Enalapril and lercanidipine EG: detailed information

Package leaflet: Information for the patient

ENALAPRIL AND LERCANIDIPINE EG 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet
1. What Enalapril and Lercanidipine EG is and what it is used for
2. What you need to know before taking Enalapril and Lercanidipine EG
3. How to take Enalapril and Lercanidipine EG
4. Possible side effects
5. How to store Enalapril and Lercanidipine EG
6. Contents of the pack and other information

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

Enalapril and Lercanidipine EG is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
[for the 10 mg/10 mg strength only]
Enalapril and Lercanidipine EG is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate blood pressure control has not been achieved with lercanidipine 10 mg alone.
[for the 20 mg/10 mg strength only]
Enalapril and Lercanidipine EG is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate blood pressure control has not been achieved with enalapril 20 mg alone.
Enalapril and Lercanidipine EG must not be used for the initial treatment of hypertension.

2. What you should know before taking Enalapril and lercanidipine EG

Do not take Enalapril and lercanidipine EG

if you are allergic to enalapril or lercanidipine, or to any of the other ingredients of this medicine (listed in section 6).
If you have previously had an allergic reaction to a medicine of the same type as those contained in Enalapril and lercanidipine EG, e.g. drugs called ACE inhibitors or calcium antagonists.
If you have previously experienced swelling of the face, lips, mouth, tongue, or larynx causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if you have had such swelling without a known cause or due to hereditary causes.
If you have diabetes or kidney problems and are taking medicines containing aliskiren to lower blood pressure.
If you are more than three months pregnant (in addition, it is better to avoid Enalapril and lercanidipine EG during the first months of pregnancy – see section on pregnancy).
If you suffer from certain heart conditions such as:
obstruction of blood flow from the heart, including narrowing of the heart's aortic valve;
untreated heart failure;
chest pain occurring at rest, worsening, or occurring frequently (unstable angina pectoris);
heart attack (myocardial infarction) occurring less than one month ago.
If you have severe kidney disease or are undergoing dialysis.
If you have severe liver disease.
If you are taking drugs that inhibit hepatic metabolism, such as:
antifungals (e.g. ketoconazole, itraconazole);
macrolide antibiotics (e.g. erythromycin, troleandomycin);
antivirals (e.g. ritonavir).
If you are simultaneously taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and lercanidipine EG:

if you have low blood pressure (which may present as weakness or dizziness, especially when standing);
if you have been seriously ill (excessive vomiting) or have recently had diarrhoea;
if you are on a low-sodium diet, taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes;
if you are over 70 years old;
if you have heart problems;
if you have a condition affecting blood vessels in the brain;
if you have kidney problems (including kidney transplant);
if you are undergoing dialysis;
if you have liver problems;
if you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cells (anaemia);
if you have vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are taking immunosuppressants, allopurinol, procainamide, or any combination of these factors;
if you are of Black African or Caribbean origin, you should be aware that patients of Black origin have a higher risk of allergic reactions with swelling of the face, lips, tongue, and throat, causing difficulty in swallowing and breathing, after taking ACE inhibitors;
if you have diabetes;
if you develop a persistent dry cough;
if you suspect (or are planning) a pregnancy. The use of Enalapril and lercanidipine EG is not recommended during the early stages of pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may severely harm your baby (see section on pregnancy);
if you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
aliskiren.
if you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, e.g. in the throat) is increased:
sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also the information provided in the section “Do not take Enalapril and lercanidipine EG”.
You should be aware that this medicine is less effective in reducing blood pressure in patients of
Black origin compared to patients of non-Black origin.

If you are about to undergo a procedure/treatment
Inform your doctor that you are taking Enalapril and lercanidipine EG if you are about to:

undergo surgery or anaesthesia (including dental anaesthesia);
undergo a cholesterol-lowering blood treatment called “LDL apheresis”;
undergo desensitisation therapy to reduce the effects of allergies to bee or wasp stings.

