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
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 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Ladinorm is and what it is used for
What you need to know before taking Ladinorm
How to take Ladinorm
Possible side effects
How to store Ladinorm
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 of these substances help control high blood pressure:

Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by reducing the production of a substance that can increase blood pressure. The medicine causes blood vessels to relax and widen, making it easier for the heart to pump blood around the body.
Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by altering the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and increases the heart's efficiency in pumping blood around the body.

Ladinorm is a medicine 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, 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 cannot pump enough blood to meet the body's needs, causing breathlessness and swelling) to reduce the risk of cardiovascular events such as myocardial infarction in patients who have previously had a myocardial infarction. Your doctor may prescribe the fixed combination medicine Ladinorm, hard capsules, if you have previously been taking ramipril and bisoprolol as separate medicines containing the same doses of active substances and administered with the same frequency as the fixed combination Ladinorm, for at least 4 weeks.

2. Important information before taking Ladinorm

When not to take Ladinorm:

if the patient is allergic to ramipril, another medicine from the ACE inhibitor class, bisoprolol, or any of the other ingredients contained in the medicine (listed in section 6.). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
if the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on hands, feet and throat, swelling of throat and tongue, swelling around eyes and mouth, difficulty breathing and swallowing.
if the patient has recently taken or is currently taking sacubitril/valsartan, a medicine used to treat certain types of chronic heart failure in adults.
if the patient is undergoing dialysis or other type of blood filtration. Depending on the device used, Ladinorm may be unsuitable for such patients.
if the patient has kidney disease with reduced blood flow to the kidney (renal artery stenosis).
if the patient is more than 3 months pregnant (also during early pregnancy Ladinorm should preferably be avoided – see section 'Pregnancy and breastfeeding').
if the patient's blood pressure is abnormally low or unstable. The doctor will need to perform appropriate assessment.
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
if the patient has acute heart failure or worsening of chronic heart failure requiring intravenous administration of medicines that increase the force of heart contractions.
if the patient has cardiogenic shock, a life-threatening acute cardiac condition caused by impaired heart function leading to low blood pressure and circulatory failure.
if the patient has heart diseases causing very slow heart rate or irregular heartbeat (second- or third-degree atrioventricular block without a pacemaker, sinoatrial block, sick sinus syndrome).
if the patient has a slow heart rate causing symptoms.
if the patient has severe asthma.
if the patient has severe circulatory problems in limbs (e.g. Raynaud's syndrome), which may cause tingling, numbness or colour changes in fingers and toes upon exposure to cold.
if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal medulla.
In cases of metabolic disorders with excess acid in the blood (metabolic acidosis).

If in doubt about starting Ladinorm, consult a doctor.
Warnings and precautions
Before starting Ladinorm, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has any of the following conditions or disorders.
The doctor may decide to take special precautions (e.g. recommend additional treatment or more frequent monitoring):

if the patient has mild respiratory disorders such as asthma or chronic obstructive pulmonary disease;
if the patient has diabetes;
if the patient is on a strict diet or fasting;
if the patient plans allergen immunotherapy (desensitisation treatment) for bee or wasp venom allergy. Ladinorm may increase the likelihood of an allergic reaction or make such a reaction more severe.
if the patient has heart rhythm disorders or coronary vasospasm causing angina (Prinzmetal's angina) or first-degree atrioventricular block;
if the patient has heart failure or other heart problems;
if the heart or brain are poorly oxygenated;
if the patient has milder circulatory disorders in limbs;
if the patient has or has had psoriasis (scaly skin lesions);
if the patient has thyroid disease. Ladinorm may mask symptoms of hyperthyroidism;
in case of treated phaeochromocytoma, a rare tumour of the adrenal medulla;
if the patient is to receive anaesthesia for surgery or dental procedures. Treatment may need to be interrupted one day before anaesthesia; consult your doctor.
if the patient has angioedema (severe allergic reaction with swelling of face, lips, tongue or throat, with difficulty swallowing or breathing). Such a reaction may occur at any time during treatment. If these symptoms occur, stop taking Ladinorm immediately and contact a doctor urgently.
if the patient has abdominal pain, vomiting and diarrhoea. These may be symptoms of intestinal angioedema.
if the patient is of Black race, as such patients have a higher risk of angioedema and the medicine may be less effective in lowering blood pressure compared to other races.
if the patient is 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 in diabetes treatment),
- racecadotril (used to treat diarrhoea),
- sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection or in cancer treatment).
if the patient is elderly;
if the patient has kidney problems (including kidney transplant);
if the patient has liver problems;
if the patient has aortic or mitral valve stenosis (narrowing of the valve releasing 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 the patient has lost large amounts of salt or fluids from the body (due to vomiting, diarrhoea, excessive sweating, low-salt diet, long-term use of diuretics, or after dialysis);
if the patient has high potassium levels in blood (confirmed by blood tests);
if the patient is taking medicines or has diseases that may reduce sodium levels in blood. The doctor may recommend regular blood tests, especially to monitor blood sodium levels, particularly in elderly patients;
if the patient has connective tissue vascular disease (collagen vascular disease), such as systemic lupus erythematosus or systemic sclerosis;
if the patient is taking any of the following medicines for high blood pressure:
- "angiotensin II receptor antagonists" (ARBs) (also called sartans – e.g. valsartan, telmisartan, irbesartan), particularly if the patient has kidney disease related to diabetes.
- aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure and electrolyte levels (e.g. potassium) in blood. See also information under the heading “When not to take Ladinorm”.
Also inform the doctor if the patient is pregnant (or may become pregnant). Ladinorm is not recommended during the first 3 months of pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the unborn child if used during this period (see section "Pregnancy and breastfeeding").

