Concoram

Package Leaflet: 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 package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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 with 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 you are allergic to amlodipine, bisoprolol, dihydropyridine derivatives, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe narrowing of the outflow tract from the left ventricle (e.g., severe aortic stenosis).
• If you have 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 you have experienced shock due to inadequate heart function (in such cases, blood pressure is very low with a risk of circulatory collapse).
• If you have a heart condition characterized by a very slow or irregular heart rate (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 asthma.
• In case of severe peripheral vascular disease.
• In case of Raynaud's syndrome, characterized by numbness, pain, and pallor of the fingers and toes upon exposure to cold.
• In case of untreated pheochromocytoma, a rare tumor of the adrenal gland.
• In case of metabolic states in which the blood becomes acidic. If any of the above conditions apply to you, consult your doctor before taking this medicine.

Warnings and precautions

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

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

If any of the above situations occur, your 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 the 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 simultaneously. Drug interactions are possible even if another medicine is taken for a short time. Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as those you 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. Antihypertensive drugs with a central action(e.g., clonidine, methyldopa, moxonidine, rilmenidine): do not stop taking these medicines without consulting your doctor. The following medicines can be taken with Concoram only in certain situations, with special caution and under medical supervision. Certain antiarrhythmic drugs(quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone): these medicines are used to treat heart rhythm disorders. Locally applied 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. Insulin and oral antidiabetic drugs.Sedatives, anesthetics.Cardiac glycosides (digitalis glycosides):these medicines are used to treat heart failure. Nonsteroidal 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 drug. Dantrolene:an infusion used in severe body temperature anomalies. Simvastatin:a medicine that lowers cholesterol levels. Potential drug interactions that require consideration by the doctor.Mefloquine:used to prevent or treat malaria. Monoamine oxidase inhibitors (MAOIs)(except MAO-B inhibitors): used to treat depression. Drugs that affect amlodipine metabolism, such as:

• ketokonazole, itraconazole (antifungal drugs),
• 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 blood pressure-lowering effect of the medicine. Grapefruit juice and grapefruit should not be consumed by patients taking Concoram. Grapefruit and grapefruit juice may lead to increased levels of amlodipine in the blood, which may cause unexpected enhancement of blood pressure lowering.

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 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 when it is possible to drive a car or operate machines after taking the medicine.

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 exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist. The recommended dose is one tablet of the strength prescribed by your 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 you feel that the effect of Concoram is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Concoram than recommended

In case of taking a higher dose of Concoram than recommended, contact your doctor immediately. Even up to 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Concoram

Take the missed dose as soon as possible. If it is almost time for the next dose, do 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 treatment

Do not stop taking Concoram suddenly or change the recommended dose without consulting your doctor, as this may lead to temporary worsening of heart failure. Treatment should not be stopped 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concoram can cause side effects, although not everybody gets them. If you experience any of the following symptoms after taking the medicine, contact your 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 affect more than 1 in 10 people)Edema. Common (may affect up to 1 in 10 people)Headache, dizziness, drowsiness (especially at the beginning of treatment), palpitations, flushing, abdominal pain, edema around the ankles, fatigue, weakness, feeling of coldness or numbness in the limbs, gastrointestinal disorders such as nausea, vomiting, changes in bowel movements, diarrhea, constipation, indigestion, and vision disturbances (including double vision), muscle cramps, shortness of breath. Uncommon (may affect up to 1 in 100 people)Insomnia, mood changes (including anxiety), depression, transient loss of consciousness (syncope), numbness, paresthesia, taste disturbances, tremors, tinnitus, hypotension, nasal congestion, 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, gynecomastia 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, bronchospasm in patients with asthma or chronic obstructive pulmonary disease. Rare (may affect up to 1 in 1,000 people)Disorientation, increased triglyceride levels, nightmares, hallucinations, i.e., abnormal sensations without detectable stimuli, similar to real ones and seeming real (illusions), decreased tear secretion (should be kept in mind when using contact lenses), hearing disorders, allergic rhinitis, hepatitis, hypersensitivity reactions, such as itching, flushing, rash, increased activity of liver enzymes. Very rare (may affect up to 1 in 10,000 people)Decreased white blood cell and platelet count, allergic reactions, increased blood sugar levels, increased tension, peripheral neuropathy, myocardial infarction, vasculitis, gastritis, gingival hyperplasia, pancreatitis, jaundice, acute skin or mucous membrane edema, 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 rash 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 or cause psoriasis-like skin changes, a complex disorder involving involuntary movements, stiffness, and muscle cramps (extrapyramidal syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. 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 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, you can help provide more information on the safety of this medicine.

5. How to store Concoram

Keep the medicine out of sight and reach of children. There are no special precautions for storage of the medicinal product. Store in the original package 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 month.

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

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

6. Contents of the package 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.

• The medicine also contains: colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Concoram looks like and contents of the package

Concoram, 5 mg + 5 mg, tablets: white or almost white, odorless, elongated, 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 and a diameter of 10 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 + 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 with a diameter of 10 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. Package: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 package leaflet: June 2022