Coripren

Package leaflet: Information for the user

Coripren 10 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side 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) and a calcium antagonist (lercanidipine), two drugs that reduce blood pressure.
Coripren is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate control of blood pressure has not been achieved with lercanidipine 10 mg alone.
Coripren is not indicated for the initial treatment of hypertension.

2. What you need to know before taking Coripren

Do not take Coripren:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to a medicine similar to those contained in Coripren, e.g. drugs called ACE inhibitors or calcium antagonists.
• if you have previously experienced swelling of the face, lips, mouth, tongue or larynx causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if such swelling occurred without known cause or due to hereditary factors.
• if you are taking or have taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin, for example in the throat).
• if you have diabetes or kidney problems and are taking medicines containing aliskiren to lower blood pressure.
• if you are more than three months pregnant (Coripren should also be avoided during the first months of pregnancy – see pregnancy section).
• if you suffer from certain heart conditions such as:
• obstruction of blood flow from the heart
• untreated heart failure
• unstable angina (chest pain occurring at rest or progressively worsening)
• heart attack occurred less than one month ago.
• if you have severe liver problems.
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit liver metabolism such as:
• antifungals (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• antivirals (e.g. ritonavir).
• if you are concurrently taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Coripren:

• if you have low blood pressure (you may feel weak or dizzy, especially when standing up)
• if you have been seriously ill (excessive vomiting) or have recently had diarrhoea
• if you are on a low-sodium diet
• if you have heart problems
• if you have a condition affecting the blood vessels in the brain
• if you have kidney problems (including kidney transplant), which could lead to higher potassium levels in the blood, with potentially serious consequences. Your doctor may decide to adjust your enalapril dose or monitor your blood potassium levels
• if you have liver problems
• if you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)
• if you suffer from vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are taking immunosuppressants, allopurinol, procainamide, or any combination of these factors
• if you are of Black African or African-Caribbean descent, you should be aware that patients of Black origin have a higher risk of allergic reactions with swelling of the face, lips, tongue and throat, causing difficulty in swallowing and breathing, while taking ACE inhibitors
• if you have diabetes, you should monitor for possible lowering of blood glucose levels, especially during the first month of treatment. Blood potassium levels may also increase
• if you are taking potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium
• if you are over 70 years old
• if you are intolerant to certain sugars (lactose).

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

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs or for 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:

• an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Coripren”.

If you are about to undergo treatment
Inform your doctor that you are taking Coripren if you are about to:

• undergo surgery or anaesthesia (including dental anaesthesia)
• undergo a cholesterol-lowering blood treatment called LDL apheresis
• undergo desensitisation therapy to reduce the effects of allergies to bee or wasp stings.

Inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding (see section
“Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Coripren in children up to 18 years of age have not yet been established.
Other medicines and Coripren
Coripren must not be taken together with certain medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including those without a prescription. This is because when Coripren is taken together with certain medicines, its effect or the effect of other medicines may change, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines used to lower blood pressure,
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting). See “Do not take Coripren”
• lithium (a medicine used to treat a certain type of depression)
• antidepressants known as tricyclic antidepressants
• antipsychotics (medicines used for mental disorders)
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• certain medicines for pain or arthritis, including gold therapy
• certain cough and cold medicines and weight-reducing medicines containing a substance called a “sympathomimetic agent”
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• astemizole or terfenadine (allergy medicines)
• amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• digoxin (a medicine used to treat heart problems)
• midazolam (a medicine used to help sleep)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
• cimetidine (more than 800 mg, a medicine used for ulcers, indigestion or heartburn).

Do not take Coripren if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin, for example in the throat).
If you are taking any of the following medicines, your risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes. Your doctor may consider it necessary to adjust the dose and/or take other precautions:
• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take Coripren” and “Warnings and precautions”).

Coripren with food, drinks and alcohol

• Take Coripren at least 15 minutes before a meal.
• A high-fat meal significantly increases drug levels in the blood.
• Alcohol consumption may enhance the effects of Coripren. Do not drink alcohol during treatment with Coripren.
• Coripren must not be taken with grapefruit or grapefruit juice, as this increases its hypotensive effect (see “Do not take Coripren”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Coripren before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Coripren is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
Breastfeeding
Coripren must not be used during breastfeeding.
Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness or drowsiness while taking this medicine.
Coripren contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Coripren

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Adults: The recommended dose is one tablet daily, taken at the same time each day, unless otherwise
prescribed by your doctor. The tablet should preferably be taken in the morning, at least 15
minutes before breakfast. The tablet must be swallowed whole with a little water. See
“Coripren with food, drink and alcohol”.
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 Coripren than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or go immediately to hospital. Take the pack with you. Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregularities or increased heart rate.
If you forget to take Coripren

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

If you stop taking Coripren
Do not stop taking this medicine unless your doctor has told you to do so.

