ZANIPRIL 10 mg/10 mg Film-Coated Tablets

Зміст інструкції

1. Zanipril 10 mg/10 mg film-coated tablets
   1. What is Zanipril and what is it used for
   2. What you need to know before taking Zanipril
   3. How to take Zanipril
   4. Possible side effects
   5. How to store Zanipril
   6. Package contents and other information
2. Zanipril 20 mg/10 mg film-coated tablets
   1. What is Zanipril and what is it used for
   2. What you need to know before taking Zanipril
   3. How to take Zanipril
   4. Possible side effects
   5. How to store Zanipril
   6. Package Contents and Other Information
3. Zanipril 20 mg/20 mg film-coated tablets
   1. What is Zanipril and what is it used for?
   2. What you need to know before taking Zanipril
   3. How to take Zanipril
   4. Possible side effects
   5. How to store Zanipril
   6. Package Contents and Other Information

Zanipril 10 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
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 Zanipril is and what it is used for
• 2. What you need to know before you take Zanipril
• 3. How to take Zanipril
• 4. Possible side effects
• 5. How to store Zanipril
• 6. Contents of the pack and other information

1. What is Zanipril and what is it used for

Zanipril is the fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two
medicines that reduce blood pressure.
Zanipril is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate control of blood pressure has not been achieved through the administration of 10 mg of lercanidipine alone.
Zanipril is not indicated for the initial treatment of hypertension.

2. What you need to know before taking Zanipril

Do not take Zanipril:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride 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 Zanipril, e.g. medicines 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 are taking or have taken sacubitril/valsartan, a medicine for the treatment of a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in an area such as the throat).
• if you have diabetes or kidney problems and are taking medicines that contain aliskiren to lower blood pressure.
• if you are more than three months pregnant (it is also better to avoid Zanipril in the first months of pregnancy - see section pregnancy).
• if you suffer from certain heart conditions such as:
• obstruction of blood flow from the heart
• untreated heart failure
• unstable angina (chest pain that occurs at rest or progressively increases)
• heart attack that occurred less than a month ago.
• if you have severe liver problems.
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit hepatic metabolism such as:
• antifungals (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• antivirals (e.g. ritonavir).
• if you are taking cyclosporine (used after transplants to prevent organ rejection) at the same time.
• together with grapefruit or grapefruit juice.

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

• if you have low blood pressure (you will notice this with weakness or dizziness, especially when standing up)
• if you have been very ill (excessive vomiting) or have recently had diarrhea
• if you are following a low-sodium diet
• if you have heart problems
• if you have a condition involving the blood vessels of the brain
• if you have kidney problems (including kidney transplant), which may result in higher levels of potassium in the blood, with serious consequences. Your doctor may decide to adjust the dose of enalapril or monitor your blood potassium levels
• if you have liver problems
• if you have blood problems, 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 vasculitic 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 when taking ACE inhibitors
• if you suffer from diabetes, you should monitor for any decrease in blood glucose levels, especially during the first month of treatment. The level of potassium in the blood may also be higher
• if you are taking potassium supplements, potassium-sparing medications or salt substitutes containing potassium
• if you are over 70 years old
• if you are intolerant to certain sugars (lactose).

If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under “Do not take Zanipril”.

If you are going to undergo treatment
Tell your doctor that you are taking Zanipril if you are about to:

• undergo surgery or anesthesia (including dental anesthesia)
• follow 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.

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

Children and adolescents
The safety and efficacy of Zanipril in children under 18 years of age have not yet been established.

Other medicines and Zanipril
Zanipril should 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 Zanipril is taken together
with certain medicines, its effect or that of other medicines may change, or some side effects may
occur more frequently.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines used to lower blood pressure,
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant used to prevent organ rejection, and heparin, a medicine used to thin the blood preventing the formation of clots). See “Do not take Zanipril”
• 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 (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, quinidine or sotalol (medicines for treating a fast heartbeat)
• phenytoin phenobarbital 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, e.g. metoprolol (a medicine for the treatment of high blood pressure, heart failure and abnormal heart rhythms)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn).

Do not take Zanipril if you have taken or are taking sacubitril/valsartan, a medicine for the treatment of
a type of long-term (chronic) heart failure in adults, due to an increased risk of
angioedema (rapid swelling under the skin in an area such as the throat).
If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes. The doctor may need to adjust the dose and/or take other precautions:
• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take Zanipril” and “Warnings and precautions”).

