Atover

Package leaflet: Information for the user

Atover 10 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
Please read all of 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atover is and what it is used for

Atover is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Atover is indicated for the treatment of high blood pressure (hypertension) in adult patients whose blood pressure has not been adequately controlled with lercanidipine 10 mg alone.
Atover is not indicated for the initial treatment of hypertension.

2. What you need to know before taking Atover

Do not take Atover:

• 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 similar type of medicine as those contained in Atover, 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 causes.
• 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 lower blood pressure.
• if you are more than three months pregnant (Atover should also be avoided during the first months of pregnancy – see section on pregnancy).
• if you have 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 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:
• antifungal agents (e.g. ketoconazole, itraconazole).
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
• antiviral agents (e.g. ritonavir).
• if you are currently 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 Atover:

• 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 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 origin, you should be aware that black patients 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 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 potassium-containing salt substitutes
• 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 and 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 regularly check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood. See also the section “Do not take Atover”.

If you are about to undergo treatment
Inform your doctor that you are taking Atover 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 Atover in children up to 18 years of age have not yet been established.
Other medicines and Atover
Atover 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 not requiring a prescription. This is because when Atover 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 Atover”
• lithium (a medicine used to treat a certain type of depression)
• antidepressant medicines 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 a “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 the treatment of 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 Atover 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 for prevention of 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 Atover” and “Warnings and precautions”).

Atover with food, drinks and alcohol

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

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 Atover before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Atover. Atover 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
Atover 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.
Atover contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Atover

Take this medicine exactly as your doctor has told you. If you are unsure, 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 "Atover with food, drinks and alcohol".
Patients with kidney problems/elderly patients: Your doctor will decide the appropriate dose based on how well your kidneys are functioning.
If you take more Atover than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or go to hospital immediately. Take the package with you. Taking more than the correct dose may cause excessive lowering of blood pressure and irregularities or acceleration of heart rate.
If you forget to take Atover

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

If you stop taking Atover
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, Atover can 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, contact 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 Atover, 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 Atover
Common (may affect up to 1 in 10 people)

• Cough;
• Dizziness, headache.

Uncommon (may affect up to 1 in 100 people)

• Changes in blood values, such as reduced platelet count;
• Increased potassium levels in the blood;
• Nervousness (anxiety);
• 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, light-headedness due to low blood pressure, changes in heart rhythm, increased heart rate, angina, shortness of breath, altered taste, increased creatinine levels in blood (usually detected by blood tests), elevated potassium levels in blood, diarrhoea, abdominal pain, tiredness (fatigue), skin rash, allergic reaction with swelling of 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 hives, hair loss, reduced kidney function, kidney failure, increased sweating, high levels of protein in urine (detected by urine test), muscle cramps, general feeling of being unwell, high temperature (fever), low levels of sugar or sodium in blood, high levels of urea in blood (all detected by blood tests), hot flushes, fast or irregular heartbeat (palpitations), dizziness (feeling 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 levels of liver enzymes or bilirubin (measured by blood tests), erythema multiforme (red spots of various shapes on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition causing redness, peeling of the skin, blisters or sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling of the skin), pemphigus (small fluid-filled blisters on the skin), reduced urine production, breast enlargement in men (gynecomastia), 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, 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 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 can be serious.
If you notice any of the following conditions, contact 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 have been observed.

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 ache, skin rash, itching, muscle pain, production of large amounts of urine, 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): 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 Atover

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 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 Atover 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 carboxymethylstarch type A, povidone K30, sodium hydrogen carbonate, magnesium stearate.
Film coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000.
Description of the appearance of Atover and contents of the pack
Atover 10 mg/10 mg are white, circular, biconvex film-coated tablets of 8.5 mm.
Atover 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 Authorization Holder and Manufacturer
Marketing Authorization Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano.
Manufacturers:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milano, Italy.
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’ Stampi, 20089 Rozzano (MI), Italy.
This medicinal product is authorized in the European Economic Area Member States under the following names:
Germany: Carmen ACE
Italy: Atover
Spain: Lercapress

Package leaflet: Information for the user

Atover 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atover is and what it is used for

Atover is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two drugs that reduce blood pressure.
Atover 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. Atover is not indicated for the initial treatment of hypertension.

3. What you need to know before taking Atover

Do not take Atover:

• 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 Atover, 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 was hereditary.
• 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, e.g. 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 (it is also advisable to avoid Atover 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 hepatic metabolism such as:
  • antifungals (e.g. ketoconazole, itraconazole).
  • macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin).
  • antivirals (e.g. ritonavir).
• if you are currently 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 Atover:

• 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 African descent, you should be aware that patients of African 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 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 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 regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “Do not take Atover”.

If you are about to undergo treatment
Inform your doctor that you are taking Atover 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 Atover in children up to 18 years of age have not yet been established.
Other medicines and Atover
Atover 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 medicines, including those without a prescription. This is because when Atover 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 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 Atover”
• lithium (a medicine used to treat a certain type of depression)
• antidepressants 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 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 that helps you 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 Atover 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, e.g. 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 your 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 Atover” and “Warnings and precautions”).

Atover with food, drinks and alcohol

• Take Atover 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 Atover. Do not drink alcohol during treatment with Atover.
• Atover must not be taken with grapefruit or grapefruit juice, as these increase its hypotensive effect (see “Do not take Atover”).

