Concoram

Leaflet attached to the packaging: information for the user

Concoram, 5 mg + 5 mg, tablets

Concoram, 5 mg + 10 mg, tablets

Concoram, 10 mg + 5 mg, tablets

Concoram, 10 mg + 10 mg, tablets

Bisoprolol fumarate + Amlodipine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Concoram and what is it used for

Concoram is indicated for the substitution treatment of hypertension in patients who have achieved blood pressure control while taking the individual active substances at the same doses as in Concoram, but in separate tablets.

2. Important information before taking Concoram

When not to take Concoram

• If the patient is allergic to amlodipine, bisoprolol, dihydropyridine derivatives, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has significant narrowing of the outflow tract from the left ventricle (e.g., high-grade narrowing of the aortic valve).
• If the patient has acute heart failure, unstable heart failure after acute myocardial infarction, or heart failure requiring intravenous administration of drugs to increase the contractile force of the heart muscle.
• If the patient has experienced shock caused by poor heart function (in such cases, blood pressure is very low with a risk of circulatory collapse).
• If the patient has heart disease characterized by very slow or irregular heart rhythm (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome).
• In case of very low blood pressure.
• In case of slowed heart rate.
• In case of severe bronchial asthma.
• In case of severe peripheral vascular disease.
• In case of Raynaud's syndrome, characterized by numbness, pain, and paleness of the fingers and toes after exposure to cold.
• In case of untreated pheochromocytoma, a rare tumor of the adrenal gland.
• In case of metabolic disorders in which the blood becomes acidic. If any of the above conditions apply to the patient, they should consult their doctor about the possibility of taking this medicine.

Warnings and precautions

Before starting to take Concoram, the patient should discuss it with their doctor or pharmacist. In some cases, it may be necessary to exercise special caution when taking Concoram, so the patient should inform their doctor if any of the following conditions apply:

• Advanced age,
• Heart failure,
• Diabetes with large fluctuations in blood sugar levels,
• Strict diet,
• Concomitant anti-allergic (desensitizing) treatment (e.g., to prevent allergic rhinitis),
• Mild disturbances of heart conduction (first-degree atrioventricular block),
• Coronary artery disease (Prinzmetal's angina),
• Vascular disease of the limbs, characterized by reduced blood flow,
• Psoriasis,
• Hyperthyroidism,
• Liver or kidney disease,
• Treated pheochromocytoma, which is a rare tumor of the adrenal gland,
• Bronchial asthma or other chronic obstructive pulmonary disease,
• If surgery is planned, the anesthesiologist should be informed about the use of Concoram.

If any of the above situations occur, the doctor may consider it necessary to implement special procedures (e.g., additional treatment).

Children and adolescents

Concoram is not recommended for use in children under 18 years of age due to a lack of data on safety and efficacy.

Concoram and other medicines

The therapeutic and adverse effects of this medicine may change under the influence of other medicines taken at the same time. Drug interactions are possible, even if another medicine is used only for a short time. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is not recommended to take the following medicines with Concoram:Calcium channel blockers of the verapamil and diltiazem type:these medicines are used to treat high blood pressure and chronic stable angina pectoris. Antihypertensive drugs with a central action(e.g., clonidine, methyldopa, moxonidine, rilmenidine): these medicines should not be discontinued without consulting a doctor. The following medicines can be used with Concoram only in certain situations, with special caution and under medical supervision: Certain anti-arrhythmic drugs(quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone): these medicines are used to treat heart rhythm disorders. Locally used beta-adrenergic blockers(e.g., eye drops used to treat glaucoma). Parasympathomimetics:these medicines are used to enhance the activity of smooth muscles in stomach, intestine, bladder, and glaucoma diseases. Insulin and oral antidiabetic drugs.Sedatives, anesthetics.Cardiac glycosides (digitalis glycosides):these medicines are used to treat heart failure. Non-steroidal anti-inflammatory drugs (NSAIDs):these medicines may be used to treat pain and joint inflammation. Sympathomimetics(e.g., isoprenaline, dobutamine, noradrenaline, adrenaline): these medicines are used to treat severe circulatory disorders, in emergency situations. All drugs that lower blood pressure, as a desired or undesired effect(e.g., antihypertensive drugs, tricyclic antidepressants, barbiturates, phenothiazines). Tacrolimus:a medicine used to change the way the immune system works. Cyclosporine:an immunosuppressive medicine. Dantrolene:an infusion used in severe body temperature anomalies. Simvastatin:a medicine that lowers cholesterol levels. Potential effects of drugs whose concomitant use with Concoram requires consideration by the doctor.Mefloquine:used to prevent or treat malaria. Monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors):used to treat depression. Medicines that affect the metabolism of amlodipine, such as:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's wort.

