ENALAPRIL/LERCANIDIPINE CINFA 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

enalapril/lercanidipine cinfa 10 mg/10 mg film-coated tablets EFG

Enalapril maleate/Lercanidipine hydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is enalapril/lercanidipine cinfa and what is it used for

enalapril/lercanidipine cinfa is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two drugs that lower blood pressure.

enalapril/lercanidipine cinfa is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled by lercanidipine 10 mg alone. enalapril/lercanidipine cinfa should not be used for the initial treatment of hypertension.

2. What you need to know before you take enalapril/lercanidipine cinfa

Do not takeenalapril/lercanidipine cinfa

• If you are allergic to enalapril maleate, lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have ever experienced an allergic reaction to a type of medicine similar to those contained in enalapril/lercanidipine, i.e. medicines called ACE inhibitors or calcium channel blockers.
• If you have ever experienced swelling of the face, lips, mouth, tongue or throat that has caused difficulty in swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitors, or if the cause of the reaction is unknown or if it is a hereditary condition.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used for the treatment of chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) is increased.

• If you have diabetes or kidney problems and are receiving treatment with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months (it is also recommended to avoid the use of enalapril/lercanidipine at the start of pregnancy, see section Pregnancy).
• If you suffer from certain heart conditions:

• obstruction of blood flow from the heart.
• untreated heart failure.
• unstable angina (chest pain that occurs at rest or increases progressively)
• during the first month after having a heart attack.

• If you have severe liver problems.
• If you have severe kidney problems or are on dialysis.
• If you are taking drugs that inhibit liver metabolism, such as:

• antifungals (such as ketoconazole or itraconazole).
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin).
• antivirals (such as ritonavir).

• If you are taking another medicine called ciclosporin (used after a transplant to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take enalapril/lercanidipine cinfa.

• If you have low blood pressure (which can manifest as dizziness or fainting, especially when standing up).
• If you have been very ill (with excessive vomiting) or have had diarrhea recently.
• If you have a restricted salt diet.
• If you have a heart condition.
• If you have a disorder that affects the blood vessels of the brain.
• If you have kidney problems (including kidney transplant). This can lead to high levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels.
• If you have liver problems.
• If you have blood problems, such as a low or absent white blood cell count (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia) or a decrease in the number of red blood cells (anemia).

• If you have a vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are on immunosuppressive therapy or are taking allopurinol or procainamide or a combination of both medicines.

• If you are a black patient, you should be aware that these patients have a higher risk of experiencing allergic reactions with inflammation of the face, lips, tongue or throat, accompanied by difficulty swallowing or breathing, when taking ACE inhibitors.
• If you are diabetic, you should monitor your blood sugar levels in case your glucose levels are low, especially during the first month of treatment. The level of potassium in the blood may also be elevated.
• If you are taking potassium supplements, potassium-sparing agents or salt substitutes that contain potassium.
• If you are over 70 years old.
• If you are taking any of the following medicines, the risk of angioedema may be increased:
• Racecadotrile, a medicine used in the treatment of diarrhea.
• Medicines used in the prevention of organ rejection after a transplant or in the treatment of cancer (e.g. temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used in the treatment of diabetes.

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

• a blocker of the angiotensin II receptor (ARB) (also known as sartans, such as valsartan, telmisartan or irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may review your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Also, see the information included under the heading “Do not take enalapril/lercanidipine cinfa”.

If you are going to undergo surgery or certain treatments soon.

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril/lercanidipine:

• any surgical intervention or if you are going to be given an anesthetic (even at the dentist's office).
• a treatment to remove cholesterol from the blood known as “LDL apheresis”.
• a desensitization treatment to reduce the effect of an allergy to bees or wasps.

You must inform your doctor if you think you are (or might become) pregnant or if you are breast-feeding (see the section Pregnancy, breast-feeding and fertility).

Children and adolescents

The safety and efficacy of enalapril/lercanidipine in children under 18 years of age have not been established.

