ROSUVASTATIN/RAMIPRIL EGIS 20 mg/5 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Rosuvastatin/Ramipril Egis 10mg/5mg hard capsules

Rosuvastatin/Ramipril Egis 10mg/10mg hard capsules

Rosuvastatin/Ramipril Egis 20mg/5mg hard capsules

Rosuvastatin/Ramipril Egis 20mg/10mg hard capsules

rosuvastatin/ramipril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Rosuvastatin/Ramipril Egis is and what it is used for
2. What you need to know before you take Rosuvastatin/Ramipril Egis
3. How to take Rosuvastatin/Ramipril Egis
4. Possible side effects
5. Storage of Rosuvastatin/Ramipril Egis
6. Contents of the pack and other information

1. What Rosuvastatin/Ramipril Egis is and what it is used for

This medicine contains two different active substances, rosuvastatin and ramipril, in one single capsule.

Rosuvastatin belongs to a group of medicines called statins, whose function is to regulate lipids (fats).

Ramipril is an angiotensin-converting enzyme inhibitor (ACE inhibitor). In patients who have high blood pressure, it widens the blood vessels, so that the heart has less work to pump blood through them.

Rosuvastatin/Ramipril Egis is used to treat high blood pressure in adults who also have one of the following diseases:

• high levels of cholesterol (primary hypercholesterolemia);
• high levels of cholesterol and fat (triglycerides) at the same time (combined or mixed hyperlipidemia);
• high risk of suffering a heart attack, stroke or other health problems related to rosuvastatin/ramipril that can be reduced.

This medicine is indicated for patients who are already taking a treatment with rosuvastatin/ramipril in separate tablets. Instead of taking rosuvastatin and ramipril in separate tablets, you will take one capsule of rosuvastatin/ramipril that contains the two active substances with the same concentration.

While taking this medicine, you should follow a diet to reduce cholesterol.

Rosuvastatin/Ramipril Egis will not help you lose weight.

2. What you need to know before you take Rosuvastatin/Ramipril Egis

Do not take Rosuvastatin/Ramipril Egis:

• If you are allergic to ramipril, any ACE inhibitor, rosuvastatin, or any of the other ingredients of this medicine (listed in section 6).

The signs of an allergic reaction can include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

• If you have ever suffered a severe allergic reaction called “angioedema”. The signs are itching, hives, red marks on the hands, feet and throat, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you have taken recently (in the last 36 hours) or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, this medicine may not be suitable for you.
• If you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis) or severe renal impairment.
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin/Ramipril Egis, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking this medicine using appropriate contraceptive methods (see the section that appears below “Pregnancy and breastfeeding”).
• If you have abnormally low or unstable blood pressure. Your doctor will need to evaluate you.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have liver disease.
• If you experience repeated or unexplained muscle pain or weakness (myopathy).
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat a viral liver infection called hepatitis C).
• If you are taking a medicine called ciclosporin (which is used, for example, after organ transplants).
• If you have ever developed a severe skin rash or peeling of the skin, blisters or ulcers in the mouth after taking Rosuvastatin/Ramipril Egis or other medicines that contain rosuvastatin.

Do not take Rosuvastatin/Ramipril Egis if any of the above conditions apply to you. If you are not sure, talk to your doctor before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatin/Ramipril Egis if:

• You have heart, liver or kidney problems.
• You have lost a lot of body salts or fluids (because you have had vomiting, diarrhea, have sweated more than usual, are on a low-salt diet, have been taking diuretics for a long time, or have had dialysis).
• You are going to undergo a treatment to reduce your allergy to bee or wasp stings (desensitization).
• You are going to receive an anesthetic. You may be given it to undergo an operation or for some dental treatment. You will need to stop taking Rosuvastatin/Ramipril Egis one day before. Ask your doctor for advice.
• Your potassium level in the blood is high (blood test results).
• You are taking any medicine or have any disease that may reduce sodium levels in the blood. Your doctor will regularly perform blood tests, especially to check sodium levels in the blood (especially in elderly people).
• You are taking any medicine that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril), or sacubitril/valsartan. For more information on sacubitril/valsartan, see section 2 “Do not take Rosuvastatin/Ramipril Egis”.
• You have a connective tissue disease, such as scleroderma or systemic lupus erythematosus.
• You are taking any of the following medicines to treat high blood pressure:

• angiotensin II receptor antagonists (ARBs) (also known as the “sartan” group, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes.
• aliskiren. Your doctor will evaluate your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in the blood at regular intervals. See also the information in the section “Do not take Rosuvastatin/Ramipril Egis”.

