
pressure, and if this happens, lying down will be helpful. If this causes you concern, talk
to your doctor.

Side effects observed with Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated
tablets
Common (may affect up to 1 in 10 people)
Cough, feeling of dizziness, headache.
Uncommon (may affect up to 1 in 100 people)
Changes in blood values such as a reduction in the number of platelets, increased potassium levels,
nervousness (anxiety), feeling dizzy when getting up, vertigo, tachycardia, fast or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper
chest (redness), 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, feeling of warmth, swelling
in the ankles.
Rare (may affect up to 1 in 1,000)
Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat,
indigestion, salty taste on the tongue, diarrhea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, hives, need to get up at night to urinate, producing a high amount of urine,
impotence.

Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (affects more than 1 in 10 people)
Blurred vision.
Common (affects less than 1 in 10 people)
Depression, chest pain, changes in heart rate, angina, shortness of breath, changes in
sense of taste, increased levels of creatinine in the blood (generally detected by a test).
Uncommon (affects less than 1 in 100 people)
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure,
confusion, insomnia or drowsiness, feeling of pins and needles in the hand or numb skin, heart attack (probably caused by very low blood pressure in some high-risk patients,
including those with problems with blood flow to the heart or brain), stroke (probably caused by
very low blood pressure in high-risk patients), runny nose, sore throat and
hoarseness, asthma, reduced motility of food in the intestine, inflammation of the pancreas, feeling of
malbeing, irritated stomach (gastric irritation), ulcer, anorexia, increased sweating,
feeling of itching or hives, hair loss, reduced kidney function, kidney failure, high
levels of protein in the urine (measured with a test), muscle cramps, general feeling of
not feeling well (malaise), high temperature (fever), low level of sugar or sodium in the blood,
elevated urea levels in the blood (all detected with a blood test).
Rare (affects less than 1 in 1,000)
Changes in laboratory values such as a reduction in the number of white blood cells, bone marrow depression,
autoimmune diseases, abnormal dreams or sleep problems, 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, liver problems such as reduced liver function,
inflammation of the liver, jaundice (yellowing of the skin and/or the whites of the eyes),
increased levels of bilirubin (measured with a blood test), erythema multiforme (red spots
on the skin, of various shapes), Stevens-Johnson syndrome (a serious skin condition in which
there is redness and peeling of the skin, blistering or sores, or detachment of the outermost layer of the skin), reduced urine production, increased volume of the breast
gland in men.
Very rare (affects less than 1 in 10,000)
Intestinal swelling (intestinal angioedema).

Lercanidipine
Rare (affects less than 1 in 1,000)
Angina pectoris (chest pain caused by insufficient blood supply to the heart), vomiting,
heartburn, muscle pain.
Very rare (affects less than 1 in 10,000)
Chest pain.
Bearing in mind the group of drugs to which lercanidipine belongs, patients with pre-existing
angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated
cases of myocardial infarction can be observed.
If any of these side effects should worsen, or if you notice the appearance of a

Consult your doctor or pharmacist for further information on side effects. Both
have a more complete list of side effects.

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.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 and Lercanidipina Teva 20 mg/10 mg, coated tablets

with film
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 Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Enalapril and Lercanidipina Teva 20 mg/10 mg film-coated tablets contain
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 20 mg of enalapril maleate and 10 mg of lercanidipine
hydrochloride.
The other ingredients are:
Core: Microcrystalline cellulose, Sodium bicarbonate, Pregelatinized starch, Sodium starch glycolate (type
A), Anhydrous colloidal silicon dioxide, Magnesium stearate
Film coating: Hypromellose, Macrogol 6000, Talc, Titanium dioxide (E171), Yellow iron oxide
(E172)

Description of the appearance of Enalapril and Lercanidipina Teva 20 mg/10 mg film-coated
tablets and package contents
Enalapril and Lercanidipina Teva 20 mg/10 mg tablets are film-coated tablets, round, biconvex, from
light yellow to yellowish in color.
Enalapril and Lercanidipina Teva 20 mg/10 mg is available in packs of 14, 28, 30, 50, 56, 90 and 100
tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg – 89143 Germany
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen – 4042 Hungary
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza – 50016 Spain

Enalapril and Lercanidipina Teva 20 mg/20 mg film-coated tablets

Enalapril maleate and lercanidipine hydrochloride

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 and Lercanidipina Teva is and what it is used for

2. What you need to know before you take Enalapril and Lercanidipina Teva

3. How to take Enalapril and Lercanidipina Teva

4. Possible side effects

5. How to store Enalapril and Lercanidipina Teva

6. Contents of the pack and other information

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

Enalapril and Lercanidipina Teva is a fixed-combination containing an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that lower blood pressure.
Enalapril and Lercanidipina Teva is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.