Children and adolescents
Ladinorm is not recommended for use in children and adolescents under 18 years of age.
Ladinorm with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
This is necessary because Ladinorm may affect the action of certain other medicines. Likewise, other medicines may affect the action of Ladinorm.
The doctor may recommend a dose adjustment or take other precautions, or even recommend discontinuation of one of the following medicines. Be sure to inform the doctor if the patient is taking any of the following medicines:

sacubitril and valsartan, used to treat certain types of chronic heart failure. Ladinorm must not be taken simultaneously with a medicine containing sacubitril/valsartan. If the patient has taken sacubitril/valsartan, they should 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 called sartans – e.g. valsartan, telmisartan, irbesartan) or aliskiren (see also information under headings “When not to take Ladinorm” and “Warnings and precautions”).
certain medicines used to treat high blood pressure, angina 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 antihypertensives): do not discontinue these medicines without prior consultation with a doctor.
certain medicines used to treat irregular or abnormal heartbeat, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone, procainamide.
cardiac glycosides (medicines used to treat heart failure, such as digoxin).
diuretics (water tablets), such as furosemide, spironolactone, triamterene, amiloride.
all medicines that may lower blood pressure, either as a desired or unwanted effect, such as:
- medicines used to treat high blood pressure,
- certain antidepressants such as imipramine, desipramine, nortriptyline, amitriptyline, mirtazapine,
- certain medicines used to treat epilepsy or during general anaesthesia (barbiturates such as phenobarbital),
- certain medicines used to treat psychosis (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 carbachol).
certain antidepressants called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moklobemide.
topical medicines containing beta-blockers (e.g. eye drops containing timolol for glaucoma treatment).
diabetes medicines, such as oral glucose-lowering agents (e.g. metformin, linagliptin, saxagliptin, sitagliptin and vildagliptin) and insulin. Ladinorm may lower blood glucose levels. Blood glucose levels should be carefully monitored during treatment with Ladinorm.
anaesthetics.
medicines used to treat pain and inflammation (e.g. non-steroidal 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. The doctor will need to monitor blood pressure.
mefloquine (a medicine used to prevent or treat malaria).
anticancer medicines (chemotherapy).
medicines that may increase potassium levels in blood, such as potassium supplements (including salt substitutes) and other medicines that may increase blood potassium, 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 to prevent rejection of transplanted organs, such as cyclosporine.
allopurinol (used to lower uric acid levels in blood).
lithium (used in psychiatric disorders). Ladinorm may increase lithium levels in blood. The doctor will need to carefully monitor lithium levels in the patient's blood.
corticosteroids used to treat inflammation, such as prednisolone.
temsirolimus, everolimus, sirolimus (used to prevent rejection of transplanted organs or in cancer treatment) and other medicines belonging to the class of so-called mTOR inhibitors.
medicines known as neprilysin inhibitors (NEP), such as racecadotril (used to treat diarrhoea).

