Concoram

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Concoram (Concor AM), 10 mg + 5 mg, tablets

Bisoprolol fumarate + Amlodipine
Concoram and Concor AM are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 abnormal heart function (in such cases, blood pressure is very low with threatening circulatory collapse).
• If the patient has heart disease characterized by very slow or irregular heart function (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 after exposure to cold.
• In case of untreated pheochromocytoma, a rare tumor of the adrenal gland.
• In case of metabolic conditions in which the blood becomes acidic. If any of the above disorders apply to the patient, they should ask 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 is necessary to exercise special caution when taking Concoram, so the patient should inform their doctor if any of the following conditions apply to them:

• old 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 conduction disorders of the heart (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,
• 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 the safety and efficacy of its use.

Concoram and other medicines

The therapeutic and unwanted 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 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): the patient should not stop taking these medicines without consulting their doctor.
The following medicines can be taken 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.
• insulin and oral anti-diabetic 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 medicines that lower blood pressure, as a desired or undesired effect (e.g., antihypertensive drugs, tricyclic antidepressants, barbiturates, phenothiazines).
• tacrolimus: this medicine is used to change the way the immune system works.
• cyclosporin: this medicine is an immunosuppressant.
• dantrolene: this medicine is used to treat severe temperature regulation disorders.
• simvastatin: this medicine reduces cholesterol levels.
• potential effects of medicines whose concomitant use with Concoram requires consideration by the doctor.
• mefloquine: this medicine is used to prevent or treat malaria.
• monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors): these medicines are 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 on 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

Pregnancy
Due 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.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
Concoram should not be taken 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 in case of alcohol consumption – therefore, the doctor will make an individual decision on which dose can be taken while driving or using machines.

Important information about some ingredients of Concoram

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

3. How to take Concoram

This medicine should always be taken according to the doctor's recommendations.
In case of doubts, the patient should consult their doctor or pharmacist.
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 dosage in case of mild or moderate liver or kidney impairment.
In severe liver or kidney impairment, the doses 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 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 for easier swallowing.
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 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 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 the treatment, the doctor will recommend a gradual reduction in 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 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 occur in more than 1 in 10 patients)
Edema.
Common (may occur in less than 1 in 10 patients)
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 vision disturbances (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 (syncope), paresthesia, taste disturbances, tremors, tinnitus, hypotension, rhinitis, cough, dryness of the mucous membranes of the mouth, hair loss, minor hemorrhages 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 obstructive pulmonary disease, muscle weakness.
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 rhinitis, hepatitis, hypersensitivity reactions, such as itching, flushing, 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, vasculitis, gastritis, gingival hyperplasia, pancreatitis, jaundice, acute edema 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 worsen 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 tell their doctor, pharmacist, or nurse.
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
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Concoram

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storage temperature.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.

Do not take this medicine if signs of deterioration are visible (change in color).

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, 10 mg + 5 mg, tablets are: 10 mg bisoprolol fumarate and 5 mg amlodipine (in the form of amlodipine besylate).
• The medicine also contains: colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Concoram looks like and what the packaging contains

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 inscription MS on the other side.
The dividing line does not divide the tablet into two equal doses, it only facilitates breaking the tablet for easier swallowing.
Packaging:
30 tablets in OPA/Aluminum/PVC//Aluminum blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or 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
Bökényföldi út 118-120, H-1165 Budapest, Hungary

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Latvia, the country of export: 11-0131

Parallel import authorization number: 325/24

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: 19.08.2024

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