Enalapril/lercanidipine Cinfa 20 mg/10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

enalapril/lercanidipine cinfa 20 mg/10 mg film-coated tablets EFG

Enalapril maleate/lercanidipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

enalapril/lercanidipine cinfa is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled with enalapril 20 mg alone. enalapril/lercanidipine cinfa should not be used for the initial treatment of hypertension.

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

Do not take enalapril/lercanidipine cinfa

• If you are allergic to enalapril maleate, lercanidipine hydrochloride, or any of the other components of this medicine (listed in section 6).

• If you have ever had an allergic reaction to a similar type of medicine contained in enalapril/lercanidipine, i.e., medicines known as ACE inhibitors or calcium channel blockers.

• If you have ever 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 if the cause of such reaction was unknown or if it was a hereditary condition.

• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of developing angioedema (rapid swelling of the throat).

• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you are more than 3 months pregnant (use of enalapril/lercanidipine is also not recommended at the beginning of pregnancy; see Pregnancy section).

• If you suffer from certain heart conditions:

• obstruction of blood outflow from the heart.

• untreated heart failure.

• unstable angina (chest discomfort occurring at rest or progressively worsening).

• during the first month after a myocardial infarction.

• If you have severe liver problems.

• If you have severe kidney problems, or if you are undergoing dialysis.

• If you are taking drugs that inhibit liver metabolism, such as:

• antifungals (e.g., ketoconazole or itraconazole).

• macrolide antibiotics (e.g., erythromycin, troleandomycin, or clarithromycin).

• antivirals (e.g., ritonavir).

• If you are taking another medicine called cyclosporine (used after organ transplantation to prevent organ rejection).

• Together with grapefruit or grapefruit juice.

Warnings and precautions

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

• If you have low blood pressure (which may manifest as dizziness or fainting, especially when standing).

• If you have been severely ill (with excessive vomiting) or have recently had diarrhea.

• If you are on a salt-restricted diet.

• If you have a heart condition.

• If you have a disorder affecting the blood vessels in the brain.

• If you have kidney problems (including kidney transplant). This may lead to high potassium levels in the blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels.

• If you have liver problems.

• If you have blood disorders, such as low or absent white blood cells (leukopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cells (anemia).

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

• If you are of Black race, you should be aware that such patients have a higher risk of developing allergic reactions with swelling of the face, lips, tongue, or throat, accompanied by difficulty in swallowing or breathing, when taking ACE inhibitors.

• If you are diabetic, you should monitor your blood sugar levels, especially during the first month of treatment, as low glucose levels may occur. Blood potassium levels may also be elevated.

• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.

• If you are over 70 years of age.

• 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 transplant rejection or 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, such as valsartan, telmisartan, or irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.

Also refer to the information under the heading “Do not take enalapril/lercanidipine cinfa”.

If you are about to undergo surgery or certain treatments.

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

• any surgical procedure or if you are to receive an anesthetic (including at the dentist’s office).
• a treatment to remove cholesterol from your 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 could be) pregnant or if you are breastfeeding (see section Pregnancy, breastfeeding, and fertility).

Children and adolescents

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

Other medicines and enalapril/lercanidipine cinfa

Enalapril/lercanidipine must not be taken with certain medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines that lower blood pressure.
• potassium supplements (including dietary salt substitutes).
• potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; heparin, a medicine used as an anticoagulant to prevent blood clots). See section “Do not take enalapril/lercanidipine cinfa”.
• lithium (a medicine used to treat a certain type of depression).
• antidepressant medicines known as “tricyclic antidepressants”.
• medicines for mental disorders, known as “antipsychotics”.
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain).
• certain medicines for pain or arthritis, including gold therapy.
• certain medicines for cough and cold, and weight-reducing 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 for treating a fast heartbeat).
• phenytoin, phenobarbital, or carbamazepine (medicines for epilepsy).
• rifampicin (a medicine for treating tuberculosis).
• digoxin (a medicine for treating heart problems).
• midazolam (a medicine to help you sleep).
• beta-blockers, e.g., metoprolol (medicines for treating high blood pressure, heart failure, and abnormal heart rhythm).
• cimetidine (when administered at daily doses exceeding 800 mg, a medicine for ulcers, indigestion, or heartburn).

Do not take enalapril/lercanidipine if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in 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 transplant rejection or to treat cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

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

• If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (also see information 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 high-fat meal significantly increases the levels of the medicine in the blood.

