Ramizek plus

Poland
Brand name Ramizek plus
Form capsules, hard
Active substance / Dosage
ramipril · 10 mg
bisoprolol · 10 mg
Prescription type Prescription only
ATC code
C09BX
Registration number 100445319
Manufacturer Adamed Pharma S.A.
Ramizek plus capsules, hard

Table of Contents

Package leaflet: Information for the patient

Ramizek Plus 2.5 mg + 1.25 mg, hard capsules
Ramizek Plus 2.5 mg + 2.5 mg, hard capsules
Ramizek Plus 5 mg + 2.5 mg, hard capsules
Ramizek Plus 5 mg + 5 mg, hard capsules
Ramizek Plus 10 mg + 5 mg, hard capsules
Ramizek Plus 10 mg + 10 mg, hard capsules
ramipril + bisoprolol fumarate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Ramizek Plus is and what it is used for

Ramizek Plus contains two active substances – bisoprolol fumarate and ramipril – in a single capsule.

  • Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. It works by dilating blood vessels, which helps the heart pump blood through the body more easily.
  • Bisoprolol fumarate belongs to a group of medicines called beta-blockers (beta-adrenolytics). Beta-adrenolytics slow the heart rate and improve the heart's efficiency in pumping blood throughout the body.

Ramizek Plus is used to treat high blood pressure (hypertension) 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, resulting in breathlessness and swelling), and/or to reduce the risk of cardiovascular events such as myocardial infarction in patients with chronic coronary artery disease (a condition in which blood flow to the heart is reduced or blocked), who have previously experienced a myocardial infarction and/or undergone a procedure to improve blood supply to the heart by widening the blood vessels supplying it, or in patients with diabetes and at least one cardiovascular risk factor.
Instead of taking bisoprolol fumarate and ramipril in separate capsules, you take only one capsule of Ramizek Plus, which contains both active substances at the same strength.

2. Important Information Before Taking Ramizek Plus

When not to take Ramizek Plus:

  • if the patient is allergic to bisoprolol or any other beta-blocker, ramipril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6),
  • if the patient has heart failure that has suddenly worsened and (or) may require hospital treatment,
  • if the patient has cardiogenic shock (severe heart disease caused by very low blood pressure),
  • if the patient has a heart condition characterized by slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome),
  • if the patient has a slow heart rate,
  • if the patient has very low blood pressure,
  • if the patient has severe asthma or severe chronic lung disease,
  • if the patient has serious circulation problems in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness of fingers and toes,
  • if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland (medulla),
  • if the patient has metabolic acidosis, a condition in which the blood contains too much acid,
  • if the patient previously experienced symptoms such as wheezing, facial swelling, swelling of the tongue or throat, intense itching, or severe skin rash during prior treatment with an ACE inhibitor, or if such symptoms occurred in the patient or a family member under any circumstances (a condition called angioedema),
  • if the patient is more than three months pregnant (Ramizek Plus is also not recommended during early pregnancy – see section “Pregnancy”),
  • if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
  • if the patient is undergoing dialysis or another type of blood filtration. Depending on the device used, Ramizek Plus may not be suitable,
  • if the patient has kidney problems involving reduced blood flow to the kidneys (renal artery stenosis),
  • if the patient is being treated with sacubitril+valsartan, a combination medicine containing sacubitril and valsartan, used in heart failure (see “Warnings and precautions” and “Other medicines and Ramizek Plus”).

Warnings and precautions
Before starting Ramizek Plus, discuss with your doctor or pharmacist if:

  • the patient has diabetes,
  • the patient has kidney problems (including a kidney transplant) or is undergoing dialysis,
  • the patient has liver problems,
  • the patient has aortic or mitral valve stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
  • the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism),
  • the patient has heart failure or any other heart problems, such as minor heart rhythm disturbances or severe chest pain at rest (Prinzmetal's angina),
  • the patient has a connective tissue disease (collagen vascular disease) such as systemic lupus erythematosus or scleroderma,
  • the patient is on a low-salt diet or uses salt substitutes containing potassium (excess potassium in the blood may cause changes in heart rate),
  • the patient has recently had diarrhoea or vomiting or is dehydrated (Ramizek Plus may cause low blood pressure),
  • the patient is scheduled for LDL apheresis (removal of cholesterol from the blood using a special device),
  • the patient is currently undergoing allergen immunotherapy or plans desensitization treatment to reduce allergic reactions to bee or wasp stings,
  • the patient is on a strict fast or diet,
  • the patient is due to undergo anaesthesia and (or) major surgery,
  • the patient has circulation problems in the limbs,
  • the patient has asthma or chronic lung disease,
  • the patient has (or has had) psoriasis,
  • the patient has an adrenal gland tumour (phaeochromocytoma),
  • the patient has thyroid disorders (Ramizek Plus may mask symptoms of hyperthyroidism),
  • the patient has angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing). This may occur at any time during treatment. If such symptoms occur, stop taking Ramizek Plus immediately and contact your doctor without delay.
  • the patient is of Black race, as such patients may have a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of non-Black races,
  • the patient is taking any of the following medicines for high blood pressure:
    • angiotensin II receptor antagonists (ARBs) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly in patients with kidney problems related to diabetes.
    • aliskiren. Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to take Ramizek Plus”.
  • the patient is taking any of the following medicines – risk of angioedema increases:
    • racecadotril (used to treat diarrhoea),
    • sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs),
    • sacubitril (available in fixed-dose combination with valsartan), used in the treatment of chronic heart failure.

