Enalapril and lercanidipine Doc Generici: detailed information

Package leaflet: Information for the user

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

Generic medicine
Please read all of 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ENALAPRIL AND LERCANIDIPINE DOC is and what it is used for
What you need to know before taking ENALAPRIL AND LERCANIDIPINE DOC
How to take ENALAPRIL AND LERCANIDIPINE DOC
Possible side effects
How to store ENALAPRIL AND LERCANIDIPINE DOC
Contents of the pack and other information

1. What ENALAPRIL AND LERCANIDIPINE DOC is and what it is used for
ENALAPRIL AND LERCANIDIPINE DOC is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that lower blood pressure.
[10 mg/10 mg]
ENALAPRIL AND LERCANIDIPINE DOC 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.
[20 mg/10 mg]
ENALAPRIL AND LERCANIDIPINE DOC 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 DOC is not indicated for the initial treatment of hypertension.

2. What you need to know before taking ENALAPRIL E LERCANIDIPINA DOC

Do not take ENALAPRIL E LERCANIDIPINA DOC:

if you are allergic to enalapril, lercanidipine or 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 E LERCANIDIPINA DOC, e.g. medicines called ACE inhibitors or calcium antagonists
if you have previously experienced 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 for an unknown reason 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 E LERCANIDIPINA DOC during the first months of pregnancy – see section “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 progressively, or occurring more frequently (unstable angina pectoris)
- heart attack (myocardial infarction) that occurred less than one month ago
if you have severe kidney problems, or if you are on dialysis
if you have severe liver problems
if you are taking medicines that inhibit hepatic metabolism such as:
- antifungal agents (e.g. ketoconazole, itraconazole)
- macrolide antibiotics (e.g. erythromycin, troleandomycin)
- antiviral agents (e.g. ritonavir)
if you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection)
with grapefruit or grapefruit juice

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL E LERCANIDIPINA DOC.

if you have low blood pressure (you may experience weakness or dizziness, especially when standing up)
if you have been severely ill (excessive vomiting) or have recently had diarrhoea
if you are on a low-salt diet, or if you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium
if you are over 70 years old
if you have heart problems
if you have a disease affecting the blood vessels in the brain
if you have kidney problems (including kidney transplant)
if you are on dialysis
if you have liver problems
if you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), reduced platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)
if you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing immunosuppressive therapy, are taking allopurinol or procainamide, or a combination of these conditions
if you are of Black African or African-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 or throat and difficulty in swallowing or breathing when taking ACE inhibitors
if you have diabetes
if you develop a persistent dry cough
if you think you are (or might become) pregnant. ENALAPRIL E LERCANIDIPINA DOC is not recommended during the first months of pregnancy, as it may cause serious harm to the unborn child if used at this time (see section “Pregnancy”)
if you are taking any of the following medicines used to treat high blood pressure:

o an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans –
e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems
related to diabetes
o aliskiren
if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
o sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs)

Your doctor may check your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section "Do not take ENALAPRIL E LERCANIDIPINA DOC".
You should be aware that this medicine is less effective in lowering blood pressure in patients of Black origin compared to patients of non-Black origin.
If you are about to undergo a treatment
Inform your doctor that you are taking ENALAPRIL E LERCANIDIPINA DOC if you are about to undergo:

surgery or anaesthesia (including dental procedures)
a treatment to remove cholesterol from the blood called LDL apheresis
desensitisation therapy to reduce the effects of allergies to bee or wasp stings

Contact your doctor immediately if you develop any of the following signs or symptoms:

yellowing of the skin and mucous membranes (see section 4). In this case, you must stop treatment with ENALAPRIL E LERCANIDIPINA DOC and your doctor will take appropriate measures.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no information available on its efficacy and safety in this age group.

Other medicines and ENALAPRIL E LERCANIDIPINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription. This is because when ENALAPRIL E LERCANIDIPINA DOC is taken together with certain medicines, the effect of ENALAPRIL E LERCANIDIPINA DOC or of the other medicines may change, or certain adverse effects may occur more frequently.
ENALAPRIL E LERCANIDIPINA DOC must not be taken with certain medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

medicines containing potassium (including salt substitutes in diets)
other medicines used to lower blood pressure, such as diuretics ("water tablets"), angiotensin II receptor antagonists or a medicine called aliskiren
lithium (a medicine used to treat certain types of depression)
antidepressant medicines called tricyclic antidepressants
medicines for severe pain (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-loss medicines containing a substance called "sympathomimetic agent"
medicines for diabetes (including oral antidiabetic medicines and insulin)
astemizole or terfenadine (medicines for allergies)
amiodarone or quinidine (medicines for treating fast heart rate)
phenytoin or carbamazepine (medicines for epilepsy)
rifampicin (a medicine for the treatment of 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 more 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 tablets", particularly potassium-sparing diuretics), other medicines that may increase potassium levels in the blood (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 E LERCANIDIPINA DOC" and "Warnings and precautions")

ENALAPRIL E LERCANIDIPINA DOC with food, beverages and alcohol
ENALAPRIL E LERCANIDIPINA DOC must not be taken with grapefruit or grapefruit juice.
Alcohol may enhance the effects of ENALAPRIL E LERCANIDIPINA DOC. Therefore, it is recommended not to drink alcohol or to minimize alcohol consumption.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking ENALAPRIL E LERCANIDIPINA DOC before starting a pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine.
ENALAPRIL E LERCANIDIPINA DOC is not recommended during the first months of pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn child if used after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Breast-feeding of newborns (in the first weeks after birth), and especially of premature infants, is not recommended while taking ENALAPRIL E LERCANIDIPINA DOC. For older infants, your doctor will advise you on the benefits and risks of taking ENALAPRIL E LERCANIDIPINA DOC during breast-feeding compared to other treatments.