• If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coripren may cause side effects, although not everyone experiences them.
The following side effects may occur with this medicine:
Some side effects may be serious.
If you notice any of the following conditions, inform your doctor immediately:
Allergic reaction presenting as swelling of the face, lips, tongue or throat, which may cause
difficulty breathing or swallowing.
At the beginning of treatment with Coripren, you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure and lying down may help if this occurs. If you are concerned,
discuss it with your doctor.

Side effects observed with Coripren
Common (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 a reduced number of platelets;
• Increased potassium levels in the blood;
• Nervousness (anxiety);
• Feeling of dizziness when standing up, vertigo;
• Tachycardia, fast or irregular heartbeat (palpitations);
• Sudden redness of the face, neck or upper chest (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Elevated liver enzyme levels;
• Skin redness;
• Joint pain;
• Increased frequency of urination;
• Feeling of weakness, fatigue, feeling hot, 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, metallic taste in the mouth, diarrhoea, dry mouth, swollen gums;
• Allergic reaction with swelling of the face, lips, tongue or throat and difficulty swallowing or breathing, skin rash, urticaria;
• Need to get up at night to urinate, production of large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, dizziness, weakness or nausea, and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, light-headedness due to low blood pressure, changes in heart rhythm, increased heart rate, angina, shortness of breath, altered taste sensation, increased creatinine levels in the blood (usually detected by a blood test), elevated potassium levels in the blood, diarrhoea, abdominal pain, fatigue (tiredness), skin rash, allergic reaction with swelling of the face, lips, tongue or throat and 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, insomnia or drowsiness, tingling or numbness of the skin, heart attack (probably due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (probably due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, chest tightness associated with asthma, reduced intestinal motility (ileus), pancreatitis, vomiting, indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, loss of appetite, itching or urticaria, hair loss, reduced kidney function, kidney failure, increased sweating, high levels of protein in the urine (detected by a urine test), hot flushes, rapid or irregular heartbeat (palpitations), vertigo (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood test values such as reduced number of white blood cells, reduced bone marrow function, autoimmune diseases, abnormal dreams or sleep disturbances, “Raynaud’s phenomenon” (in which hands and feet may become very cold and white due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as reduced 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 on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition with redness and peeling of the skin, blisters or sores), exfoliative dermatitis/erythroderma (severe skin rash with skin peeling), pemphigus (small fluid-filled blisters on the skin), reduced urine output, breast enlargement in men (gynaecomastia), swelling of glands in the neck, armpits or groin, accumulation of fluid or other substances in the lungs (seen on X-ray), inflammation of cheeks, gums, tongue, lips or throat.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from the available data)
Excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue or confusion.
A symptom complex has been reported which may include some or all of the following symptoms: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.
Lercanidipine
Some side effects may be serious.
If you notice any of the following conditions, inform your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain due to insufficient blood flow to the heart), allergic reactions (symptoms include itching, skin rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of heart attack may occur.
Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, drop in blood pressure, heartburn, nausea, stomach discomfort, skin rash, itching, muscle pain, increased urine production, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from the available data): swollen gums, changes in liver function (detected by blood tests), cloudy fluid (during dialysis through a tube in the abdomen), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Ask your doctor or pharmacist for further information about side effects; they have a more complete list of possible side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 blister pack and carton after the word
EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture. Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Coripren contains
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: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch type A, povidone K30, sodium hydrogen carbonate, magnesium stearate.
Coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000.
Description of the appearance of Coripren and pack sizes
Coripren 10 mg/10 mg are white, circular, biconvex film-coated tablets of 8.5 mm.
Coripren 10 mg/10 mg is available in packs containing 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano, Italy.
Sales Licensee: Italfarmaco S.p.A., Viale F. Testi, 330 - 20126 Milano
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano, Italy.
This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy: Coripren
Spain: Coripren

Package leaflet: Information for the user

Coripren 20 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side 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) and a calcium antagonist (lercanidipine), two drugs that reduce blood pressure.
Coripren is indicated for the treatment of high blood pressure (hypertension) in adult patients in whom adequate control of blood pressure has not been achieved with enalapril 20 mg alone.
Coripren is not indicated for the initial treatment of hypertension.