Zanipril with food, drinks and alcohol

• Take Zanipril at least 15 minutes before a meal.
• A high-fat meal significantly increases the levels of the drug in the blood.
• Drinking alcohol may increase the effects of Zanipril. Do not consume alcohol during treatment with Zanipril.
• Zanipril should not be taken with grapefruit or grapefruit juice, which increase its hypotensive effect (see “Do not take Zanipril”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you are (or may become) pregnant. Your doctor will normally
advise you to stop taking Zanipril before starting a pregnancy or as soon as you
find out you are pregnant and advise you to take another medicine instead of
Zanipril. Zanipril is not recommended during pregnancy, and should not be taken after the third month, in
as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Zanipril should not be used during breastfeeding.

Driving and operating machinery
Avoid driving a vehicle or operating machinery if you experience
dizziness, weakness or drowsiness while taking this medicine.

Zanipril contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Zanipril

Take this medicine following exactly the instructions of your doctor. If you have any 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 tablet must be swallowed whole with a little water. See
“Zanipril with food, drinks and alcohol”

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 Zanipril than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or
go to hospital immediately. Bring the packaging with you. Taking a dose of medicine higher
than the correct one can cause an excessive drop in blood pressure and the appearance of irregularities or
acceleration of the heart rate.

If you forget to take Zanipril

• If you forget to take the 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 Zanipril
Do not stop taking the medicine unless your doctor has told you to do so.

• If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zanipril can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Allergic reaction manifesting with swelling of the face, lips, tongue or throat which can cause
difficulty breathing or swallowing.
At the beginning of treatment with Zanipril you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure and if this happens it would be helpful to lie down. If you are
concerned about this, talk to your doctor.

Side effects observed with Zanipril
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 lower number of platelets;
• Increased potassium levels 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 (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Higher levels of liver enzymes;
• Skin redness;
• Joint pain;
• Increased number of times you urinate;
• Feeling of weakness, fatigue, feeling hot, 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 in the tongue, diarrhea, dry mouth, gum swelling;
• Allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or breathing, rash, urticaria;
• Need to get up at night to urinate, production of large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine when taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, feeling dizzy, weakness or nausea and cough.
Common (may affect up to 1 in 10)
Depression, headache, fainting (syncope), chest pain, feeling lightheaded due to
low blood pressure, changes in heart rhythm, accelerated heartbeat, angina, shortness of breath,
altered sense of taste, increased creatinine levels in the blood (usually detected with a
test), high potassium levels in the blood, diarrhea, abdominal pain, fatigue (asthenia),
rash, allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or
breathing.
Uncommon (may affect up to 1 in 100)
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion,
nervousness, insomnia or drowsiness, feeling of pins and needles 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, chest tightness
associated with asthma, reduced intestinal motility (ileus), inflammation of the pancreas, vomiting, indigestion, constipation,
irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, itching or urticaria, hair loss, reduced kidney function, kidney failure, increased sweating, high levels of protein
in the urine (measured with a test), muscle cramps, general feeling of discomfort, high temperature
(fever), low blood sugar or sodium levels, high urea levels in the blood (all detected with
a blood test), hot flushes, accelerated or irregular heartbeat (palpitations),
vertigo (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000)
Changes in blood values such as reduction in the number of white blood cells, reduced bone marrow function, autoimmune diseases, abnormal dreams or sleep disorders, “Raynaud’s phenomenon” (where
hands and feet can become very cold and white due to reduced blood flow), inflammation
of the nose, pneumonia, liver problems such as decreased liver function, inflammation of the liver,
jaundice (yellowing of the skin or eyes), increased levels of liver enzymes or bilirubin (measured with a
blood test), erythema multiforme (red patches of different shapes on the
skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition in
which redness and peeling of the skin, blisters or sores occur), exfoliative dermatitis/erythrodermia (severe rash with skin peeling), pemphigus (small
fluid-filled bumps on the skin), decreased urine production, enlargement of the male breast (gynecomastia), swelling of the lymph nodes in the neck, armpits or groin,
accumulation of fluid or other substances in the lungs (seen on an X-ray), inflammation of cheeks,
gums, tongue, lips.
Very rare (may affect up to 1 in 10,000)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from the available data)
Overproduction of the antidiuretic hormone, causing fluid retention, leading to weakness,
fatigue or confusion.
A complex of symptoms has been reported that may include some or all of the following: fever,
inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain
(arthralgia/arthritis). Rash, photosensitivity or other skin manifestations may occur.

