ENALAPRIL/LERCANIDIPINE TECNIGEN 20 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

Enalapril maleate/Lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

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

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

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

Enalapril/Lercanidipine TecniGen is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled with enalapril 20 mg alone.

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

2. What you need to know before you take Enalapril/Lercanidipine TecniGen

Do not take Enalapril/LercanidipineTecniGen:

• 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 experienced an allergic reaction to a type of medicine similar to those contained in Enalapril/Lercanidipine TecniGen, i.e., drugs called ACE inhibitors or calcium channel blockers.
• If you have ever experienced swelling of the face, lips, mouth, tongue, or throat that has caused difficulty 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 diabetes or kidney problems and are receiving treatment with a blood pressure-lowering medicine that contains aliskiren.
• If you are more than 3 months pregnant (it is also recommended to avoid the use of Enalapril/Lercanidipine TecniGen at the start of pregnancy, see section pregnancy).
• If you suffer from certain heart conditions:
• obstruction of blood flow from the heart, including narrowing of the aortic valve
• untreated heart failure
• chest pain that occurs at rest, worsens, or occurs more frequently (unstable angina)
• during the first month after having a heart attack.
• If you have severe kidney problems or are on dialysis.
• If you have severe liver problems.
• If you are taking drugs that inhibit liver metabolism, such as:
• antifungals (e.g., ketoconazole, itraconazole).
• macrolide antibiotics (e.g., erythromycin, troleandomycin).
• antivirals (e.g., ritonavir).
• If you are taking another medicine called cyclosporine (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 TecniGen:

• 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 salt-restricted diet.
• If you are over 70 years old.
• If you have a heart condition.
• If you have a disorder that affects the blood vessels in the brain.
• If you have kidney problems (including kidney transplant).
• If you are undergoing dialysis.
• If you have liver problems.
• If you have blood problems, such as a low or absent white blood cell count (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in the number of red blood cells (anemia).
• If you have a vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive treatment, are taking 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.
• If you have a dry, persistent cough.
• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes that contain potassium.
• If you are pregnant or think you may be pregnant. Enalapril/Lercanidipine TecniGen is not recommended at the start of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).
• If you are taking any of the following medicines used to treat high blood pressure:
• a blocker of the angiotensin II receptor (BRA) (also known as sartans, such as valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

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

Also, see the information included under the heading “Do not take Enalapril/Lercanidipine TecniGen”.

You should be aware that this medicine reduces blood pressure with less efficacy in black patients than in patients of other races.

If you are going to undergo surgery or certain treatments soon

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

• 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.

Tell your doctor immediatelyif you experience any of the following signs or symptoms:

• yellowing of the skin and mucous membranes (see section 4).

In that case, you should stop treatment with Enalapril/Lercanidipine TecniGen and your doctor will take the necessary measures.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no information on its efficacy and safety.

Taking Enalapril/Lercanidipine TecniGen with other medicines

Enalapril/Lercanidipine TecniGen 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. When taking Enalapril/Lercanidipine TecniGen with certain medicines, the effect of Enalapril/Lercanidipine TecniGen or the other medicines may be altered or certain side effects may occur more frequently.

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

• medicines that contain potassium (including salt substitutes in the diet)
• other medicines that lower blood pressure, such as diuretics
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called "tricyclic antidepressants"
• medicines for severe pain (narcotics, such as morphine)
• medicines for the treatment of mental problems, called "antipsychotics"
• non-steroidal anti-inflammatory drugs, 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 or quinidine (medicines for the treatment of a fast heartbeat)
• phenytoin 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 (medicines that treat high blood pressure and heart problems)
• a medicine for ulcers and acidity called cimetidine administered at daily doses above 800 mg

It is possible that your doctor may need to change your dose and/or take other precautions:

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

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

• It should be taken at least 15 minutes before meals.
• Enalapril/Lercanidipine TecniGen should not be taken with grapefruit or grapefruit juice.
• Alcohol may increase the effect of Enalapril/Lercanidipine TecniGen. Therefore, it is recommended that you avoid alcohol consumption or limit it strictly.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Enalapril/Lercanidipine TecniGen before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Enalapril/Lercanidipine TecniGen. The use of Enalapril/Lercanidipine TecniGen is not recommended at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the fetus if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (during the first weeks after birth), and in particular in premature babies, while taking Enalapril/Lercanidipine TecniGen. In the case of an older infant, your doctor will advise you on the benefits and risks of taking Enalapril/Lercanidipine TecniGen during breastfeeding, compared to other treatments.

