PATIENT INFORMATION LEAFLET

Coripren 10 mg/10 mg Film-Coated Tablets

Enalapril maleate/lercanidipine hydrochloride

Read this leaflet carefully before you start taking this medicine because 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Coripren is and what it is used for

2.What you need to know before you start taking Coripren

3.How to take Coripren

4.Possible side effects

5.Storage of Coripren

6.Contents of the pack and additional information

Coripren is a fixed combination of an angiotensin-converting enzyme inhibitor (enalapril maleate) and a calcium channel blocker (lercanidipine hydrochloride), two medications that reduce blood pressure.

Coripren is used to treat high blood pressure (hypertension) in adult patients in whom lercanidipine 10 mg does not adequately control blood pressure on its own. Coripren should not be used as initial treatment for hypertension.

Do not take Coripren

•If you are allergic to enalapril maleate or lercanidipine hydrochloride, or to any of the other components of this medication (listed in section 6).

•If you have ever had an allergic reaction to a type of medication similar to those contained in Coripren, i.e., 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 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 sacubitrilo/valsartan, a medication used to treat chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) increases.

•If you have diabetes or kidney problems and are being treated with a medication to reduce blood pressure that contains aliskiren.

•If you are more than 3 months pregnant (it is also recommended to avoid taking Coripren at the beginning of pregnancy, see section Pregnancy).

•If you have certain heart conditions:

oObstruction of blood flow from the heart.

oUntreated heart failure.

oUnstable angina (chest pain that occurs at rest or worsens progressively)

oDuring the first month after having a myocardial infarction

•If you have severe liver problems.

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

•If you are taking medications that inhibit liver metabolism, such as:

antifungals (such as ketoconazole or itraconazole)

macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin)

antivirals (such as 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 take Coripren:

• 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 have a heart problem.

•If you have a condition that affects blood vessels in the brain.

•If you have kidney problems (including kidney transplant).This may lead to high levels of potassium in the blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium level.

•If you have liver problems.

•If you have blood problems, such as a low or absent white blood cell count (leucopenia, 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 on immunosuppressive therapy, or are taking allopurinol or procainamide or a combination of both medications.

•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, you should control your blood sugar levels, especially during the first month of treatment. Potassium levels in the blood may also be elevated.

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

•If you are over 70 years old.

•If you have an intolerance to certain sugars (lactose).

If you are taking any of the following medications, the risk of angioedema may be increased:

•Racecadotrilo, a medication used to treat diarrhea.

•Medications used in organ rejection prevention after a transplant or in cancer treatment (e.g., temsirolimus, sirolimus, everolimus).

•Vildagliptina, a medication used to treat diabetes.

If you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as "sartanes" for example, valsartan, temisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- aliskiren.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium), at regular intervals.

See also the information under the heading "Do not take Coripren".

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 taking Coripren:

• any surgical intervention or if you are to be administered an anesthetic (even at the dentist's office)
• a treatment to extract cholesterol from the blood known as "apheresis of LDL"

a desensitization treatment, to reduce the effect of an allergy to bees or wasps.

You should inform your doctor if you think you are (or may be) pregnant or if you are breastfeeding (see the section Pregnancy, breastfeeding, and fertility).

Children and adolescents

Coripren has not been established as safe and effective in children under 18 years old.

Other medications and Coripren

Coripren 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, including over-the-counter medications. This is because when Coripren is taken with other medications, the effect of Coripren or 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:

• other medications that lower blood pressure
• potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ rejection; heparin, an anticoagulant medication used to prevent blood clots). See section "Do not take Coripren"
• lithium (a medication used to treat a certain type of depression)
• tricyclic antidepressants
• antipsychotic medications
• nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medications that reduce inflammation and are used to combat pain)
• certain medications for pain or arthritis, including gold therapy
• certain medications for cough and cold, and medications used to reduce weight that contain a substance called "sympathomimetic agent"
• medications for diabetes (including oral antidiabetic medications and insulin)
• astemizol or terfenadine (allergy medications)
• amiodarone, quinidine, or sotalol (medications for rapid heart rate)
• phenytoin, phenobarbital, or carbamazepine (medications for epilepsy)
• rifampicin (a medication for tuberculosis)
• digoxin (a medication for heart problems)
• midazolam (a medication to help you sleep)
• beta-blockers, e.g., metoprolol (medications that treat high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (administered at doses above 800 mg per day, a medication for ulcers, indigestion, or acid reflux)

Do not take Coripren if you have taken or are currently taking sacubitrilo/valsartan, a medication used to treat chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) increases.

If you are taking any of the following medications, the risk of angioedema may be increased:

•Racecadotrilo, a medication used to treat diarrhea.

•Medications used in organ rejection prevention after a transplant or in cancer treatment (e.g., temsirolimus, sirolimus, everolimus).

•Vildagliptina, a medication 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 Coripren" and "Warnings and precautions".

Coripren with food, drinks, and alcohol

• Coripren should be taken at least 15 minutes before meals.

•A fatty meal significantly increases the levels of the medication in the blood

• Alcohol may increase the effect of Coripren. During Coripren treatment, alcohol should not be consumed.
• Coripren should not be taken with grapefruit or grapefruit juice, as it may increase its antihypertensive effect (see "Do not take Coripren").