Do not stop taking Ramizek Plus suddenly, as this may lead to serious worsening of heart condition. Do not abruptly discontinue treatment, especially in patients with coronary artery disease.
The patient must inform the doctor if she suspects she is pregnant (or may become pregnant). Use of Ramizek Plus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).

Children and adolescents
Ramizek Plus is not recommended for use in children and adolescents under 18 years of age.

Ramizek Plus and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
Some medicines may alter the effect of Ramizek Plus or its effect may alter other medicines. Such interactions may reduce the effectiveness of one or both medicines and may increase the risk or severity of adverse effects.
Be sure to inform your doctor if the patient is taking any of the following medicines:

  • medicines used to control blood pressure or treat heart conditions (such as amiodarone, amlodipine, clonidine, cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil),
  • other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also information under “When not to take Ramizek Plus” and “Warnings and precautions”) or diuretics (medicines that increase urine production by the kidneys),
  • potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, or other medicines that may increase potassium levels in the body (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
  • potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses from 12.5 mg to 50 mg daily,
  • sympathomimetic medicines used to treat shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine),
  • estramustine used in cancer therapy,
  • medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
  • sacubitril/valsartan (used in the treatment of chronic heart failure). See section “When not to take Ramizek Plus” and “Warnings and precautions”.
  • lithium used to treat mania or depression,
  • certain antidepressants such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors),
  • rifampicin, an antibiotic used to treat infections,
  • ergotamine derivatives, medicines used to treat dementia and migraine headaches,
  • certain antipsychotics used to treat schizophrenia,
  • certain antiepileptic medicines (phenytoin, barbiturates such as phenobarbital),
  • anaesthetics used during surgical procedures,
  • vasodilators, including nitrates,
  • trimethoprim used to treat infections,
  • anticancer medicines (chemotherapy),
  • immunosuppressive medicines (medicines that suppress the body's immune system), such as cyclosporine, tacrolimus, used in autoimmune disorders or after organ transplantation,
  • corticosteroids used to treat inflammatory conditions, e.g. prednisolone,
  • allopurinol used to treat gout,
  • parasympathomimetic medicines used to treat conditions such as Alzheimer's disease or glaucoma,
  • topical beta-blockers used to treat glaucoma (may increase intraocular pressure),
  • mefloquine used to prevent or treat malaria,
  • baclofen used to treat muscle stiffness in conditions such as multiple sclerosis,
  • gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
  • medicines used to treat diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin,
  • non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac, or high-dose aspirin used to treat arthritis, headache, pain, or inflammation.

Taking Ramizek Plus with food, drink, and alcohol
Ramizek Plus should be taken before a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient must inform the doctor if she suspects she is pregnant (or may become pregnant). The doctor will usually advise stopping Ramizek Plus before conception or immediately after pregnancy is confirmed and will recommend an alternative medicine. Use of Ramizek Plus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to breastfeed. Ramizek Plus is not recommended for breastfeeding mothers, and the doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Ramizek Plus generally does not affect alertness, but some patients may experience centrally-mediated dizziness or weakness due to low blood pressure, especially at the start of treatment, after a dose change, or when combined with alcohol. If such symptoms occur, the ability to drive or operate machinery may be impaired.

Lactose
Ramizek Plus 2.5 mg + 1.25 mg contains 40.97 mg of lactose (20.49 mg glucose and 20.49 mg galactose) per dose. This should be taken into account in patients with diabetes.
Ramizek Plus 2.5 mg + 2.5 mg contains 40.97 mg of lactose (20.49 mg glucose and 20.49 mg galactose) per dose. This should be taken into account in patients with diabetes.
Ramizek Plus 5 mg + 2.5 mg contains 81.94 mg of lactose (40.97 mg glucose and 40.97 mg galactose) per dose. This should be taken into account in patients with diabetes.
Ramizek Plus 5 mg + 5 mg contains 81.94 mg of lactose (40.97 mg glucose and 40.97 mg galactose) per dose. This should be taken into account in patients with diabetes.
Ramizek Plus 10 mg + 5 mg contains 163.88 mg of lactose (81.94 mg glucose and 81.94 mg galactose) per dose. This should be taken into account in patients with diabetes.
Ramizek Plus 10 mg + 10 mg contains 163.88 mg of lactose (81.94 mg glucose and 81.94 mg galactose) per dose. This should be taken into account in patients with diabetes.