Ladinorm and alcohol
Drinking alcohol while taking Ladinorm may cause dizziness. If the patient is unsure how much alcohol can be consumed during treatment with this medicine, they should consult their doctor, as blood pressure-lowering medicines and alcohol may mutually enhance their sedative effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
If the patient thinks she is pregnant (or may become pregnant), she should inform her doctor.
Ladinorm should not be used during the first 12 weeks of pregnancy, and must not be used after the 13th week of pregnancy, as its use during pregnancy may harm the unborn child. If the patient becomes pregnant while taking Ladinorm, she should inform her doctor immediately. Before planning a pregnancy, treatment should be changed to another suitable medicine.

Breast-feeding
Ladinorm is not recommended during breast-feeding.
Driving and operating machinery
Ladinorm may affect the ability to drive and operate machinery.
If the medicine causes dizziness, fatigue or headache, driving and operating machinery should be avoided and the patient should consult a doctor immediately.
Ladinorm contains sodium
The medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. the medicine 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

This medicine should always be taken exactly as recommended by the doctor or pharmacist. In case of doubt,
consult your doctor or pharmacist.
Use in adults
The recommended dose is 1 capsule daily, as prescribed by the doctor.
The capsule should be swallowed whole, without chewing or crushing, with a drink. The capsule should be
taken in the morning, with or without food.
Use in kidney disease
If the patient has kidney disease, the doctor may prescribe a lower dose of Ladinorm.
Use in liver disorders
If the patient has impaired liver function, Ladinorm is not suitable and should not be used.
Use in children and adolescents
Ladinorm is not recommended for use in children and adolescents under 18 years of age.
Taking more Ladinorm than recommended
Seek immediate medical advice or go to the nearest hospital emergency department.
The patient should not drive themselves, but ask someone else to take them to hospital or call an ambulance.
Take the medicine packaging along. This will help the doctor identify which medicine has been taken.
If you miss a dose of Ladinorm
If a dose of Ladinorm is missed, take the next dose at the usual time. Do not take a double dose to make up
for the missed capsule.
Stopping Ladinorm
Do not stop taking Ladinorm suddenly. If the patient wishes to discontinue treatment with Ladinorm,
they should consult their doctor first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop taking this medicine and contact your doctor immediately if any of the following adverse reactions occur – urgent medical care may be required:

Swelling of the face, lips, mouth, tongue and (or) throat, making swallowing or breathing difficult, together with itching and rash. These may be symptoms of a severe allergic reaction.
Severe skin reactions, including severe skin rash, ulceration of the mouth, worsening of pre-existing skin disease, redness, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

You should immediately inform your doctor if the following occur:

Faster, irregular or forceful heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious problems such as heart attack and stroke.
Shortness of breath or cough. These may be symptoms of lung disease.
Worsening of heart failure causing increased breathlessness and (or) fluid retention.
Easy bruising, prolonged bleeding, various types of bleeding (e.g. bleeding gums), purple spots, skin changes or more frequent infections than usual, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
Severe abdominal pain which may radiate to the back. This may be a symptom 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 colour), nausea or vomiting, muscle cramps, confusion and seizures, which may result from inappropriate vasopressin (antidiuretic hormone) secretion.

Other adverse reactions include:
Common (may affect up to 1 in 10 people):

Blood test results indicating increased potassium levels in the blood,
Headache,
Dizziness,
Feeling of coldness or numbness in hands or feet,
Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting quickly from a lying position,
Dry, irritating cough, sinusitis or bronchitis, shortness of breath,
Pain or discomfort in the stomach or intestines, diarrhoea, constipation, indigestion, nausea or vomiting,
Skin rash with or without raised skin lesions,
Muscle cramps or pain,
Chest pain,
Feeling of fatigue.

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

Blood test results indicating altered liver 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 reduced appetite,
Sleep disturbances, including excessive drowsiness,
Depression, feeling of low mood, anxiety, increased nervousness or restlessness,
Sensation of spinning (vertigo),
Unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations (paresthesia),
Loss or change in taste perception,
Eye problems, including blurred vision,
Slowed or accelerated heartbeat, irregular or forceful heartbeat,
Swelling of hands or feet. This may be a sign of fluid retention in the body.
Hot flushes,
Nasal congestion,
Breathing difficulties or worsening of asthma,
Intestinal swelling, called "intestinal angioedema", manifesting as abdominal pain, vomiting and diarrhoea,
Abdominal bloating or heartburn (gastritis) or dryness in the mouth,
Excessive sweating,
Itching,
Muscle weakness,
Joint pain,
Increased daily urine output,
Worsening of kidney function (including kidney failure),
Presence of protein in the urine,
Impotence in men, decreased libido in men and women,
Fever,
Feeling of weakness.