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or may be) pregnant. Your doctor will usually recommend that you stop taking Coripren before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Coripren. It is not recommended during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may severely harm the fetus if used after the third month of pregnancy.

Breastfeeding

Coripren should not be taken during breastfeeding.

Driving and operating machines

If you experience dizziness, weakness, or somnolence with this medication, you should not drive or operate machines.

Coripren contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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. See “Taking Coripren with food, drinks, and alcohol”

Patients with kidney problems/elderly people: Your doctor will decide the dose of medication you should take, taking into account how well your kidneys are functioning.

If you take more Coripren than you should:

Do not exceed the prescribed dose. If you have taken more Coripren 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, or go to the hospital immediately. Bring the packaging and the medication leaflet with you to the healthcare professional.

A dose higher than the correct one may cause excessive blood pressure drop and your heart may beat irregularly or faster.

If you forget to take Coripren:

• 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 interrupt treatment with Coripren:

• 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 medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may cause the following side effects:

Some side effects may be serious.

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;

When you start taking Coripren, 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 Coripren

Frequent (may affect up to 1 in 10 people)

Cough, feeling of dizziness, headache.

Rare (may affect up to 1 in 100 people)

Changes in blood parameters, such as a decrease in platelet count, an 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 sick (nausea), increase in liver enzyme levels, skin redness, joint pain, increased urination frequency, feeling weak, fatigue, feeling hot, 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 sensation on the tongue, diarrhea, dry mouth, gum inflammation, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty swallowing or breathing, skin rash, urticaria, nocturia, polyuria, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

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

Blurred vision, feeling of dizziness, weakness, or discomfort, 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 or irregular heartbeat (palpitations), angina, shortness of breath, alterations in taste, increased creatinine levels in the blood (usually detected through a blood test), high potassium levels in the blood, diarrhea, abdominal pain, fatigue, rash, allergic reaction with inflammation of the face, lips, tongue, or throat that causes difficulty swallowing or breathing.

Rare (may affect up to 1 in 100 people)

Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion, nervousness, somnolence or insomnia, feeling of pins and needles or numbness, myocardial infarction (possibly caused by very low blood pressure in 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 congestion, sore throat, and hoarseness, asthma associated with chest tightness, intestinal ileus, pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastritis), dry mouth, ulcers, anorexia, itching or urticaria, hair loss, renal function impairment, renal insufficiency, increased sweating, high protein levels in the urine (measured through a blood test), 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), redness, rapid or irregular heartbeat (palpitations), vertigo (dizziness), tinnitus (ringing in the ears), impotence.

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), nasal inflammation, pneumonia, liver problems, such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzyme or bilirubin levels (measured through a blood test), erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome, and toxic epidermal necrolysis (a severe skin condition characterized by skin redness and scaly formation, blistering, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or skin shedding), pemphigus (small blisters filled with fluid on the skin), decreased urine production, gynecomastia (breast enlargement in men), inflamed glands in the neck, armpits, or groin, fluid or other substance accumulation in the lungs (visible on X-rays), inflammation of the cheeks, gums, tongue, lips, and throat.

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

Intestinal inflammation (intestinal angioedema).

Frequency unknown (cannot be estimated from available data)

Excessive production of antidiuretic hormone causing fluid retention, leading to weakness, fatigue, or confusion.

A set of symptoms that may include one or more 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

Some of these side effects may be serious. If you experience any of these side effects, consult your doctor.

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

Angina pectoris (chest pain caused by heart blood supply problems), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.

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 medications to which lercanidipine belongs. Isolated cases of myocardial infarction may be observed.

Other possible side effects:

Frequent (may affect up to 1 in 10 people): headache, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Rare (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, discomfort, abdominal pain, skin rash, itching, muscle pain, increased urination frequency, weakness or fatigue.

Rare (may affect up to 1 in 1,000 people): somnolence, vomiting, diarrhea, urticaria, increased urination frequency, chest pain.

Frequency unknown (cannot be estimated from available data): gum swelling, changes in liver function (detected through blood tests), cloudy fluid (during hemodialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

If any of the side effects worsen, or if you experience any type of side effect not listed in this prospectus, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about side effects, as they have a more comprehensive list of side effects.

Reporting side effects

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

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 the box after CAD. The expiration date is the last day of the month indicated.

Store Coripren in the original packaging to protect it from light and moisture. Do not store at a temperature above 25°C.

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

Composition of Coripren

The active principles are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 10 mg of enalapril maleate (equivalent to 7.64 mg of enalapril) and 10 mg of lercanidipine hydrochloride (equivalent to 9.44 mg of lercanidipine).

The other components are:

Core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, povidone K30, sodium bicarbonate, magnesium stearate.

Coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000.

Appearance of the product and contents of the container.

Coripren 10 mg/10 mg are white, circular, biconvex tablets of 8.5 mm.

Coripren 10 mg/10 mg is supplied in containers of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98, and 100 tablets. Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Recordati Ireland Limited. Raheens East, Ringaskiddy Co. Cork. Ireland

Local representative:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300. 50180 Utebo (Zaragoza).

Responsible for manufacturing:

Recordati Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – I-20148 Milan, Italy.

This medicine is authorized in the EEA Member States with the following names:

Italy:Coripren

Spain:Coripren

The date of the last review of this leaflet: 07/2021

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/