Package Insert: Information for the Patient

Enalapril/Lercanidipino TecniGen 20 mg/10 mg Film-Coated Tablets

Enalapril maleate/Lercanidipine hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 not listed in this package insert. See section 4.

Enalapril/LercanidipinoTecniGen is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipino), two medications that lower blood pressure.

Enalapril/LercanidipinoTecniGen is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled by enalapril 20 mg alone.

Enalapril/LercanidipinoTecniGenshould not be used for the initial treatment of hypertension.

Do not take Enalapril/LercanidipineTecniGen:

• If you are allergic to enalapril or lercanidipine, or to any of the other components of this medication (including those listed in section 6).
• If you have ever experienced an allergic reaction to a type of medication similar to those contained inEnalapril/LercanidipineTecniGen, that is, medications 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 medication called an ACE inhibitor, or if the cause of the reaction was unknown or if it was a hereditary condition.
• If you have diabetes or have a kidney function disorder and are receiving treatment with a medication that lowers blood pressure that contains aliskiren.
• If you are more than 3 months pregnant (also recommended to avoid the use ofEnalapril/LercanidipineTecniGen from the start of pregnancy, see section Pregnancy).
• If you have certain heart conditions:
• obstruction of blood flow from the heart, including aortic valve narrowing
• untreated heart failure
• chest pain that occurs at rest, worsens, or occurs more frequently (unstable angina)
• within the first month after experiencing a heart attack.
• If you have severe kidney problems or are undergoing dialysis.
• If you have severe liver problems
• If you are taking medications that inhibit hepatic metabolism, such as:
• antifungals (e.g., ketoconazole, itraconazole).
• macrolide antibiotics (e.g., erythromycin, troleandomycin).
• antivirals (e.g., ritonavir).
• If you are taking another medication 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 takeEnalapril/LercanidipineTecniGen:

• If you have low blood pressure (which may manifest as dizziness or fainting, especially when standing).
• If you have been very ill (with excessive vomiting) or have had diarrhea recently.
• If you have restricted salt use in your diet.
• If you are over 70 years old.
• If you have a heart problem.
• If you have a disorder that affects 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 disorders, such as a low white blood cell count (leucopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in red blood cell count (anemia).
• If you have a vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive treatment, are taking alopurinol 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 swelling of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing, when taking ACE inhibitors.
• If you are diabetic.
• If you have persistent and dry cough.
• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes that contain potassium.
• If you are pregnant, or if you think you may be.Enalapril/LercanidipineTecniGen 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 after the third month of pregnancy (see section Pregnancy).
• If you are taking any of the following medications used to treat high blood pressure:
• a BRA (also known as sartanes, such as valsartan, telmisartan, or irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may review 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 takeEnalapril/LercanidipineTecniGen”.

You should be aware that this medication reduces blood pressure less effectively in black patients than in patients of other races.

If you are about to undergo surgery or certain treatments soon

If you are about to undergo any of the following procedures, inform your doctor that you are takingEnalapril/LercanidipineTecniGen:

• any surgical intervention or if you are to be administered an anesthetic (even at a dentist's consultation)
• a treatment to extract cholesterol from your blood known as “LDL apheresis”
• a desensitization treatment, to reduce the effect of an allergy to bees or wasps.

Inform 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 discontinue treatment withEnalapril/LercanidipineTecniGenand your doctor will take the necessary measures.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years old, as there is no information on its efficacy and safety.

Taking Enalapril/LercanidipineTecniGenwith other medications

Enalapril/LercanidipineTecniGen should not be taken with certain medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. When takingEnalapril/LercanidipineTecniGen with certain medications, the effect ofEnalapril/LercanidipineTecniGenor the other medications may be modified or certain adverse effects may occur more frequently.

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

• medications containing potassium (including salt substitutes in your diet)
• other medications that lower blood pressure, such as diuretics
• lithium (a medication used to treat a certain type of depression)
• tricyclic antidepressants (medications used to treat depression)
• narcotics (medications used to treat intense pain, such as morphine)
• antipsychotics (medications used to treat mental health problems)
• nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medications that reduce inflammation and can be used to treat pain)
• medications used to treat pain or arthritis, including gold therapy
• medications used to treat cough and cold, and medications that contain a substance called “sympathomimetic agent”
• medications used to treat diabetes (including oral antidiabetic medications and insulin)
• astemizol or terfenadine (medications used to treat allergies)
• amiodarone or quinidine (medications used to treat a rapid heart rate)
• phenytoin or carbamazepine (medications used to treat epilepsy)
• rifampicin (a medication used to treat tuberculosis)
• digoxin (a medication used to treat heart problems)
• midazolam (a medication used to help you sleep)
• beta-blockers (medications used to treat high blood pressure and heart problems)
• cimetidine administered at doses above 800 mg per day

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

• If you are taking a BRA (BRA) or aliskiren (see also the information included under the headings “Do not takeEnalapril/LercanidipineTecniGen” and “Warnings and precautions”).

