Ladinorm

Package Leaflet: Information for the User

Ladinorm, 5 mg + 5 mg, hard capsules

Ladinorm, 5 mg + 10 mg, hard capsules

Ladinorm, 10 mg + 5 mg, hard capsules

Ladinorm, 10 mg + 10 mg, hard capsules

Ramipril + Bisoprolol fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Ladinorm is and what it is used for

Ladinorm contains two different active substances, ramipril and bisoprolol, in one capsule. Both substances help control high blood pressure:

• Ramipril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Its action is to reduce the production of substances that can increase blood pressure. The medicine causes relaxation and dilation of blood vessels, making it easier for the heart to pump blood in the body.
• Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by changing the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and increases the efficiency of the heart in pumping blood in the body.

Ladinorm is used in adults to treat high blood pressure (hypertension) or hypertension associated with chronic coronary artery disease (a condition in which blood flow to the heart is reduced or completely blocked) in patients with

• certain heart and blood vessel diseases (history of coronary artery 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 condition in which the heart is unable to pump enough blood to meet the body's needs, causing shortness of breath and swelling) to reduce the risk of cardiac events, such as myocardial infarction in patients who have already had a myocardial infarction. The doctor may prescribe the combination preparation Ladinorm, hard capsules, if the patient has previously taken ramipril and bisoprolol as separate medicines containing the same doses of active substances and administered with the same frequency as the combination preparation Ladinorm.

2. Important information before taking Ladinorm

When not to take Ladinorm:

• if you are allergic to ramipril, another ACE inhibitor, bisoprolol, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if you have ever had a severe allergic reaction called angioedema. Its symptoms are: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing and swallowing.
• if you have recently taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of chronic heart failure in adults.
• if you are undergoing dialysis or blood filtration of another type. Depending on the device used, Ladinorm may not be suitable for use in such a patient.
• if you have kidney disease in which blood flow to the kidney is reduced (renal artery stenosis),
• if you are more than 3 months pregnant (also in early pregnancy, it is better to avoid Ladinorm - see 'Pregnancy and breastfeeding').
• if your blood pressure is abnormally low or unstable. The doctor will need to make an appropriate assessment.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have acute heart failure or if you have worsening chronic heart failure, requiring intravenous drugs that increase the strength of heart muscle contractions.
• if you have cardiogenic shock, a life-threatening cardiac condition caused by inadequate heart function, leading to low blood pressure and circulatory failure.
• if you have heart diseases that cause very slow heart rate or irregular heartbeat (second- or third-degree atrioventricular block without a pacemaker, sinoatrial block, sick sinus syndrome).
• if you have a slow heart rate that causes symptoms.
• if you have severe asthma.
• if you have severe circulatory problems in the limbs (e.g., Raynaud's syndrome), which can cause tingling, numbness, or color changes in the fingers and toes after exposure to cold.
• if you have an untreated pheochromocytoma, a rare tumor of the adrenal gland.
• In cases of metabolic disorders in which there is too much acid in the blood (metabolic acidosis).

In case of doubt before starting treatment with Ladinorm, consult your doctor.

Warnings and precautions

Before starting treatment with Ladinorm, discuss it with your doctor or pharmacist.
Tell your doctor if you have any of the following conditions or disorders.
The doctor may decide to take special precautions (e.g., prescribe additional treatment or perform more frequent checks):

