Enalapril and lercanidipine EG Stada: detailed information

Patient Information Leaflet: Information for the User

ENALAPRIL AND LERCANIDIPINE EG STADA 20 mg/20 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Enalapril and Lercanidipine EG STADA is and what it is used for
What you need to know before taking Enalapril and Lercanidipine EG STADA
How to take Enalapril and Lercanidipine EG STADA
Possible side effects
How to store Enalapril and Lercanidipine EG STADA
Contents of the pack and other information

1. What Enalapril and lercanidipine EG STADA is and what it is used for

Enalapril and lercanidipine EG STADA is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Enalapril and lercanidipine EG STADA is used 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 lercanidipine EG STADA

DO NOT take Enalapril and lercanidipine EG STADA:

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 similar to those contained in Enalapril and lercanidipine EG STADA, i.e. medicines called ACE inhibitors or calcium antagonists;
if you have previously had swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or when the cause of the swelling was unknown or hereditary;
if you have taken or are currently taking sacubitril / valsartan, a medicine used to treat a type of chronic heart failure in adults, as there is an increased risk of angioedema (rapid swelling under the skin in areas such as the throat);
if you have diabetes or kidney problems and are being treated with a medicine containing aliskiren to reduce blood pressure;
if you are more than three months pregnant (in addition, it is best to avoid Enalapril and lercanidipine EG STADA during the first months of pregnancy – see section ‘Pregnancy’);
if you suffer from certain heart conditions: obstruction to blood flow from the heart, untreated heart failure, unstable angina (chest pain occurring at rest or progressively worsening), or a heart attack occurred less than one month ago;
if you have severe liver problems;
if you suffer from severe kidney problems or are undergoing dialysis;
if you are taking medicines that inhibit liver metabolism, such as: antifungals (e.g. ketoconazole, itraconazole), macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin), antivirals (e.g. ritonavir);
if you are currently taking another medicine called cyclosporine (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 lercanidipine EG STADA if:

you have low blood pressure (you may feel weak or dizzy, especially when standing);
you have recently been very ill (excessive vomiting) or have had diarrhoea;
you are on a low-salt diet;
you suffer from heart problems;
you have a condition affecting the blood vessels in the brain;
you have kidney problems (including kidney transplant). This may lead to increased potassium levels in the blood, which can be dangerous. Your doctor may consider adjusting your enalapril dose or monitoring your blood potassium levels;
you have liver problems;
you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia);
you suffer from collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, scleroderma), are taking immunosuppressants, allopurinol, procainamide, or any combination of these factors applies to you;
you are of Black ethnicity – you should be aware that patients of Black ethnicity 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;
you suffer from diabetes. You should monitor for low blood sugar levels, especially during the first month of treatment. Your blood potassium levels may also be higher;
you are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes;
you are over 70 years old.

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

racecadotril, used to treat diarrhoea;
medicines used to prevent organ transplant rejection and to treat 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 (ARB) (also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
aliskiren.
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information in section “DO NOT take Enalapril and lercanidipine EG STADA”.
If you are about to undergo treatment
Inform your doctor that you are taking Enalapril and lercanidipine EG STADA if you are about to:
undergo surgery or receive anaesthesia (including dental anaesthesia);
undergo a treatment to remove cholesterol from the blood called “LDL apheresis”;
undergo desensitisation therapy to reduce the effects of possible allergies to bee or wasp stings.

Inform your doctor if you think you are (or could be) 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, as there is no information on its efficacy and safety.
Other medicines and Enalapril and lercanidipine EG STADA
Enalapril and lercanidipine EG STADA must not be taken with certain medicines.
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 when Enalapril and lercanidipine EG STADA is taken with certain medicines, its effect or that of the other medicines may change, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

other medicines to lower blood pressure;
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting). See “DO NOT take Enalapril and lercanidipine EG STADA”;
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 may be used to help relieve pain);
certain medicines for pain or arthritis, including gold therapy;
certain medicines for cough 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, quinidine or sotalol (medicines to treat fast heartbeat);
phenytoin, phenobarbital or carbamazepine (medicines for epilepsy);
rifampicin (a medicine used to treat tuberculosis);
digoxin (a medicine used to treat heart problems);
midazolam (a medicine to help sleep);
beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders);
cimetidine (a medicine for ulcers, indigestion and heartburn taken at doses exceeding 800 mg). Do not take Enalapril and lercanidipine EG STADA if you have taken or are currently taking sacubitril / valsartan, a medicine used to treat chronic heart failure in adults, as there is an increased risk of angioedema (rapid swelling under the skin, e.g. in the throat). If you are taking any of the following medicines, there may be an increased risk of angioedema:
racecadotril, a medicine used to treat diarrhoea;
medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
vildagliptin, a medicine used to treat diabetes.