• You have had repeated or unexplained muscle pain, have a personal or family history of muscle problems, or have had muscle problems when taking another cholesterol-lowering medicine. Tell your doctor immediately if you experience unexplained muscle pain, especially if you feel dizzy or have a fever. Also, talk to your doctor or pharmacist if you feel constant muscle weakness.
• You have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).
• You regularly drink a lot of alcohol.
• Your thyroid does not work properly (hypothyroidism).
• You are taking other medicines called fibrates to lower your cholesterol (see the section “Other medicines and Rosuvastatin/Ramipril Egis”).
• You are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see the section “Other medicines and Rosuvastatin/Ramipril Egis”.
• You are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatin/Ramipril Egis can cause serious muscle problems (rhabdomyolysis), see the section “Other medicines and Rosuvastatin/Ramipril Egis”.
• You are over 70 years old (your doctor will decide what dose of rosuvastatin/ramipril is suitable for you).
• You have severe respiratory failure.
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor will decide what dose of rosuvastatin/ramipril is suitable for you.

If any of the above applies to you (or you are not sure), talk to your doctor before taking this medicine.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop taking Rosuvastatin/Ramipril Egis and seek medical attention immediatelyif you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This can be identified by a simple test that shows if the levels of liver enzymes in the blood are elevated. For this reason, your doctor will regularly perform this blood test (liver function test) during treatment with rosuvastatin/ramipril. It is essential that you attend your doctor's appointments to undergo the prescribed tests.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing it. You may be at risk of developing diabetes if your blood sugar and fat levels are high, you are overweight, and you have high blood pressure.

Children and adolescents

The use of Rosuvastatin/Ramipril Egis is not recommended in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ramipril Egis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Rosuvastatin/Ramipril Egis may affect the way other medicines work. Also, other medicines may affect the way rosuvastatin/ramipril works.

Tell your doctor if you are taking any of the following medicines:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure.
• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Rosuvastatin/Ramipril Egis”).
• Ciclosporin (a medicine used, for example, after organ transplants to prevent rejection of the transplanted organ). Do not take this medicine while taking ciclosporin.
• Medicines used to treat cancer (chemotherapy, such as regorafenib, darolutamide).
• Diuretics, such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or with sulfamethoxazole (for infections), and heparin (an anticoagulant).
• Corticosteroids used to treat inflammation, such as prednisolone.
• Allopurinol (used to reduce uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhea).
• It is possible that your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information in the sections “Do not take Rosuvastatin/Ramipril Egis” and “Warnings and precautions”).
• Medicines for diabetes, such as oral glucose-lowering medicines and insulin. Rosuvastatin/ramipril may lower blood sugar levels. Check your blood sugar levels carefully while taking this medicine.
• Lithium (for mental health problems). Rosuvastatin/ramipril may increase lithium levels in the blood. Your doctor will need to check your lithium levels carefully.
• Warfarin, ticagrelor, or clopidogrel, or any other medicine used to prevent blood clotting (its anticoagulant effect and the risk of bleeding may increase if taken with this medicine).
• Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe). During concomitant use, the effect of rosuvastatin increases.
• Medicines for indigestion that contain aluminum and magnesium (used to neutralize stomach acid; decrease plasma levels of rosuvastatin). This effect can be mitigated if this type of medicine is taken 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases if used concomitantly.
• Fusidic acid (an antibiotic). If you need to take fusidic acid to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking Rosuvastatin/Ramipril Egis again. Taking this medicine with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• An oral contraceptive (the pill). The levels of sex hormones absorbed by the oral contraceptive increase.
• Capmatinib (used to treat cancer);
• Hormone replacement therapy (elevated hormone levels in the blood).
• Fostamatinib (used to treat low platelet counts);
• Febuxostat (used to treat and prevent high uric acid levels in the blood);
• Teriflunomide (used to treat multiple sclerosis);
• Antivirals such as ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (used to treat infections, including HIV and hepatitis C). See sections “Do not take Rosuvastatin/Ramipril Egis” and “Warnings and precautions”.

If any of the above applies to you (or you are not sure), talk to your doctor before taking this medicine.

If you go to the hospital or receive treatment for another illness, tell the doctors that you are taking rosuvastatin/ramipril.

Taking Rosuvastatin/Ramipril Egis with alcohol

If you drink alcohol while taking rosuvastatin/ramipril, you may feel dizzy or drowsy. If you want to know how much alcohol you can drink while taking this medicine, talk to your doctor, as medicines used to lower blood pressure and alcohol can have addictive effects.

Pregnancy and breastfeeding

Pregnancy

Do not take rosuvastatin/ramipril if you are pregnant, trying to become pregnant, or think you may be pregnant, as its use during pregnancy may be harmful to the baby. If you become pregnant while taking Rosuvastatin/Ramipril Egis, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking this medicine using appropriate contraceptive methods.