Lercanidipine
Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Rare (may affect up to 1 in 1,000)
Angina pectoris (chest pain caused by insufficient blood flow to the heart), allergic reactions (the
symptoms include itching, rash, urticaria), fainting.
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 be observed.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate,
feeling of rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or
upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn,
nausea, stomach pain, rash, itching, muscle pain, producing large
amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000): drowsiness, vomiting, diarrhea, urticaria, increased
number of times you urinate, chest pain.
Not known (frequency cannot be estimated from the available data): swelling of the gums,
changes in liver function (detected with blood tests), cloudy fluid (during dialysis through a tube in the abdomen), swelling of the face, lips, tongue or throat which can cause difficulty
breathing or swallowing.
If any of these side effects become severe, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Ask your doctor or pharmacist for further information about side
effects, who 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Zanipril

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the box after the word
EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture. 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. Package contents and other information

What Zanipril contains
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated 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 other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A, povidone K30,
sodium hydrogen carbonate, magnesium stearate.
Film coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000.

Description of Zanipril and package contents
Zanipril 10 mg/10 mg are film-coated tablets, white in colour, circular and biconvex with a diameter of 8.5 mm.
Zanipril 10 mg/10 mg is available in packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan.
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’ Stampi, 20089 Rozzano (MI), Italy.

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria: Zanipril 10 mg/10 mg Filmtabletten
Belgium: Zanicombo
Bulgaria: Lercapril
Cyprus: Zaneril
Denmark: Zanipress
Estonia: Lercaril
Finland: Zanipress
France: Zanextra
Greece: Lercaprel
Ireland: Lercaril
Iceland: Zanipress
Latvia: Lercaprel
Lithuania: Lercaprel 10 mg/10 mg plėvele dengtos tabletės
Luxembourg: Zanicombo
Malta: Zanipress
Norway: Zanipress
Netherlands: Lertec
Poland: Lercaprel
Portugal: Zanipress
United Kingdom: Zaneril
Romania: Lercaril 10 mg/10 mg
Slovenia: Lercaprel 10 mg/10 mg
Sweden: Zanitek
Hungary: Coripren

Zanipril 20 mg/10 mg film-coated tablets

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

1. What is Zanipril and what is it used for

Zanipril is a fixed-dose combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two
medicines that reduce blood pressure.
Zanipril is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate control of blood pressure has not been achieved with the sole administration of 20 mg of enalapril. Zanipril
is not indicated for the initial treatment of hypertension.

3. What you need to know before taking Zanipril

Do not take Zanipril:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride 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 Zanipril, e.g. medicines 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 ACE inhibitor, or without any known cause or due to hereditary reasons.
• if you are taking or have taken sacubitril/valsartan, a medicine for the treatment of a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in an area such as the throat).
• if you have diabetes or kidney problems and are taking medicines that contain aliskiren to lower blood pressure.
• if you are more than three months pregnant (it is also best to avoid Zanipril 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
• untreated heart failure
• unstable angina (chest pain that occurs at rest or progressively increases)
• heart attack that occurred less than a month ago.
• if you have severe liver problems
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit hepatic metabolism such as:
• antifungals (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• 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 Zanipril:

• if you have low blood pressure (you will notice this with weakness or dizziness, especially when standing up)
• if you have been very ill (excessive vomiting) or have recently had diarrhoea
• if you are following a low-sodium diet
• if you have heart problems
• if you have a condition involving blood vessels in the brain
• if you have kidney problems (including kidney transplant), which may result in higher levels of potassium in the blood, with serious consequences. Your doctor may decide to adjust the dose of enalapril or monitor your blood potassium levels
• if you have liver problems
• if you have blood problems, 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 (anaemia)
• if you suffer from vasculitic 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 colour, you should be aware that patients of colour have a greater risk of allergic reaction with swelling of the face, lips, tongue and throat with difficulty in swallowing and breathing when taking ACE inhibitors
• if you suffer from diabetes, you should monitor any decrease in blood glucose levels, especially during the first month of treatment. The level of potassium in the blood may also be higher
• if you are taking potassium supplements, potassium-sparing drugs or salt substitutes containing potassium
• if you are over 70 years of age
• if you are intolerant to certain sugars (lactose).