Your doctor may consider adjusting your dose and/or taking other precautions:

if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the sections “DO NOT take Enalapril and lercanidipine EG STADA” and “Warnings and precautions”).

Enalapril and lercanidipine EG STADA with food, drinks and alcohol

Enalapril and lercanidipine EG STADA should be taken at least 15 minutes before a meal.
A high-fat meal significantly increases blood levels of the medicine.
Alcohol may enhance the effect of Enalapril and lercanidipine EG STADA. Do not consume alcohol during treatment with Enalapril and lercanidipine EG STADA.
Do not take Enalapril and lercanidipine EG STADA with grapefruit or grapefruit juice, as this may increase the hypotensive effect (see “DO NOT take Enalapril and lercanidipine EG STADA”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy and fertility
Use of Enalapril and lercanidipine EG STADA is not recommended in women who could become pregnant. During early pregnancy, Enalapril and lercanidipine EG STADA should not be taken beyond three months of pregnancy, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Enalapril and lercanidipine EG STADA must not be used during breastfeeding.
Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness or drowsiness while taking this medicine.
Enalapril and lercanidipine EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Enalapril and Lercanidipine EG STADA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults
The recommended dose is one tablet once daily, unless otherwise prescribed by your doctor.
Patients with kidney problems/elderly patients
Your doctor will decide the dosage based on kidney function.
Method of administration
Enalapril and Lercanidipine EG STADA is for oral use only.
The tablet should be taken at the same time every day, preferably in the morning, at least 15 minutes before breakfast. Swallow the tablet whole with water. See “Enalapril and Lercanidipine EG STADA with food, drinks and alcohol”.
If you take more Enalapril and Lercanidipine EG STADA than you should
Do not exceed the prescribed dose. If you take more than the prescribed amount, consult your doctor or go to hospital immediately. Take the medicine pack with you.
Taking an excessive dose of this medicine may cause a severe drop in blood pressure and the heart may beat irregularly or faster than normal.
If you forget to take Enalapril and Lercanidipine EG STADA

If you forget to take a tablet, skip the missed dose.
Take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking Enalapril and Lercanidipine EG STADA

Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about using this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the use of this medicine:
Some side effects may be serious.
If you experience any of the following symptoms, contact your doctor immediately.

Allergic reaction presenting as swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing.

At the beginning of treatment with Enalapril and lercanidipine EG STADA, you may feel weak or dizzy or have blurred vision; this is caused by a sudden drop in blood pressure and lying down may help. If this concerns you, speak to your doctor.
Side effects observed with enalapril/lercanidipine
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 results such as reduced number of blood platelets;
increased potassium levels in the blood;
nervousness (anxiety);
dizziness upon standing;
vertigo;
rapid heartbeat;
fast 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 enzyme levels;
skin redness;
joint pain;
increased need to urinate;
feeling of weakness;
fatigue;
feeling hot;
swelling of the ankles.

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

anaemia;
allergic reactions;
ringing in the ears (tinnitus);
fainting;
dry throat;
sore throat;
indigestion;
salty taste sensation in the mouth;
diarrhoea;
dry mouth;
gum swelling;
allergic reactions associated with swelling of the face, lips, tongue or throat and difficulty breathing or swallowing;
skin rash, urticaria;
waking at night to urinate, increased urine production.

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

blurred vision;
dizziness, weakness or feeling unwell;
cough.

Common (may affect less than 1 in 10 people):

depression;
headache;
fainting (syncope);
chest pain;
lightheadedness due to low blood pressure;
changes in heart rhythm;
rapid heartbeat;
angina;
shortness of breath;
altered sense of taste;
increased creatinine levels in blood (usually detected by blood test);
high potassium levels in blood;
diarrhoea;
abdominal pain;
fatigue;
skin rash;
allergic reactions associated with swelling of the face, lips, tongue or throat and difficulty breathing or swallowing.