Breastfeeding

Do not take rosuvastatin/ramipril if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines

Some people feel dizzy after taking Rosuvastatin/Ramipril Egis. If you feel dizzy, talk to your doctor before driving or using machines.

Rosuvastatin/Ramipril Egis contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially “sodium-free”.

3. How to take Rosuvastatin/Ramipril Egis

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

You should maintain a low-cholesterol diet while taking Rosuvastatin/Ramipril Egis.

The recommended dose is one capsule of the established dose.

Take Rosuvastatin/Ramipril Egis once a day.

Take the capsule at the same time every day with or without food. The capsule should be swallowed whole with a little water.

Use in children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

If you take more Rosuvastatin/Ramipril Egis than you should

Talk to your doctor or go to the nearest hospital emergency department because you may need medical attention. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Take the medicine package with you so that the doctor knows what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forgot to take Rosuvastatina/Ramipril Egis

Do not worry, skip the missed dose and take the next dose that corresponds to you at the established time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Rosuvastatina/Ramipril Egis

Talk to your doctor if you want to stop taking rosuvastatina/ramipril.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause side effects, although not all people suffer from them.

It is essential that you know how these side effects will be.

Stop taking Rosuvastatina/Ramipril Egis and seek immediate medical attention if you experience any of the following side effects. You may need urgent medical treatment:

• Swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing and swallowing, as well as itching and skin rashes. This can be a sign of a severe allergic reaction to Rosuvastatina/Ramipril Egis.
• Severe skin reactions, such as circular or target-like red patches, not elevated on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome) and worsen due to a pre-existing skin condition (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
• Widespread skin rash, elevated body temperature, and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS] or drug hypersensitivity syndrome).
• Unusual muscle pains that last longer than expected. In rare cases, these can become potentially life-threatening muscle damage known as rhabdomyolysis, which causes general discomfort, fever, and kidney failure.
• Lupus-like syndromes (including skin rashes, joint disorders, and blood consequences).
• Muscle rupture.

Talk to your doctor immediately if you experience:

• Fast heart rate, strong or irregular heartbeats (palpitations), chest pain, chest tightness, or more serious problems, such as myocardial infarction or stroke.
• Difficulty breathing or coughing. These symptoms can be signs of lung problems.
• Bruises that appear more easily, bleeding that lasts longer than usual, any sign of bleeding (e.g., gum bleeding), purple spots on the skin, or getting infections more easily than usual, sore throat, and fever, fatigue, dizziness, or paleness. These symptoms can indicate the presence of blood or bone marrow problems.
• Severe stomach pain that can reach the back. This pain can be a sign of pancreatitis (inflammation of the pancreas).

• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These symptoms can be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other side effects

Tell your doctor if any of the following symptoms worsen or last more than a few days.

Frequent(may affect up to 1 in 10 people)

• Headache or feeling of fatigue or weakness.
• Dizziness.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.

• Dry cough with tingling, inflammation of the paranasal sinuses (sinusitis) or bronchitis, feeling of insufficient breathing.
• Stomach or intestinal pain, constipation, diarrhea, dyspepsia, nausea, or vomiting.
• Skin rash with or without elevation in the area.
• Chest pain.
• Muscle cramps or muscle pains.
• Higher than normal potassium levels in the blood observed in blood tests.
• Diabetes. It is more likely if your blood sugar and fat levels are high, you are overweight, and you have high blood pressure. Your doctor will monitor you while you take this medication.

Uncommon(may affect up to 1 in 100 people)

• Balance problems (vertigo).
• Itching and unusual skin sensitivity, such as numbness, tingling, pinching, or prickling

in the skin (paresthesia).

• Loss or change of taste.
• Sleep problems, including drowsiness.
• Feeling of depression, anxiety, increased nervousness, or concern.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Severe stomach pain (inflamed pancreas).
• Intestinal inflammation called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, dry mouth.
• Frequent urination throughout the day.
• More sweating than usual.
• Loss or decreased appetite (anorexia).
• Increased or irregular heartbeats.
• Swollen arms and legs. This can be a sign that your body is retaining more water than usual.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.

• Impotence in men and decreased libido in men and women.
• Increased number of certain white blood cells (eosinophilia) observed in blood tests.
• Blood tests showing changes in the way the liver, pancreas, or kidneys function.
• Skin rash, itching, or other skin reactions.

• Increased protein in the urine. It usually returns to normal on its own without having to stop taking this medication.

