Coripren 10 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Coripren 10 mg/10 mg film-coated tablets

Enalapril maleate/lercanidipine hydrochloride

Read the entire 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, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Coripren is and what it is used for

Coripren is a fixed combination of an ACE inhibitor (enalapril maleate) and a calcium channel blocker (lercanidipine hydrochloride), two medicines that reduce blood pressure.

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

2. What you need to know before taking 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 medicine similar to those contained in Coripren, i.e., drugs known as 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 type of medicine 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 sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of developing angioedema (rapid swelling of the throat).

• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you are more than 3 months pregnant (use of Coripren is also advised to be avoided at the beginning of pregnancy; see Pregnancy section).

• If you suffer from certain heart conditions:

  o obstruction of blood outflow from the heart.

  o untreated heart failure.

  o unstable angina (chest discomfort occurring at rest or progressively worsening)

  o during the first month after 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 drugs that inhibit hepatic metabolism, such as:

  o antifungals (e.g., ketoconazole or itraconazole)

  o macrolide antibiotics (e.g., erythromycin, troleandomycin, or clarithromycin)

  o antivirals (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 starting to take Coripren:

• If you have low blood pressure (which may present as dizziness or fainting, especially when standing).
• If you have been severely ill (with excessive vomiting) or have recently had diarrhea.
• If your diet is low in salt.
• If you have a heart condition.
• If you have a disorder affecting 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 enalapril dose or monitor your potassium levels.
• If you have liver problems.
• If you have blood disorders, such as low or absent white blood cells (leukopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anemia).
• If you have a collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, or are taking allopurinol or procainamide, or a combination of both.
• 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, you should monitor your blood sugar levels, especially during the first month of treatment, as they may be low. Blood potassium levels may also be elevated.
• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.
• If you are over 70 years of age.
• If you have 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 in the treatment of diarrhea.
• Medicines used to prevent organ rejection after transplantation or in cancer treatment (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used in the treatment of diabetes.

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

• an angiotensin II receptor antagonist (ARA-II) (also known as “sartans,” e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may 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 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 Coripren:

• any surgical intervention or if you are to receive an anesthetic (even at the dentist’s office)
• a treatment to remove cholesterol from your blood known as “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bees or wasps.

You must inform your doctor if you think you are (or could be) pregnant or if you are 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.

Other medicines and Coripren

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

• other medicines that lower blood pressure
• potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; cyclosporine, 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 mental disorders, known as "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, and medicines used to reduce weight 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 treating rapid heartbeat)
• phenytoin, phenobarbital, or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine for the treatment of tuberculosis)
• digoxin (a medicine for treating heart problems)
• midazolam (a medicine to help you sleep)
• beta-blockers, e.g., metoprolol (medicines that treat high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (administered at daily doses exceeding 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 this increases the risk of angioedema (rapid swelling under the skin, such as in the throat).

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

• Racecadotril, a medicine used in the treatment of diarrhea.
• Medicines used in the prevention of organ rejection after transplantation or in the treatment of cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used in the treatment of diabetes.

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

If you are taking an angiotensin II receptor antagonist (ARA-II) or aliskiren (see also 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 high-fat meal significantly increases the levels of the medicine in the blood.

  • Alcohol may enhance the effect of Coripren. During treatment with Coripren, alcohol consumption should not be allowed.
  • Coripren must 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 must inform your doctor if you think you are (or could be) pregnant. Your doctor will generally advise you to stop taking Coripren before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. It is not recommended during pregnancy, and must 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.

Breastfeeding

Coripren must not be taken during breastfeeding.

Driving and use of machines

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

Coripren contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free.”

3. How to take Coripren

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults: unless your doctor has told you otherwise, the recommended dose is one tablet once daily, at the same time each day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Tablets must be swallowed whole with water. See "Taking Coripren with food, drinks and alcohol".

Patients with renal problems/elderly people: your doctor will decide the dose of medicine you should take, based on 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, call the Toxicology Information Service at telephone number 91 562 04 20, or go immediately to hospital. Take the medicine pack and leaflet with you when seeing a healthcare professional.

A dose higher than the correct one may cause an excessive 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 missed dose.
• Take the next dose according to your regular schedule.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Coripren

• Do not stop taking this 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 can cause adverse effects, although not everyone will experience them. This medicine may cause the following adverse effects:

Some adverse effects may 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, which may cause difficulty breathing or swallowing;

When you start taking Coripren, you may feel weak or dizzy, or notice that your vision becomes blurred; this is caused by a sudden drop in blood pressure, and if it occurs, lying down may be helpful. If you are concerned, consult your doctor.

Adverse 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 parameters, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness upon standing, 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 levels of liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of weakness, tiredness, 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 in the mouth, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing, skin rash, urticaria, waking up at night to urinate, production of large amounts of urine, impotence.

Additional adverse effects observed with enalapril or lercanidipine used alone

Enalapril

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

Blurred vision, dizziness, weakness or malaise, 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, dyspnoea, disturbances in taste, increased blood creatinine levels (usually detected by blood test), elevated blood potassium levels, diarrhoea, abdominal pain, fatigue, rash, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 people)

Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, nervousness, drowsiness or insomnia, tingling sensation in the skin or numbness, 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), 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, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, itching or urticaria, hair loss, impaired kidney function, renal failure, increased sweating, high levels of protein in urine (measured by test), muscle cramps, general feeling of discomfort, high temperature (fever), low blood sugar or sodium levels, high blood urea levels (all measured by blood test), flushing, rapid or irregular heartbeats (palpitations), vertigo (dizziness), ringing in the ears (tinnitus), impotence.

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

Changes in blood test parameters, such as decreased white blood cell count, bone marrow depression, autoimmune disorders, unusual dreams or sleep disorders, Raynaud's phenomenon (in which hands and feet may become intensely cold and turn white due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased levels of liver enzymes or bilirubin (measured by blood test), erythema multiforme (red spots of various shapes appearing on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition involving redness, scaling or peeling of the skin, blistering or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin), decreased urine production, breast gland enlargement in men (gynaecomastia), swollen glands in the neck, armpits or groin, accumulation of fluid or other substances in the lungs (as seen on X-rays), swelling of cheeks, gums, tongue, lips and throat.

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

Intestinal angioedema.

Frequency not known (cannot be estimated from available data)

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

A group of symptoms has been reported which may include one or more 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 occur.

Lercanidipine

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

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

Angina (chest pain due to reduced blood supply to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.

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 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, swelling of the ankles.

Uncommon (may affect up to 1 in 100 people): dizziness, drop in blood pressure, heartburn, malaise, stomach pain, skin rash, itching, muscle pain, increased urine output, weakness or fatigue.

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

Frequency not known (cannot be estimated from available data): gum swelling, changes in liver function (detected in blood tests), cloudy fluid (during peritoneal dialysis via a tube inserted into the abdomen), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the adverse effects worsen, or if you experience any adverse effect not listed in this leaflet, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about adverse effects, as both have access to a more complete list.

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: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and the outer packaging after EXP. The expiry 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Coripren

The active substances 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 package.

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

Coripren 10 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 medicinal product is authorized in the EEA Member States under the following names:

Italy: Coripren
Spain: Coripren

Date of the most recent revision of this leaflet: 07/2021

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