Uncommon (may affect less than 1 in 100 people):

anaemia (both aplastic and haemolytic);
sudden drop in blood pressure;
confusion;
nervousness;
insomnia or drowsiness;
tingling or numbness of the skin;
heart attack (likely due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain);
stroke (likely due to very low blood pressure in high-risk patients);
runny nose;
sore throat and hoarseness;
asthma associated with chest tightness;
slow movement of food through the intestine (ileus);
inflammation of the pancreas;
feeling unwell (vomiting);
indigestion;
constipation;
irritated stomach (gastric irritation);
dry mouth;
ulcer;
loss of appetite;
itching or hives;
hair loss;
impaired kidney function;
kidney failure;
increased sweating;
high levels of protein in urine (detected by urine test);
muscle cramps;
general feeling of discomfort (malaise);
high body temperature (fever);
low blood sugar or sodium levels;
elevated blood urea levels (all detected by blood tests);
flushing;
fast or irregular heartbeat (palpitations);
dizziness (sensation of spinning);
ringing in the ears (tinnitus);
impotence.

Rare (may affect less than 1 in 1,000 people):

changes in blood test results such as reduced number of white blood cells;
reduced bone marrow function;
autoimmune diseases;
altered dreams or sleep disturbances;
Raynaud’s phenomenon (where hands and feet may become very cold and white due to reduced blood flow);
inflammation of the nose;
pneumonia;
liver problems such as reduced liver function, inflammation of the liver, jaundice (yellowing of the skin or whites of the eyes), increased liver enzymes and bilirubin levels (detected by blood tests);
erythema multiforme (different-shaped red spots on the skin);
Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin conditions causing redness, peeling, blisters or sores);
exfoliative dermatitis/erythroderma (severe skin rash with peeling and shedding of the skin);
pemphigus (small fluid-filled blisters on the skin);
reduced urine output;
breast enlargement in men (gynaecomastia);
swelling of glands in the neck, armpit or groin;
fluid or other substance accumulation in the lungs (as seen on X-ray);
inflammation of cheeks, gums, tongue, lips or throat.

Very rare (may affect less than 1 in 10,000 people):

intestinal swelling (intestinal angioedema).

Not known (frequency cannot be estimated from the available data):

excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue or confusion;
a symptomatic complex has been reported that may include some or all of the following: o fever; o inflammation of blood vessels (serositis/vasculitis); o muscle pain (myalgia/myositis); o joint pain (arthralgia/arthritis);
skin rash, photosensitivity or other dermatological manifestations may occur.

Lercanidipine
Some side effects may be serious.
If you experience any of the following symptoms, contact your doctor immediately:
Rare (may affect less than 1 in 1,000 people):

angina pectoris (chest pain caused by insufficient blood flow to the heart);
allergic reactions (symptoms include itching, skin rash, urticaria);
fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the class of medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may occur.
Other possible side effects:
Common (may affect up to 1 in 10 people):

headache;
rapid heartbeat;
sensation of fast or irregular heartbeat (palpitations);
sudden flushing of the face, neck or upper chest (flushing);
swelling of the ankles.

Uncommon (may affect up to 1 in 100 people):

dizziness;
low blood pressure;
heartburn;
feeling unwell;
stomach pain;
skin rash;
itching;
muscle pain;
passage of large amounts of urine;
feeling of weakness or fatigue.

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

drowsiness;
vomiting;
diarrhoea;
urticaria;
increased need to urinate;
chest pain.

Not known (frequency cannot be estimated from the available data):

gum swelling;
altered liver function (detected in blood tests);
cloudy dialysis fluid (when undergoing peritoneal dialysis);
swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contact your doctor or pharmacist for further information about side effects. Both have a more complete list of possible side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 Enalapril and Lercanidipine EG STADA

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 carton after "EXP:". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enalapril and lercanidipine EG STADA contains
The active substances are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains 20 mg of enalapril maleate and 20 mg of lercanidipine hydrochloride.
The other components are:
Core: microcrystalline cellulose, sodium bicarbonate, pregelatinized starch, sodium carboxymethylstarch
(type A), anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Enalapril and lercanidipine EG STADA and pack sizes
Enalapril and lercanidipine EG STADA 20 mg/20 mg film-coated tablets are available as round, biconvex tablets with a colour ranging from orange to light orange.
Enalapril and lercanidipine EG STADA 20 mg/20 mg is available in packs containing 14, 28, 30, 50, 56, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan - Italy
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Baden-Wuerttemberg - Germany
This medicinal product is authorised in the European Economic Area countries under the following
names:
DE Enalaprilmaleat/Lercanidipinhydrochlorid AL 20 mg/20 mg Filmtabletten
DK Enalaprilmaleat/Lercanidipinhydrochlorid "Stada"
FR Enalapril/Lercanidipine EG 20mg/20mg, comprimé pelliculé
IT Enalapril e Lercanidipina EG STADA
PT Enalapril + Lercanidipina Ciclum