Coripren

Leaflet accompanying the packaging: patient information

Coripren, 20 mg + 20 mg, film-coated tablets

Enalapril maleate + Lercanidipine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Coripren and what is it used for
• 2. Important information before taking Coripren
• 3. How to take Coripren
• 4. Possible side effects
• 5. How to store Coripren
• 6. Contents of the pack and other information

1. What is Coripren and what is it used for

Coripren is a combination medicine that contains two active substances that lower blood pressure: an angiotensin-converting enzyme (ACE) inhibitor, enalapril, and a calcium antagonist, lercanidipine. Coripren is used to treat high blood pressure (hypertension) in adult patients who are already taking enalapril and lercanidipine as separate medicines.

2. Important information before taking Coripren

When not to take Coripren:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction after taking medicines similar to the substances contained in Coripren, i.e. after taking other ACE inhibitors or other calcium antagonists;
• if you have ever had swelling of the face, lips, tongue, or throat, causing difficulty in swallowing or breathing (angioedema), caused by treatment with an ACE inhibitor, or if such swelling has occurred for unknown reasons or is hereditary;
• if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the skin and mucous membranes, e.g. in the throat) may increase;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• after the 3rd month of pregnancy (you should also avoid taking Coripren in early pregnancy - see section "Pregnancy, breastfeeding and fertility");
• if you have certain heart diseases:
• narrowing of the outflow of blood from the left ventricle, including narrowing of the aortic valve,
• untreated heart failure,
• unstable angina pectoris (chest pain at rest or progressively worsening),
• within 1 month after a heart attack (myocardial infarction);
• if you have severe liver problems;
• if you have severe kidney problems or are undergoing dialysis;
• if you are taking medicines that inhibit the activity of liver enzymes, such as:
• antifungal medicines (such as ketoconazole, itraconazole),
• macrolide antibiotics (such as erythromycin, troleandomycin),
• antiviral medicines (such as ritonavir);
• if you are taking a medicine called cyclosporin (used to prevent rejection of a transplanted organ);
• at the same time as grapefruit or grapefruit juice.

Warnings and precautions

Before taking Coripren, discuss it with your doctor or pharmacist. You should inform your doctor or pharmacist:

• if you have low blood pressure (which may cause dizziness or fainting, especially when standing up);
• if you have severe vomiting or have recently had diarrhea;
• if you are on a low-salt diet;
• if you have heart problems;
• if you have problems with blood vessels in the brain;
• if you have kidney problems (including after a kidney transplant). This may lead to a significant increase in potassium levels in the blood. Your doctor may adjust the dose of enalapril or monitor potassium levels in the blood;
• if you have liver problems;
• if you have blood disorders, such as a decrease in the number of or lack of white blood cells (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in the number of red blood cells (anemia);
• if you have collagenosis (e.g. systemic lupus erythematosus, rheumatoid arthritis, or systemic sclerosis), are undergoing immunosuppressive therapy, or are taking medicines containing allopurinol or procainamide, or any combination of these medicines;
• black patients should be aware of the increased risk of allergic reactions with swelling of the face, lips, tongue, or throat, causing difficulty in swallowing or breathing when taking ACE inhibitors;
• if you have diabetes. You should monitor your blood glucose levels to detect any decrease in glucose levels, especially during the first month of treatment. Potassium levels in the blood may also be increased;
• if you are taking potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes;
• if you are over 70 years old;
• if you have intolerance to some sugars (lactose).

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

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

If you are taking any of the following medicines used to treat high blood pressure:

• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also section "When not to take Coripren". If you are scheduled for a medical procedure If you are scheduled for any of the following procedures, tell your doctor that you are taking Coripren:

• surgical procedure or anesthesia (including dental procedures);
• treatment to remove cholesterol from the blood (LDL apheresis);
• desensitization treatment to reduce allergy to bee or wasp stings.

