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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

enalapril maleate/lercanidipine hydrochloride

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

3. How to take Enalapril/Lercanidipine Teva-ratiopharm

4. Possible side effects

5. How to store Enalapril/Lercanidipine Teva-ratiopharm

6. Contents of the pack and other information

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

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

Enalapril/lercanidipino is used to treat high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipino as separate tablets.

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

DO NOT take Enalapril/Lercanidipine Teva-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 Teva-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 causing difficulty in 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, e.g. in the throat area) 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 Teva-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 flow out of the heart

• untreated congestive heart failure

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

• during the first month after a heart attack (myocardial infarction)

• if you have severe liver problems

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

• if you are taking hepatic metabolism inhibitor medicines 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 transplant to prevent organ rejection).

• together 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 may present as dizziness or fainting, especially when standing)

• you have been severely ill (with excessive vomiting) or have recently had diarrhoea

• you are on a salt-restricted diet

• you have a heart condition

• you have a disorder affecting the blood vessels of the brain

• 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 enalapril dose or monitor your blood potassium levels

• you have liver problems

• you have blood disorders, such as low or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)

• you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are on treatment that suppresses your immune system, are taking allopurinol or procainamide, or a combination of these

• 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 in swallowing or breathing, when taking ACE inhibitors

• 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 high

• you have a dry, persistent cough

• 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 diarrhoea;
• 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 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 Teva-ratiopharm”.

If you are undergoing 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 to receive any anaesthetic (even at the dentist’s office)
• a treatment to remove cholesterol from your blood, known as “LDL apheresis”
• a desensitisation 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 Teva-ratiopharm have not been established in children up to 18 years of age.

Taking Enalapril/Lercanidipine Teva-ratiopharm with other medicines

Enalapril/Lercanidipine Teva-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 medicines obtained without a prescription. This is because when Enalapril/Lercanidipine Teva-ratiopharm is taken together with other medicines, the effect of Enalapril/Lercanidipine Teva-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 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)
• antidepressant medicines called “tricyclic antidepressants”
• medicines for mental disorders, called “antipsychotics”
• non-steroidal anti-inflammatory medicines, 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 medicines used to reduce weight that contain 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 rapid 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 (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 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, e.g. in the throat area) is increased.

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

• racecadotril, a medicine used to treat diarrhoea;
• 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) or aliskiren (see also the information under the headings “Do not take Enalapril/Lercanidipine Teva-ratiopharm” and “Warnings and 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 high-fat meal significantly increases the blood levels of this medicine.

• Alcohol may enhance the effect of Enalapril/Lercanidipine Teva-ratiopharm. Do not consume alcohol during treatment with this medicine.

• Enalapril/Lercanidipine Teva-ratiopharm must not be taken with grapefruit or grapefruit juice, as they may increase its hypotensive effect (see “Do not take Enalapril/Lercanidipine Teva-ratiopharm”).

Pregnancy, breastfeeding and fertility

Pregnancy and fertility

Inform your doctor if you think you are (or could be) pregnant. Enalapril/Lercanidipine is not recommended for women who may become pregnant, nor during early 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 Teva-ratiopharm must not be used during breastfeeding.

Driving and use of machines

If you experience dizziness, weakness, fatigue or drowsiness during treatment with this medicine, DO NOT drive or operate machinery.

Enalapril/Lercanidipine Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e. essentially “sodium-free”.

3. How to take Enalapril/Lercanidipino Teva-ratiopharm

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Adults: unless otherwise directed by your doctor, the recommended dose is one tablet once daily at the same time each day. Tablets should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablets whole with water. See “Taking Enalapril/Lercanidipino Teva-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/Lercanidipino Teva-ratiopharm than you should

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

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

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

If you forget to take Enalapril/Lercanidipino Teva-ratiopharm

• If you forget to take your tablet, do not take the missed dose.
• Take the next dose as scheduled.
• DO NOT take a double dose to make up for the forgotten dose.

If you stop taking Enalapril/Lercanidipino Teva-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 Teva may produce adverse effects, although not everyone will experience them. This medicine may cause the following adverse effects:

Some adverse effects may be serious.

Immediately inform your doctor 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/Lercanidipino Teva-ratiopharm, you may feel weak or dizzy, or notice that your vision becomes blurred; this is caused by a sudden drop in blood pressure, and if it occurs, it may help to lie down. If you are concerned, consult your doctor.

Adverse effects observed with Enalapril/Lercanidipine

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 values, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness when standing up, vertigo, rapid heartbeat, fast or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increased levels of liver enzymes, 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 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, getting up at night to urinate, increased urine production, impotence.

Additional adverse effects observed with enalapril or lercanidipine alone

Enalapril

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

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

Frequent (may affect up to 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 by blood test), high blood potassium levels, diarrhoea, abdominal pain, tiredness (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, tingling sensation or numbness of the skin, myocardial infarction (possibly caused by 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 chest tightness, slowed movement of food through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or urticaria, hair loss, impaired kidney function, increased sweating, renal failure, high levels of protein in urine (measured by urine test), muscle cramps, general malaise, high temperature (fever), low levels of blood sugar or sodium, high levels of urea in blood (all measured by 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 values, 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 may 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 levels of liver enzymes or bilirubin (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), 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 angioedema (intestinal swelling)

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 the 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)

Angina (chest pain caused by reduced blood supply to the heart), 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 be observed.

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, low 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 dialysis fluid (when undergoing peritoneal dialysis through a tube in the abdomen), swelling of the face, tongue or throat which 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 they both have access to a more complete list.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can 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 Teva-ratiopharm

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

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

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Teva-ratiopharm 20 mg/20 mg film-coated tablets EFG

The active substances are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.28 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).

The other components are:

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

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

Appearance of the product and contents of the pack

Enalapril/Lercanidipine Teva-ratiopharm 20 mg/20 mg tablets are film-coated, orange to light orange, round, biconvex tablets with a diameter of approximately 11 mm and a thickness of approximately 5 mm.

Enalapril/Lercanidipine Teva-ratiopharm 20 mg/20 mg is available in packs containing 14, 28, 30, 50, 56, 90 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ 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
Spain

or

Merckle GmbH
Ludwig-Merckle Strasse 3
Blaubeuren 89143
Germany

Date of latest revision of this leaflet: September 2021

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 on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83962/P_83962.html

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