Taking Enalapril/LercanidipineTecniGenwith food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you may be (or if you are) pregnant. Generally, your doctor will advise you to stop takingEnalapril/LercanidipineTecniGen before becoming pregnant or as soon as you know you are pregnant and will recommend taking another medication instead ofEnalapril/LercanidipineTecniGen . Enalapril/LercanidipineTecniGen 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 used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Enalapril/LercanidipineTecniGen is not recommended for neonates (during the first weeks after birth), and particularly for premature babies, while takingEnalapril/LercanidipineTecniGen. In the case of an older infant, your doctor will advise you on the benefits and risks of takingEnalapril/LercanidipineTecniGen during breastfeeding, compared to other treatments.

Driving and operating machinery

If you experience dizziness, weakness, fatigue, or somnolence during treatment with this medication, you should not drive or operate machinery.

.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, 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 every 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 medication dose you should take, taking into account how well your kidneys are functioning.

If you take more Enalapril/Lercanidipino 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used, or go to the hospital immediately. Bring the packaging with you. A dose higher than the correct one can cause excessive blood pressure drop and your heart may beat irregularly or faster, you may feel restless or drowsy and have pain in the side and back.

If you forgot to take Enalapril/Lercanidipino TecniGen

• If you forgot 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 interrupt treatment with Enalapril/Lercanidipino TecniGen

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. This medication may cause the following side effects:

Stop taking Enalapril/Lercanidipino TecniGen and inform your doctor immediately if you notice any of the following side effects:

• Allergic reaction accompanied by swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.
• Severe skin reactions including skin rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering, or skin peeling (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 blurry; this is caused by a sudden drop in blood pressure, and if it happens, it will be helpful to lie down. If you are concerned, consult your doctor.

Side effects observed with Enalapril/Lercanidipino TecniGen

Frequent (may affect up to 1 in 10 people)

Cough, feeling of dizziness, headache.

Infrequent (may affect up to 1 in 100 people)

Changes in blood parameters, such as a decrease in platelet count, increase in potassium levels in the blood, nervousness (anxiety), feeling of dizziness when standing up, vertigo, 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), increase in liver enzyme levels, skin redness, joint pain, increased urination frequency, feeling of weakness, fatigue, feeling of heat, inflammation of the ankles.

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 tongue, diarrhea, dry mouth, inflammation of the gums and lips, skin rash, urticaria, waking up at night to urinate, producing large amounts of urine, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

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

Blurry 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, taste alterations, skin rash, fatigue, increase in potassium levels in the blood, increase in creatinine levels in the blood (usually detected through a blood test).

Infrequent (may affect up to 1 in 100 people)

Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion, somnolence or insomnia, feeling of pinpricks in the skin or numbness, myocardial infarction (possibly caused by very low blood pressure in certain high-risk patients, including those with heart or brain blood supply problems), stroke (possibly due to very low blood pressure in high-risk patients), nasal discharge, sore throat and hoarseness, asthma, slowed movement of food through the intestines, pancreatitis, feeling sick, indigestion, stomach irritation (gastritis), dry mouth, ulcers, anorexia, increased sweating, itching or urticaria, hair loss, renal function alteration, renal insufficiency, high protein levels in the urine (measured through a blood test), impotence, muscle cramps, general feeling of discomfort, high temperature (fever), low blood sugar or sodium levels, high urea levels in the blood (all measured through a blood test).

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

Changes in blood parameters, 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 may become intensely cold and acquire a white color 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 through a blood test), decreased urine production, gynecomastia in men, erythema multiforme (red spots of different shapes appearing on the skin), Stevens-Johnson syndrome (a severe skin condition characterized by skin redness and scaling, blistering, or skin peeling).

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

Intestinal inflammation (intestinal angioedema).

Unknown frequency (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 that may include some or all of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia, arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

Lercanidipine

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

Angina pectoris (chest pain caused by inadequate blood supply to the heart), vomiting, heartburn, 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 frequency, duration, or severity of attacks associated with treatment with the group of medications to which lercanidipine belongs. Isolated cases of myocardial infarction may be observed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril/LercanidipinoTecniGen

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

Appearance of the product and content of the container

Enalapril/Lercanidipino TecniGen20 mg/10 mg film-coated tablets EFGare round, biconvex, yellow film-coated tablets. The dimensions of the tablets are specified: height 4 mm, diameter 9 mm.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

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, Malpica Industrial Estate

50016 Zaragoza

Spain

Last review date of this leaflet: June 2017

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/