Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Concoram (Concor AM), 5 mg + 10 mg, tablets
Bisoprololum fumaras + Amlodipinum
Concoram and Concor AM are different trade names for the same medicinal product.
Please read all of this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Concoram is and what it is used for
Important information before taking Concoram
How to take Concoram
Possible side effects
How to store Concoram
Contents of the pack and other information

1. What Concoram is and what it is used for

Concoram is indicated for substitution treatment of arterial hypertension in patients whose blood pressure has been controlled by concomitant administration of the individual active substances at the same doses as those in Concoram, but given as 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 obstruction of the left ventricular outflow tract (e.g. severe aortic valve stenosis).
If the patient has acute heart failure, unstable heart failure following acute myocardial infarction, or heart failure requiring intravenous administration of drugs to increase myocardial contractility.
If the patient has experienced cardiogenic shock (a condition in which blood pressure is very low, leading to life-threatening circulatory collapse).
If the patient has a heart condition characterized by very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome).
In case of very low arterial blood pressure.
In case of slow 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 fingers and toes upon exposure to cold.
In case of untreated phaeochromocytoma, a rare tumour of the adrenal medulla.
In case of metabolic conditions in which blood pH becomes acidic.
If any of the above conditions apply to the patient, consult a doctor before taking this medicine.

Warnings and precautions
Before starting treatment with Concoram, discuss it with your doctor or pharmacist.
Particular caution is required when using Concoram in certain situations. Inform your doctor if any of the following conditions apply to you:

advanced age,
heart failure,
diabetes with large fluctuations in blood glucose 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 spasm (Prinzmetal's angina),
peripheral vascular disease characterized by reduced blood flow,
psoriasis,
hyperthyroidism,
liver or kidney disease,
treated phaeochromocytoma, a rare tumour of the adrenal gland,
bronchial asthma or other chronic obstructive pulmonary disease,
if surgery is planned, inform the anaesthesiologist that you are taking Concoram.

If any of the above conditions apply, your doctor may consider it necessary to initiate special management (e.g. additional treatment).

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

Concoram and other medicines
The therapeutic and adverse effects of this medicine may be altered by other medicines taken simultaneously.
Drug interactions are possible even if the other medicine is used only for a short period.
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Concomitant use of the following medicines with Concoram is not recommended.

Calcium antagonists of the verapamil and diltiazem type: these medicines are used to treat high blood pressure and chronic stable angina.
Centrally-acting antihypertensive agents (e.g. clonidine, methyldopa, moxonidine, rilmenidine): do not stop taking these medicines without consulting your doctor.

The following medicines may be used concomitantly with Concoram only in certain situations, with special caution and under medical supervision.

Certain antiarrhythmic medicines (quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone): these are used to treat cardiac arrhythmias.
Topically applied beta-adrenergic blockers (e.g. eye drops used in glaucoma treatment).
Parasympathomimetics: these medicines are used to enhance smooth muscle activity in gastrointestinal disorders, bladder dysfunction, and glaucoma.
Insulin and oral antidiabetic medicines.
Sedatives and anaesthetics.
Cardiac glycosides (digitalis glycosides): medicines used in the treatment of heart failure.
Non-steroidal anti-inflammatory drugs (NSAIDs): these medicines are used to treat pain and joint inflammation.
Sympathomimetics (e.g. isoprenaline, dobutamine, noradrenaline, adrenaline): these are used in the treatment of severe circulatory disorders and emergency conditions.
All medicines that lower blood pressure, either as a desired or adverse effect (e.g. antihypertensives, tricyclic antidepressants, barbiturates, phenothiazines).
Tacrolimus: a medicine used to modify immune system function.
Cyclosporine: an immunosuppressive medicine.
Dantrolene: an infusion used in severe temperature regulation disorders.
Simvastatin: a medicine that reduces cholesterol levels.

Potential interactions requiring medical evaluation when used concomitantly with Concoram:

Mefloquine: used for prevention or treatment of malaria.
Monoamine oxidase inhibitors (MAO inhibitors) (except MAO-B inhibitors): used in the treatment of depression.
Medicines affecting amlodipine metabolism, for example:

ketoconazole, itraconazole (antifungal agents),
ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV treatment),
rifampicin, erythromycin, clarithromycin (antibiotics),
St John's wort (Hypericum perforatum).

Concoram, food, drink and alcohol
Alcohol may enhance the blood pressure-lowering effect of this medicine.
Grapefruit juice and grapefruit must not be consumed by patients taking Concoram.
Grapefruit and grapefruit juice may increase blood levels of amlodipine, potentially causing unexpected and pronounced lowering of blood pressure.

Pregnancy, breastfeeding and fertility
Pregnancy
Due to insufficient clinical experience with use in pregnant women, Concoram should be used during pregnancy only after careful assessment by the doctor of the benefit-risk ratio of treatment. Therefore, if you are pregnant or planning pregnancy, inform your doctor immediately.
If Concoram is used during pregnancy, careful monitoring of the foetus 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 operating machinery
Concoram may impair the ability to drive or operate machinery due to possible occurrence of dizziness, headache, fatigue or nausea—especially at the beginning of treatment, during dose adjustments, or if alcohol is consumed. Therefore, the decision whether it is safe to drive or operate machinery should be made individually by the doctor, depending on the dose used.