If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under “Do not take Zanipril”.

If you are going to undergo treatment
Tell your doctor that you are taking Zanipril if you are about to:

• undergo surgery or anaesthesia (including dental anaesthesia)
• undergo treatment to remove cholesterol from the blood called LDL apheresis
• undergo desensitization therapy to reduce the effect of allergies to bee or wasp stings.

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

Children and adolescents
The safety and efficacy of Zanipril in children under 18 years of age have not yet been established.

Other medicines and Zanipril
Zanipril 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, even those available without a prescription. This is because when Zanipril is taken together with certain medicines, its effect or that of the other medicines may change, or some side effects may occur more frequently.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines used to lower blood pressure,
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant used to prevent organ rejection, and heparin, a medicine used to thin the blood preventing the formation of clots). See “Do not take Zanipril”
• 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 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, quinidine or sotalol (medicines for treating a fast heartbeat)
• phenytoin, phenobarbital 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, e.g. metoprolol (a medicine for the treatment of high blood pressure, heart failure and irregular heartbeats)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn).

Do not take Zanipril if you have taken or are taking sacubitril/valsartan, a medicine for the treatment of a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in an area such as the throat).
If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes. The doctor may need to adjust the dose and/or take other precautions:
• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take Zanipril” and “Warnings and precautions”).

Zanipril with food, drinks and alcohol

• Take Zanipril at least 15 minutes before a meal.
• A high-fat meal significantly increases the levels of the drug in the blood.
• Drinking alcohol may increase the effects of Zanipril. Do not consume alcohol while being treated with Zanipril.
• Zanipril should not be taken with grapefruit or grapefruit juice, which increase its hypotensive effect (see “Do not take Zanipril”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you may be (or become) pregnant. Your doctor will normally advise you to stop taking Zanipril before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Zanipril. Zanipril is not recommended during pregnancy, and must not be taken after the third month, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Zanipril must not be used during breastfeeding.

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

Zanipril contains lactose.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Zanipril

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 tablet must be swallowed whole with a little water. See
“Zanipril with food, drinks and alcohol”

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

If you take more Zanipril than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or
go to hospital immediately. Bring the packaging with you. Taking a dose of medication higher
than the correct one may cause an excessive drop in blood pressure and the appearance of irregularities or
acceleration of the heart rate.

If you forget to take Zanipril

• If you forget to take the 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 Zanipril
Do not stop taking the medicine unless your doctor has told you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zanipril can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Allergic reaction manifesting with swelling of the face, lips, tongue or throat which can cause
difficulty breathing or swallowing.
At the beginning of treatment with Zanipril you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure and if this happens it may help to lie down. If you are
concerned about this, talk to your doctor.

Side effects observed with Zanipril
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 lower number of platelets;
• Increased potassium levels 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 (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Higher levels of liver enzymes;
• Skin redness;
• Joint pain;
• Increased frequency of urination;
• Feeling of weakness, fatigue, feeling hot, swelling of the ankles.

Rare (may affect up to 1 in 1,000 people)

