Sobicombi

Leaflet accompanying the packaging: patient information

Sobycombi, 5 mg + 5 mg, tablets

Sobycombi, 5 mg + 10 mg, tablets

Sobycombi, 10 mg + 5 mg, tablets

Sobycombi, 10 mg + 10 mg, tablets

Bisoprolol fumarate + amlodipine

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sobycombi and what is it used for
• 2. Important information before taking Sobycombi
• 3. How to take Sobycombi
• 4. Possible side effects
• 5. How to store Sobycombi
• 6. Contents of the packaging and other information

1. What is Sobycombi and what is it used for

Sobycombi contains two active substances: bisoprolol and amlodipine.
Sobycombi is indicated for the treatment of high blood pressure (hypertension) and/or heart disease (stable coronary disease) in patients who have achieved adequate control while taking bisoprolol and amlodipine concurrently, in the same doses as in the Sobycombi combination product.

2. Important information before taking Sobycombi

When not to take Sobycombi

• if the patient is allergic to bisoprolol, amlodipine, or any of the other ingredients of this medicine (listed in section 6), or to any calcium channel blocker. Allergy may manifest as itching, redness of the skin, or difficulty breathing.
• in patients with severe asthma,
• in patients with severe circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, pallor, or cyanosis of the fingers and toes,
• in patients with untreated pheochromocytoma, a rare tumor of the adrenal gland,
• in patients with metabolic acidosis, a condition in which there is an increased concentration of acids in the blood,
• in patients with acute heart failure,
• in patients with worsening heart failure requiring intravenous administration of drugs that improve the contractility of the heart muscle,
• if the patient has a slow heart rate,
• in patients with low blood pressure,
• in patients with certain heart diseases that cause very slow or irregular heart rhythm,
• in case of cardiogenic shock, a severe and acute heart disorder, the consequences of which are low blood pressure and circulatory failure,
• if the patient has a narrowing of the aortic valve of the heart (aortic stenosis),
• in patients with heart failure after a heart attack.

Warnings and precautions

Before starting to take Sobycombi, you should discuss it with your doctor or pharmacist.
You should inform your doctor if you have or have had any of the following conditions:

• diabetes,
• strict fasting,
• certain heart diseases, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina),
• kidney or liver disease,
• less severe circulatory disorders in the limbs,
• a history of psoriasis (psoriasis),
• adrenal gland tumor,
• thyroid disorders,
• recent myocardial infarction,
• heart failure,
• significant increase in blood pressure (hypertensive crisis),
• chronic lung disease or mild asthma; you should immediately inform your doctor if you experience breathing difficulties, cough, shortness of breath during physical exertion, etc. while taking Sobycombi.

In addition, you should inform your doctor if you are planning:

• desensitization treatment (e.g., to prevent hay fever), as Sobycombi may increase the likelihood of an allergic reaction or its severity,
• anesthesia (e.g., for surgery), as Sobycombi may affect the body's response to the administered drugs.

Children and adolescents

Sobycombi should not be used in children and adolescents under 18 years of age, as the benefits and risks of its use in this patient group have not been studied.

Sobycombi and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Without special recommendation by the doctor, you should not take the following medicines at the same time as Sobycombi:

• certain medicines used to treat high blood pressure, angina pectoris, or irregular heart rhythm (calcium channel blockers, such as verapamil or diltiazem),
• certain antihypertensive medicines, such as clonidine, methyldopa, moxonidine, or rilmenidine. However, you should not stop taking these medicines without consulting your doctor first.