Driving and using machines

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

.

3. How to take Enalapril/Lercanidipine TecniGen

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

Adults:unless your doctor tells you otherwise, the recommended dose is one tablet once a day, at the same time each day. The tablet should be taken preferably in the morning, at least 15 minutes before breakfast. The tablets should be swallowed whole with water.

Patients with kidney problems/advanced age: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 TecniGen than you should

If you have taken more tablets than you should or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used, or go to the hospital immediately. Bring the package with you. A dose higher than the correct one may cause a significant drop in blood pressure and your heart may beat irregularly or faster, you may feel restless or drowsy, and have pain in your side and back.

If you forget to take Enalapril/Lercanidipine TecniGen

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

If you stop taking Enalapril/Lercanidipine TecniGen

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

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

4. Possible Adverse Effects

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

Stop taking Enalapril/LercanidipinoTecniGenand inform your doctor immediately if you notice any of the following adverse effects:

• Allergic reaction accompanied by swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing.
• Severe skin reactions including skin rash, ulcers in the mouth, worsening of a pre-existing skin disease, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

When you start taking Enalapril/Lercanidipino TecniGen, 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/LercanidipinoTecniGen

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 test values, such as a decrease in platelet count, increased potassium levels in the blood, nervousness (anxiety), feeling of dizziness when standing up, 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 of discomfort (nausea), increased liver enzyme levels, skin redness, 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, inflammation of the gums and lips, skin rash, hives, 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 people)

Blurred vision, feeling of dizziness, cough, feeling of discomfort (nausea), feeling of weakness.

Frequent (may affect up to 1 in 10 people)

Depression, fainting, chest pain, changes in heart rate, angina, difficulty breathing, diarrhea, abdominal pain, alterations in taste, skin rash, fatigue, increased potassium levels in the blood, increased creatinine levels in the blood (usually detected by analysis).

Uncommon (may affect up to 1 in 100 people)

Anemia (including aplastic anemia and hemolytic anemia), sudden drop in blood pressure, confusion, drowsiness or insomnia, feeling 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, slowed movement of food through the intestine, pancreatitis, feeling unwell, indigestion, stomach irritation (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or hives, hair loss, kidney function alteration, kidney failure, high protein levels in the urine (measured by analysis), impotence, muscle cramps, feeling of general discomfort, high temperature (fever), low blood sugar or sodium levels, high urea levels in the blood (all measured by blood analysis).

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

Changes in blood test values, such as a decrease in white blood cell count, bone marrow depression, autoimmune diseases, unusual dreams or sleep disorders, Raynaud's phenomenon (in which the hands and feet can become intensely cold and turn white due to low blood flow), pulmonary infiltrates, nasal inflammation, pneumonia, tongue inflammation, liver problems, such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased bilirubin levels (measured by blood analysis), decreased urine production, male breast hypertrophy, erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome (a severe skin condition in which the skin turns red and scales, blisters, or peels off).

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

Intestinal inflammation (intestinal angioedema).

Frequency not known (cannot be estimated from available data)

Overproduction of antidiuretic hormone, which causes fluid retention, and leads to weakness, fatigue, or confusion.

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

Lercanidipino

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

Chest pain (angina pectoris), vomiting, acid reflux, muscle pain.

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

Chest pain.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. 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. Conservation of Enalapril/Lercanidipino TecniGen

Keep this medicine out of the 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 CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of 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/LercanidipinoTecniGen

• The active ingredients 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 ingredients are: Core: sodium hydrogen carbonate, microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch potato type A, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Enalapril/Lercanidipino TecniGen 20 mg/10 mg film-coated tablets EFG are round, biconvex, and yellow in color. The dimensions of the tablets are specified: height 4 mm, diameter 9 mm.

They are presented in blister packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Merckle GmbH

Graf-Arco-Str. 3 89079 Ulm

Germany

or

TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)

Pallagi út 13,

H-4042 Debrecen

Hungary

or

TEVA PHARMA S.L.U.

C/C, n. 4, Polígono Industrial Malpica

50016 Zaragoza

Spain

Date of the Last Revision of this Prospectus: June 2017

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