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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enalapril/Lercanidipine ratiopharm 20 mg/10 mg film-coated tablets EFG

Enalapril maleate/lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine, as 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. Do not give it to others, even if they have the same symptoms as you, as it may 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.

Contents of this leaflet

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

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

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

Enalapril/Lercanidipine ratiopharm 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 ratiopharm should not be used for the initial treatment of hypertension.

2. What you need to know before taking Enalapril/Lercanidipine ratiopharm

DO NOT take Enalapril/Lercanidipine ratiopharm

• 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 ever had an allergic reaction to a type of medicine similar to those contained in Enalapril/Lercanidipine ratiopharm, 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 caused difficulty swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitors, or if the cause of the 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 a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin, such as in the throat) is high.

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

• If you are more than 3 months pregnant (it is also advisable to avoid Enalapril/Lercanidipine ratiopharm in the early stages of pregnancy – see section “Pregnancy, breastfeeding, and fertility”).

• If you have any of the following heart conditions:

  • obstruction of blood outflow from the heart
  • untreated congestive heart failure
  • unstable angina (chest discomfort occurring at rest or progressively worsening)
  • within the first month after a myocardial infarction (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 (e.g., ketoconazole or itraconazole).
  • macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin).
  • antiviral medicines (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

Talk to your doctor or pharmacist before taking Enalapril/Lercanidipine ratiopharm:

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

• 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 higher potassium levels in the blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels.

• If you have liver problems.

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

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

• If you are of Black race, you should be aware that such patients have a higher risk of allergic reactions with swelling 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 for low blood glucose levels, especially during the first month of treatment. Your blood potassium levels may also be elevated.

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

If you are taking any of the following medicines, your risk of developing 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-II) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor 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 ratiopharm”.

If you are undergoing surgery

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

• any surgical procedure or if you are to receive an anesthetic (even 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 ratiopharm in children up to 18 years of age have not been established.

Taking Enalapril/Lercanidipine ratiopharm with other medicines

Enalapril/Lercanidipine ratiopharm must not be taken with certain medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because when Enalapril/Lercanidipine ratiopharm is taken at the same time as other medicines, the effect of Enalapril/Lercanidipine ratiopharm or of the other medicines may be altered, or certain adverse 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 blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See “Do not take Enalapril/Lercanidipine ratiopharm”.
• lithium (a medicine used to treat a certain type of depression).
• antidepressant medicines 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 relieve pain).
• certain medicines for pain or arthritis, including gold therapy.
• certain medicines for cough and cold, 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 heart rate).
• phenytoin, phenobarbital, or carbamazepine (medicines for epilepsy).
• rifampicin (a medicine to treat tuberculosis).
• digoxin (a medicine to treat heart problems).
• midazolam (a medicine to help you sleep).
• beta-blockers, e.g., metoprolol (a medicine to treat high blood pressure, heart failure, and abnormal heart rhythm).
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn).

Do not take Enalapril/Lercanidipine 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, such as in the throat) is increased.

If you are taking any of the following medicines, your risk of developing 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:

• if you are taking an angiotensin II receptor antagonist (ARA-II) or aliskiren (see also information under the headings “Do not take Enalapril/Lercanidipine ratiopharm” and “Warnings and precautions”).

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

• Enalapril/Lercanidipine ratiopharm should be taken at least 15 minutes before a meal.
• A high-fat meal significantly increases blood levels of this medicine.
• Alcohol may enhance the effect of Enalapril/Lercanidipine ratiopharm. Do not consume alcohol during treatment with Enalapril/Lercanidipine ratiopharm.
• Enalapril/Lercanidipine ratiopharm must not be taken with grapefruit or grapefruit juice, as they may increase its hypotensive effect (see “Do not take Enalapril/Lercanidipine ratiopharm”).

Pregnancy, breastfeeding, and fertility

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 ratiopharm before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine instead of enalapril/lercanidipine.

Enalapril/Lercanidipine ratiopharm is not recommended during pregnancy and must 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.

Breastfeeding

Enalapril/Lercanidipine ratiopharm must not be used during breastfeeding.

Driving and using machines

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

Enalapril/Lercanidipine ratiopharm contains sodium

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

3. How to take Enalapril/Lercanidipine ratiopharm

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

Adults: unless otherwise indicated by your doctor, the recommended dose is one tablet once daily at the same time each day. The tablets should preferably be taken in the morning, at least 15 minutes before breakfast. The tablets must be swallowed whole with water. See "Taking Enalapril/Lercanidipine ratiopharm with food, drinks and alcohol."