Inform your doctor about pregnancy, suspected pregnancy, or planning to become pregnant, as well as breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents

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

Coripren with other medicines

Coripren should not be taken with certain medicines. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription. If Coripren is taken with other medicines, the effect of Coripren or the other medicine may be altered, and certain side effects may occur more frequently. In particular, inform your doctor about taking any of the following medicines:

• other blood pressure-lowering medicines;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent blood clots). See section "When not to take Coripren";
• lithium (used to treat a certain type of depression);
• medicines used to treat depression, known as tricyclic antidepressants;
• medicines used to treat mental disorders, known as antipsychotics;
• non-steroidal anti-inflammatory medicines (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors (medicines that reduce inflammation and relieve pain);
• certain painkillers or medicines used to treat arthritis, including gold salts;
• certain medicines used to treat coughs and colds, and to aid weight loss, containing sympathomimetics;
• antidiabetic medicines (including oral antidiabetics and insulin);
• astemizole and terfenadine (antihistamines);
• amiodarone, quinidine, or sotalol (medicines used to treat irregular heart rhythm);
• phenytoin, phenobarbital, and carbamazepine (antiepileptic medicines);
• rifampicin (a medicine used to treat tuberculosis);
• digoxin (a medicine used to treat heart problems);
• midazolam (a medicine used to treat sleep disorders);
• beta-blockers, e.g. metoprolol (medicines used to treat high blood pressure, heart failure, and irregular heart rhythm);
• cimetidine (at a daily dose greater than 800 mg, a medicine used to treat stomach ulcers and heartburn).

Do not take Coripren if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the skin and mucous membranes, e.g. in the throat) may increase. If you have taken or recently taken any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

Your doctor may recommend a change in dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Coripren" and "Warnings and precautions").

Coripren with food, drink, and alcohol

• Coripren should be taken at least 15 minutes before a meal.
• A high-fat meal significantly increases the level of the medicine in the blood.
• Alcohol may enhance the effect of Coripren. You should not drink alcohol while taking Coripren.
• Coripren should not be taken with grapefruit or grapefruit juice, as they may enhance the effect of the medicine (see section "When not to take Coripren").

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Coripren is not recommended for patients planning to become pregnant, in early pregnancy, and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the baby. Breastfeeding You should not take Coripren while breastfeeding.

Driving and using machines

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

Coripren contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Coripren

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults: If your doctor has not prescribed otherwise, the usual dose is one tablet once daily, taken at the same time every day. The tablet should be taken in the morning, at least 15 minutes before breakfast. The tablets should be swallowed whole with water. See section "Coripren with food, drink, and alcohol" Patients with kidney problems/elderly patients: Your doctor will determine the appropriate dose of Coripren based on your kidney function.

Taking a higher dose of Coripren than recommended

Do not exceed the recommended dose. If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately. Take the medicine package with you. Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregular or rapid heart rhythm.

Missing a dose of Coripren

• If you miss a dose, skip the missed dose.
• Then take the next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

Stopping treatment with Coripren

• Do not stop taking this medicine unless your doctor tells you to.
• If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coripren can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine:

Some side effects can be serious.

You should contact your doctor or go to the hospital immediately if you experience any of the following side effects:

• allergic reaction with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing.

After starting to take Coripren, you may experience fainting, dizziness, or blurred vision. This is due to a sudden drop in blood pressure. If you experience these symptoms, lie down until they pass. If you have any doubts, ask your doctor.

Side effects observed with Coripren

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 results, such as a decrease in platelet count
• increased potassium levels in the blood
• irritability (nervousness)
• dizziness when standing up, feeling of spinning (vertigo)
• rapid or irregular heart rhythm (palpitations)
• sudden reddening of the face, neck, or upper chest (flushing), low blood pressure
• abdominal pain, constipation, nausea
• increased liver enzyme activity
• skin rash
• joint pain
• increased urination
• feeling of weakness, fatigue, flushing, swelling of the ankles

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

• anemia
• allergic reactions
• ringing in the ears (tinnitus)
• fainting
• dryness of the throat, sore throat
• indigestion, unpleasant taste, diarrhea, dry mouth, swelling of the gums
• allergic reactions with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing, skin rash, hives
• nocturia, increased urine output
• impotence

Additional side effects related to the individual components of Coripren (enalapril or lercanidipine)