Before taking any of the following medicines at the same time as Sobycombi, you should consult your doctor - Sobycombi may affect the action of other medicines, and other medicines may affect the action of Sobycombi, or more frequent medical monitoring may be necessary:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium channel blockers, such as felodipine),
• certain medicines used to treat irregular or abnormal heart rhythm (class I antiarrhythmic drugs, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide,

propafenone),

• certain medicines used to treat irregular or abnormal heart rhythm (class III antiarrhythmic drugs, such as amiodarone),
• beta-adrenergic blockers used locally (e.g., eye drops with timolol used to treat glaucoma),
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetic drugs, such as tacrine or carbachol) or medicines used in acute heart conditions (sympathomimetic drugs, such as isoprenaline and dobutamine),
• antidiabetic medicines, including insulin,
• anesthetics (e.g., during surgery),
• digitalis glycosides used to treat heart failure,
• nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac),
• any medicines that may lower blood pressure as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptics or anesthetics (barbiturates, such as phenobarbital), or certain antipsychotics (phenothiazines, such as levomepromazine),
• mefloquine, used to prevent or treat malaria,
• medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide,
• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infections),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort (Hypericum perforatum),
• verapamil, diltiazem (medicines used to treat heart diseases),
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system),
• simvastatin (a medicine that lowers blood cholesterol levels),
• cyclosporin (an immunosuppressive medicine).

Sobycombi may further lower blood pressure if the patient is taking other medicines used to treat high blood pressure.

Pregnancy and breastfeeding

There is a risk that taking Sobycombi during pregnancy may be harmful to the fetus.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
The safety of amlodipine in pregnancy has not been established in humans. If the patient is pregnant or thinks she may be pregnant or plans to have a child, she should consult her doctor before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended while taking Sobycombi.

Driving and using machines

Sobycombi may affect the ability to drive or use machines, depending on the patient's tolerance to the medicine. If the patient experiences nausea, dizziness, fatigue, or headache while taking Sobycombi, they should not drive or use machines and should contact their doctor immediately.

Sobycombi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Sobycombi

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Sobycombi is one tablet per day.
Tablets should be taken in the morning, with water, with or without food. Tablets should not be chewed or crushed.
It is important to take the medicine regularly. You should visit your doctor for the next appointment before using up the prescribed amount of medicine.
The score line on the tablet (if present) is not intended for breaking the tablet.

Taking a higher dose of Sobycombi than recommended

If you take more Sobycombi tablets than your doctor prescribed, you should contact your doctor immediately. Taking too many tablets may cause your blood pressure to be too low or even dangerously low. You may experience dizziness, a feeling of emptiness in your head, fainting, or weakness. If the blood pressure drop is significant, it may lead to shock. Your skin may become cool and moist, and you may lose consciousness. Symptoms of overdose may also include slow heart rate, severe breathing difficulties, or tremors (due to low blood sugar levels). If you take too many Sobycombi tablets, you should seek medical help immediately.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Sobycombi

You should not worry if you miss a dose. You should skip the missed dose and take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping Sobycombi treatment

You should not stop taking Sobycombi without consulting your doctor. Otherwise, your condition may return to what it was before treatment started or may worsen.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sobycombi can cause side effects, although not everybody gets them.
The most serious side effects are related to heart function:

• slow heart rate (may occur in less than 1 in 100 patients),
• worsening heart failure (may occur in less than 1 in 100 patients),
• slow or irregular heart rhythm (may occur in less than 1 in 100 patients).

If you experience any of the following very rare but serious side effects after taking the medicine, you should contact your doctor immediately:

• sudden, wheezing breathing, chest pain, shortness of breath, or difficulty breathing,
• swelling of the eyelids, face, or lips,
• swelling of the tongue or throat, causing severe difficulty breathing,
• severe skin reactions, including severe rash, hives, redness of the skin, itching, blistering, peeling, and skin swelling, or other allergic reactions,
• heart attack, abnormal heart rhythm,
• pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition. If you experience dizziness, weakness, or difficulty breathing, you should contact your doctor immediately.

BISOPROLOL
Common:may occur in up to 1 in 10 patients

• dizziness, headache,
• feeling of cold or numbness in hands or feet,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation,
• feeling of fatigue.

Uncommon:may occur in up to 1 in 100 patients

• sleep disorders,
• depression,
• slow heart rate,
• low blood pressure,
• breathing difficulties in patients with asthma or chronic lung disease,
• muscle weakness, muscle cramps,
• feeling of weakness.