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

• Feeling of instability or confusion.
• Vascular stenosis, reduced perfusion through blood vessels (hypoperfusion), inflammation of blood vessels (vasculitis)
• Red and swollen tongue.
• Severe skin peeling, bulging rash with itching.
• Nail problems (e.g., loss or separation of a nail from the bed).
• Skin rash or bruising.
• Spots on the skin and coldness in the extremities.
• Red, swollen, itchy, or teary eyes.
• Altered hearing and ringing in the ear.
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin observed in blood tests.

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

• Being more sensitive to the sun than usual.
• Jaundice (yellowish color of the skin and eyes), hepatitis (inflammation of the liver), blood in the urine, nerve damage in the legs and arms (such as numbness), joint pain, memory loss, and increased breast size in men (gynecomastia).

Frequency not known(cannot be estimated from the available data)

• Difficulty concentrating.
• Swollen mouth.
• Very low number of blood cells (of all types) observed in blood tests
• Lower than normal sodium level observed in blood tests.
• Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and convulsions due to inadequate secretion of vasopressin (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Depression
• Fingers and toes that change color when cold and then tingling or pain when warming up (Raynaud's phenomenon).
• Slowed or altered reactions.
• Feeling of prickling.
• Alteration of the way things smell.
• Hair loss.
• Cough.
• Sleep disorders, including insomnia and nightmares.
• Tendon injuries and constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of side effects

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

5. Storage of Rosuvastatina/Ramipril Egis

Keep this medication out of sight and reach of children.

Store below 25°C in the original packaging to protect it from moisture and light.

Do not use this medication after the expiration date shown on the box and blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rosuvastatina/Ramipril Egis

The active ingredients are rosuvastatina and ramipril.

Rosuvastatina/Ramipril Egis 10 mg/5 mg hard capsules:

Each capsule contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina and 5 mg of ramipril.

Rosuvastatina/Ramipril Egis 10 mg/10 mg hard capsules:

Each capsule contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina and 10 mg of ramipril.

Rosuvastatina/Ramipril Egis 20 mg/5 mg hard capsules:

Each capsule contains rosuvastatina calcium equivalent to 20 mg of rosuvastatina and 5 mg of ramipril.

Rosuvastatina/Ramipril Egis 20 mg/10 mg hard capsules:

Each capsule contains rosuvastatina calcium equivalent to 20 mg of rosuvastatina and 10 mg of ramipril

The other components are:

Capsule content:silicified microcrystalline cellulose (microcrystalline cellulose [E460]; anhydrous colloidal silica [E551]); magnesium stearate (E572); anhydrous colloidal silica [E551]); microcrystalline cellulose (E460); crospovidone type B; hypromellose; sodium stearyl fumarate; hydrophobic colloidal silica; yellow iron oxide (E172).

Capsule shell:

Rosuvastatina/Ramipril Egis 10 mg/5 mg hard capsules:

titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide, gelatin.

Rosuvastatina/Ramipril Egis 10 mg/10 mg hard capsules:

titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), gelatin.

Rosuvastatina/Ramipril Egis 20 mg/5 mg hard capsules:

titanium dioxide (E171), red iron oxide (E172), black iron oxide, gelatin.

Rosuvastatina/Ramipril Egis 20 mg/10 mg hard capsules:

titanium dioxide (E171), red iron oxide (E172), gelatin.

Appearance of the product Rosuvastatina/Ramipril Egis and package contents

Rosuvastatina/Ramipril Egis 10 mg/5 mg hard capsules:

hard gelatin capsule without any marking, with Coni-Snap type autoblocking system, size 2, with white body and red terra cotta cap filled with two tablets.

Rosuvastatina/Ramipril Egis 10 mg/10 mg hard capsules:

hard gelatin capsule without any marking, with Coni-Snap type autoblocking system, size 0, with pink body and red terra cotta cap filled with two tablets.

Rosuvastatina/Ramipril Egis 20 mg/5 mg hard capsules:

hard gelatin capsule without any marking, with Coni-Snap type autoblocking system, size 0, with white body and brown oxidized cap filled with two tablets.

Rosuvastatina/Ramipril Egis 20 mg/10 mg hard capsules:

hard gelatin capsule without any marking, with Coni-Snap type autoblocking system, size 0, with pink body and brown oxidized cap filled with two tablets.

Package sizes: 30, 60, 90, or 100 hard capsules in OPA/ALU/PVC//ALU blisters packaged in a cardboard box.

Not all package sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary

Manufacturers

Egis Pharmaceuticals PLC

1165 Budapest, Bökényföldi út 118-120.

Hungary

Or

Egis Pharmaceuticals PLC

9900 Körmend, Mátyás király u. 65.

Hungary

Or

Lek Pharmaceuticals d.d.

1526 Ljubljana, Verovškova Ulica 57

Slovenia

This medication is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this leaflet: August 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/