Patient Information Leaflet

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including those 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
What you need to know 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 the 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 outflow tract from the left ventricle of the heart (e.g. high-grade 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 enhance 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 pallor of fingers and toes upon exposure to cold.
In case of untreated phaeochromocytoma, a rare tumour of the adrenal gland.
In case of metabolic conditions in which blood pH becomes acidic.
If any of the above conditions applies 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.
In certain cases, special caution is required when using Concoram. Please inform your doctor if any of the following conditions apply to you:

advanced age,
heart failure,
diabetes with marked 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 blood flow disorders (Prinzmetal's angina),
vascular disease of the limbs 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 anaesthetist 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 taken only for a short period.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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 to treat high blood pressure and chronic stable angina.
Centrally-acting antihypertensive agents (e.g. clonidine, methyldopa, moxonidine, rilmenidine): do not discontinue these medicines without consulting your doctor.

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

Some antiarrhythmic medicines (quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone): these are used to treat heart rhythm disorders.
Topically applied beta-blockers (e.g. eye drops used in glaucoma treatment).
Parasympathomimetics: these medicines are used to enhance smooth muscle activity in diseases of the stomach, intestines, urinary bladder, and in 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 are used to treat 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 response.
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, e.g.:
- ketoconazole, itraconazole (antifungal agents),
- ritonavir, indinavir, nelfinavir (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 must not be consumed by patients taking Concoram.
Grapefruit and grapefruit juice may increase blood levels of amlodipine, potentially causing an unexpected and pronounced drop in blood pressure.

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 you are pregnant or planning to become pregnant, 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 using machines
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 dose changes, and if alcohol is consumed. Therefore, the decision on whether and at what dose it is safe to drive or operate machinery should be made individually by the doctor.

Important information about some of the 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 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.
Usually, no dose adjustment is necessary in cases of mild or moderate liver or kidney dysfunction.
Doses may need to be adjusted in severe liver or kidney dysfunction.
Elderly patients
No dose adjustment is required in elderly patients; however, caution is advised when increasing the dose.
Method of administration
Concoram tablets should be taken in the morning, with or without food, with a small amount of liquid, without chewing.
The score line on the tablet is only intended to facilitate breaking the tablet 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.
Symptoms such as breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur within 24–48 hours after ingestion.
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 treatment with Concoram
Do not stop taking Concoram suddenly or change the prescribed dose without consulting your doctor, as doing so may lead to a temporary worsening of heart failure. Treatment should not be abruptly discontinued, 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 experiences 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 all over the 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 flushing of the face, abdominal pain, swelling around the ankles, fatigue, weakness, feeling cold or numbness in the limbs, gastrointestinal disturbances such as nausea, vomiting, changes in bowel habits, 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), depression, transient loss of consciousness (fainting), hypotension, paraesthesia, taste disturbances, tremor, tinnitus, low blood pressure, inflammation of the nasal mucosa, 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, disturbances in urination, nocturia, impotence, breast enlargement in men, chest pain, pain, malaise, weight gain, weight loss, sleep disorders, cardiac conduction disorders, worsening of pre-existing heart failure, cardiac arrhythmias, slow heart rate (below 50 beats per minute), low blood pressure, bronchospasm in patients with bronchial asthma or a history of obstructive lung 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), decreased tear production (this should be considered 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 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 the eyelids, lips, joints, genital area, vocal cords, throat and tongue (angioedema), severe skin or mucosal inflammation with red blisters (erythema multiforme), widespread erythema and skin peeling (exfoliative dermatitis), severe blistering lesions of the skin and oral, genital and anal mucous membranes, 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 areas of itchy, scaly and red skin) or cause psoriasiform skin lesions, and may also cause a complex movement 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, inform your doctor, pharmacist or nurse. Adverse effects can also 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 Warsaw
Phone: +48 22 49 21 301
Fax: +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 the 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 month indicated.
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 package and other information

What Concoram contains

The active substances in Concoram 10 mg + 10 mg tablets are: 10 mg of bisoprolol fumarate and 10 mg of amlodipine (as amlodipine besylate).
Other ingredients are: 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, slightly convex tablets, 10 mm in size, with a score line on one side and the 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 blisters made of OPA/Aluminium/PVC//Aluminium, packed 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: 11-0133
Parallel import authorisation number: 13/25
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