Rare:may occur in up to 1 in 1,000 patients

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion,
• liver inflammation, which may cause yellowing of the skin or eyes,
• abnormal results of some blood tests used to assess liver function or lipid levels,
• allergic reactions, such as itching, redness, rash,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

Very rare:may occur in up to 1 in 10,000 patients

• irritation and redness of the eye (conjunctivitis),
• hair loss,
• exacerbation of psoriasis (psoriasis); psoriasis-like rash.

AMLODIPINE
The following common side effectshave been reported. If any of these are troublesome for you or last longer than a week, you should consult your doctor.
Very common:may occur in more than 1 in 10 patients

• edema (fluid retention).

Common:may occur in up to 1 in 10 patients

• headache, dizziness, drowsiness (especially at the start of treatment),
• palpitations (feeling of strong heartbeat), sudden flushing (especially of the face),
• abdominal pain, nausea,
• change in bowel habits, diarrhea, constipation, indigestion,
• fatigue, weakness,
• visual disturbances, double vision,
• muscle cramps,
• ankle edema.

Other reported side effects are listed below. If any of these worsen or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.
Uncommon:may occur in up to 1 in 100 patients

• mood changes, anxiety, depression, insomnia,
• tremors, allergic rhinitis, dizziness, fainting,
• numbness or tingling of limbs, loss of pain sensation,
• ringing in the ears,
• low blood pressure,
• rhinitis and (or) nasal congestion due to inflammation of the nasal mucosa,
• cough,
• dryness of the mucous membranes of the mouth, vomiting,
• hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• urination disorders, increased need to urinate at night, increased frequency of urination,
• erectile dysfunction, discomfort or breast enlargement in men,
• pain, malaise,
• joint or muscle pain, back pain,
• weight gain or weight loss.

Rare:may occur in up to 1 in 1,000 patients

• disorientation.

Very rare:may occur in up to 1 in 10,000 patients

• decreased white blood cell count, decreased platelet count, which may lead to the formation of unusual bruises and easy bleeding,
• increased blood sugar levels (hyperglycemia),
• nerve disorders that may cause weakness, numbness, or tingling,
• gum swelling,
• abdominal bloating (gastritis),
• liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, which may affect the results of some diagnostic tests,
• increased muscle tone,
• vasculitis, often with accompanying skin rash,
• increased sensitivity to light.

Unknown:frequency cannot be estimated from the available data

• tremors, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sobycombi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after 'Lot'.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Sobycombi contains

• -The active substances of Sobycombi are bisoprolol fumarate and amlodipine (as amlodipine besylate). Sobycombi, 5 mg + 5 mg, tablets Each tablet contains 5 mg of bisoprolol fumarate and 5 mg of amlodipine (as amlodipine besylate). Sobycombi, 5 mg + 10 mg, tablets Each tablet contains 5 mg of bisoprolol fumarate and 10 mg of amlodipine (as amlodipine besylate). Sobycombi, 10 mg + 5 mg, tablets Each tablet contains 10 mg of bisoprolol fumarate and 5 mg of amlodipine (as amlodipine besylate). Sobycombi, 10 mg + 10 mg, tablets Each tablet contains 10 mg of bisoprolol fumarate and 10 mg of amlodipine (as amlodipine besylate).
• Other ingredients (excipients) are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, and magnesium stearate (E470b). See section 2 "Sobycombi contains sodium".

What Sobycombi looks like and contents of the pack

5 mg + 5 mg: white, round, biconvex tablets with beveled edges (diameter: 6.9-7.1 mm, thickness: 3.0-5.0 mm)
5 mg + 10 mg: white, round, slightly biconvex tablets with beveled edges and the inscription CS on one side (diameter: 10.0-10.2 mm, thickness: 3.4-5.0 mm)
10 mg + 5 mg: white, oval, biconvex tablets with a score line on one side (length: 13.0-13.3 mm, width: 8 mm, thickness: 3.4-5.0 mm); the score line on the tablet is not intended for breaking the tablet
10 mg + 10 mg: white, round, slightly biconvex tablets with beveled edges and a score line on one side (diameter: 10.0-10.2 mm, thickness: 3.4-5.0 mm); the score line on the tablet is not intended for breaking the tablet
Packaging:28, 30, 56, 60, 84, and 90 tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:06.08.2022