RAMIPRIL/BISOPROLOL EGIS 5 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Ramipril/Bisoprolol Egis5 mg/5 mg hard capsules

Ramipril/Bisoprolol Egis5 mg/10 mg hard capsules

Ramipril/Bisoprolol Egis10 mg/5 mg hard capsules

Ramipril/Bisoprolol Egis10 mg/10 mg hard capsules

ramipril/bisoprolol fumarate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ramipril/Bisoprolol Egis and what is it used for
2. What you need to know before taking Ramipril/Bisoprolol Egis
3. How to take Ramipril/Bisoprolol Egis
4. Possible side effects
5. Storage of Ramipril/Bisoprolol Egis
6. Package contents and additional information

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

Ramipril/Bisoprolol Egis hard capsules contain two different active substances, ramipril and bisoprolol, in a single capsule. Both substances help control high blood pressure:

• Ramipril belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by reducing the production of substances that can increase blood pressure. It causes the blood vessels to relax and widen, making it easier for the heart to pump blood throughout the body.
• Bisoprolol belongs to a group of medications called beta blockers. These medications work by affecting the body's response to certain nerve impulses, mainly in the heart. As a result, bisoprolol slows the heart rate and makes the heart pump blood more efficiently throughout the body.

Ramipril/Bisoprolol Egis hard capsules are a medication used in adults to treat high blood pressure (hypertension) or hypertension with chronic coronary artery disease (a disease in which the blood supply to the heart is reduced or blocked) in patients with

• certain diseases that affect the heart and blood vessels (history of coronary heart disease or stroke, or peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor, and/or
• chronic heart failure with left ventricular dysfunction (a disease in which the heart is unable to pump enough blood to meet the body's needs, leading to shortness of breath and swelling) to reduce the risk of cardiac events, such as myocardial infarction in patients who have already suffered a myocardial infarction.

Your doctor may prescribe a fixed-dose combination of Ramipril/Bisoprolol Egis hard capsules if you are already taking ramipril and bisoprolol at the same dose and frequency for at least four weeks, but as separate products.

2. What you need to know before taking Ramipril/bisoprolol Egis

Do not takeRamipril/bisoprolol Egishard capsules:

• if you are allergic to ramipril, any other ACE inhibitor medicine, bisoprolol, 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 had a severe allergic reaction called “angioedema”. The signs include itching, hives, red marks on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• if you have recently taken or are currently 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, treatment with ramipril/bisoprolol may not be suitable for you.
• if you have kidney problems where the blood flow to the kidney is reduced (renal artery stenosis),
• if you are pregnant for more than 3 months (it is also best to avoid ramipril/bisoprolol at the beginning of pregnancy; see the section ‘Pregnancy and breastfeeding’).
• if your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you have acute heart failure or if your heart failure worsens, requiring the injection of medicines into a vein that increase the heart's contractile force.
• if you have cardiogenic shock, which is a severe acute heart condition caused by abnormal heart function and leading to low blood pressure and circulatory failure.
• if you have certain heart conditions that cause a very slow heart rate or irregular heartbeats (second or third degree atrioventricular block without a pacemaker, sinoatrial block, sick sinus syndrome).
• if you have a slow heart rate, which causes discomfort.
• if you have severe asthma.
• if you have severe blood circulation problems in the limbs (such as Raynaud's syndrome), which can cause numbness, tingling, or discoloration of the fingers and toes when exposed to cold.
• if you have an untreated phaeochromocytoma, which is a rare tumor of the adrenal gland.
• in case of a metabolic disorder when there is too much acid in the blood (metabolic acidosis).

If you are not sure, consult your doctor before taking ramipril/bisoprolol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ramipril/bisoprolol.

