ENALAPRIL/LERCANIDIPINE TEVA-RATIOPHARM 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril/Lercanidipine Teva-ratiopharm 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.

• Keep this leaflet, as 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 Teva-ratiopharm and what is it used for
2. What you need to know before you take Enalapril/Lercanidipine Teva-ratiopharm
3. How to take Enalapril/Lercanidipine Teva-ratiopharm
4. Possible side effects
5. Storage of Enalapril/Lercanidipine Teva-ratiopharm
6. Contents of the pack and further information

1. What is Enalapril/Lercanidipine Teva-ratiopharm and what is it used for

Enalapril/Lercanidipine Teva-ratiopharm is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that lower blood pressure.

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

2. What you need to know before you take Enalapril/Lercanidipine Teva-ratiopharm

Do not takeEnalapril/Lercanidipine Teva-ratiopharm

• If you are allergic to enalapril or lercanidipine or toany of the other ingredients of this medicine (listed in section 6).

• If you have ever had an allergic reaction to a type of medicine similar to those contained in Enalapril/Lercanidipine Teva-ratiopharm, i.e. medicines called ACE inhibitors or calcium channel blockers.
• If you have ever had 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 to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• If you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant (it is also best to avoid Enalapril/Lercanidipine Teva-ratiopharm in the early stages of pregnancy - see section “Pregnancy, breast-feeding and fertility”).
• If you are suffering from any of the following heart diseases:

• obstruction of blood flow from the heart
• untreated congestive 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 if you are undergoing dialysis.
• If you are taking medicines that inhibit liver metabolism, such as:

• antifungal medicines (such as ketoconazole or itraconazole).
• macrolide antibiotics (such as erythromycin, troleandomycin, 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 Teva-ratiopharm:

• 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 problem.
• If you have a disorder that affects the blood vessels in the brain.
• If you have kidney problems (including kidney transplant). This may lead to higher 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 in the blood.
• 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 disease of the collagen (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing treatment that suppresses your immune system, are taking the medicines allopurinol or procainamide, or a combination of these.
• 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 check your blood for low blood sugar levels, especially during the first month of treatment. Your potassium levels in the blood may also be high.
• If you have a dry and persistent cough.
• If you are taking potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium.

• If you are taking any of the following medicines, the risk of angioedema may increase:
• • racecadotril, a medicine used to treat diarrhea.
  • medicines used to prevent organ transplant rejection and for 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 (hypertension).
• an angiotensin II receptor antagonist (ARA) (also known as “sartans” - e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril/Lercanidipine Teva-ratiopharm”.

If you are going to undergo any of the following procedures

If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril/Lercanidipine Teva-ratiopharm

• any surgical procedure or if you are going to be given an anesthetic (even at the dentist)
• 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 should inform your doctor if you think you are (or might become) pregnant or if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”).

Children and adolescents

The safety and efficacy of Enalapril/Lercanidipine Teva-ratiopharm in children under 18 years of age have not been established.

Taking Enalapril/Lercanidipine Teva-ratiopharm with other medicines

Enalapril/Lercanidipine Teva 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, including those obtained without a prescription. This is because when Enalapril/Lercanidipine Teva-ratiopharm is taken at the same time as other medicines, the effect of Enalapril/Lercanidipine Teva-ratiopharm or the other medicines may be altered, 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 the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See “Do not take Enalapril/Lercanidipine Teva-ratiopharm”.
• lithium (a medicine used to treat 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 (a medicine to treat high blood pressure, heart failure, and irregular heart rhythm)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn)

Do not take Enalapril/Lercanidipine Teva-ratiopharm if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in the area of the throat) is increased.

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

• racecadotril, a medicine used to treat diarrhea.
• medicines used to prevent organ transplant rejection and for 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:

Taking Enalapril/Lercanidipine Teva-ratiopharm with food, drinks, and alcohol

• Enalapril/Lercanidipine Teva-ratiopharm should be taken at least 15 minutes before a meal.
• A fatty meal significantly increases the blood levels of this medicine.

• Alcohol may increase the effect of Enalapril/Lercanidipine Teva-ratiopharm. Do not consume alcohol during treatment with this medicine.
• Enalapril/Lercanidipine Teva-ratiopharm should not be taken with grapefruit or grapefruit juice, as they may increase its hypotensive effect (see “Do not take Enalapril/Lercanidipine Teva-ratiopharm”).

Pregnancy, breast-feeding, and fertility

Pregnancy and fertility

Tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Enalapril/Lercanidipine Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of enalapril/lercanidipine. This medicine is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Enalapril/Lercanidipine Teva-ratiopharm should not be used during breast-feeding.

Driving and using machines

If you develop dizziness, weakness, fatigue, or drowsiness during treatment with this medicine, do not drive vehicles or use machines.