Rare (may affect up to 1 in 1000 people):

Blood test results indicating decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration, increased liver enzyme activity (AlAT, AspAT), increased levels of certain lipids.
Nightmares, hallucinations,
Feeling of trembling,
Confusion,
Balance disorders,
Reduced tear production (dry eyes),
Redness, itching, swelling or watering of the eyes (conjunctivitis),
Hearing disturbances or tinnitus,
Vasoconstriction, reduced blood flow through vessels (hypoperfusion), vasculitis,
Allergic rhinitis,
Redness and swelling of the tongue,
Allergy-like reactions such as itching, redness, rash,
Severe peeling or flaking of the skin, itchy nodular skin lesions (exfoliative dermatitis), urticaria,
Nail disorders (e.g. loosening or separation of the nail plate from the nail bed),
Skin discoloration,
Erectile dysfunction.

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

Hair loss,
Onset or worsening of scaly skin lesions (psoriasis) or psoriasiform rash,
Increased sensitivity to light.

Frequency unknown (frequency cannot be estimated from available data):

Test results indicating increased levels of antinuclear antibodies, decreased sodium concentration or decreased blood cell count,
Difficulty concentrating,
Colour changes in fingers and toes when cold, followed by tingling or pain upon warming (Raynaud's phenomenon),
Slowed or weakened reactions,
Burning sensation,
Changes in smell perception,
Small ulcers in the mouth (aphthae),
Breast enlargement in men.

Some of these adverse reactions have been reported more frequently in patients with chronic heart failure (bradycardia very common, worsening of heart failure and fatigue common).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ladinorm

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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.

The other ingredients are:
Capsule contents: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A), colloidal anhydrous silica (E551), colloidal hydrophobic silica, magnesium stearate (E572), crospovidone type B, hypromellose, iron oxide yellow (E172), sodium stearyl fumarate.

Capsule shell:
Ladinorm 5 mg + 5 mg, hard capsules:
Gelatin, titanium dioxide (E171), Allura red AC (E129), brilliant blue FCF (E133), iron oxide yellow (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), iron oxide black (E172), azorubine (carmoisine) (E122), iron oxide yellow (E172).
Ladinorm 10 mg + 10 mg, hard capsules:
Gelatin, titanium dioxide (E171), iron oxide black (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-sealing hard gelatin capsule of Coni-Snap type, unmarked, size 2, with a matt, whitish-yellow body and a matt dark pink cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white colour, marked with the letter "E" on one side and unmarked on the other side.

Ladinorm 5 mg + 10 mg, hard capsules:
A self-sealing hard gelatin capsule of Coni-Snap type, unmarked, size 0, with a matt yellow body and a matt dark pink cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white colour, marked with the letter "E" on one side and unmarked on the other side.

Ladinorm 10 mg + 5 mg, hard capsules:
A self-sealing hard gelatin capsule of Coni-Snap type, unmarked, size 0, with a matt whitish-yellow body and a matt dark violet cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white colour, marked with the letter "E" on one side and unmarked on the other side.

Ladinorm 10 mg + 10 mg, hard capsules:
A self-sealing hard gelatin capsule of Coni-Snap type, unmarked, size 0, with a matt yellow body and a matt dark violet cap, containing 2 tablets. One tablet, containing ramipril, is a round, biconvex tablet in light yellow colour, without any markings; white and yellowish-brown specks may appear on the tablet surface. The second tablet, containing bisoprolol, is a round, biconvex tablet in white or almost white colour, marked with the letter "E" on one side and unmarked on the other side.

Pack sizes: 10, 14, 28, 30, 60 or 100 hard capsules in blisters made of OPA/Al/PVC/Al, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised 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 cápsulas duras
Italy: Ramipril/bisoprololo Egis
Portugal: Ramipril/bisoprolol Egis 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg cápsulas
Germany: Ramipril/bisoprolol Egis 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg, 10 mg/10 mg hartkapsel

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00