2. What you need to know before taking Enalapril and Lercanidipina Teva

DO NOT take Enalapril and Lercanidipina Teva

• 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 medicine similar to Enalapril and Lercanidipina Teva, such as medicines called ACE inhibitors or calcium channel blockers.
• If you have previously experienced swelling of the face, lips, mouth, tongue or throat which caused difficulties with swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitor, or without a known cause or hereditary cause.
• If you suffer from diabetes or kidney problems and are being treated with medicines to reduce blood pressure containing aliskiren.
• If you are more than three months pregnant (it is also best to avoid Enalapril and Lercanidipina Teva in the first months of pregnancy - see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from certain heart conditions:
• 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 progressively worsens or is felt more frequently (unstable angina);
• if you have had a heart attack less than a month ago.
• If you have severe kidney problems, or if you are undergoing dialysis.
• If you suffer from severe liver problems.
• If you are taking medicines that inhibit liver metabolism such as:
• antifungals (e.g., ketoconazole, itraconazole);
• macrolide antibiotics (e.g., erythromycin, troleandomycin);
• antivirals (e.g., ritonavir).
• If you are taking cyclosporine at the same time (used after transplants to prevent organ rejection).
• Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipina Teva:

• If you have low blood pressure (you may feel unwell or dizzy, especially when standing up).
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-salt diet.
• If you have heart problems.
• If you have a condition involving blood vessels in the brain.
• If you suffer from kidney problems (including kidney transplant).
• If you suffer from liver problems.
• If you suffer from blood disorders, such as a reduction 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 collagen vascular diseases (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma).
• If you are a patient of colour, you should be aware that patients of colour have a higher risk of allergic reactions with swelling of the face, lips, tongue or throat, with difficulty swallowing and breathing, while taking ACE inhibitors.
• If you suffer from diabetes.
• If you develop a persistent dry cough.
• If you are taking potassium supplements, potassium-sparing agents or salt substitutes containing potassium.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (ARAII) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation).

The doctor may check your kidney function, blood pressure and the amount of electrolytes
in the blood (e.g. potassium) at regular intervals.
See also what is reported in the section "Do not take Enalapril and Lercanidipina Teva".

Tell your doctor if you are going to have a treatment
Tell your doctor that you are taking Enalapril and Lercanidipina Teva if you are going to have
one of the following treatments:

• surgery or anesthesia (including dental anesthesia)
• a treatment to remove cholesterol from the blood, called “LDL-apheresis”
• a desensitization therapy to reduce the effect of allergies from bee or wasp stings. Tell your doctor if you think you are pregnant (or planning to become pregnant) or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is no
information on its effectiveness and safety.

Other medicines and Enalapril and Lercanidipina Teva
Enalapril and Lercanidipina Teva must not be taken with some medicines.
Tell 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 Lercanidipina Teva is taken with certain medicines, the effect of Enalapril and
Lercanidipina Teva or that of the other medicines may be altered, or some side effects
may occur more frequently.
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 angiotensin II receptor antagonists, diuretics (medicines that increase the need to urinate) or a medicine called aliskiren
• other medicines that can increase potassium levels in the body (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental health problems called “antipsychotics”
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain)
• some medicines for pain or arthritis, including gold therapy
• some medicines for coughs and colds and weight loss medicines containing a substance called “sympathomimetic agent”
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• astemizole or terfenadine (medicines for allergies)
• amiodarone or quinidine (medicines for treating a fast heartbeat)
• phenytoin or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• digoxin (a medicine for treating heart problems)
• midazolam (a medicine that helps you sleep)
• beta-blockers (medicines for treating 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 after transplantation (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (ARAII) or aliskiren (see also what is reported under "Do not take Enalapril and Lercanidipina Teva" and "Warnings and precautions”).

Enalapril and Lercanidipina Teva with food, drinks and alcohol

• Enalapril and Lercanidipina Teva should be taken at least 15 minutes before a meal.
• Drinking alcohol can increase the effects of Enalapril and Lercanidipina Teva. For this reason, it is advisable not to drink alcohol or to minimize its consumption.
• Enalapril and Lercanidipina Teva MUST NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you may be pregnant (or are planning to become pregnant). The use of
Enalapril and Lercanidipina Teva is not recommended in women who may be pregnant and in the early
stages of pregnancy and MUST NOT be taken after the first 3 months of
pregnancy, as the medicine may 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 (in the first weeks after birth), and especially premature babies, should be avoided if
you are taking Enalapril and Lercanidipina Teva. In the case of an older child, your doctor
should inform you about the benefits and risks of taking Enalapril and Lercanidipina Teva while
breastfeeding, compared to other treatments.