Important information about certain excipients in Concoram
Concoram contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Concoram

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
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 your doctor.
Dosage adjustment is usually not necessary in cases of mild or moderate liver or kidney impairment.
Dosage may need to be adjusted in severe liver or kidney impairment.
Elderly patients
Dosage adjustment is not required in elderly patients; however, caution is advised when increasing the dose.
Method of administration
Take one Concoram tablet in the morning, with or without food, with a small amount of fluid. Do not chew the tablet.
The tablet's score line is intended only to facilitate breaking for easier swallowing.
If you feel that the effect of Concoram is too strong or too weak, consult your doctor or pharmacist.
Taking more Concoram than recommended
If you take more tablets than recommended, contact your doctor immediately.
Even 24 to 48 hours after taking the medicine, shortness of breath due to 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 one, as this will not compensate for the missed dose and may increase the risk of overdose.
Stopping Concoram treatment
Do not stop taking Concoram suddenly or change the prescribed dose without consulting your doctor, as this may lead to a temporary worsening of heart failure. Treatment should not be stopped abruptly, especially in patients with ischemic heart disease. If discontinuation is necessary, your doctor will recommend gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the symptoms listed below occur after taking the medicine, you should immediately
contact your doctor:

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

Very common (may affect more than 1 in 10 patients)
Swelling.

Common (may affect up to 1 in 10 patients)
Headache, dizziness, drowsiness (especially at the beginning of treatment), palpitations, sudden facial flushing, abdominal pain, swelling around the ankles, fatigue, weakness, feeling of coldness or numbness in limbs, gastrointestinal disturbances such as nausea, vomiting, changes in bowel rhythm, diarrhoea, constipation, indigestion, and visual disturbances (including double vision), muscle cramps, shortness of breath.

Uncommon (may affect up to 1 in 100 patients)
Insomnia, mood changes (including anxiety), depression, transient loss of consciousness (fainting), hypoglycaemia, paraesthesia, taste disturbances, tremor, tinnitus, hypotension, nasal mucosal inflammation, cough, dryness of the oral mucosa, alopecia, small skin and mucosal haemorrhages (purpura), skin discolouration, excessive sweating, itching, rash, eruption, urticaria, joint pain, muscle pain, back pain, frequent urination, urinary disorders, nocturia, impotence, gynaecomastia in men, chest pain, pain, malaise, weight gain, weight loss, sleep disorders, cardiac conduction disturbances, worsening of pre-existing heart failure, cardiac arrhythmias, bradycardia (heart rate below 50 beats per minute), low blood pressure, bronchospasm in patients with a history of bronchial asthma or chronic obstructive pulmonary disease, muscle weakness.

Rare (may affect up to 1 in 1000 patients)
Disorientation, increased triglyceride levels, nightmares, hallucinations (false perceptions without detectable stimuli, resembling real sensations and appearing real), reduced tear secretion (this should be kept in mind if wearing contact lenses), hearing disturbances, allergic rhinitis, hepatitis, hypersensitivity reactions such as itching, sudden facial flushing, rash, increased liver enzyme activity.

Very rare (may affect up to 1 in 10,000 patients)
Decreased white blood cell and platelet counts, allergic reactions, increased blood glucose levels, increased tension, peripheral neuropathy, myocardial infarction, vasculitis, gastritis, gingival hyperplasia, pancreatitis, jaundice, acute swelling of the skin or mucous membranes, most commonly affecting eyelids, lips, joints, genital area, larynx, pharynx and tongue (angioedema), severe inflammation of the skin or mucous membranes with red blisters (erythema multiforme), widespread erythema and skin peeling (exfoliative dermatitis), severe blistering skin and mucosal lesions in the oral cavity, genital area and anus, accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome), photosensitivity, conjunctivitis. Medicines with a mechanism of action similar to bisoprolol (active substance) may induce or exacerbate psoriasis (a chronic skin disease characterised by areas of itchy, scaly and red skin) or cause psoriasiform skin lesions, and may cause a complex disorder involving involuntary movements, rigidity and muscle spasms, tremor (extrapyramidal syndrome).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 49 21 301
faks: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Concoram

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding 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 stated month.
Do not take this medicine if you notice signs of deterioration (change in colour).
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the package and other information

What Concoram contains

The active substances in Concoram 5 mg + 10 mg tablets are: 5 mg bisoprolol fumarate and 10 mg amlodipine (as amlodipine besylate).
Other ingredients: colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (type A), microcrystalline cellulose.

What Concoram looks like and contents of the pack
White or almost white, odourless, round, flat tablets with bevelled edges, 10 mm in diameter, with a score line on one side and an imprint "MS" on the other side. The score line does not divide the tablet into two equal doses and is intended only to facilitate breaking the tablet for easier swallowing.
Packaging:
30 tablets in OPA/Aluminum/PVC//Aluminum blisters in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Merck Serono SIA
Duntes iela 23A, LV-1005, Riga, Latvia
Manufacturer:
EGIS Pharmaceuticals PLC.
1165 Budapest, Bökényföldi út 118-120, Hungary
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation Number in Latvia, country of export: 11-0132
Parallel Import Authorisation Number: 14/25
This medicinal product is authorised for marketing in the European Economic Area countries 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