Concoram

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Concoram(Concor AM)

5 mg + 5 mg, Tablets

Bisoprolol Fumarate + Amlodipine
Concoram and Concor AM are different trade names for the same medicinal product.

Before Taking the Medicinal Product, Read the Leaflet Carefully, as it Contains Important Information for the Patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicinal product has been prescribed specifically for one person. It should not be given to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 pack 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 the patient is hypersensitive to amlodipine, bisoprolol, dihydropyridine derivatives, or any of the other ingredients of this medicinal product (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 medicinal products to increase the contractile force of the heart muscle.
• If the patient has experienced cardiogenic shock (in such cases, blood pressure is very low with a risk of circulatory collapse).
• If the patient has a 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 pallor 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 disorders apply to the patient, they should consult their doctor about the possibility of taking this medicinal product.

Warnings and precautions

Before starting to take Concoram, the patient should discuss it with their doctor or pharmacist.
In some cases, it is 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 desensitization treatment (e.g., to prevent allergic rhinitis),
• mild conduction disorders (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, 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 the lack of data on safety and efficacy.

Concoram and other medicinal products

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

• ketokonazole, itraconazole (antifungal agents),
• 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 medicinal product on lowering blood pressure.
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 intensification of blood pressure reduction.

Pregnancy, breastfeeding, and fertility

Pregnancy
Due to the lack of sufficient clinical experience with the use of Concoram in pregnant women, the medicinal product 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 medicinal product during pregnancy, careful monitoring of the fetus and newborn may be necessary.
Breastfeeding
It 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, as dizziness, headache, fatigue, or nausea may occur – especially at the beginning of treatment, during changes in treatment, and in case of alcohol consumption – therefore, the doctor will make an individual decision on the dose after which it is possible to drive a car or operate machines.

Important information about some ingredients of Concoram

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

3. How to take Concoram

This medicinal product should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Concoram is available in the following strengths: 5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg, 10 mg + 10 mg.
Recommended dose: one tablet of the strength prescribed by the doctor.
Usually, there is no need to modify the dose 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 dose in elderly patients; however, caution is recommended when increasing the dose.
Method of administration
The 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 its breaking into two halves 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 immediately contact their doctor.
Even 24-48 hours after taking the medicinal product, shortness of breath caused by excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Concoram

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

Stopping Concoram treatment

The patient should not stop taking Concoram suddenly or change the recommended dose without consulting their doctor, as this may lead to a transient 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 dose reduction.
In case of any further doubts about the use of this medicinal product, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• severe skin reactions, including severe 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, somnolence (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 visual disturbances (including double vision), muscle cramps, dyspnea.
Uncommon (may affect up to 1 in 100 people)
Insomnia, mood changes (including anxiety), depression, transient loss of consciousness (syncope), paresthesia, taste disturbances, tremor, tinnitus, hypotension, rhinitis, cough, dryness of the mucous membranes of the mouth, alopecia, minor hemorrhages in the skin and mucous membranes (petechiae), skin discoloration, increased sweating, itching, rash, eruption, urticaria, arthralgia, myalgia, 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 bronchial asthma or a history of 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 (this should be taken into account in case of contact lens use), 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 angioedema, 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. Medicinal products with a mechanism of action similar to that of bisoprolol (the active substance) may cause or exacerbate psoriasis or psoriatic-like skin changes, a complex disorder involving involuntary movements, stiffness, and muscle cramps (extrapyramidal syndrome).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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.
By reporting side effects, it is possible to gather more information on the safety of the medicinal product.

5. How to store Concoram

The medicinal product should be stored out of sight and reach of children.
There are no special recommendations for storage temperature. The medicinal product should be stored in its original packaging to protect it from light.
The medicinal product should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

The medicinal product should not be taken if signs of deterioration are observed (change in color).

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

6. Contents of the pack and other information

What Concoram contains

• The active substances of Concoram, 5 mg + 5 mg, tablets are 5 mg of bisoprolol fumarate and 5 mg of amlodipine (in the form of amlodipine besylate).
• The medicinal product also contains: colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Concoram looks like and contents of the pack

Concoram, 5 mg + 5 mg, tablets are 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.
Packaging:
30 tablets in OPA/Al/PVC//Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Merck Serono SIA
Duntes iela 23A
LV-1005 Riga
Latvia

Manufacturer:

EGIS Pharmaceuticals PLC.
1165 Budapest, Bökényföldi út 118-120, Hungary
Merck Healthcare KGaA
Frankfurter Str. 250, 64293 Darmstadt, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:11-0130

Parallel import authorization number: 65/24

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

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

Date of leaflet approval: 13.02.2024

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