If you experience any of the following signs or symptoms, contact your doctor immediately:

yellowing of the skin or mucous membranes (see section 4). In such cases, stop treatment with Enalapril and lercanidipine EG. Your doctor will take appropriate measures.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as there is insufficient information on its efficacy and safety.

Other medicines and Enalapril and lercanidipine EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because the effect of Enalapril and lercanidipine EG or of other medicines may change when taken together, or certain side effects may occur more frequently.

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

potassium-containing medicines (including salt substitutes in diets);
other medicines used to lower blood pressure, such as diuretics ("water pills"), angiotensin II receptor blockers, or a medicine called aliskiren;
lithium (a medicine used to treat a certain type of depression);
medicines for depression called "tricyclic antidepressants";
strong painkillers (narcotics, such as morphine);
medicines for mental disorders called "antipsychotics";
non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain);
certain medicines for pain or arthritis, including gold therapy;
certain cough and cold medicines and weight-reduction 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 fast heart rate);
phenytoin and carbamazepine (medicines for epilepsy);
rifampicin (a medicine for treating tuberculosis);
digoxin (a medicine for treating heart problems);
midazolam (a medicine that helps with sleep);
beta-blockers (medicines for treating high blood pressure and heart problems);
a medicine for ulcers and heartburn called cimetidine, taken at daily doses exceeding 800 mg;
medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”;
potassium supplements or potassium-containing salt substitutes, diuretics ("water pills", particularly so-called potassium-sparing diuretics), other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Enalapril and lercanidipine EG” and “Warnings and precautions”).

Enalapril and lercanidipine EG with food, beverages, and alcohol
Do not take Enalapril and lercanidipine EG with grapefruit or grapefruit juice. Alcohol may increase the effect of Enalapril and lercanidipine EG. Therefore, it is advisable not to drink alcohol or to minimize alcohol consumption.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you suspect (or are planning) a pregnancy. Normally, your doctor will advise you to stop treatment with Enalapril and lercanidipine EG before you become pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine to replace Enalapril and lercanidipine EG. The use of Enalapril and lercanidipine EG is not recommended during the early stages of pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may severely harm your baby.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding of newborns (during the first weeks after birth), and especially of premature infants, is not recommended if you are taking Enalapril and lercanidipine EG. For older infants, your doctor will inform you about the benefits and risks of taking Enalapril and lercanidipine EG while breastfeeding compared to other treatments.

Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine.

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

3. How to take Enalapril and lercanidipine EG

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Adults: The recommended dose is one tablet daily, taken at the same time every
day, unless otherwise prescribed by your doctor. The tablet should be taken
preferably in the morning, at least 15 minutes before breakfast. Tablets must be
swallowed whole with water.
Patients with kidney problems/elderly patients: Your doctor will determine the appropriate dose based on how well your kidneys are functioning.
If you take more Enalapril and lercanidipine EG than you should
If you take more medicine than you should, consult your doctor or go to hospital immediately.
Take the pack with you. Taking an excessive dose of the medicine may cause
excessive drop in blood pressure and the occurrence of irregular heartbeat or
tachycardia. Restlessness or drowsiness may occur, as well as pain in the side and back.
If you forget to take Enalapril and lercanidipine EG
If you forget to take a tablet, skip the missed dose.
Take the next dose as usual.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Enalapril and lercanidipine EG
Do not stop taking this medicine unless your doctor has told you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine:

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

Allergic reaction presenting as swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing.
Severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disease, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

At the beginning of treatment with Enalapril and Lercanidipine EG, you may feel weak or dizzy or experience blurred vision; this is due to a sudden drop in blood pressure, and lying down may help if this occurs. If you are concerned, speak to your doctor.

Side effects observed with Enalapril and Lercanidipine EG

Common (may affect up to 1 in 10 people):
Cough, dizziness, headache.

Uncommon (may affect up to 1 in 100 people):
Changes in blood test values such as reduced number of blood platelets, increased potassium levels in the blood, nervousness (anxiety), feeling dizzy when standing up, vertigo, tachycardia, rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), elevated liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, hot flushes, swelling of the ankles.