• Anemia;
• Allergic reactions;
• Tinnitus (ringing in the ears);
• Fainting;
• Dry throat, sore throat;
• Indigestion, salty taste in the mouth, diarrhea, dry mouth, gum swelling;
• Allergic reaction with swelling of the face, lips, tongue or throat and difficulty swallowing or breathing, rash, urticaria;
• Need to get up at night to urinate, production of large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine when taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, feeling dizzy, weakness or nausea and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, feeling lightheaded due to
low blood pressure, changes in heart rhythm, accelerated heartbeat, angina, shortness of breath,
altered sense of taste, increased creatinine levels in the blood (usually detected with a
test), high potassium levels in the blood, diarrhea, abdominal pain, fatigue,
rash, allergic reaction with swelling of the face, lips, tongue or throat and difficulty swallowing or
breathing.
Uncommon (may affect up to 1 in 100 people)
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion,
nervousness, insomnia or drowsiness, 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, chest tightness
associated with asthma, reduced intestinal motility (ileus), pancreatitis, vomiting, indigestion, constipation,
irritated stomach (gastric irritation), dry mouth, ulcers, anorexia, itching or urticaria, hair loss,
reduced kidney function, kidney failure, increased sweating, high protein levels
in the urine (measured with a test), muscle cramps, general feeling of unwellness, high temperature
(fever), low blood sugar or sodium levels, high urea levels in the blood (all detected with
a blood test), hot flushes, accelerated or irregular heartbeat (palpitations),
vertigo (feeling of spinning), tinnitus (ringing in the ears), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood values such as reduced 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), inflammation
of the nose, pneumonia, liver problems such as decreased liver function, inflammation of the liver,
jaundice (yellowing of the skin or eyes), increased levels of liver enzymes or bilirubin (measured with a
blood test), erythema multiforme (red patches of different shapes on the
skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition in
which redness and peeling of the skin, blisters or sores occur), exfoliative dermatitis/erythrodermia (severe skin rash with peeling skin), pemphigus (small
fluid-filled bumps on the skin), decreased urine production, enlargement of the male breast glands (gynecomastia), swelling of the lymph nodes in the neck, armpits or groin,
accumulation of fluid or other substances in the lungs (seen on an X-ray), inflammation of cheeks,
gums, tongue, lips.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from available data)
Overproduction of the antidiuretic hormone, causing fluid retention, leading to weakness,
fatigue or confusion.
A complex of symptoms has been reported that may include some or all of the following: fever,
inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain
(arthralgia/arthritis). Rash, photosensitivity or other skin manifestations may occur.

Lercanidipine
Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain caused by insufficient blood flow to the heart), allergic reactions (the
symptoms include itching, rash, urticaria), fainting.
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 be observed.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate,
feeling of fast or irregular heartbeat (palpitations), sudden flushing of the face, neck or
upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn
stomach, nausea, stomach pain, rash, itching, muscle pain, frequent urination, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, urticaria, increased
frequency of urination, chest pain.
Not known (frequency cannot be estimated from available data): gum swelling,
changes in liver function (detected with blood tests), cloudy fluid (during dialysis through a tube in the abdomen), swelling of the face, lips, tongue or throat which can cause difficulty
breathing or swallowing.
If any of these side effects become severe, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. Ask your doctor or pharmacist for further information about side
effects, who 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Zanipril

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 box after the word
EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture. 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Zanipril contains
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated 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).
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A, povidone K30,
sodium hydrogen carbonate, magnesium stearate.
Film coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000, quinoline yellow
(E104), yellow iron oxide (E172).

Description of Zanipril and package contents
Zanipril 20 mg/10 mg are film-coated tablets, yellow in colour, circular and biconvex with a diameter of 8.5 mm.
Zanipril 20 mg/10 mg is available in packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan.
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’ Stampi, 20089 Rozzano (MI), Italy.

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria: Zanipril 20 mg/10 mg Filmtabletten
Belgium: Zanicombo
Bulgaria: Lercapril
Cyprus: Zaneril
Denmark: Zanipress
Estonia: Lercaprel
Finland: Zanipress
France: Zanextra
Greece: Lercaprel
Ireland: Lercaril
Iceland: Zanipress
Latvia: Lercaprel
Lithuania: Lercaprel 20 mg/10 mg plėvele dengtos tabletės
Luxembourg: Zanicombo
Malta: Zanipress
Norway: Zanipress
Netherlands: Lertec
Poland: Lercaprel
Portugal: Zanipress
United Kingdom: Zaneril
Romania: Lercaril 20 mg/10 mg
Slovenia: Lercaprel 20 mg/10 mg
Sweden: Zanitek
Hungary: Coripren

Zanipril 20 mg/20 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
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 Zanipril is and what it is used for
• 2. What you need to know before you take Zanipril
• 3. How to take Zanipril
• 4. Possible side effects
• 5. How to store Zanipril
• 6. Contents of the pack and other information