Sodium
Ramizek Plus contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to take Ramizek Plus

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The recommended dose is one capsule once daily. The capsule should be swallowed in the morning before a meal, with a glass of water.
Patients with kidney disease
The physician will adjust the dose of Ramizek Plus in patients with moderate kidney disease.
Ramizek Plus is not recommended in cases of severe kidney disease.
Patients with liver function disorders
The physician will closely monitor patients with mild or moderate liver disease when initiating treatment with Ramizek Plus.
Use in children and adolescents
Use in children and adolescents is not recommended.
Taking more Ramizek Plus than recommended
If more capsules have been taken than prescribed, contact a physician or pharmacist immediately.
The most likely consequence of overdose is low blood pressure, which may cause dizziness or fainting (in such cases, lying down with elevated legs may help), severe breathing difficulties, tremor (due to decreased blood sugar levels), and slowed heart rate.
Missing a dose of Ramizek Plus
It is important to take the medicine daily, as regular treatment is more effective. However, if a dose of Ramizek Plus is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Ramizek Plus
Do not suddenly stop taking Ramizek Plus or change the dose without consulting a physician, as this may lead to serious worsening of heart condition. Treatment should not be abruptly discontinued, especially in patients with coronary artery disease.
If you have any further questions about the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine and contact your doctor immediately if any of the following adverse reactions occur:

  • Severe central dizziness or fainting caused by low blood pressure (common – may occur in up to 1 in 10 people),
  • Worsening of heart failure causing severe shortness of breath and/or fluid retention in the body (common – may occur in up to 1 in 10 people),
  • Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (uncommon – may occur in up to 1 in 100 people),
  • Sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon – may occur in up to 1 in 100 people),
  • Unusual rapid or irregular heartbeat, chest pain (angina), sensation of pressure in the chest or more serious problems, including myocardial infarction (uncommon – may occur in up to 1 in 100 people),
  • Weakness of arms or legs or speech problems, which may be signs of a possible stroke (frequency cannot be determined from available data),
  • Pancreatitis, which may cause severe abdominal pain radiating to the back, accompanied by severe malaise (uncommon – may occur in up to 1 in 100 people),
  • Yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (rare – may occur in up to 1 in 1000 people),
  • Severe skin reactions, including rash, oral ulcers, worsening of pre-existing skin conditions, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) (frequency unknown – frequency cannot be determined from available data).

Ramizek Plus is generally well tolerated, but, as with any medicine, patients may experience various adverse reactions, particularly at the beginning of treatment.
If you notice any of the adverse reactions listed below or not listed below, inform your doctor or pharmacist immediately:
Very common (may occur in more than 1 in 10 people):

  • Slowed heartbeat.

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

  • Headache,
  • Central dizziness,
  • Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly,
  • Numbness of hands or feet,
  • Cold sensation in hands or feet,
  • Dry, persistent cough,
  • Shortness of breath,
  • Sinusitis or bronchitis,
  • Chest pain,
  • Gastrointestinal disturbances such as nausea, vomiting, abdominal or intestinal pain, indigestion or dyspepsia, diarrhoea, constipation,
  • Allergic reactions such as skin rash with or without raised areas, itching,
  • Muscle cramps, muscle pain (myalgia),
  • Feeling of fatigue,
  • Tiredness,
  • Blood tests showing higher than normal potassium levels.

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

  • Peripheral dizziness,
  • Loss or disturbance of taste,
  • Tingling (paresthesia),
  • Blurred vision,
  • Tinnitus (ringing in the ears),
  • Nasal congestion, breathing difficulties or worsening of asthma,
  • Nasal mucositis, nasal obstruction,
  • Intestinal angioedema, presenting with abdominal pain, vomiting and diarrhoea,
  • Epigastric pain including inflammation of the gastric mucosa,
  • Sudden flushing (especially of the face),
  • Mood swings,
  • Sleep disturbances,
  • Depression, anxiety, nervousness or restlessness,
  • Dry mouth,
  • Sweating,
  • Kidney problems,
  • Increased urine output during the day,
  • Impotence,
  • Eosinophilia (an increase in a type of white blood cells),
  • Drowsiness,
  • Palpitations,
  • Rapid heartbeat (tachycardia),
  • Irregular heart rate (atrioventricular conduction disturbances),
  • Muscle weakness,
  • Arthralgia (joint pain),
  • Localized swelling (peripheral oedema),
  • Fever,
  • Loss or reduced appetite (anorexia),
  • Changes in laboratory parameters: increased number of certain white blood cells (eosinophilia), increased blood urea levels, increased blood creatinine levels, increased liver enzyme activity, increased serum bilirubin levels indicating changes in liver, pancreas or kidney function,
  • Increased protein in urine,
  • Oral ulcers.