• if you have a milder respiratory disease, such as asthma or chronic obstructive pulmonary disease;
• if you have diabetes;
• if you are on a strict diet or fasting;
• if you are planning to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings. Ladinorm may increase the risk of an allergic reaction or make it more severe.
• if you have heart rhythm disorders or muscle contractions of blood vessels that can cause coronary perfusion disorders (Prinzmetal's angina or first-degree atrioventricular block);
• if you have heart failure or other heart problems;
• if the heart or brain is poorly oxygenated;
• if you have milder circulatory problems in the limbs;
• if you have or have had psoriatic skin lesions (psoriasis);
• if you have thyroid disease. Ladinorm may mask symptoms of hyperthyroidism;
• in the case of treated pheochromocytoma, a rare tumor of the adrenal gland;
• if you are to receive anesthesia for surgery or dental procedures. It may be necessary to discontinue treatment the day before anesthesia; consult your doctor,
• if you have angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing). Such a reaction can occur at any time during treatment. If such symptoms occur, discontinue Ladinorm and seek medical attention immediately.
• if you have abdominal pain, vomiting, and diarrhea. This may be a sign of intestinal angioedema;
• if you are of black race, as these patients are at higher risk of angioedema and the medicine may be less effective in lowering blood pressure than in people of other races;
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• 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 rejection of transplanted organs or to treat cancer).
• if you are elderly;
• if you have kidney problems (including kidney transplantation);
• if you have liver problems;
• if you have aortic or mitral valve stenosis (narrowing of the valve that releases blood from the heart or narrowing of the valve between the left atrium and left ventricle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• if you have lost a lot of salt or fluids from your body (due to vomiting, diarrhea, excessive sweating, low-salt diet, or prolonged use of diuretics or dialysis);
• if you have high potassium levels in your blood (confirmed by blood test results);
• if you are taking medicines or have diseases that can lower sodium levels in your blood. Your doctor may recommend regular blood tests, especially to monitor sodium levels in your blood, especially in the elderly;
• if you have collagen vascular disease, such as systemic lupus erythematosus or systemic sclerosis;
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonists (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetic kidney disease.
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also the information under 'When not to take Ladinorm'.
• You should also tell your doctor if you are pregnant (or may become pregnant). It is not recommended to take Ladinorm during the first 3 months of pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period (see 'Pregnancy and breastfeeding').

Children and Adolescents

Ladinorm should not be used in children and adolescents under 18 years of age.

Ladinorm and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is necessary because Ladinorm may affect the action of some other medicines. Other medicines may also affect the action of Ladinorm.
Your doctor may recommend changing the dose or taking other precautions, or even recommend complete discontinuation of one of the following medicines. Be sure to tell your doctor if you are taking any of the following medicines:

• sacubitril and valsartan, used to treat a certain type of chronic heart failure. Do not take Ladinorm with a medicine containing sacubitril/valsartan. If you have taken sacubitril/valsartan, wait 36 hours after the last dose of sacubitril/valsartan before starting Ladinorm (see 'When not to take Ladinorm'). After stopping Ladinorm, wait 36 hours after the last dose of Ladinorm before starting sacubitril/valsartan.
• angiotensin II receptor antagonists (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan) or aliskiren (see also the information under 'When not to take Ladinorm' and 'Warnings and precautions').
• certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium channel blockers, such as verapamil, diltiazem, felodipine, amlodipine).
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine (so-called centrally acting antihypertensive agents): do not stop taking these medicines without consulting your doctor.
• certain medicines used to treat irregular or abnormal heartbeat, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone, procainamide).
• digitalis glycosides (medicines used to treat heart failure, such as digoxin).
• diuretics (diuretics), such as furosemide, spironolactone, triamterene, amiloride.
• all medicines that can lower blood pressure, as a desired or undesired effect, such as:
• medicines used to treat high blood pressure,
• certain medicines used to treat depression, such as imipramine, desipramine, nortriptyline, amitriptyline, mirtazapine,
• certain medicines used to treat epilepsy or during general anesthesia (barbiturates, such as phenobarbital),
• certain medicines used to treat a mental illness characterized by loss of contact with reality (phenothiazines, such as levomepromazine, chlorpromazine, and promethazine),
• nitrates (used to treat or prevent angina pectoris),
• 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 carbachol).
• certain medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.
• topically applied medicines containing beta-blockers (such as eye drops containing timolol for glaucoma treatment).
• medicines for diabetes, such as oral glucose-lowering medicines (e.g., metformin, linagliptin, saxagliptin, sitagliptin, and vildagliptin) and insulin. Ladinorm may lower blood glucose levels. During treatment with Ladinorm, blood glucose levels should be carefully monitored.
• anesthetics.
• medicines used to treat pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs, 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 (a medicine used to prevent or treat malaria).
• medicines used to treat cancer (chemotherapy).
• medicines that can increase potassium levels in the blood, such as potassium supplements (including salt substitutes) and other medicines that can increase potassium levels in the blood, such as trimethoprim, alone or in combination with sulfamethoxazole (used to treat bacterial infections), heparin (a medicine used to thin the blood to prevent clots),
• medicines used to prevent rejection of transplanted organs, such as cyclosporine,
• allopurinol (used to lower uric acid levels in the blood).
• lithium (used to treat mental illnesses). Ladinorm may increase lithium levels in the blood. Your doctor will need to carefully monitor lithium levels in your blood.
• corticosteroids used to treat inflammation, such as prednisolone.
• temsirolimus, everolimus, sirolimus (used to prevent rejection of transplanted organs 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 to treat diarrhea).