You must inform your doctor if you have or have had any of the following diseases. It is possible that your doctor will want to take special measures (for example, administer additional treatment or perform more frequent checks):

• if you have less severe respiratory diseases, such as asthma or other chronic obstructive pulmonary disease;
• if you have diabetes;
• if you are on a strict diet or fasting;
• if you are going to undergo treatment to reduce the effects of an allergy to bee or wasp stings (desensitization). This medicine may make it more likely that you experience an allergic reaction, or that such a reaction is more severe.
• if you have heart rhythm disorders or vascular muscle spasm, which can cause coronary perfusion disorders (Prinzmetal's angina or first-degree atrioventricular block);
• if you have heart failure or any other heart problem;
• if the heart or brain has a deficient oxygen supply;
• if you have less severe blood circulation problems in the limbs;
• if you have or have had a scaly skin rash (psoriasis);
• if you have thyroid disorders. Ramipril/bisoprolol may mask the symptoms of an overactive thyroid;
• in case of treated phaeochromocytoma, which is a rare tumor of the adrenal gland;
• if you are going to receive anesthesia. It may be administered for an operation or for any dental procedure. You may need to stop treatment a day in advance; ask your doctor for advice,
• if you have angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). This can occur at any time during treatment. If you have such symptoms, you must stop taking ramipril/bisoprolol and see a doctor immediately.
• if you have abdominal pain, vomiting, and diarrhea. This could be a sign of intestinal angioedema;
• if you are black, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering your blood pressure than in patients who are not black;
• if you are taking any of the following medicines, the risk of angioedema may increase:

• vildagliptin and other medicines belonging to the class of so-called gliptins (used to treat diabetes),
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ rejection or to treat cancer).

• if you are elderly;
• if you have kidney problems (including kidney transplant);
• if you have liver problems;
• if you have aortic and mitral valve stenosis (narrowing of the valve that allows blood to leave the heart or narrowing of the valve between the left atrium and left ventricle of the heart) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
• if you have lost a lot of body salts or fluids (due to illness/vomiting, having diarrhea, sweating more than usual, following a low-salt diet, taking diuretics (water pills) for a long time, or having undergone dialysis);
• if you have high levels of potassium in your blood (as shown by blood test results);
• if you are taking medicines or have diseases that can lower the levels of sodium in your blood. Your doctor may perform periodic blood tests, especially to check the levels of sodium in your blood, especially if you are elderly;
• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma;
• if you are taking any of the following medicines used to treat high blood pressure:

• an “angiotensin II receptor blocker” (ARB) (also known as sartans, for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals. See also the information under the heading “Do not take Ramipril/bisoprolol Egis hard capsules”.

• You must inform your doctor if you think you are (or might become) pregnant. Ramipril/bisoprolol Egis is not recommended during the first 3 months of pregnancy, and must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

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

Other medicines and Ramipril/bisoprolol Egis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because ramipril/bisoprolol can affect how other medicines work. Some medicines can also affect how ramipril/bisoprolol works.

Your doctor may need to change your dose, take other precautions, or even ask you to stop taking one of the medicines. Make sure to tell your doctor if you are taking any of the following medicines:

• sacubitril and valsartan used to treat a type of long-term (chronic) heart failure. Do not take ramipril/bisoprolol with medicines that contain sacubitril/valsartan. If you have been taking sacubitril/valsartan, wait 36 hours after taking the last dose of sacubitril/valsartan before starting to take ramipril/bisoprolol (see “Do not take Ramipril/bisoprolol Egis hard capsules”). If you stop taking ramipril/bisoprolol, wait 36 hours after taking the last dose of ramipril/bisoprolol before starting to take sacubitril/valsartan.
• angiotensin II receptor blocker (ARB) (also known as sartans, for example, valsartan, telmisartan, irbesartan) or aliskiren (see also the information under the headings “Do not take Ramipril/bisoprolol Egis hard capsules” and “Warnings and precautions”).
• certain medicines used to treat high blood pressure, angina, or irregular heartbeats (calcium antagonists such as verapamil, diltiazem, felodipine, amlodipine).
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine (so-called centrally acting antihypertensives): do not stop taking these medicines without consulting your doctor first.
• certain medicines used to treat irregular or abnormal heartbeats, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone, procainamide).

• cardiac glycosides (medicines used to treat heart failure, such as digoxin).
• diuretics (water pills) such as furosemide, spironolactone, triamterene, amiloride.
• any medicine that can lower blood pressure as a desired or undesired effect, such as:

• medicines used to treat high blood pressure,
• certain medicines for depression, such as imipramine, desipramine, nortriptyline, amitriptyline, mirtazapine,
• certain medicines used to treat epilepsy or during anesthesia (barbiturates, such as phenobarbital),
• certain medicines used to treat mental illnesses characterized by a loss of contact with reality (phenothiazines, such as levomepromazine, chlorpromazine, and promethazine),
• nitrates (used to treat or prevent angina),
• baclofen, a muscle relaxant,
• medicines used to treat benign prostatic hyperplasia, such as alfuzosin, doxazosin, prazosin, tamsulosin, terazosin.

• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (so-called parasympathomimetics, such as rivastigmine or carbacol).
• certain medicines for depression, called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.
• beta-blocker medicines for local application (such as timolol in eye drops for the treatment of glaucoma).
• medicines for diabetes, such as oral hypoglycemic agents (for example, metformin, linagliptin, saxagliptin, sitagliptin, and vildagliptin) and insulin. Ramipril/bisoprolol may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking this medicine.
• anesthetic agents.
• medicines used to relieve pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac, or indomethacin, and high doses of acetylsalicylic acid).
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as isoprenaline, dobutamine, norepinephrine, epinephrine, ephedrine, dopamine. Your doctor will need to monitor your blood pressure.
• mefloquine (used to prevent or treat malaria).
• cancer medicines (chemotherapy).
• medicines that can increase the amount of potassium in your blood, such as potassium supplements (including salt substitutes), and other medicines that can increase the amount of potassium in your blood, such as trimethoprim alone or in combination with sulfamethoxazole (for bacterial infections), heparin (a medicine used to thin the blood to prevent clots),
• medicines to prevent organ rejection after a transplant, such as cyclosporine,
• allopurinol (used to reduce uric acid in the blood).
• lithium (for mental health problems). Ramipril/bisoprolol Egis may increase the amount of lithium in your blood. Your doctor will need to closely monitor your lithium levels.
• steroid medicines for inflammation, such as prednisolone.
• temsirolimus, everolimus, sirolimus (used to prevent organ rejection or to treat cancer) and other medicines belonging to the class of so-called mTOR inhibitors.
• medicines called neprilysin inhibitors (NEP), such as racecadotril (used against diarrhea).

Ramipril/bisoprolol Egis with alcohol

Drinking alcohol during treatment with ramipril/bisoprolol may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking this medicine, discuss it with your doctor, as medicines used to lower blood pressure and alcohol can enhance each other's sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant.

You must not take ramipril/bisoprolol in the first 12 weeks of pregnancy, and you must not take it at all after the 13th week, as its use during pregnancy may be harmful to your baby.

If you become pregnant while taking ramipril/bisoprolol, inform your doctor immediately. You should be switched to an alternative treatment before planning a pregnancy.

Breastfeeding

Ramipril/bisoprolol is not recommended if you are breastfeeding.

Driving and using machines

Ramipril/bisoprolol Egis may affect your ability to drive or use machines. If this medicine makes you feel dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately.

Ramipril/bisoprolol Egis contains sodium

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

Ramipril/bisoprolol Egis 10 mg/5 mg hard capsules and Ramipril/bisoprolol Egis 10 mg/10 mg hard capsules contain carmoisine, azorubine

Carmoisine, azorubine may cause allergic reactions.

3. How to take Ramipril/bisoprolol Egis

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

Use in adults

The recommended dose is one capsule daily of the dose prescribed by your doctor.

Swallow the capsule whole without chewing, with a little liquid in the morning, with or without food.

Use in kidney disease

If you have kidney disease, your doctor may choose a lower dose of ramipril/bisoprolol.

Use in liver disease

Ramipril/bisoprolol is not suitable for you and you must not take it if you have liver failure.

Use in children and adolescents

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

If you take more Ramipril/bisoprolol Egis than you should

Inform your doctor or go immediately to the emergency department of the nearest hospital. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Take the medicine package with you. This will help the doctor know what you have taken.

If you forget to take Ramipril/bisoprolol Egis

If you forget to take a dose of ramipril/bisoprolol, 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 Ramipril/bisoprolol Egis

Do not stop taking ramipril/bisoprolol suddenly. Talk to your doctor if you want to stop taking this medicine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking this medicine and seek medical help immediately if you experience any of the following adverse effects - you may need urgent medical treatment:

• Swelling of the face, lips, mouth, tongue, and/or throat, which makes swallowing or breathing difficult, as well as itching and skin rashes. This could be a sign of a severe allergic reaction.
• Severe skin reactions, including intense skin rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience

• Faster heart rate, irregular or strong beats (palpitations), chest pain, chest tightness, or more serious problems, such as myocardial infarction and stroke.
• Shortness of breath or cough. These can be signs of pulmonary problems.
• Worsening of heart failure, causing increased shortness of breath and/or fluid retention.
• Bruising more easily, bleeding for longer than usual, any sign of bleeding (such as gum bleeding), purple spots, skin spots, or getting infections more easily than usual, sore throat, and fever, feeling tired, weak, dizzy, or having pale skin. These can be signs of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This 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 can be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Concentrated urine (dark color), feeling or being sick, having muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone).