Concoram with food, drink, and alcohol

Alcohol may enhance the effect of the medicine, which consists of lowering blood pressure. Grapefruit juice and grapefruit should not be consumed by patients taking Concoram. Grapefruit and grapefruit juice may lead to an increase in the concentration of amlodipine in the blood, which may cause unforeseen intensification of blood pressure reduction.

Pregnancy, breastfeeding, and fertility

PregnancyDue to the lack of sufficient clinical experience with the use of Concoram in pregnant women, the medicine can be taken only after careful evaluation of the benefit-risk ratio by the doctor. In case of pregnancy or planned pregnancy, it is necessary to inform the doctor about it. In case of use of the medicine during pregnancy, careful monitoring of the fetus and newborn may be necessary. BreastfeedingIt has been shown that small amounts of amlodipine pass into human milk. Concoram is not recommended during breastfeeding.

Driving and using machines

Concoram may impair the ability to drive and use machines because dizziness, headache, fatigue, or nausea may occur - especially at the beginning of treatment, during changes in treatment, and when consuming alcohol. The doctor will decide individually after administering which dose the patient can drive or operate machines.

Important information about some ingredients of Concoram

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Concoram

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is one tablet of the strength prescribed by the doctor. Usually, there is no need to modify the dosage in case of mild or moderate liver or kidney impairment. In severe liver or kidney impairment, the dose may be changed. Elderly patients There is no need to modify the dosage in elderly patients, however, caution is recommended when increasing the dose. Method of administrationThe Concoram tablet should be taken in the morning, with or without food, with a small amount of liquid, without chewing. The dividing line on the tablet only facilitates breaking the tablet to make it easier to swallow. If the patient feels that the effect of Concoram is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Concoram than recommended

In case of taking a higher dose of Concoram than recommended, the patient should contact their doctor immediately. Even up to 24-48 hours after taking the medicine, shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Concoram

The patient should take the missed dose as soon as possible. If it is almost time for the next dose, the patient should not take a double dose to make up for the missed dose, as it is impossible to make up for the missed dose, and there is a risk of overdose.

Stopping Concoram

The patient should not stop taking Concoram suddenly or change the recommended dose without consulting their doctor, as this may lead to transient worsening of heart failure. Treatment should not be discontinued abruptly, especially in patients with coronary heart disease. If it is necessary to stop treatment, the doctor will recommend gradual reduction of the dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Concoram can cause side effects, although not everybody gets them. If any of the following symptoms occur after taking the medicine, the patient should see their doctor immediately:

• Severe skin reactions, including strong rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