Ladinorm and alcohol

Drinking alcohol during treatment with Ladinorm may cause dizziness. If you have any doubts about how much alcohol you can drink while taking this medicine, talk to your doctor,
as blood pressure-lowering medicines and alcohol can enhance each other's sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you think you are pregnant (or may become pregnant), tell your doctor.
Ladinorm should not be taken during the first 12 weeks of pregnancy, and it should not be taken after

• the 13th week of pregnancy, as its use during pregnancy may harm the baby. If you become pregnant while taking Ladinorm, tell your doctor immediately. Before planned pregnancy, the treatment should be changed to another suitable medicine.

Breastfeeding
Ladinorm should not be used during breastfeeding.

Driving and using machines

Ladinorm may affect your ability to drive and use machines.
If the medicine causes dizziness or fatigue, or causes headaches, do not drive or operate machinery and consult your doctor immediately.

Ladinorm contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is considered 'sodium-free'.
Ladinorm, 10 mg + 5 mg, hard capsules, and Ladinorm, 10 mg + 10 mg, hard capsules
contain azorubine (carmoisine)
Azorubine (carmoisine) may cause allergic reactions.

3. How to take Ladinorm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose is 1 capsule per day in the dose prescribed by your doctor.
Swallow the capsule whole, without chewing or crushing, with a drink of water. The capsule should be taken in the morning, with or without food.
Kidney problems
If you have kidney problems, your doctor may prescribe a lower dose of Ladinorm.
Liver problems
If you have liver problems, Ladinorm is not suitable for you and should not be taken.

Children and adolescents

Ladinorm should not be used in children and adolescents under 18 years of age.

Overdose

Immediately consult your doctor or go to the emergency department of the nearest hospital. The patient should not drive a car, but should ask someone else to drive them to the hospital or call an ambulance. Take the medicine package with you. This will help the doctor know what medicine has been taken.

Missed dose

If you miss a dose of Ladinorm, take the next dose at the usual time. Do not take a double dose to make up for the missed capsule.

Stopping treatment

Do not stop taking Ladinorm suddenly. If you want to stop taking Ladinorm, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects – you may need urgent medical attention:

Any of the following side effects may be a sign of a serious allergic reaction – seek immediate medical attention:

• Swelling of the face, lips, mouth, tongue, and/or throat, difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction.
• Severe skin reactions, including severe rash, mouth ulcers, exacerbation of existing skin disease, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell your doctor immediately if you experience:

• Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious problems, such as myocardial infarction and stroke.
• Shortness of breath or cough. These may be symptoms of lung disease.
• Worsening of heart failure, causing increased shortness of breath and/or fluid retention.
• Easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), purple spots, skin changes, or more frequent infections, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. This may be a sign of pancreatitis.
• Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disease, such as hepatitis or liver damage.
• Concentrated urine (dark in color), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to inadequate secretion of antidiuretic hormone (SIADH).

Other side effects include:

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

• blood test results showing high potassium levels in the blood,
• headache,
• dizziness,
• feeling of coldness or numbness in the hands or feet,
• fainting, hypotension (abnormally low blood pressure), especially when standing up quickly or sitting up from a lying position,
• dry, irritating cough, sinusitis, or bronchitis, shortness of breath,
• stomach or intestinal pain or discomfort, diarrhea, constipation, indigestion, nausea, or vomiting,
• skin rash with or without itching,
• muscle cramps or pain,
• chest pain,
• feeling of tiredness.

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

• blood test results showing changed liver or kidney function (increased liver enzyme activity, increased bilirubin levels), pancreas (increased pancreatic enzyme activity), or kidney (increased urea or creatinine levels),
• increased number of eosinophils (a type of white blood cell) in the blood,
• loss of or decreased appetite,
• sleep disorders, including excessive sleepiness,
• depression, feeling of sadness, anxiety, increased nervousness, or restlessness,
• feeling of trembling,
• feeling of confusion,
• balance disorders,
• decreased tear secretion (dry eyes),
• redness, itching, swelling, or tearing of the eyes (conjunctivitis),
• hearing or ringing in the ears,
• vasoconstriction, decreased blood flow through blood vessels (hypoperfusion), vasculitis,
• allergic rhinitis,
• redness and swelling of the tongue,
• allergic reactions, such as itching, redness, rash,
• severe skin peeling or blistering, itchy, lumpy skin rash (exfoliative dermatitis), hives,
• nail disorders (e.g., loosening or separation of the nail plate from the nail bed),
• skin spots
• erectile dysfunction.