Other adverse effects are:

Frequent(may affect up to 1 in 10 people):

• Blood tests showing higher than normal potassium levels in the blood,
• headache,
• dizziness,
• feeling of coldness or numbness in hands or feet,
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly,
• dry, tickly cough, inflammation of the paranasal sinuses (sinusitis) or bronchitis, difficulty breathing,
• stomach or intestinal pain or discomfort, diarrhea, constipation, indigestion, feeling of discomfort,
• skin rash with or without relief,
• muscle cramps or pain,
• chest pain,
• feeling of tiredness.

Uncommon(may affect up to 1 in 100 people):

• Blood tests showing changes in liver function (increased liver enzyme levels, elevated bilirubin levels), pancreas (increased pancreatic enzymes) or kidney function (increased urea or creatinine levels),
• an excess of eosinophils (a type of white blood cell) in the blood,
• loss or decrease in appetite (anorexia),
• sleep problems, including drowsiness,
• depression, feeling depressed, anxious, more nervous than usual, or restless,
• feeling of spinning (vertigo),
• unusual skin sensations such as numbness, tingling, pinching, burning, or dragging on the skin (paresthesia),
• loss or change in taste,
• eye problems, such as blurred vision,
• slower or faster heart rate, irregular or forceful heartbeat,
• swollen arms and legs. This can be a sign that the body is retaining more water than usual.
• flushing,
• stuffy nose,
• difficulty breathing or worsening of asthma,
• inflammation of the intestine, known as "intestinal angioedema," which presents symptoms such as abdominal pain, vomiting, and diarrhea,
• abdominal swelling or stomach burning (gastritis) or dry mouth,
• sweating more than usual,
• itching,
• muscle weakness,
• joint pain,
• passing more water (urine) than usual throughout the day,
• decreased kidney function (including kidney failure),
• presence of excess protein in the urine,
• sexual dysfunction in men, decreased sexual desire in men or women,
• fever,
• feeling of weakness.

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

• Blood tests showing a decrease in the number of red blood cells, white blood cells, or platelets, or the amount of hemoglobin, increased liver enzyme levels (ALT, AST), elevated levels of certain fats.
• nightmares, hallucinations,
• feeling of shakiness,
• feeling of confusion,
• balance disorder,
• decreased tear flow (dry eye),
• redness, itching, swelling, or tearing of the eyes (conjunctivitis),
• ear problems and ringing in the ears,
• vascular stenosis, reduced perfusion through blood vessels (hypoperfusion), inflammation of blood vessels (vasculitis),
• allergic nasal discharge,
• red and swollen tongue,
• allergic reactions such as itching, flushing, skin rash,
• scaling or severe scaling of the skin, itchy and crusty rash (exfoliative dermatitis), hives,
• nail problems (such as loosening or separation of a nail from its bed),
• skin spots
• erection problems.

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

• hair loss,
• appearance or worsening of scaly skin rash (psoriasis), psoriasis-like rash,
• increased sensitivity to the sun.

Frequency Not Known(frequency cannot be estimated from available data):

• Blood tests showing an increase in antinuclear antibodies, lower than normal sodium levels, or very few blood cells,
• difficulty concentrating,
• fingers and toes changing color when cold and then tingling or hurting when warmed (Raynaud's phenomenon),
• slow or altered reactions,
• burning sensation,
• change in the way things smell,
• small mouth ulcers (canker sores),
• breast enlargement in men.

Some of the adverse effects have been reported more frequently in patients with chronic heart failure (very frequent slower heart rate, worsening of heart failure, and frequent feeling of weakness).