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

  • Nightmares, hallucinations,
  • Reduced tear production (dry eyes),
  • Redness, itching, swelling or watering of the eyes,
  • Excessive skin peeling, itchy papular rash,
  • Nail disorders (e.g. loosening or separation of the nail from the nail bed),
  • Hearing problems, liver inflammation which may cause yellowing of the skin or whites of the eyes,
  • Vasculitis (inflammation of blood vessels),
  • Skin spots and cold extremities,
  • Tremor, balance disturbances,
  • Changes in laboratory parameters: increased fat levels, decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin levels,
  • Allergic rhinitis.

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

  • Confusion,
  • Pancreatitis (causing severe epigastric pain radiating to the back),
  • Hair loss,
  • Appearance or worsening of scaly skin rash (psoriasis), psoriasiform rash,
  • Increased skin sensitivity to sunlight (photosensitivity reaction).

Frequency not known (frequency cannot be determined from available data):

  • Difficulty concentrating,
  • Discoloration, numbness and pain in fingers and toes (Raynaud's phenomenon),
  • Low sodium levels, very low blood sugar levels (hypoglycaemia) in diabetic patients,
  • Inflammation of the tongue,
  • Breast enlargement in men,
  • Coordination problems, slowed or impaired reactions,
  • Burning sensation,
  • Smell disturbances.

Adverse reactions such as concentrated urine (dark colour), nausea or vomiting, muscle cramps, confusion and seizures may occur during treatment with ACE inhibitors, which may be caused by abnormal ADH (antidiuretic hormone) secretion. If any of these symptoms occur, contact your doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur in the patient, including any adverse reactions 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, 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 to provide more information on the safety of the medicine.

5. How to store Ramizek Plus

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not store in a refrigerator or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ramizek Plus contains

  • The active substances are ramipril and bisoprolol fumarate.

  • Other excipients:
    Capsule contents: Monohydrate lactose, polyvinyl alcohol, sodium croscarmellose (E468), sodium stearyl fumarate, microcrystalline cellulose, calcium hydrogen phosphate, anhydrous, crospovidone type A, colloidal silicon dioxide, anhydrous, magnesium stearate.

    AquaPolish P yellow coating: Hypromellose (E 464), hydroxypropylcellulose (E463), medium-chain triglycerides, talc (E 553b), titanium dioxide (E 171), yellow iron oxide (E 172).
    Capsule shell: Titanium dioxide (E 171), gelatin, red iron oxide (E 172) – [in 10 mg+10 mg, 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg capsules], yellow iron oxide (E 172) – [in 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg, 2.5 mg+2.5 mg, 2.5 mg+1.25 mg capsules], quinoline yellow (E 104) – [in 5 mg+2.5 mg, 2.5 mg+2.5 mg, 2.5 mg+1.25 mg capsules].
    Printing ink: Shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonium hydroxide, potassium hydroxide.

What Ramizek Plus looks like and contents of the pack

Ramizek Plus 2.5 mg + 1.25 mg, hard capsules
The capsule has a yellow cap printed in black with "2.5 mg" and a white body printed in black with "1.25 mg".
Contents of the 2.5 mg + 1.25 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramizek Plus 2.5 mg + 2.5 mg, hard capsules
The capsule has a yellow cap printed in black with "2.5 mg" and a yellow body printed in black with "2.5 mg".
Contents of the 2.5 mg + 2.5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramizek Plus 5 mg + 2.5 mg, hard capsules
The capsule has an orange cap printed in black with "5 mg" and a yellow body printed in black with "2.5 mg".
Contents of the 5 mg + 2.5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramizek Plus 5 mg + 5 mg, hard capsules
The capsule has an orange cap printed in black with "5 mg" and an orange body printed in black with "5 mg".
Contents of the 5 mg + 5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramizek Plus 10 mg + 5 mg, hard capsules
The capsule has a reddish-brown cap printed in black with "10 mg" and an orange body printed in black with "5 mg".
Contents of the 10 mg + 5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramizek Plus 10 mg + 10 mg, hard capsules
The capsule has a reddish-brown cap printed in black with "10 mg" and a reddish-brown body printed in black with "10 mg".
Contents of the 10 mg + 10 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as two yellow, biconvex, coated, round tablets.

Packaging: BOPA/Aluminium/PVC/Aluminium blisters.
The blisters and the patient information leaflet are packed in a cardboard box.
Capsules are available in packs of:
10, 30, 60 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A,
05–152 Czosnów
tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice