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

Patient Information Leaflet

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, 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 these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

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

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

Do not take Enalapril/Lercanidipine TecniGen:

• 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 medicine similar to those contained in Enalapril/Lercanidipine TecniGen, 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 medicine called ACE inhibitors, or if the cause of the reaction was unknown or if it was a hereditary condition.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (use of Enalapril/Lercanidipine TecniGen is also not recommended at the beginning of pregnancy; see pregnancy section).
• If you have certain heart conditions:
  • obstruction of blood outflow from the heart, including aortic valve stenosis
  • untreated heart failure
  • chest pain occurring at rest, worsening, or increasing in frequency (unstable angina)
  • during the first month after a heart attack (myocardial infarction).
• If you have severe kidney problems or are undergoing dialysis.
• If you have severe liver problems.
• If you are taking drugs that inhibit hepatic metabolism, such as:
  • antifungal agents (e.g., ketoconazole, itraconazole)
  • macrolide antibiotics (e.g., erythromycin, troleandomycin)
  • antiviral agents (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

Consult your doctor or pharmacist before taking Enalapril/Lercanidipine TecniGen if:

• You have low blood pressure (which may present as dizziness or fainting, especially when standing up).
• You have been severely ill (with excessive vomiting) or have recently had diarrhea.
• You are on a salt-restricted diet.
• You are over 70 years old.
• You have a heart condition.
• You have a disorder affecting the blood vessels in the brain.
• You have kidney problems (including kidney transplant).
• You are undergoing dialysis.
• You have liver problems.
• You have blood disorders, such as low or absent white blood cells (leukopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cell count (anemia).
• You have a collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are receiving immunosuppressive therapy, or are taking allopurinol, procainamide, or any 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 in swallowing or breathing, when taking ACE inhibitors.
• If you are diabetic.
• If you have a persistent dry cough.
• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.
• If you are pregnant or think you might be pregnant. Enalapril/Lercanidipine TecniGen is not recommended at the beginning of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).
• If you are taking any of the following medicines for high blood pressure:
  • an angiotensin II receptor blocker (ARB) (also known as sartans, such as valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.

Also refer to the information provided under the heading “Do not take Enalapril/Lercanidipine TecniGen”.

Please note that this medicine is less effective in lowering blood pressure in Black patients compared to patients of other races.

If you are about to undergo surgery or certain treatments

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

• Any surgical procedure or administration of anesthetics (including at the dentist’s office)
• A treatment to remove cholesterol from your blood known as “LDL apheresis”
• A desensitization treatment to reduce the effects of an allergy to bees or wasps.

Contact your doctor immediately if you experience any of the following signs or symptoms:

• Yellowing of the skin or mucous membranes (see section 4).

In such a case, you must stop treatment with Enalapril/Lercanidipine TecniGen and your doctor will take appropriate measures.

Children and adolescents

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

Taking Enalapril/Lercanidipine TecniGen with other medicines

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

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

• Medicines containing potassium (including dietary salt substitutes)
• 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 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 or weight-reducing medicines containing a substance called "sympathomimetic agent"
• Medicines for diabetes (including oral antidiabetic medicines and insulin)
• Astemizole or terfenadine (medicines for allergies)
• Amiodarone or quinidine (medicines for rapid heartbeat)
• Phenytoin or carbamazepine (medicines for epilepsy)
• Rifampicin (a medicine for the treatment of tuberculosis)
• Digoxin (a medicine for heart problems)
• Midazolam (a medicine to help you sleep)
• Beta-blockers (medicines for high blood pressure and heart problems)
• Cimetidine (a medicine for ulcers and acidity) when taken at daily doses exceeding 800 mg

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

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

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

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Enalapril/Lercanidipine TecniGen before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. Use of Enalapril/Lercanidipine TecniGen is not recommended at the beginning of pregnancy and must 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

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended in neonates (during the first weeks after birth), and especially in premature infants, while taking Enalapril/Lercanidipine TecniGen. For 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 while taking this medicine, you should not drive or operate machinery.

3. How to take Enalapril/Lercanidipino TecniGen

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

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 TecniGen than you should

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

If you forget to take Enalapril/Lercanidipino TecniGen

• 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 forgotten doses.

If you stop taking Enalapril/Lercanidipino TecniGen

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, this medicine may cause adverse effects, although not everyone experiences them. This medicine may cause the following adverse effects:

Stop taking Enalapril/Lercanidipino TecniGene and 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, which 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 TecniGene, 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 help. If you are concerned, consult your doctor.

Adverse effects observed with Enalapril/Lercanidipino TecniGene

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 upon standing, 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 unwell (nausea), increased liver enzyme levels, 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 mouth, diarrhoea, dry mouth, swelling of the gums and lips, skin rash, urticaria, getting up at night to urinate, 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, dizziness, cough, feeling unwell (nausea), feeling of weakness.

Frequent (may affect up to 1 in 10 people)
Depression, fainting, chest pain, changes in heart rate, angina, difficulty breathing, diarrhoea, abdominal pain, disturbances in taste sensation, skin rash, fatigue, increased blood potassium levels, increased blood creatinine levels (usually detected by blood test).

Uncommon (may affect up to 1 in 100 people)
Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, drowsiness or insomnia, tingling 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), nasal discharge, sore throat and hoarseness, asthma, slowed movement of food through the intestine, pancreatitis, feeling sick, indigestion, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or urticaria, hair loss, impaired kidney function, kidney failure, high levels of protein in urine (measured by testing), impotence, muscle cramps, general feeling of discomfort, high temperature (fever), low blood sugar or sodium levels, high blood urea levels (all measured by blood test).

Rare (may affect up to 1 in 1,000 people)
Changes in blood test values, such as decreased white blood cell count, bone marrow suppression, autoimmune diseases, 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, tongue inflammation, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased bilirubin levels (measured by blood test), reduced urine output, gynecomastia in men (breast gland enlargement), erythema multiforme (red spots of various shapes appearing on the skin), Stevens-Johnson syndrome (a serious skin condition involving skin redness and scaling, blistering, open sores, or peeling of the top layer of skin from underlying layers).

Very rare (may affect up to 1 in 10,000 people)
Intestinal angioedema (intestinal swelling).

Frequency not known (cannot be estimated from available data)
Excessive production of antidiuretic hormone, leading to fluid retention and causing weakness, fatigue, or confusion.

A group of symptoms has been reported which may include one or all of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia, arthritis). Skin rash, photosensitivity, or other skin manifestations may also occur.

Lercanidipino

Rare (may affect up to 1 in 1,000 people)
Angina (chest pain due to insufficient blood supply to the heart), vomiting, acid reflux, muscle pain.

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

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 lercanidipino belongs. Isolated cases of myocardial infarction may occur.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 TecniGen

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

Do not use this medicine after the expiry date stated on the blister pack and on the 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 containers at a SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Lercanidipine TecniGen

• The active substances 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 potato starch 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 contents of the pack

Enalapril/Lercanidipine TecniGen 20 mg/10 mg film-coated tablets EFG are yellow, round, biconvex film-coated tablets. The tablet dimensions are specified as: height 4 mm, diameter 9 mm.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: June 2017

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