Reporting Adverse Effects

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

5. Storage of Ramipril/bisoprolol Egis

Store below 25 °C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ramipril/bisoprolol Egis

The active ingredients are ramipril and bisoprolol fumarate.

Ramipril/bisoprolol Egis 5 mg/5 mg hard capsules:

The capsules contain 5 mg of ramipril and 5 mg of bisoprolol fumarate.

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

The capsules contain 5 mg of ramipril and 10 mg of bisoprolol fumarate.

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

The capsules contain 10 mg of ramipril and 5 mg of bisoprolol fumarate.

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

The capsules contain 10 mg of ramipril and 10 mg of bisoprolol fumarate.

Other components are:

Capsule core:microcrystalline cellulose (E460), sodium carboxymethyl starch type A, colloidal anhydrous silica (E551), hydrophobic colloidal silica, magnesium stearate (E572), crospovidone type B, hypromellose, yellow iron oxide (E172), sodium fumarate, and stearic acid.

Capsule shell:

Ramipril/bisoprolol Egis 5 mg/5 mg hard capsules:

Gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue FCF (E133), yellow iron oxide (E172).

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

Gelatin, titanium dioxide (E171), allura red AC (E129), brilliant blue FCF (E133), quinoline yellow (E104).

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

Gelatin, titanium dioxide (E171), black iron oxide (E172), carmoisine, azorubine (E122), yellow iron oxide (E172).

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

Gelatin, titanium dioxide (E171), black iron oxide (E172), carmoisine, azorubine (E122), quinoline yellow (E104).

Product Appearance and Package Contents

Ramipril/bisoprolol Egis 5 mg/5 mg hard capsules:

Hard gelatin capsule, without markings, with an automatic closing system, Coni Snap type, size 2, with a white-yellowish opaque body and a dark pink opaque cap, filled with two tablets. One of the tablets, which contains ramipril, is round, biconvex, pale yellow in color, without markings on either side; on the surface of this tablet, white and yellowish-brown spots are observed. The other tablet, which contains bisoprolol, is white or almost white, round, biconvex, with the letter E engraved on one side and without markings on the other.

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

Hard gelatin capsule, without markings, with an automatic closing system, Coni Snap type, size 0, with a yellow opaque body and a dark pink opaque cap, filled with two tablets. One of the tablets, which contains ramipril, is round, biconvex, pale yellow in color, without markings on either side; on the surface of this tablet, white and yellowish-brown spots are observed. The other tablet, which contains bisoprolol, is round, biconvex, white or almost white in color, with the letter E engraved on one side and without markings on the other.

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

Hard gelatin capsule, without markings, with an automatic closing system, Coni Snap type, size 0, with a white-yellowish opaque body and a dark purple opaque cap, filled with two tablets. One of the tablets, which contains ramipril, is round, biconvex, pale yellow in color, without markings on either side; on the surface of the tablets, white and yellowish-brown spots are observed. The other tablet, which contains bisoprolol, is white or almost white, round, biconvex, with the letter E engraved on one side and without markings on the other.

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

Hard gelatin capsule, without markings, with an automatic closing system, Coni Snap type, size 0, with a yellow opaque body and a dark purple opaque cap, filled with two tablets. One of the tablets, which contains ramipril, is round, biconvex, pale yellow in color, without markings on either side; on the surface of the tablets, white and yellowish-brown spots are observed. The other tablet, which contains bisoprolol, is round, biconvex, white or almost white in color, with the letter E engraved on one side and without markings on the other.

Package sizes: 10, 14, 28, 30, 60, or 100 hard capsules in OPA/Al/PVC//Al blisters, packaged in a cardboard box.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Egis Pharmaceuticals PLC

1106 Budapest

Keresztúri út 30-38.

Hungary

Manufacturer:

Egis Pharmaceuticals PLC, Site 2

1165 Budapest, Bökényföldi út 118-120

Hungary

Egis Pharmaceuticals PLC, Site 3

9900 Körmend, Mátyás király u. 65.

Hungary

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

Hungary Diptensa 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg hard capsules

Poland Ladinorm

Spain Ramipril/bisoprolol Egis 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg hard capsules

Italy Ramipril/bisoprolol Egis

Portugal Ramipril/bisoprolol Egis 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg hard capsules

Germany Ramipril/bisoprolol Egis 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg hard capsules

Date of the last revision of this leaflet: June 2024

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