Driving and using machines
Do not drive or operate machinery if during treatment with this medicine you experience dizziness, weakness, fatigue or drowsiness.

ENALAPRIL E LERCANIDIPINA DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ENALAPRIL AND LERCANIDIPINE DOC

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Adults: Unless otherwise prescribed by your doctor, the recommended dose is one tablet daily,
taken at the same time each day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. The tablet must be swallowed whole with a glass of water.
Patients with kidney problems/elderly patients: Your doctor will decide the dose of medicine based on how well your kidneys are functioning.
If you take more ENALAPRIL AND LERCANIDIPINE DOC than you should
If you have taken more medicine than you should, consult your doctor or go to hospital immediately.
Take the pack with you. Taking more than the correct dose may cause an excessive drop in blood pressure, your heart may beat irregularly or faster, you may become agitated or feel sleepy, and may experience pain in your side and back.
If you forget to take ENALAPRIL AND LERCANIDIPINE DOC
If you forget to take your tablet, skip the missed dose.
Take your next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you stop taking ENALAPRIL AND LERCANIDIPINE DOC
Do not stop treatment with this medicine unless told to do so by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everybody experiences them.
The following side effects may occur with this medicine:
Stop taking ENALAPRIL AND LERCANIDIPINE DOC and contact your doctor if you notice any
of the following symptoms:

allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing
severe skin reactions including rash, mouth ulcers, worsening of a 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 DOC, you may feel weak or dizzy or experience 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), feeling dizzy when standing up, vertigo, tachycardia, fast or irregular heartbeat (palpitations), sudden reddening 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 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 very low blood pressure, dry throat, sore throat, indigestion, metallic taste in the mouth, diarrhoea, dry mouth, swelling of the gums and lips, rash, urticaria, waking up at night to urinate, production of large amounts of urine, impotence
Additional side effects with enalapril or lercanidipine taken alone
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, feeling dizzy, cough, feeling unwell (nausea), feeling weak
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, 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 sensation in the skin, heart attack (probably due to very low blood pressure in 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, pancreatitis, 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 urine (detected by testing), impotence, muscle cramps, general feeling of being unwell (malaise), high temperature (fever), low blood sugar or sodium levels, elevated blood urea levels (all detected by blood tests)
Rare (may affect up to 1 in 1,000 people):
Changes in laboratory values such as reduced number of white blood cells, bone marrow suppression, autoimmune diseases, altered dreams or sleep disorders, Raynaud's phenomenon (where hands and feet may become very cold and white due to reduced blood flow), pulmonary infiltrates, inflammation of the nose, pneumonia, swollen tongue, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased bilirubin levels (measured by blood test), reduced urine output, breast enlargement in men
Very rare (may affect up to 1 in 10,000 people):
Swelling of the intestine (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 complex of symptoms 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 manifestations such as rash, photosensitivity or other skin problems may also occur.
Lercanidipine
Rare (may affect up to 1 in 1,000 people):
Angina pectoris (chest pain due to insufficient blood supply 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 be observed.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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.
How to store ENALAPRIL AND LERCANIDIPINE DOC
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 outer carton after "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 from light and moisture.
Do not dispose of medicines 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 E LERCANIDIPINA DOC 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, monohydrate lactose, magnesium stearate,
povidone K30, sodium starch glycolate type A, sodium hydrogen carbonate
Tablet coating:
[10 mg/10 mg]: Opadry II white 85F18422 containing polyvinyl alcohol, titanium dioxide (E171),
macrogol PEG 3350, talc
[20 mg/10 mg]: Opadry II yellow 85F32645 containing: polyvinyl alcohol, titanium dioxide (E171),
macrogol PEG 3350, talc, yellow iron oxide (E172)
Description of the appearance of ENALAPRIL E LERCANIDIPINA DOC and package contents
The film-coated tablets of ENALAPRIL E LERCANIDIPINA DOC 10 mg/10 mg are white to off-white, oval, biconvex, with a diameter of 9.5 mm x 7.5 mm.
The film-coated tablets of ENALAPRIL E LERCANIDIPINA DOC 20 mg/10 mg are yellow, round, biconvex, with a diameter of 9 mm.
Pack sizes:
28 tablets in Al/OPA/PVC/Al blisters
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milan, Italy
Manufacturer
Balkanpharma, Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Enalaprilmaleat/Lercanidipinhydrochlorid DOC 10+10 mg and 20+10 mg film-coated tablets
Italy: ENALAPRIL E LERCANIDIPINA DOC