Enalapril/Lercanidipine Teva-ratiopharm contains sodium

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

3. How to take Enalapril/Lercanidipine Teva-ratiopharm

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults: unless otherwise indicated by your doctor, the recommended dose is one tablet once a day at the same time each day. The tablets 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 Teva-ratiopharm 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 Teva-ratiopharm than you should

Do not exceed the prescribed dose. If you have taken more tablets than you should, consult your doctor immediately or go to the hospital. Bring the pack with you. A dose higher than the correct one may cause a marked fall in blood pressure and your heart may beat irregularly or faster.

In case of overdose or accidental ingestion, call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Enalapril/Lercanidipine Teva-ratiopharm

• 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 the forgotten dose.

If you stop taking Enalapril/Lercanidipine Teva-ratiopharm

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

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

4. Possible Adverse Effects

Like all medicines, Enalapril/Lercanidipine Teva-ratiopharm 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. 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 that can cause difficulty breathing or swallowing;

When you start taking Enalapril/Lercanidipine Teva-ratiopharm, 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 occurs, it will be helpful to lie down. If you are concerned, consult your doctor.

Adverse Effects Observed with Enalapril/Lercanidipine Teva-ratiopharm

Frequent (may affect up to 1 in 10 people)

Cough, feeling of dizziness, headache

Uncommon (may affect up to 1 in 100 people)

Changes in blood parameter values, such as a decrease in platelet count, increased potassium concentration in 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 people)

Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste in the mouth, 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, getting up at night to urinate, producing large amounts of urine, impotence.

Additional Adverse Effects Observed with Enalapril or Lercanidipine Alone

Enalapril

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

Blurred vision, feeling dizzy, weak, or sick, and cough

Frequent (may affect up to 1 in 10 people)

Depression, headache, fainting (syncope), chest pain, feeling of dizziness due to low blood pressure, changes in heart rate, rapid heartbeat, angina, shortness of breath, alterations in taste, increased creatinine levels in blood (usually detected through analysis), high potassium levels in blood, diarrhea, abdominal pain, 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 people)

Anemia (including aplastic 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 chest oppression, slowing of food movement through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or hives, hair loss, alteration of renal function, renal failure, increased sweating, high protein levels in urine (measured through analysis), muscle cramps, feeling of general discomfort, high temperature (fever), low sugar or sodium levels in blood, high urea levels in blood (all measured through blood analysis), reddening, rapid or irregular heartbeats (palpitations), vertigo (feeling of spinning), ringing in the ears (tinnitus), impotence.

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

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 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 through 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 of the skin), or pemphigus (small fluid-filled bumps on the skin), decreased urine production, breast tissue growth in males (gynecomastia), inflammation of the glands in the neck, armpits, or groin, fluid accumulation or other substances in the lungs (as seen on X-rays), inflammation of the cheeks, gums, tongue, lips, or throat.

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

Intestinal inflammation (intestinal angioedema)

Frequency not known (frequency cannot be estimated from available data)

Overproduction of antidiuretic hormone that causes fluid retention, resulting in weakness, fatigue, or confusion.

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

Lercanidipine

Some of the adverse effects can be serious.

If any of the following occur, inform your doctor immediately:

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

Chest pain (pain in the chest caused by lack of blood supply to the heart),

allergic reactions (symptoms include itching, rash, hives), fainting

Patients with pre-existing chest pain 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 people):

Headache, rapid heartbeat, rapid or irregular heartbeats (palpitations), sudden reddening of the face, neck, or upper chest (flushing), ankle swelling.

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

Dizziness, low blood pressure, stomach acid, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, feeling of weakness or fatigue.

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

Somnolence, vomiting, diarrhea, hives, increased urination, chest pain.

Frequency not known (frequency cannot be estimated from available data):

Gum inflammation, changes in liver function (detected through blood analysis), cloudy fluids (when dialysis is performed through a tube in the abdomen), inflammation of the face, tongue, or throat that can cause difficulty breathing or swallowing.

If any of the adverse effects worsen, or if you experience any type of adverse effect that does not appear 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 type of adverse effects, consult your doctor or pharmacist, even if it is an adverse effect that does not appear 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 Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the 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 Teva-ratiopharm

The active substances are enalapril maleate and lercanidipine hydrochloride.

Each tablet contains: 10 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride.

The other ingredients are:

Core: microcrystalline cellulose, sodium hydrogen carbonate, pregelatinized maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

Product Appearance and Package Contents

Enalapril/Lercanidipine Teva-ratiopharm 10 mg/10 mg tablets are film-coated, white to off-white, round, biconvex tablets.

Enalapril/Lercanidipine Teva-ratiopharm 10 mg/10 mg is available in packages of 14, 28, 30, 50, 56, 90, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

Alcobendas, 28108 Madrid (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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Enalapril/Lercanidipine Teva-ratiopharm 10 mg/10 mg film-coated tablets EFG

Portugal: Enalapril + Lercanidipin Teva

Date of the last revision of this leaflet: September 2021

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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79707/P_79707.html