Patients with kidney 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 ratiopharm than you should

Do not exceed the prescribed dose. If you have taken more tablets than prescribed, contact your doctor immediately or go to the hospital straight away. Take the packaging with you.

A dose higher than the correct one may cause an excessive drop 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 ratiopharm

• 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 the forgotten dose.

If you stop taking Enalapril/Lercanidipine ratiopharm

• 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, Enalapril/Lercanidipine ratiopharm may produce adverse effects, although not everyone experiences them. This medicine can 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 ratiopharm, you may feel weak or dizzy, or notice blurred vision; this is caused by a sudden drop in blood pressure, and if it occurs, lying down may be helpful. If you are concerned, consult your doctor.

Adverse effects observed with Enalapril/Lercanidipine ratiopharm

Frequent (may affect up to 1 in 10 people)

Cough, dizziness, headache

Uncommon (may affect up to 1 in 100 people)

Changes in blood test parameters, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness upon standing, vertigo, rapid heartbeat, fast or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (erythema), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increased levels of liver enzymes, skin redness, joint pain, increased frequency of urination, feeling weak, fatigue, sensation of warmth, 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 tongue, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing, skin rash, urticaria, waking up at night to urinate, 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 people)

Blurred vision, dizziness, weakness, feeling sick, and cough

Frequent (may affect less than 1 in 10 people)

Depression, headache, fainting (syncope), chest pain, dizziness due to low blood pressure, changes in heart rate, rapid heartbeat, angina, dyspnoea, disturbances in taste sensation, increased blood creatinine levels (usually detected via blood test), high blood potassium levels, diarrhoea, abdominal pain, fatigue, rash, allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 people)

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, hoarseness, asthma—associated 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 (detected via urine test), muscle cramps, general malaise, high temperature (fever), low blood sugar or sodium levels, high blood urea levels (all detected via blood test), flushing, rapid or irregular heartbeats (palpitations), vertigo (sensation of spinning), ringing in the ears (tinnitus), impotence.

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

Changes in blood test parameters, such as decreased white blood cell count, bone marrow depression, autoimmune disorders, unusual dreams or sleep disorders, Raynaud's phenomenon (in which hands and feet become intensely cold and turn white due to reduced blood flow), pulmonary infiltrates, 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 via blood test), erythema multiforme (red spots of various shapes appearing on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition involving redness, scaling, blistering, or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), or pemphigus (small fluid-filled blisters on the skin), decreased urine production, breast gland enlargement in men (gynaecomastia), swelling of glands in the neck, armpits, or groin, accumulation of fluid or other substances in the lungs (as seen on X-rays), swelling of cheeks, gums, tongue, lips, 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)

Excessive production of antidiuretic hormone causing fluid retention, resulting in weakness, fatigue, or confusion.

A complex 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, and other skin manifestations may also occur.

Lercanidipine

Some of these adverse effects may be serious.

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

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

Chest pain due to reduced blood supply to the heart (angina), allergic reactions (symptoms include 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 people):

Headache, rapid heart rate, fast or irregular heartbeats (palpitations), sudden redness of the face, neck, or upper chest (flushing), swelling of the ankles.

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

Dizziness, decreased blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.

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

Drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.

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

Gum swelling, changes in liver function (detected in blood tests), cloudy fluid (when undergoing dialysis through a tube in the abdomen), swelling of the face, 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 can consult your doctor or pharmacist for more information about adverse effects, as both have access to a more complete list of adverse effects.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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/Lercanidipine ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following "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 unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Lercanidipine ratiopharm 20 mg/10 mg film-coated tablets EFG

The active substances are enalapril maleate and lercanidipine hydrochloride.

Each tablet contains: 20 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride.

The other components are:

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

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the container

Enalapril/Lercanidipine ratiopharm 20 mg/10 mg tablets are yellowish, round, biconvex, film-coated tablets.

Enalapril/Lercanidipine ratiopharm 20 mg/10 mg is available in pack sizes of 14, 28, 30, 50, 56 and 100 tablets.

Only certain 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.
Calle C, nº 4, Polígono Industrial Malpica
Zaragoza 50016
Spain

or

Merckle GmbH
Ludwig-Merckle-Strasse 3
Blaubeuren 89143
Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Austria: Enalapril/Lercanidipin ratiopharm 20 mg/10 mg Filmtabletten

Spain: Enalapril/Lercanidipino ratiopharm 20 mg/10 mg comprimidos recubiertos con película EFG

Portugal: Enalapril + Lercanidipin ratiopharm

Date of the most recent review of this leaflet: July 2024

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