Rare (may affect up to 1 in 1,000 people):
Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting due to severe drop in blood pressure, dry throat, sore throat, indigestion, salty taste in the mouth, diarrhoea, dry mouth, swelling of the gums and lips, skin rash, urticaria, waking up at night to urinate, increased urine production, impotence.

Additional side effects with enalapril or lercanidipine taken separately

Enalapril

Very common (may affect more than 1 in 10 people):
Blurred vision, feeling of dizziness, cough, feeling unwell (nausea), feeling of weakness.

Common (may affect up to 1 in 10 people):
Depression, fainting, chest pain, changes in heart rhythm, angina, shortness of breath, diarrhoea, abdominal pain, altered taste, skin rash, fatigue, increased potassium levels in the blood, increased creatinine levels in the blood (usually detected by a blood test).

Uncommon (may affect up to 1 in 100 people):
Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, insomnia or drowsiness, tingling or numbness of the skin, heart attack (probably due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (probably due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, reduced intestinal motility, inflammation of the pancreas, malaise, indigestion, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or urticaria, hair loss, reduced kidney function, kidney failure, high levels of protein in the urine (measured by a test), impotence, muscle cramps, general feeling of malaise, high temperature (fever), low levels of sugar or sodium in the blood, elevated blood urea levels (all detected by blood tests).

Rare (may affect up to 1 in 1,000 people):
Changes in blood test 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 may become very cold and white due to reduced blood flow), lung infiltrates, inflammation of the nose, pneumonia, swelling of the tongue, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin and/or whites of the eyes), increased bilirubin levels (measured by blood test), decreased urine output, enlargement of the breast gland in men.

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

Frequency not known (frequency cannot be estimated from the available data):
Excessive production of antidiuretic hormone, leading to fluid retention, resulting in weakness, fatigue or confusion.

A complex symptom has been reported which may include some or all of the following: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.

Lercanidipine

Rare (may affect up to 1 in 1,000 people):
Angina pectoris (chest pain due to insufficient blood flow to the heart), vomiting, heartburn, muscle pain.

Very rare (may affect up to 1 in 10,000 people):
Chest pain.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may occur.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril and Lercanidipine EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or container, following the wording “EXP.” The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enalapril and lercanidipine EG contains

The active substances are enalapril and lercanidipine. Each tablet contains 10 mg of enalapril maleate, equivalent to 7.64 mg of enalapril, and 10 mg of lercanidipine hydrochloride, equivalent to 9.44 mg of lercanidipine.
The active substances are enalapril and lercanidipine. Each tablet contains 20 mg of enalapril maleate, equivalent to 15.29 mg of enalapril, and 10 mg of lercanidipine hydrochloride, equivalent to 9.44 mg of lercanidipine.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone K30, sodium carboxymethyl starch Type A, sodium bicarbonate. Tablet coating: [only for the 10 mg/10 mg strength]: Opadry II white 85F18422 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol PEG 3350, talc. [only for the 20 mg/10 mg strength]: Opadry II yellow 85F32645 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol PEG 3350, talc, yellow iron oxide (E172).

Description of the appearance of Enalapril and lercanidipine EG and contents of the pack
Enalapril and lercanidipine EG 10 mg/10 mg film-coated tablets are oval, biconvex tablets of white or off-white colour, with a diameter of 9.5 x 7.5 mm.
Enalapril and lercanidipine EG 20 mg/10 mg film-coated tablets are round, biconvex, yellow tablets with a diameter of 9 mm.

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

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

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

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:
Germany: Enalaprilmaleat/Lercanidipinhydrochlorid AL 10mg/10 mg Filmtabletten
Enalaprilmaleat/Lercanidipinhydrochlorid AL 20mg/10 mg Filmtabletten
France: Enalapril/Lercanidipine EG 10 mg/10 mg, comprimé pelliculé
Enalapril/Lercanidipine EG 20 mg/10 mg, comprimé pelliculé
Denmark: Enalapril/Lercanidipin STADA Arzneimittel AG
Enalapril/Lercanidipin STADA Arzneimittel AG
Italy: ENALAPRIL E LERCANIDIPINA EG