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

• hair loss,
• onset or worsening of psoriatic skin lesions (psoriasis) or psoriasis-like rash,
• increased sensitivity to light.

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

• blood test results showing increased antinuclear antibody titers, decreased sodium levels, or decreased blood cell count,
• difficulty concentrating,
• color changes in the fingers and toes when cold, followed by tingling or pain when warmed up (Raynaud's phenomenon),
• slowed or weakened reactions,
• burning sensation,
• change in sense of smell,
• small mouth ulcers (aphthae),
• breast enlargement in men.

Some of these side effects have been reported more frequently in patients with chronic heart failure (very common: slowed heart rate, common: worsening of heart failure).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ladinorm

Store in a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ladinorm contains

The active substances are ramipril and bisoprolol fumarate.
Ladinorm, 5 mg + 5 mg, hard capsules:
The capsules contain 5 mg of ramipril and 5 mg of bisoprolol fumarate.
Ladinorm, 5 mg + 10 mg, hard capsules:
The capsules contain 5 mg of ramipril and 10 mg of bisoprolol fumarate.
Ladinorm, 10 mg + 5 mg, hard capsules:
The capsules contain 10 mg of ramipril and 5 mg of bisoprolol fumarate.
Ladinorm, 10 mg + 10 mg, hard capsules:
The capsules contain 10 mg of ramipril and 10 mg of bisoprolol fumarate.
Other ingredients are:
Contents of the capsule:microcrystalline cellulose (E460), sodium carboxymethylcellulose (type A), colloidal anhydrous silica (E551), silica, hydrophobic colloidal, magnesium stearate (E572), crospovidone type B, hypromellose, yellow iron oxide (E172), sodium fumarate.
Capsule shell:
Ladinorm, 5 mg + 5 mg, hard capsules:
Gelatin, titanium dioxide (E171), Allura Red AC (E129), Brilliant Blue FCF (E133), yellow iron oxide (E172).
Ladinorm, 5 mg + 10 mg, hard capsules:
Gelatin, titanium dioxide (E171), Allura Red AC (E129), Brilliant Blue FCF (E133), quinoline yellow (E104).
Ladinorm, 10 mg + 5 mg, hard capsules:
Gelatin, titanium dioxide (E171), black iron oxide (E172), azorubine (carmoisine) (E122), yellow iron oxide (E172).
Ladinorm, 10 mg + 10 mg, hard capsules:
Gelatin, titanium dioxide (E171), black iron oxide (E172), azorubine (carmoisine) (E122), quinoline yellow (E104).

What Ladinorm looks like and contents of the pack

Ladinorm, 5 mg + 5 mg, hard capsules:
A self-locking hard gelatin capsule of Coni Snap type, without markings, size 2, with a matte yellowish-white body and a matte dark pink cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow color, without any markings; the tablet surface may have white and yellowish-brown spots. The other tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white color, with the letter E on one side and without any markings on the other side.
Ladinorm, 5 mg + 10 mg, hard capsules:
A self-locking hard gelatin capsule of Coni Snap type, without markings, size 0, with a matte yellow body and a matte dark pink cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow color, without any markings; the tablet surface may have white and yellowish-brown spots. The other tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white color, with the letter E on one side and without any markings on the other side.
Ladinorm, 10 mg + 5 mg, hard capsules:
A self-locking hard gelatin capsule of Coni Snap type, without markings, size 0, with a matte yellowish-white body and a matte dark purple cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow color, without any markings; the tablet surface may have white and yellowish-brown spots. The other tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white color, with the letter E on one side and without any markings on the other side.
Ladinorm, 10 mg + 10 mg, hard capsules:
A self-locking hard gelatin capsule of Coni Snap type, without markings, size 0, with a matte yellow body and a matte dark purple cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow color, without any markings; the tablet surface may have white and yellowish-brown spots. The other tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white color, with the letter E on one side and without any markings on the other side.
Pack sizes: 10, 14, 28, 30, 60, or 100 hard capsules in OPA/Al/PVC/Al blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Egis Pharmaceuticals PLC
Kereszturi út 30-38
1106 Budapest
Hungary
Manufacturer:
Egis Pharmaceuticals PLC, Site 2
Bökényföldi út 118-120
1165 Budapest,
Hungary
Egis Pharmaceuticals PLC, Site 3
Mátyás király u. 65
9900 Körmend,
Hungary

This medicinal product 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
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the package leaflet