3. What you need to know before taking Coripren

Do not take Coripren:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to a medicine of the same type as those contained in Coripren, e.g. medicines called ACE inhibitors or calcium antagonists.
• if you have previously experienced swelling of the face, lips, mouth, tongue or larynx causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if such swelling occurred without known cause or due to hereditary factors.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin, for example in the throat).
• if you have diabetes or kidney problems and are taking medicines containing aliskiren to reduce blood pressure.
• if you are more than three months pregnant (it is also advisable to avoid Coripren during the early months of pregnancy – see section on pregnancy).
• if you suffer from certain heart conditions such as:
• obstruction of blood flow from the heart
• untreated heart failure
• unstable angina (chest pain occurring at rest or progressively worsening)
• heart attack occurred less than one month ago.
• if you have severe liver problems
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit hepatic metabolism such as:
• antifungal agents (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• antiviral agents (e.g. ritonavir).
• if you are simultaneously taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Coripren:

• if you have low blood pressure (you may feel weak or dizzy, especially when standing up)
• if you have been seriously ill (excessive vomiting) or have recently had diarrhoea
• if you are on a low-sodium diet
• if you have heart problems
• if you have a condition affecting the blood vessels in the brain
• if you have kidney problems (including kidney transplant), which could lead to higher levels of potassium in the blood, with potentially serious consequences. Your doctor may decide to adjust your enalapril dose or monitor your blood potassium levels
• if you have liver problems
• if you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)
• if you suffer from vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are taking immunosuppressants, allopurinol, procainamide, or any combination of these factors
• if you are of Black African or Caribbean descent, you should be aware that patients of Black origin have a higher risk of allergic reactions with swelling of the face, lips, tongue and throat, causing difficulty in swallowing and breathing, while taking ACE inhibitors
• if you have diabetes, you should monitor for possible lowering of blood glucose levels, especially during the first month of treatment. Blood potassium levels may also be increased
• if you are taking potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium
• if you are over 70 years old
• if you are intolerant to certain sugars (lactose).

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

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs or for cancer treatment (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:

• an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example 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 section “Do not take Coripren”.

If you are about to undergo treatment
Inform your doctor that you are taking Coripren if you are about to:

• undergo surgery or anaesthesia (including dental anaesthesia)
• undergo a cholesterol-lowering blood treatment called LDL apheresis
• receive desensitisation therapy to reduce the effects of allergies to bee or wasp stings.

Inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding (see section
“Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Coripren in children up to 18 years of age have not yet been established.
Other medicines and Coripren
Coripren must not be taken together with certain medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription. This is because when Coripren is taken together with certain medicines, its effect or that of the other medicines may change, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines indicated to lower blood pressure,
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting). See “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 called antipsychotics
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• certain medicines for pain or arthritis, including gold therapy
• certain cough and cold medicines and 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, quinidine or sotalol (medicines to treat fast heartbeat)
• 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 sleep)
• beta-blockers, e.g. metoprolol (a medicine for treating high blood pressure, heart failure and heart rhythm disorders)
• cimetidine (more than 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
a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin, for example in the throat).
If you are taking any of the following medicines, your risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes. Your doctor may consider it necessary to adjust the dose and/or take other precautions:
• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take Coripren” and “Warnings and precautions”).

Coripren with food, drinks and alcohol

• Take Coripren at least 15 minutes before a meal.
• A high-fat meal significantly increases drug levels in the blood.
• Alcohol consumption may enhance the effects of Coripren. Do not drink alcohol during treatment with Coripren.
• Coripren must not be taken with grapefruit or grapefruit juice, as these increase its hypotensive effect (see “Do not take Coripren”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Coripren before starting pregnancy or as soon as you know you are pregnant, and will recommend another medicine instead of Coripren. Coripren is not recommended during pregnancy, and must not be taken after the third month, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
Breastfeeding
Coripren must not be used during breastfeeding.
Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness or drowsiness while taking this medicine.
Coripren contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Coripren

Take this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Adults: The recommended dose is one tablet daily, taken at the same time each day, unless otherwise prescribed by your doctor. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. The tablet must be swallowed whole with a small amount of water. See "Coripren with food, drinks and alcohol".
Patients with kidney problems/elderly patients: Your doctor will determine the appropriate dose based on how well your kidneys are functioning.
If you take more Coripren than you should
Do not exceed the recommended dose. If you take more medicine than prescribed, consult your doctor or go immediately to the hospital. Take the pack with you. Taking more than the correct dose may cause an excessive drop in blood pressure and may lead to irregularities or acceleration of the heart rate.
If you forget to take Coripren

