CORIPREN 20 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take Coripren

Do not take Coripren

• If you are allergic to enalapril maleate or lercanidipine hydrochloride, 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 Coripren, i.e. medicines 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 taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) is increased.
• If you have diabetes or kidney problems and are being treated 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 Coripren at the start of pregnancy, see section Pregnancy).
• If you suffer from certain heart conditions:

o obstruction of blood flow from the heart

o untreated heart failure

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

o during the first month after having a heart attack.

• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that inhibit liver metabolism, such as:

o antifungals (such as ketoconazole or itraconazole)

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

o antivirals (such as ritonavir)

• If you are taking another medicine 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 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 are on a low-salt diet.
• 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). This may lead to high levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels.
• If you have liver problems.
• If you have blood disorders, 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 disease of the collagen (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive therapy, or are taking allopurinol or procainamide or a combination of both medicines.
• 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, you should monitor your blood sugar levels, especially during the first month of treatment. The level of potassium in the blood may also be elevated.
• If you are taking potassium supplements, potassium-sparing diuretics, 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 medicines, the risk of angioedema may be increased:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection after a transplant or to treat 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, termisartan, irbesartan), especially if you have diabetic kidney problems.
• aliskiren.

Your doctor may need to 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 Coripren".

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 Coripren:

• any surgical procedure or if you are going to be given an anesthetic (even in the dentist's office)
• 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.

You should inform your doctor if you think you are (or might become) pregnant or if you are breast-feeding (see the section Pregnancy, breast-feeding, and fertility).

Children and adolescents

The safety and efficacy of Coripren in children under 18 years have not been established.

Other medicines and Coripren

Coripren 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, including those obtained without a prescription. This is because when Coripren is taken with other medicines, the effect of Coripren 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:

• other medicines that lower blood pressure
• potassium supplements (including salt substitutes in the diet), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent organ rejection; heparin, a medicine used as an anticoagulant to prevent blood clots). See section "Do not take Coripren"
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called "tricyclic antidepressants"
• medicines for the treatment of mental problems, called "antipsychotics"
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and can be used to treat pain)
• certain medicines for pain or arthritis, including gold therapy
• certain medicines for the treatment of cough and cold and weight-reducing 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, quinidine, or sotalol (medicines for the treatment of a fast heart rate)
• phenytoin, phenobarbital, 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, e.g., metoprolol (medicines that treat high blood pressure, heart failure, and irregular heartbeat)
• cimetidine (given at daily doses above 800 mg, a medicine for ulcers, indigestion, or heartburn)

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

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

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection after a transplant or to treat 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 Coripren" and "Warnings and precautions").

Taking 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 medicine in the blood.
  • Alcohol may increase the effect of Coripren. During treatment with Coripren, you should not consume alcohol.
  • Coripren should not be taken with grapefruit or grapefruit juice, as it may increase its anti-hypotensive effect (see "Do not take Coripren").

Pregnancy, breast-feeding, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Coripren before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Coripren. Coripren is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may seriously harm the fetus if used after the third month of pregnancy.

Breast-feeding

Coripren should not be taken during breast-feeding.

Driving and using machines

If you experience dizziness, weakness, or drowsiness with this medicine, you should not drive or operate machinery.

Coripren contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Coripren

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

Adults: unless your doctor has told 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. See "Taking Coripren with food, drinks, and alcohol".

Patient with kidney problems/elderly:your doctor will decide the dose of medicine that you should take, depending on how well your kidneys are working.

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 Toxicology Information Service, telephone 91 562 04 20, or go to the hospital immediately. Take the package and the leaflet of the medicine with you to the healthcare professional.

A dose higher than the correct one may cause a significant drop in blood pressure 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 forgotten dose.
• Take the next dose following the usual schedule.
• Do not take a double dose to make up for the forgotten doses.

If you stop taking Coripren

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 may cause the following adverse effects:

Some adverse effects can be serious.

Tell your doctor immediately if you notice any of the following adverse effects:

An allergic reaction accompanied by swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing;

When you start taking Coripren, 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 happens, it will be helpful to lie down. If you are concerned, consult your doctor.

Adverse Effects Observed with Coripren

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 parameter values, such as a decrease in platelet count, increased potassium concentration in blood, nervousness (anxiety), feeling of dizziness when standing up, vertigo, rapid heartbeat, rapid or irregular heartbeat (palpitations), sudden reddening of the face, neck, or upper chest (erythema), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increased liver enzyme levels, skin reddening, 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 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, hives, getting up at night to urinate, producing large amounts of urine, impotence.

Additional Adverse 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 heartbeats, angina, shortness of breath, alterations in taste, increased creatinine levels in blood (usually detected through analysis), high potassium levels in blood, diarrhea, abdominal pain, fatigue, rash, allergic reaction with inflammation of the face, lips, tongue, or throat with difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 people)

Anemia (including aplastic anemia and hemolytic anemia), sudden drop in blood pressure, confusion, nervousness, somnolence, or insomnia, sensation 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 blood supply problems 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 with chest tightness, slowing of food movement through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastric irritation), dry mouth, ulcer, anorexia, itching, or hives, hair loss, alteration of kidney function, kidney failure, increased sweating, high protein levels in urine (measured through analysis), muscle cramps, feeling of general discomfort, high temperature (fever), low sugar or sodium levels in blood, high urea levels in blood (all measured through blood analysis), reddening, rapid or irregular heartbeats (palpitations), vertigo (feeling of dizziness), ringing in the ears (tinnitus), impotence.

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

Changes in blood parameter values, 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 can become intensely cold and turn white 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 blood analysis), erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome, and toxic epidermal necrolysis (a severe skin condition in which the skin becomes red and scaly, forming blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin), pemphigus (small blisters filled with fluid on the skin), decreased urine production, breast enlargement in males (gynecomastia), inflamed glands in the neck, armpits, or groin, fluid accumulation or other substances in the lungs (as seen on X-rays), cheek, gum, tongue, lip, or throat inflammation.

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

Intestinal inflammation (intestinal angioedema).

Frequency not known (cannot be estimated from available data)

Excessive production of antidiuretic hormone that causes fluid retention, leading 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.

Lercanidipine

Some of these adverse effects can be serious. If you experience any of these adverse effects, consult your doctor.

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

Chest pain (pain in the chest caused by lack of blood supply to the heart), allergic reactions (with symptoms such as itching, rash, hives), fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks associated with treatment with the group 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 or irregular heartbeats (palpitations), sudden reddening of the face, neck, or upper chest, ankle swelling.

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

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

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

If any of the adverse effects worsen, or if you experience any type of adverse effect that does not appear in this leaflet, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about adverse effects, as they have a more complete list of adverse effects.

Reporting Adverse Effects

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

5. Storage of Coripren

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

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. 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 Coripren

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: 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, quinoline yellow (E104), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Coripren 20 mg/10 mg are yellow, circular, biconvex tablets, 8.5 mm in diameter.

Coripren 20 mg/10 mg is supplied in packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98, and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Local Representative:

Casen Recordati, S.L., Autovía de Logroño, km 13.300, 50180 Utebo (Zaragoza)

Manufacturer:

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 under the following names:

Italy: Coripren

Spain: Coripren

Date of the last revision of this leaflet: 07/2021

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/