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 + 5 mg, tablets
Bisoprololum fumaras + Amlodipinum
Concoram and Concor AM are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents

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 therapy in the treatment of hypertension in patients
whose blood pressure has been controlled by concomitant administration of the individual
active substances at the same doses as those contained in Concoram, but given 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 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 (in such cases blood pressure is very low with 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 tumor 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 this with your doctor or pharmacist.
Special caution may be required when using Concoram in certain situations. Inform your doctor if any of the following conditions apply to the patient:

advanced age,
heart failure,
diabetes with large fluctuations in blood glucose levels,
strict diet,
concomitant allergen-specific immunotherapy (desensitization) (e.g. to prevent allergic rhinitis),
mild conduction disorders of the heart (first-degree atrioventricular block),
coronary artery disorders (Prinzmetal's angina),
peripheral vascular disease characterized by reduced blood flow,
psoriasis,
hyperthyroidism,
liver or kidney disease,
treated phaeochromocytoma, a rare tumor of the adrenal gland,
bronchial asthma or other chronic obstructive pulmonary disease,
if surgery is planned, inform the anaesthesiologist about taking Concoram.

If any of the above conditions are present, the 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.
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

The following medicines are not recommended to be used concomitantly with Concoram.

Calcium antagonists of the verapamil and diltiazem type: these medicines are used in the treatment of high blood pressure and chronic stable angina.
Centrally-acting antihypertensive medicines (e.g. clonidine, methyldopa, moxonidine, rilmenidine): do not discontinue these medicines without consulting a doctor.

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

Some antiarrhythmic medicines (quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone): these medicines are used to treat cardiac arrhythmias.
Locally applied beta-adrenolytics (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 may be used to treat pain and joint inflammation.
Sympathomimetics (e.g. isoprenaline, dobutamine, noradrenaline, adrenaline): these medicines 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 the immune system response.
Cyclosporine: an immunosuppressive medicine.
Dantrolene: an intravenous infusion used in severe body temperature abnormalities.
Simvastatin: a medicine that reduces cholesterol levels.

Potential interactions requiring consideration by the doctor 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, e.g.:
- ketoconazole, itraconazole (antifungal medicines),
- ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV treatment),
- rifampicin, erythromycin, clarithromycin (antibiotics),
- St. John's wort (Hypericum perforatum).

Concoram with food, drink and alcohol
Alcohol may enhance the blood pressure-lowering effect of this medicine.
Grapefruit juice and grapefruit should not be consumed by patients taking Concoram.
Grapefruit and grapefruit juice may increase the blood concentration of amlodipine, which could lead to an unpredictable intensification of blood pressure reduction.

Pregnancy, breastfeeding and fertility
Pregnancy
Due to insufficient clinical experience with use in pregnant women, Concoram should be taken only after careful assessment by the doctor of the benefit-risk ratio of treatment. Therefore, if the patient is pregnant or planning pregnancy, inform the doctor immediately.
If Concoram is used 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 operating machinery
Concoram may impair the ability to drive and operate machinery, as dizziness, headache, fatigue or nausea may occur—especially at the beginning of treatment, during dosage adjustments, or if alcohol is consumed. Therefore, the doctor will individually decide at which dose the patient may resume driving or operating machinery.

Important information about certain ingredients of Concoram
This medicine 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 according to the doctor's instructions. 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, swallowing it whole with a small
amount of liquid. Do not chew the tablet.
The break line on the tablet is only intended to facilitate breaking it into halves 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 have taken more tablets than recommended, contact your doctor immediately.
Symptoms such as breathlessness due to fluid accumulation in the lungs (pulmonary oedema)
may occur within 24 to 48 hours after taking the medicine.
If you forget to take a dose of Concoram
Take the missed dose as soon as you remember. If it is almost time for your 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
discontinued abruptly, especially in patients with ischaemic heart disease. If discontinuation is
necessary, your doctor will advise gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur after taking the medicine, consult a doctor immediately:

Severe skin reactions, including severe rash, urticaria, redness of the skin over the entire 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 occur in more than 1 in 10 patients)
Swelling.

Common (may occur in less than 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 cold or numbness in the 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 occur in less than 1 in 100 patients)
Insomnia, mood changes (including anxiety), transient loss of consciousness (fainting), hypoglycaemia, paraesthesia, taste disturbances, tremor, tinnitus, hypotension, nasal mucosal inflammation, cough, dryness of the oral mucosa, hair loss, small haemorrhages on the skin and mucous membranes (purpura), skin discoloration, excessive sweating, itching, rash, skin 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 occur in less than 1 in 1,000 patients)
Disorientation, increased triglyceride levels, nightmares, hallucinations (false perceptions without detectable stimuli, resembling real sensations), reduced tear secretion (this should be considered when wearing contact lenses), hearing disturbances, allergic rhinitis, hepatitis, hypersensitivity reactions such as itching, sudden facial flushing, rash, increased liver enzyme activity.

Very rare (may occur in less than 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 skin or mucosal inflammation 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 characterized by itchy, scaly and red skin patches) or cause psoriasiform skin lesions, and may also cause a complex movement disorder involving involuntary movements, muscle stiffness and spasms, tremor (extrapyramidal syndrome).

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

5. How to store the medicine Concoram

Keep the medicine out of 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 any 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Concoram contains

The active substances in Concoram 5 mg + 5 mg tablets are: 5 mg bisoprolol fumarate and 5 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, elongated, slightly convex tablets, 9.5 mm long and 4.5 mm wide, with a score line on one side and the imprint "MS" on the other. 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/Aluminium/PVC//Aluminium blisters, packed in a cardboard carton.
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
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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 11-0130
Parallel Import Licence number: 327/24
This medicinal product is authorised 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