• If you forget to take the tablet, skip the missed dose.
• Take your next dose as usual.
• Do not take a double dose to make up for a forgotten dose. If you stop taking Coripren Do not stop taking this medicine unless your doctor has told you to. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coripren may cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Some side effects can be serious.
If you notice any of the following conditions, tell your doctor immediately:
Allergic reaction presenting as swelling of the face, lips, tongue or throat, which may cause
difficulty breathing or swallowing.
At the beginning of treatment with Coripren, you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure, and lying down may help if this occurs. If you are concerned,
discuss it with your doctor.

Side effects observed with Coripren
Common (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 a lower number of platelets;
• Increased potassium levels in the blood;
• Nervousness (anxiety);
• Dizziness upon standing up, vertigo;
• Tachycardia, fast or irregular heartbeat (palpitations);
• Sudden redness of the face, neck or upper chest (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Elevated liver enzyme levels;
• Skin redness;
• Joint pain;
• Increased frequency of urination;
• Feeling of weakness, fatigue, feeling hot, 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 and difficulty swallowing or breathing, skin rash, urticaria;
• Need to get up at night to urinate, production of large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine taken separately

Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, dizziness, weakness or nausea, and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, light-headedness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina, shortness of breath, altered sense of taste, increased creatinine levels in blood (usually detected by a blood test), elevated potassium levels in blood, diarrhoea, abdominal pain, tiredness (fatigue), skin rash, allergic reaction with swelling of the face, lips, tongue or throat and 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, insomnia or drowsiness, tingling or numbness of the skin, heart attack (possibly due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (possibly due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, chest tightness associated with asthma, reduced intestinal motility (ileus), pancreatitis, vomiting, indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, loss of appetite, itching or urticaria, hair loss, reduced kidney function, kidney failure, increased sweating, high levels of protein in urine (detected by urine test), hot flushes, rapid or irregular heartbeat (palpitations), dizziness (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood values such as reduced white blood cell count, reduced bone marrow function, autoimmune diseases, abnormal dreams or sleep disorders, “Raynaud’s phenomenon” (in which hands and feet may become very cold and white due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin levels (detected by blood test), erythema multiforme (red spots of various shapes on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition involving redness, peeling of the skin, blisters or sores), exfoliative dermatitis/erythroderma (severe skin rash with skin peeling), pemphigus (small fluid-filled blisters on the skin), reduced urine output, breast enlargement in men (gynaecomastia), swelling of glands in the neck, armpits or groin, accumulation of fluid or other substances in the lungs (seen on X-ray), inflammation of cheeks, gums, tongue, lips or throat.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from available data)
Excessive production of antidiuretic hormone, causing fluid retention, resulting in weakness, fatigue or confusion.
A symptom complex has been reported which may include some or all of the following symptoms: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.

Lercanidipine
Some side effects can be serious.
If you notice any of the following conditions, tell your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain caused by insufficient blood flow to the heart), allergic reactions (symptoms include itching, skin rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of heart attack may occur.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach discomfort, skin rash, itching, muscle pain, increased urine output, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from available data): gum swelling, changes in liver function (detected by blood tests), cloudy dialysis fluid (during peritoneal dialysis), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. Ask your doctor or pharmacist for further information about side effects—they have a more complete list of possible side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 blister and the carton after the word
EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture. Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Coripren contains
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: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch type A, povidone K30, sodium hydrogen carbonate, magnesium stearate.
Film coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000, quinoline yellow (E104), iron oxide yellow (E172).

Description of the appearance of Coripren and contents of the pack
Coripren 20 mg/10 mg are yellow, circular, biconvex film-coated tablets of 8.5 mm.
Coripren 20 mg/10 mg is available in packs containing 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 Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano, Italy.
Sales Licensee: Italfarmaco S.p.A., Viale F. Testi, 330 - 20126 Milano, Italy
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano, Italy.

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Coripren
Spain: Coripren

Package leaflet: Information for the user

Coripren 20 mg/20 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side 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) and a calcium antagonist (lercanidipine), two drugs that reduce blood pressure.
Coripren is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.