Very common (may occur in more than 1 in 10 patients)Edema. Common (may occur in less than 1 in 10 patients)Headache, dizziness, drowsiness (especially at the beginning of treatment), palpitations, sudden reddening of the face, abdominal pain, edema around the ankles, fatigue, weakness, feeling of cold or numbness in the limbs, gastrointestinal disorders such as nausea, vomiting, changes in bowel movements, diarrhea, constipation, indigestion, and vision disorders (including double vision), muscle cramps, shortness of breath. Uncommon (may occur in less than 1 in 100 patients)Insomnia, mood changes (including anxiety), depression, transient loss of consciousness (fainting), numbness, paresthesia, taste disorders, tremors, tinnitus, hypotension, inflammation of the nasal mucosa, cough, dryness of the mucous membranes of the mouth, hair loss, minor bleeding in the skin and mucous membranes (petechiae), skin discoloration, increased sweating, itching, rash, eruption, urticaria, joint pain, muscle pain, back pain, frequent urination, urinary disorders, nocturia, impotence, breast enlargement in men, chest pain, pain, malaise, weight gain, weight loss, sleep disorders, conduction disorders in the heart, worsening of existing heart failure, arrhythmias, slow heart rate (less than 50 beats per minute), low blood pressure, bronchial spasm in patients with bronchial asthma or obstructive pulmonary disease. Rare (may occur in less than 1 in 1000 patients)Disorientation, increased triglyceride levels, nightmares, hallucinations, i.e., abnormal sensations without detectable stimuli, similar to real ones and seeming real (illusions), decreased tear secretion (this should be kept in mind when using contact lenses), hearing disorders, allergic inflammation of the nasal mucosa, liver inflammation, hypersensitivity reactions, such as itching, sudden reddening of the face, rash, increased activity of liver enzymes. Very rare (may occur in less than 1 in 10,000 patients)Decreased white blood cell and platelet count, allergic reactions, increased blood sugar levels, increased tension, peripheral neuropathy, myocardial infarction, inflammation of small blood vessels, stomach inflammation, gingival hyperplasia, pancreatitis, jaundice, acute swelling of the skin or mucous membranes, most often of the eyelids, lips, joints, genital area, larynx, and tongue (angioedema), severe skin or mucous membrane inflammation with red blisters (erythema multiforme), widespread erythema and skin peeling (exfoliative dermatitis), severe, blistering damage to the skin and mucous membranes of the mouth, genital area, and anus, with fever, sore throat, and fatigue (Stevens-Johnson syndrome), hypersensitivity to light, conjunctivitis. Medicines with a mechanism of action similar to bisoprolol (the active substance) may cause or exacerbate psoriasis (a chronic skin disease characterized by areas of itchy, scaly, and reddened skin) or cause psoriasis-like skin changes, a complex disorder involving involuntary movements, stiffness, and muscle cramps, tremors (extrapyramidal syndrome).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Concoram

The medicine should be stored in a place that is out of sight and reach of children. There are no special recommendations for storing the medicinal product. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the carton and blister (year/month). The expiry date refers to the last day of the stated month.

Do not take this medicine if you notice signs of deterioration (color change).

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Concoram contains

• The active substances of Concoram, 5 mg + 5 mg, tablets are: 5 mg bisoprolol fumarate and 5 mg amlodipine (in the form of besylate), Concoram, 5 mg + 10 mg, tablets: 5 mg bisoprolol fumarate and 10 mg amlodipine (in the form of besylate), Concoram, 10 mg + 5 mg, tablets: 10 mg bisoprolol fumarate and 5 mg amlodipine (in the form of besylate),

Concoram, 10 mg + 10 mg, tablets: 10 mg bisoprolol fumarate and 10 mg amlodipine (in the form of besylate).

• In addition, the medicine contains: colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Concoram looks like and contents of the packaging

Concoram, 5 mg + 5 mg, tablets: white or almost white, odorless, oblong, slightly convex tablets with a length of 9.5 mm and a width of 4.5 mm with a dividing line on one side and the imprint MS on the other side. The dividing line does not divide the tablet into two equal doses, it only facilitates breaking the tablet to make it easier to swallow. Concoram, 5 mg + 10 mg, tablets: white or almost white, odorless, round, flat tablets with a beveled edge, 10 mm in size, with a dividing line on one side and the imprint MS on the other side. The dividing line does not divide the tablet into two equal doses, it only facilitates breaking the tablet to make it easier to swallow. Concoram, 10 mg + 5 mg, tablets: white or almost white, odorless, oval, slightly convex tablets with a length of 13 mm and a width of 7 mm with a dividing line on one side and the imprint MS on the other side. The dividing line does not divide the tablet into two equal doses, it only facilitates breaking the tablet to make it easier to swallow. Concoram, 10 mg + 10 mg, tablets: white or almost white, odorless, round, slightly convex tablets, 10 mm in size, with a dividing line on one side and the imprint MS on the other side. The dividing line does not divide the tablet into two equal doses, it only facilitates breaking the tablet to make it easier to swallow. Packaging:28, 30, 56, or 90 tablets in blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sp. z o.o. Al. Jerozolimskie 142B 02-305 Warsaw Poland

Manufacturer

EGIS Pharmaceuticals PLC Bökényföldi út 118-120 H-1165 Budapest Hungary Merck Healthcare KGaA Frankfurter Strasse 250 64293 Darmstadt Germany

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

Austria Concor AMLO Concor AM Concor AM Czech Republic Concor Combi Hungary Italy Bulgaria Croatia Concor AMLO CONGEXAM Latvia Concor AM Poland Concoram Romania Concor AM Slovakia Concor Combi

Date of last revision of the leaflet: June 2022