Other medicines and enalapril/lercanidipine cinfa

Enalapril/lercanidipine should not be taken with certain medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is because when enalapril/lercanidipine is taken with certain medicines, the effect of enalapril/lercanidipine or the other medicines may be altered, or certain side effects may occur more frequently.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines that lower blood pressure.
• potassium supplements (including salt substitutes in the diet).
• potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medicine used in the prevention of organ rejection; heparin, a medicine used as an anticoagulant to prevent blood clots). See section “Do not take enalapril/lercanidipine cinfa”.
• lithium (a medicine used for the treatment of a certain type of depression).
• medicines for depression called “tricyclic antidepressants”.
• medicines for the treatment of mental problems, called “antipsychotics”.
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and can be used to combat pain).
• certain medicines for pain or arthritis, including gold therapy.
• certain medicines for the treatment of cough and cold and weight loss medicines that contain a substance called “sympathomimetic agent”.
• medicines for the treatment of diabetes (including oral antidiabetic medicines and insulin).
• astemizole or terfenadine (medicines for allergies).
• amiodarone, quinidine or sotalol (medicines for the treatment of a fast heart rate).
• 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 to help you sleep).
• beta-blockers, e.g. metoprolol (medicines that treat high blood pressure, heart failure and abnormal heart rhythm).
• cimetidine (administered at daily doses above 800 mg, a medicine for ulcers, indigestion or acidity).

Do not take enalapril/lercanidipine if you have taken or are currently taking sacubitril/valsartan, a medicine used for the treatment of chronic heart failure in adults, as the risk of angioedema (rapid swelling of the skin, such as the throat) is increased.

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

• Racecadotrile, a medicine used in the treatment of diarrhea.
• Medicines used in the prevention of organ rejection after a transplant or in the treatment of cancer (e.g. temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used in the treatment of diabetes.

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

• If you are taking a blocker of the angiotensin II receptor (ARB) or aliskiren (also see the information included under the headings “Do not take enalapril/lercanidipine cinfa” and “Warnings and precautions”).

Taking enalapril/lercanidipine cinfa with food, drinks and alcohol

Enalapril/lercanidipine should be taken at least 15 minutes before meals.

A fatty meal significantly increases the levels of the medicine in the blood.

Alcohol may increase the effect of enalapril/lercanidipine. During treatment with enalapril/lercanidipine, you should not consume alcohol. Enalapril/lercanidipine should not be taken with grapefruit or grapefruit juice, as it may increase its anti-hypotensive effect (see “Do not take enalapril/lercanidipine cinfa”).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy and fertility

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking enalapril/lercanidipine before you become pregnant or as soon as you find out you are pregnant and will recommend that you take a different medicine instead of enalapril/lercanidipine. The use of enalapril/lercanidipine is not recommended in women who can become pregnant or at the start of pregnancy, and it should not be taken if you are pregnant for more than three months, as it can cause serious harm to the fetus if used after the third month of pregnancy.

Breast-feeding

Enalapril/lercanidipine should not be taken during breast-feeding.

Driving and using machines

If you experience dizziness, weakness or drowsiness with this medicine, you should not drive or operate machinery.

enalapril/lercanidipine cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take enalapril/lercanidipine cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults: unless your doctor tells you otherwise, the recommended dose is one tablet once a day, at the same time each day. The tablet should be taken preferably in the morning, at least 15 minutes before breakfast. The tablets should be swallowed whole with water. See “Taking enalapril/lercanidipine cinfa with food, drinks and alcohol”.

Patients with kidney problems/elderly patients: your doctor will decide the dose of medicine you should take, taking into account how well your kidneys are working.

If you take more enalapril/lercanidipine cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Take the package and the leaflet of the medicine to the healthcare professional.

A dose higher than the correct one may cause a significant drop in blood pressure and your heart may beat irregularly or faster.

If you forget to take enalapril/lercanidipine cinfa

• If you forget to take your tablet, do not take the forgotten dose.
• Take the next dose following the usual schedule.
• Do not take a double dose to make up for forgotten doses.

If you stop taking enalapril/lercanidipine cinfa

Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. This medicine may cause the following adverse effects:

Some adverse effects can be serious.

Tell your doctor immediately if you notice any of the following adverse effects:

• An allergic reaction accompanied by swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing;

When you start taking enalapril/lercanidipine, you may feel weakness or dizziness, or notice that your vision becomes blurred; this is caused by a sudden drop in blood pressure, and if it happens, it will be helpful to lie down. If you are concerned, consult your doctor.

Adverse Effects Observed with Enalapril/Lercanidipine

Frequent (may affect up to 1 in 10 patients)

Cough, feeling of dizziness, headache.

Uncommon (may affect up to 1 in 100 patients)

Changes in blood parameter values, such as a decrease in platelet count, increased potassium concentration in the blood, nervousness (anxiety), feeling of dizziness when standing up, vertigo, rapid heartbeat, rapid or irregular heartbeat (palpitations), sudden reddening of the face, neck, or upper chest (erythema), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increased liver enzyme levels, skin reddening, joint pain, increased urination frequency, feeling of weakness, fatigue, feeling of heat, ankle swelling.

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

Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste on the tongue, diarrhea, dry mouth, gum inflammation, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty swallowing or breathing, skin rash, hives, nocturia, production of large amounts of urine, impotence.

Additional Adverse Effects Observed with Enalapril or Lercanidipine Alone

Enalapril

Very frequent (may affect more than 1 in 10 patients)

Blurred vision, feeling of dizziness, weakness or discomfort, and cough.

Frequent (may affect up to 1 in 10 patients)

Depression, headache, fainting (syncope), chest pain, dizziness due to low blood pressure, changes in heart rate, rapid heartbeats, angina, shortness of breath, alterations in taste, increased creatinine levels in the blood (usually detected by analysis), high potassium levels in the blood, diarrhea, abdominal pain, fatigue, rash, allergic reaction with inflammation of the face, lips, tongue, or throat with difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 patients)

Anemia (including aplastic anemia and hemolytic anemia), sudden drop in blood pressure, confusion, nervousness, somnolence or insomnia, sensation of pins and needles in the skin or numbness, myocardial infarction (possibly caused by very low blood pressure in certain high-risk patients, including those with coronary or cerebral blood supply problems), stroke (possibly due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma associated with chest tightness, slowing of food movement through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastric irritation), dry mouth, ulcer, anorexia, itching or hives, hair loss, renal function alteration, renal failure, increased sweating, high protein levels in the urine (measured by analysis), muscle cramps, feeling of general discomfort, high temperature (fever), low sugar or sodium levels in the blood, high urea levels in the blood (all measured by blood analysis), reddening, rapid or irregular heartbeats (palpitations), vertigo (feeling of dizziness), ringing in the ears (tinnitus), impotence.

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

Changes in blood parameter values, such as a decrease in white blood cell count, bone marrow depression, autoimmune diseases, strange dreams or sleep disorders, "Raynaud's phenomenon" (in which the hands and feet can become intensely cold and turn white due to low blood flow), nasal inflammation, pneumonia, liver problems, such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzyme or bilirubin levels (measured by blood analysis), erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin condition in which the skin turns red and forms scales, blisters, or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small blisters filled with fluid on the skin), decreased urine production, breast enlargement in men (gynecomastia), inflamed glands in the neck, armpits, or groin, fluid accumulation or other substances in the lungs (as seen on X-rays), cheek, gum, tongue, lip, or throat inflammation.

Very rare (may affect up to 1 in 10,000 patients)

Intestinal inflammation (intestinal angioedema).

Frequency not known (cannot be estimated from available data)

Excessive production of antidiuretic hormone that causes fluid retention, leading to weakness, fatigue, or confusion.

A set of symptoms has been reported that may include one or more of the following: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity, or other skin manifestations may occur.

Lercanidipine

Some of these adverse effects can be serious. If you experience any of these adverse effects, consult your doctor.

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

Chest pain (pain in the chest caused by lack of blood supply to the heart), allergic reactions (with symptoms such as itching, rash, hives), fainting.

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

Other possible adverse effects:

Frequent (may affect up to 1 in 10 patients): headache, rapid or irregular heartbeats (palpitations), sudden reddening of the face, neck, or upper chest, ankle swelling.

Uncommon (may affect up to 1 in 100 patients): dizziness, low blood pressure, heartburn, discomfort, stomach pain, skin rash, itching, muscle pain, increased urination, weakness or fatigue.

Rare (may affect up to 1 in 1,000 patients): somnolence, vomiting, diarrhea, hives, increased urination frequency, chest pain.

Frequency not known (cannot be estimated from available data): gum swelling, changes in liver function (detected by blood analysis), cloudy fluid (when performing hemodialysis through a tube into the abdominal cavity), swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing.

If any of the adverse effects worsen, or if you experience any adverse effect not listed in this leaflet, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about adverse effects, as they have a more complete list of adverse effects.

Reporting Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril/Lercanidipine Cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril/Lercanidipine Cinfa

• 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:

Tablet core: microcrystalline cellulose, sodium hydrogen carbonate, pregelatinized corn starch, sodium carboxymethyl cellulose (type A) (from potato), anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose, macrogol 6000, talc, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

White, round, and biconvex film-coated tablets.

They come in polyamide-aluminum-PVC/aluminum blisters.

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

TEVA Gyógyszergyár Zrt.

Pallagi út 13, Debrecen H-4042

Hungary

or

Teva Pharma S.L.U.

C/ C, nº 4, Polígono Industrial Malpica

Zaragoza 50016

or

Merckle GmbH

Ludwig-Merckle-Straße 3

Blaubeuren 89143

Germany

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Leaflet: February 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79824/P_79824.html

QR code to: https://cima.aemps.es/cima/dochtml/p/79824/P_79824.html