4. What you need to know before taking Coripren

Do not take Coripren:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to a medicine of the same type as those contained in Coripren, e.g. medicines called ACE inhibitors or calcium antagonists.
• if you have previously experienced swelling of the face, lips, mouth, tongue or larynx causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if you have had unexplained or hereditary angioedema.
• if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in areas such as the throat).
• if you have diabetes or kidney problems and are taking medicines containing aliskiren to lower blood pressure.
• if you are more than three months pregnant (Coripren should also be avoided during the first months of pregnancy – see pregnancy section).
• if you suffer from certain heart conditions such as:
  • obstruction of blood flow from the heart
  • untreated heart failure
  • unstable angina (chest pain occurring at rest or worsening progressively)
  • heart attack within the last month.
• if you have severe liver problems.
• if you have severe kidney problems, or if you are on dialysis.
• if you are taking medicines that inhibit liver metabolism such as:
  • antifungals (e.g. ketoconazole, itraconazole)
  • macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin)
  • antivirals (e.g. ritonavir)
• if you are concurrently taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Coripren:

• if you have low blood pressure (you may feel weak or dizzy, especially when standing up)
• if you have been seriously ill (excessive vomiting) or have recently had diarrhoea
• if you are on a low-sodium diet
• if you have heart problems
• if you have a condition affecting the blood vessels in the brain
• if you have kidney problems (including kidney transplant), which may lead to higher potassium levels in the blood, potentially causing serious consequences. Your doctor may decide to adjust your enalapril dose or monitor your blood potassium levels
• if you have liver problems
• if you have blood disorders such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia)
• if you have vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are taking immunosuppressants, allopurinol, procainamide, or any combination of these factors
• if you are of Black African or African-Caribbean origin, as patients of these ethnicities have a higher risk of allergic reactions with swelling of the face, lips, tongue and throat, leading to difficulty in swallowing and breathing while taking ACE inhibitors
• if you have diabetes, you should monitor for possible drops in blood glucose levels, especially during the first month of treatment. Blood potassium levels may also increase
• if you are taking potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium
• if you are over 70 years old
• if you are intolerant to certain sugars (lactose).

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

• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent rejection of transplanted organs or for 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:

• an angiotensin II receptor antagonist (AIIRA) (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 section “Do not take Coripren”.

If you are about to undergo treatment
Inform your doctor that you are taking Coripren if you are about to:

• undergo surgery or receive anaesthesia (including dental anaesthesia)
• undergo a cholesterol-lowering treatment called LDL apheresis
• undergo desensitisation therapy to reduce the effects of allergies to bee or wasp stings.

Inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding (see section
“Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Coripren in children up to 18 years of age have not yet been established.
Other medicines and Coripren
Coripren must not be taken together with certain medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription. This is because when Coripren is taken together with certain medicines, its effect or that of the other medicines may change, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines used to lower blood pressure
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to prevent blood clots). See “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 called antipsychotics
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• certain medicines for pain or arthritis, including gold therapy
• certain cough and cold medicines and 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, quinidine or sotalol (medicines to treat fast heart rate)
• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• digoxin (a medicine used to treat heart problems)
• midazolam (a medicine to help sleep)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
• cimetidine (more than 800 mg), a medicine for ulcers, indigestion or heartburn.

Do not take Coripren if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, due to an increased risk of angioedema (rapid swelling under the skin in areas such as the throat).
If you are taking any of the following medicines, your risk of angioedema may be increased:

• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent rejection of transplanted organs or for cancer (e.g. temsirolimus, sirolimus, everolimus)
• vildagliptin, a medicine used to treat diabetes. Your doctor may consider it necessary to adjust the dose and/or take other precautions:
  • if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take Coripren” and “Warnings and precautions”).

Coripren with food, drinks and alcohol

• Take Coripren at least 15 minutes before a meal.
• A high-fat meal significantly increases drug levels in the blood.
• Alcohol may enhance the effects of Coripren. Do not consume alcohol during treatment with Coripren.
• Coripren must not be taken with grapefruit or grapefruit juice, as they increase its blood pressure-lowering effect (see “Do not take Coripren”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Coripren is not recommended for women who could become pregnant and during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.
Breastfeeding
Coripren must not be used during breastfeeding.
Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness or drowsiness while taking this medicine.
Coripren contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Coripren