Driving and operating machinery
DO NOT drive a vehicle or operate machinery if you experience
dizziness, weakness, fatigue or drowsiness while taking the medicine.

Enalapril and Lercanidipina Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially “sodium-free”.

3. How to take Enalapril and Lercanidipina Teva

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

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

Patients with kidney problems/elderly:your doctor will decide the dose of medicine to take in
based on how your kidneys are functioning.

If you take more Enalapril and Lercanidipina Teva than you should
If you take more medicine than you should, consult your doctor or go to the hospital immediately.
Bring the product packaging with you.
Taking an excessive dose of the medicine can cause an excessive drop in blood
pressure and the appearance of irregularities or an acceleration of the heart rate.

If you forget to take Enalapril and Lercanidipina Teva

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

If you stop taking Enalapril and Lercanidipina Teva

• Do not stop taking the medicine until your doctor tells you to.
• If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril and Lercanidipine Teva can cause side effects, although not everyone
will experience them. The following side effects may occur with the use of
this medicine:

Some side effects can be serious.
If any of the following effects occur, tell your doctor immediately:

• Allergic reaction with swelling of the face, lips, tongue or throat, which can cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipine Teva you may feel faint
or dizzy, or have blurred vision; this is caused by a sudden drop in blood
pressure, and if this happens, lying down will be helpful. If this causes you concern, talk
to your doctor.

Side effects observed with Enalapril and Lercanidipine Teva
Common(may affect up to 1 in 10 people)
Cough, feeling of dizziness, headache.

Uncommon(may affect up to 1 in 100 people)
Changes in blood values such as a reduction in the number of platelets, increased potassium levels, 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 liver enzyme levels, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue,
feeling of warmth, swelling of the ankles.

Rare(may affect up to 1 in 1,000 people)
Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat,
indigestion, salty taste on the tongue, diarrhea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, hives, need to get up at night to urinate, production of a large amount of urine,
impotence.

Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common(may affect more than 1 in 10 people)
Blurred vision.

Common(may affect up to 1 in 10 people)
Depression, chest pain, changes in heart rate, angina, shortness of breath, alteration of
taste, 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, feeling of tingling or numbness, heart attack
(probably caused by very low blood pressure in some high-risk patients,
including those with problems with blood flow to the heart or brain), stroke (probably caused
by very low blood pressure in high-risk patients), runny nose, sore throat and
hoarseness, asthma, reduced motility of food in the intestine, pancreatitis, vomiting, irritated stomach (gastric irritation), ulcer,
anorexia, increased sweating, feeling of itching or hives, hair loss, reduced kidney function, kidney failure, high levels of protein in the urine (measured with a test), muscle cramps,
general feeling of discomfort, 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 people)
Changes in laboratory values such as a reduction in the number of white blood cells, bone marrow depression,
autoimmune diseases, abnormal dreams or sleep problems, 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, liver problems such as reduced 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), erythema multiforme
(red patches on the skin, of various shapes), Stevens-Johnson syndrome (a serious skin condition characterized by redness and peeling of the skin, formation of blisters or sores,
or detachment of the outermost layer of skin), reduced urine production, increased
volume of the mammary gland in men.

Very rare(may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).

Lercanidipine
Rare(may affect up to 1 in 1,000 people)
Angina pectoris (chest pain caused by insufficient blood supply to the heart), vomiting,
heartburn, muscle pain.

Very rare(may affect up to 1 in 10,000 people)
Chest pain.
Bearing in mind the group of drugs to which lercanidipine belongs, patients with pre-existing
angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated
cases of myocardial infarction have been observed.
If any of these side effects should worsen, or if you notice any not listed in this leaflet, tell your
pharmacist.
Ask your doctor or pharmacist for more information about side effects. Both
have a more complete list of side effects.

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 reported at the address 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 and Lercanidipina Teva

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 packaging after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Lercanidipina Teva contains
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.28 mg of
enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).

The other ingredients are:
Core: microcrystalline cellulose, sodium bicarbonate, pregelatinized starch (corn), sodium starch
glycolate (type A), anhydrous colloidal silica, magnesium stearate.
Film coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172).

Description of the appearance of Enalapril and Lercanidipina Teva and contents of the pack
Enalapril and Lercanidipina Teva 20 mg/20 mg is in film-coated tablets of round,
biconvex shape with a colour ranging from orange to light orange, with a diameter of approximately 11 mm and a
thickness of approximately 5 mm.
Enalapril and Lercanidipina Teva 20 mg/20 mg is available in packs of 14, 28, 30, 50, 56, 90 and
100 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg – 89143 Germany
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen – 4042 Hungary
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza – 50016 Spain