1. What is Zanipril and what is it used for?

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

4. What you need to know before taking Zanipril

Do not take Zanipril:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride 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 Zanipril, e.g. medicines called ACE inhibitors or calcium channel blockers.
• if you have previously experienced swelling of the face, lips, mouth, tongue or larynx that has caused difficulty in swallowing or breathing (angioedema) after taking a type of medicine called an ACE inhibitor, or without any known cause or hereditary cause.
• if you have taken or are taking sacubitril/valsartan, a medicine for the treatment of a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in an area such as the throat).
• if you have diabetes or kidney problems and are taking medicines that contain aliskiren to lower blood pressure.
• if you are more than three months pregnant (it is also best to avoid Zanipril 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
• untreated heart failure
• unstable angina (chest pain that occurs at rest or progressively increases)
• heart attack that occurred less than a month ago.
• if you have severe liver problems.
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit hepatic metabolism such as:
• antifungals (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• 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 Zanipril:

• if you have low blood pressure (you will notice this 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
• if you have heart problems
• if you have a condition involving the blood vessels of the brain
• if you have kidney problems (including kidney transplant), which may result in higher levels of potassium in the blood, with serious consequences. Your doctor may decide to adjust the dose of enalapril or monitor your blood potassium levels
• if you have liver problems
• if you have blood problems, 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 vasculopathic 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 greater risk of allergic reaction with swelling of the face, lips, tongue and throat with difficulty swallowing and breathing when taking ACE inhibitors
• if you suffer from diabetes, you should monitor for any decrease in blood glucose levels, especially during the first month of treatment. The level of potassium in the blood may also be higher
• if you are taking potassium supplements, potassium-sparing drugs or salt substitutes containing potassium
• if you are over 70 years old
• if you are intolerant to certain sugars (lactose).

If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under “Do not take Zanipril”.

If you are going to undergo treatment
Tell your doctor that you are taking Zanipril if you are about to:

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

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

Children and adolescents
The safety and efficacy of Zanipril in children under 18 years of age have not yet been established.

Other medicines and Zanipril
Zanipril 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 Zanipril is taken together
with certain medicines, its effect or that of the other medicines may change, or some side
effects may occur more frequently.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines used to lower blood pressure,
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant used to prevent organ rejection, and heparin, a medicine used to thin the blood and prevent clots). See “Do not take Zanipril”
• 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 (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, quinidine or sotalol (medicines for treating fast heartbeat)
• phenytoin phenobarbital 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, e.g. metoprolol (a medicine for the treatment of high blood pressure, heart failure and irregular heartbeat)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn).

Do not take Zanipril if you have taken or are taking sacubitril/valsartan, a medicine for the treatment of
a type of long-term (chronic) heart failure in adults, due to an increased risk of
angioedema (rapid swelling under the skin in an area such as the throat).
If you are taking any of the following medicines, the risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

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

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take Zanipril” and “Warnings and precautions”).

Zanipril with food, drinks and alcohol

• Take Zanipril at least 15 minutes before a meal.
• A high-fat meal significantly increases the levels of the drug in the blood.
• Drinking alcohol may increase the effects of Zanipril. Do not drink alcohol during treatment with Zanipril.
• Zanipril must not be taken with grapefruit or grapefruit juice, which increase its hypotensive effect (see “Do not take Zanipril”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Tell your doctor if you think you are (or might become) pregnant. Zanipril is not recommended in women
who could become pregnant and in the early stages of pregnancy, and must not be taken after the third month, as
it could cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Zanipril must not be used during breastfeeding.

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

Zanipril contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Zanipril

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 tablet must be swallowed whole with a little water. See
“Zanipril with food, drinks and alcohol”

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 Zanipril than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or
go to hospital immediately. Bring the packaging with you. Taking a dose of medicine higher
than the correct one can cause an excessive drop in blood pressure and the appearance of irregularities or
acceleration of the heart rate.

If you forget to take Zanipril

• If you forget to take the 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 Zanipril
Do not stop taking the medicine unless your doctor has told you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zanipril can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Allergic reaction manifesting with swelling of the face, lips, tongue or throat which can cause
difficulty breathing or swallowing.
At the beginning of treatment with Zanipril you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure and if this happens it may help to lie down. If you are
concerned about this, talk to your doctor.