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 Atover before becoming pregnant or as soon as you know you are pregnant, and will recommend
an alternative medicine. Atover is not recommended during 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
Atover 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.
Atover contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Atover

Take this medicine exactly as directed 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 "Atover with food, drinks and alcohol".
Patients with kidney problems/elderly patients: Your doctor will determine the dose of the medicine based on how well your kidneys are functioning.
If you take more Atover than you should
Do not exceed the recommended doses. If you take more medicine than prescribed, consult your doctor or go immediately to the hospital. Bring the pack with you. Taking a higher dose than recommended may cause excessive lowering of blood pressure and the occurrence of irregularities or increased heart rate.
If you forget to take Atover

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

If you stop taking Atover
Do not stop taking this medicine unless your doctor has told you to.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atover can cause side effects, although not everyone experiences them.
The following side effects may occur with this medicine:
Some side effects can 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 Atover, 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 Atover
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 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);
• Increased 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, lightheadedness due to low blood pressure, changes in heart rhythm, increased heart rate, angina, shortness of breath, altered taste, increased creatinine levels in blood (usually detected by blood test), elevated potassium levels in blood, diarrhoea, abdominal pain, fatigue (tiredness), skin rash, allergic reaction with swelling of 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 (likely due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (likely 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 urine test), muscle cramps, general feeling of being unwell, high temperature (fever), low blood sugar or sodium levels, elevated blood urea levels (all detected by blood test), hot flushes, fast 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 test values such as reduced white blood cell count, 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 liver enzymes or bilirubin levels (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 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, leading to weakness, fatigue or confusion.
A syndrome 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, 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 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, production of large amounts of urine, feeling of weakness or tiredness.
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): swollen gums, changes in liver function (detected by blood tests), cloudy fluid (during peritoneal dialysis), swelling of 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, please inform 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 Atover

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 medicines 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 Atover 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 carboxymethyl starch 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 Atover and contents of the pack
Atover 20 mg/10 mg are yellow, round, biconvex film-coated tablets of 8.5 mm.
Atover 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 Milan, Italy.

Manufacturers:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy.
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’ Stampi, 20089 Rozzano (MI), Italy.

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Carmen ACE
Italy: Atover
Spain: Lercapress

Package leaflet: Information for the user

Atover 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 they have the same symptoms as yours, because 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 Atover is and what it is used for
2. What you need to know before taking Atover
3. How to take Atover
4. Possible side effects
5. How to store Atover
6. Contents of the pack and other information

1. What Atover is and what it is used for

Atover is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Atover 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 Atover

Do not take Atover:

• 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 Atover, e.g. drugs known as 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 type of 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 lower blood pressure.
• if you are more than three months pregnant (Atover should also be avoided during the early 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 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 currently 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 Atover:

• if you have low blood pressure (you may feel weak or dizzy, especially when standing up)
• if you have been severely 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, 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 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 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 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 Atover”.

If you are about to undergo treatment
Inform your doctor that you are taking Atover 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 allergic reactions 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 Atover in children up to 18 years of age have not yet been established.
Other medicines and Atover
Atover 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 medicines, including those without a prescription. This is because when Atover is taken together with certain medicines, its effect or that 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 intended 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 organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting). See “Do not take Atover”
• lithium (a medicine used to treat a certain type of depression)
• antidepressant medicines called tricyclic antidepressants
• medicines for mental disorders called antipsychotics
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to 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 to treat rapid heartbeat)
• phenytoin, phenobarbital or carbamazepine (epilepsy medicines)
• rifampicin (a medicine used to treat tuberculosis)
• digoxin (a medicine used to treat heart problems)
• midazolam (a medicine that helps with 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 Atover 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 Atover” and “Warnings and precautions”).

Atover with food, drinks and alcohol

• Take Atover 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 Atover. Do not consume alcohol during treatment with Atover.
• Atover must not be taken with grapefruit or grapefruit juice, as these increase its hypotensive effect (see “Do not take Atover”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Atover is not recommended for women
who may 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 baby if used after the third month of pregnancy.
Breastfeeding
Atover 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.
Atover contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Atover

Take this medicine exactly as your doctor has told you. If you are unsure, 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. Swallow the tablet whole with a small amount of water. See "Atover with food, drink and alcohol".
Patients with kidney problems/elderly patients: Your doctor will decide the dose of the medicine based on how well your kidneys are working.
If you take more Atover 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 irregularities or acceleration of heart rate.
If you forget to take Atover

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

If you stop taking Atover
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atover can 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, contact 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 Atover, you may experience weakness or dizziness or have blurred vision;
this is caused by a sudden drop in blood pressure and lying down may help. If you are concerned, speak to your doctor.
Side effects observed with Atover
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 results, 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 of discomfort (nausea);
• Higher levels of liver enzymes;
• 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, light-headed feeling caused by low blood pressure, changes in heart rhythm, increased heart rate, angina, shortness of breath, altered sense of taste, 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 sensation in the skin, heart attack (likely due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (likely 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, fast 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 test results 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 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 the available data)
Excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, tiredness, or confusion.
A syndrome 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, contact 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 tiredness.
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): gum swelling, changes in liver function (detected by blood tests), cloudy 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 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; 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 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 Atover

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 following 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 Atover 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 carboxymethylamidone, 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 Atover and contents of the pack
Atover 20 mg/20 mg are orange-colored, circular, biconvex tablets, 12 mm in diameter.
Atover 20 mg/20 mg is available in packs containing 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 and 100 film-coated 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.
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:
Germany: Carmen ACE
Italy: Atover
Spain: Lercapress