Enalapril

Very common (may affect more than 1 in 10 people):
blurred vision, dizziness, weakness, nausea, cough
Common (may affect up to 1 in 10 people):
depression, headache, fainting, chest pain, feeling of emptiness in the head due to low blood pressure, irregular heart rhythm, rapid heart rhythm, angina pectoris, shortness of breath, taste disturbances, increased creatinine levels in the blood (usually detected in laboratory tests), high potassium levels in the blood, diarrhea, abdominal pain, fatigue, skin rash, allergic reactions with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing
Uncommon (may affect up to 1 in 100 people):
anemia (including aplastic and hemolytic), sudden drop in blood pressure, confusion, irritability, insomnia or drowsiness, feeling of tingling or numbness, heart attack (usually due to very low blood pressure in patients at high risk, including those with coronary artery disease and cerebrovascular disease), stroke (usually due to very low blood pressure in patients at high risk), runny nose, sore throat, asthma with chest tightness, slowed bowel movements, pancreatitis, vomiting, indigestion, constipation, dry mouth, stomach ulcer, loss of appetite, itching or hives, hair loss, kidney problems, kidney failure, excessive urination, gynecomastia (breast enlargement in men), lymph node enlargement in the neck, armpits, and groin, fluid accumulation or other substances in the lungs (detected on X-rays), inflammation of the lining of the cheeks, gums, tongue, lips, or throat
Rare (may affect up to 1 in 1,000 people):
changes in blood test results, such as a decrease in white blood cell count, bone marrow suppression, autoimmune diseases, strange dreams or sleep disturbances, Raynaud's phenomenon (feeling of coldness and paleness of the fingers and toes due to reduced blood flow), inflammation of the nasal mucosa, pneumonia, liver problems, including liver failure, hepatitis, jaundice (yellowing of the skin or eyes), high levels of liver enzymes or bilirubin in the blood (detected in laboratory tests), erythema multiforme (red patches of various shapes on the skin), Stevens-Johnson syndrome, and toxic epidermal necrolysis (severe skin reaction with redness and shedding of the skin, blistering, or peeling), pemphigus (formation of small fluid-filled blisters on the skin)
Very rare (may affect up to 1 in 10,000 people):
intestinal angioedema (angioedema of the intestines)
Unknown (frequency cannot be estimated from available data):
excessive production of antidiuretic hormone, leading to water retention, causing weakness, fatigue, or confusion
There have been reports of a syndrome that may include some or all of the following symptoms: fever, vasculitis (inflammation of the blood vessels), muscle pain (myalgia or myositis), joint pain (arthralgia or arthritis). Skin rash, increased sensitivity to light, or other skin symptoms may occur.

Lercanidipine

Some side effects can be serious.

You should contact your doctor immediately if you experience any of the following side effects:

Rare (may affect up to 1 in 1,000 people):
angina pectoris (chest pain due to insufficient blood supply to the heart), allergic reactions (symptoms include itching, rash, hives), fainting
In patients with angina pectoris, taking medicines of the same class as lercanidipine may cause an increase in the frequency, duration, or severity of angina attacks. Isolated cases of myocardial infarction have been reported.
Other possible side effects:

Common (may affect up to 1 in 10 people): headache, rapid heart rhythm, rapid or irregular heart rhythm (palpitations), sudden reddening of the face, neck, or upper chest (flushing), swelling of the ankles
Uncommon (may affect up to 1 in 100 people): dizziness, sudden drop in blood pressure, heartburn, nausea, abdominal pain, skin rash, itching, muscle pain, increased urination, feeling of weakness or fatigue
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, hives, increased urination, chest pain
Unknown (frequency cannot be estimated from available data): gum swelling, liver problems (detected in blood tests), cloudy dialysate (during dialysis through a tube inserted in the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coripren

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. The abbreviation "Lot" on the packaging and blister means "Batch number". The abbreviation "EXP" on the packaging and blister means "Expiry date". Store in the original package to protect from light and moisture. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Coripren contains

• The active substances of Coripren are enalapril maleate and lercanidipine hydrochloride. Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.29 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone (K 30), sodium hydrogen carbonate, magnesium stearate. Tablet coating: hypromellose 5 cP, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), talc, red iron oxide (E 172).

What Coripren looks like and contents of the pack

Orange, round, biconvex film-coated tablets, 12 mm in diameter. Coripren is available in packs of 14, 28, or 56 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium Lercaprel
Bulgaria Renovia Ace
Estonia Lercapin Ace
France Lercapress
Germany Zaneril
Greece Zaneril
Hungary Lercaton Plus
Italy Lercaprel
Latvia Lercapin Ace
Lithuania Lercapin Ace 20 mg/20 mg plėvele dengtos tabletės
Poland Coripren
Portugal Zanitek
Romania Coripren
Slovenia Lercapressecomb 20 mg/20 mg

Date of last revision of the leaflet: 07/2021