Side effects observed with Zanipril
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 decreased number of platelets;
• Increased potassium levels 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 (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Higher levels of liver enzymes;
• Skin redness;
• Joint pain;
• Increased number of times you urinate;
• Feeling of weakness, fatigue, feeling hot, 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, swollen gums;
• Allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or breathing, rash, urticaria;
• Need to get up at night to urinate, producing large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine when taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, feeling dizzy, weakness or nausea and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, feeling lightheaded due to
low blood pressure, changes in heart rhythm, accelerated heartbeat, angina, shortness of breath,
altered sense of taste, increased creatinine levels in the blood (usually detected with a
test), high potassium levels in the blood, diarrhea, abdominal pain, fatigue,
rash, allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or
breathing.
Uncommon (may affect up to 1 in 100 people)
Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion,
nervousness, 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, chest tightness
associated with asthma, reduced intestinal motility (ileus), inflammation of the pancreas, vomiting, indigestion, constipation,
irritated stomach (gastric irritations), dry mouth, ulcers, anorexia, itching or urticaria, hair loss,
reduced kidney function, kidney failure, increased sweating, high protein levels
in the urine (measured with a test), 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), hot flushes, accelerated or irregular heartbeat (palpitations),
vertigo (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood values such as reduced number of white blood cells, reduced bone marrow function, autoimmune diseases, abnormal dreams or sleep disorders, “Raynaud’s phenomenon” (where
hands and feet can become very cold and white due to reduced blood flow), inflammation
of the nose, pneumonia, liver problems such as decreased liver function, inflammation of the liver,
jaundice (yellowing of the skin or eyes), increased levels of liver enzymes or bilirubin (measured with a
blood test), erythema multiforme (red spots of different shapes on the
skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition in
which redness and peeling of the skin, blisters or sores occur), exfoliative dermatitis/erythrodermia (severe skin rash with peeling skin), pemphigus (small
fluid-filled bumps on the skin), reduced urine production, enlargement of the male breast glands (gynecomastia), swelling of the glands in the neck, armpits or groin,
accumulation of fluid or other substances in the lungs (seen on an X-ray), inflammation of cheeks,
gums, tongue, lips.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from the available data)
Overproduction of the antidiuretic hormone, which causes fluid retention, resulting in weakness,
fatigue or confusion.
A complex of symptoms has been reported that may include some or all of the following: fever,
inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain
(arthralgia/arthritis). Rash, photosensitivity or other skin manifestations may occur.

Lercanidipine
Some side effects may be serious.
If you notice any of the following, tell your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain caused by insufficient blood flow to the heart), allergic reactions (the
symptoms include itching, rash, urticaria), fainting.
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 be observed.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate,
feeling of rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or
upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn,
nausea, stomach pain, rash, itching, muscle pain, producing large
amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, urticaria, increased
number of times you urinate, chest pain.
Not known (frequency cannot be estimated from the available data): swollen gums,
changes in liver function (detected with blood tests), cloudy fluid (during dialysis through a tube in the abdomen), swelling of face, lips, tongue or throat which can cause difficulty
breathing or swallowing.
If any of these side effects become severe, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. Ask your doctor or pharmacist for further information about side
effects, who 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Zanipril

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 on the package after the word
EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture. 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. Package Contents and Other Information

What Zanipril Contains
The active ingredients are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.29 mg of enalapril) and
20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, povidone K30, sodium
hydrogen carbonate, magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), talc,
red iron oxide (E172).

Description of Zanipril and Package Contents
Zanipril 20 mg/20 mg are orange, circular and biconvex 12 mm tablets.
Zanipril 20 mg/20 mg is available in packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan.
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria: Zanipril 20 mg/20 mg Filmtabletten
Belgium: Zanicombo
Bulgaria: Lercapril
Cyprus: Zaneril
Denmark: Zanipress
Estonia: Lercaril
Finland: Zanipress
France: Zanextra
Germany Zanipress
Greece: Lercaprel
Ireland: Lercaril
Iceland: Zanipress
Italy: Zanipril
Latvia: Lercaprel
Lithuania: Lercaprel 20 mg/20 mg plėvele dengtos tabletės
Luxembourg: Zanicombo
Malta: Zanipress
Norway: Zanipress
Netherlands: Lertec
Poland: Lercaprel
Portugal: Zanipress
United Kingdom: Zaneril
Romania: Lercaril 20mg/20mg coated tablets
Slovenia: Lercaprel 20 mg/20 mg film-coated tablets
Spain: Zanipress
Sweden: Zanitek
Hungary: Coripren