Take this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Adults: The recommended dose is one tablet daily, taken at the same time every day, unless otherwise prescribed by your doctor. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablet whole with a little water. See “Coripren with food, drinks and alcohol”.
Patients with kidney problems/elderly patients: Your doctor will determine the appropriate dose based on how well your kidneys are functioning.
If you take more Coripren than you should
Do not exceed the recommended dose. If you take more medicine than prescribed, consult your doctor or go to hospital immediately. Take the pack with you. Taking more than the correct dose may cause excessive lowering of blood pressure and may lead to irregularities or increased heart rate.
If you forget to take Coripren

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

If you stop taking Coripren
Do not stop taking this medicine unless your doctor has told you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coripren may cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Some side effects may be serious.
If you notice any of the following conditions, inform your doctor immediately:
Allergic reaction presenting as swelling of the face, lips, tongue or throat, which may cause
difficulty breathing or swallowing.
At the beginning of treatment with Coripren, you may experience weakness or dizziness or blurred vision;
this is caused by a sudden drop in blood pressure and lying down may help. If this concerns you, discuss it with your doctor.

Side effects observed with Coripren
Common (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 a lower number of platelets;
• Increased potassium levels in the blood;
• Nervousness (anxiety);
• Feeling of dizziness when standing up, vertigo;
• Tachycardia, fast or irregular heartbeat (palpitations);
• Sudden redness of the face, neck or upper chest (hot flushes), low blood pressure;
• Abdominal pain, constipation, feeling unwell (nausea);
• Elevated liver enzyme levels;
• Skin redness;
• Joint pain;
• Increased frequency of urination;
• Feeling of weakness, fatigue, feeling hot, 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, metallic taste in the mouth, diarrhoea, dry mouth, gum swelling;
• Allergic reaction with swelling of the face, lips, tongue or throat and difficulty swallowing or breathing, skin rash, urticaria;
• Need to get up at night to urinate, production of large amounts of urine;
• Impotence.

Additional side effects observed with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, dizziness, weakness or nausea, and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, feeling of lightheadedness caused by low blood pressure, changes in heart rhythm, increased heart rate, angina, shortness of breath, altered sense of taste, increased creatinine levels in blood (usually detected by a test), elevated potassium levels in blood, diarrhoea, abdominal pain, fatigue (tiredness), skin rash, allergic reaction with swelling of the face, lips, tongue or throat and 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, insomnia or drowsiness, tingling or numbness sensation of the skin, heart attack (probably due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (probably due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, chest tightness associated with asthma, reduced intestinal motility (ileus), pancreatitis, vomiting, indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, loss of appetite, itching or hives, hair loss, reduced kidney function, kidney failure, increased sweating, high levels of protein in urine (detected by a test), hot flushes, fast or irregular heartbeat (palpitations), vertigo (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood values such as reduced number of white blood cells, reduced bone marrow function, autoimmune diseases, abnormal dreams or sleep disorders, “Raynaud’s phenomenon” (in which hands and feet may become very cold and white due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as reduced 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 on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin condition involving redness and peeling of the skin, blisters or sores), exfoliative dermatitis/erythroderma (severe skin rash with skin peeling), pemphigus (small fluid-filled blisters on the skin), reduced urine output, breast enlargement in men (gynaecomastia), swelling of glands in the neck, armpits or groin, accumulation of fluid or other substances in the lungs (seen on X-ray), inflammation of cheeks, gums, tongue, lips or throat.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from available data)
Excessive production of antidiuretic hormone, causing fluid retention, resulting in weakness, fatigue or confusion.
A symptomatic complex has been reported which may include some or all of the following symptoms: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.

Lercanidipine
Some side effects may be serious.
If you notice any of the following conditions, inform your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain caused by inadequate blood flow to the heart), allergic reactions (symptoms include itching, skin rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of heart attack may occur.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, increased heart rate, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flushes), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach discomfort, skin rash, itching, muscle pain, increased urine production, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from available data): gum swelling, changes in liver function (detected by blood tests), cloudy fluid (during dialysis through a tube in the abdomen), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. Ask your doctor or pharmacist for further information about side effects, as they have a more complete list of possible side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 which is stated on the blister and the carton after the word
EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture. Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Coripren contains
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
20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).
The other components are:
Core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, sodium hydrogen carbonate, magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), talc, red iron oxide (E172).
Description of the appearance of Coripren and the contents of the pack
Coripren 20 mg/20 mg are orange-colored, circular, biconvex tablets of 12 mm.
Coripren 20 mg/20 mg is available 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 Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.
Concessionaire for sales: Italfarmaco S.p.A., Viale F. Testi, 330 - 20126 Milan, Italy
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.
This medicinal product is authorized in the European Economic Area countries under the following
names:
Italy: Coripren