Alcohol may enhance the effect of enalapril/lercanidipine. Alcohol should not be consumed during treatment with enalapril/lercanidipine. Enalapril/lercanidipine must not be taken with grapefruit or grapefruit juice, as this may increase its antihypertensive effect (see “Do not take enalapril/lercanidipine cinfa”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy and fertility

Inform your doctor if you think you are (or could be) pregnant. Your doctor will usually advise you to stop taking enalapril/lercanidipine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of enalapril/lercanidipine is not recommended in women who may become pregnant or during early pregnancy, and must not be taken if you are more than three months pregnant, as it may seriously harm the fetus if used after the third month of pregnancy.

Breastfeeding

Enalapril/lercanidipine must not be taken during breastfeeding.

Driving and using machines

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

enalapril/lercanidipine cinfa contains sodium

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

3. How to take enalapril/lercanidipine cinfa

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Patients with renal problems/elderly patients: your doctor will decide the dose of medicine you should take, based on how well your kidneys are functioning.

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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take the medicine package and leaflet with you when consulting a healthcare professional.

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

If you forget to take enalapril/lercanidipine cinfa

• If you forget to take your tablet, do not take the missed dose.
• Take the next dose according to your 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 about 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 everyone will experience them. This medicine may cause the following adverse effects:

Some adverse effects may be serious.

Inform 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, which may cause difficulty breathing or swallowing;

When you start taking enalapril/lercanidipine, you may feel weak or dizzy, or notice blurred vision; this is caused by a sudden drop in blood pressure, and if this occurs, lying down may be helpful. If you are concerned, consult your doctor.

Adverse effects observed with enalapril/lercanidipino

Frequent (may affect up to 1 in 10 patients)

Cough, dizziness, headache.

Uncommon (may affect up to 1 in 100 patients)

Changes in blood test parameters, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness upon standing, vertigo, rapid heartbeat, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (erythema), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increased liver enzyme levels, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, sensation of warmth, swelling of the ankles.

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

Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste in the mouth, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing, skin rash, urticaria, nocturia, production of large amounts of urine, impotence.

Additional adverse effects observed with enalapril or lercanidipino alone

Enalapril

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

Blurred vision, dizziness, weakness or malaise, 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, dyspnoea, disturbances in taste, increased blood creatinine levels (usually detected by blood test), elevated blood potassium levels, diarrhoea, abdominal pain, tiredness (fatigue), rash, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 patients)

Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, nervousness, drowsiness or insomnia, skin tingling or numbness, myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, including those with impaired blood supply to the heart or brain), 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, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, itching or urticaria, hair loss, impaired kidney function, renal failure, increased sweating, high protein levels in urine (measured by urine test), muscle cramps, general malaise, high temperature (fever), low blood sugar or sodium levels, high blood urea levels (all measured by blood test), flushing, rapid or irregular heartbeats (palpitations), dizziness (sensation of spinning), ringing in the ears (tinnitus), impotence.

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

Changes in blood test parameters, such as decreased white blood cell count, bone marrow depression, autoimmune diseases, unusual dreams or sleep disorders, Raynaud's phenomenon (in which hands and feet become intensely cold and turn white due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin levels (measured by blood test), erythema multiforme (red spots of various shapes appearing on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin condition involving redness, scaling or peeling of the skin, blistering or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin), decreased urine production, breast enlargement in men (gynaecomastia), swollen glands in the neck, armpits or groin, accumulation of fluid or other substances in the lungs (as seen on X-ray), swelling of the cheeks, gums, tongue, lips and throat.

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

Intestinal angioedema (intestinal inflammation).

Frequency not known (cannot be estimated from available data)

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

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

Lercanidipino

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

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

Angina (chest pain due to reduced blood supply to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.

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

Other possible adverse effects:

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

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

Rare (may affect up to 1 in 1,000 patients): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.

Frequency not known (cannot be estimated from available data): gum swelling, changes in liver function (detected in blood tests), cloudy fluid (during peritoneal dialysis), swelling of the face, lips, tongue or throat that may 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 may consult your doctor or pharmacist for further information about adverse effects, as both have access to a more complete list.

Reporting of adverse effects

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

5. Storage of enalapril/lercanidipino cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of enalapril/lercanidipine cinfa

• The active substances 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 components are:

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

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated tablets, light yellow to yellow, round and biconvex.

Presented in blisters made of polyamide-aluminum-PVC/aluminum.

Each pack 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

Spain

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 most recent revision of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79821/P_79821.html

QR code link: https://cima.aemps.es/cima/dochtml/p/79821/P_79821.html