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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 combination product Sobycombi.

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 antagonist. Allergy may manifest as itching, skin redness, 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, paleness, 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 exacerbation of heart failure requiring intravenous administration of drugs that improve heart muscle contractility,
• 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 in the heart (aortic stenosis),
• in patients with heart failure after a heart attack.

Warnings and precautions

Before starting to take Sobycombi, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they 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,
• mild 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; the patient should immediately inform their doctor if they experience breathing difficulties, cough, shortness of breath during physical exertion, etc. while taking Sobycombi.

In addition, the patient should inform their doctor if they 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

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.
Without special recommendation by the doctor, the patient should not take the following medicines concurrently with Sobycombi:

• certain medicines used to treat high blood pressure, angina pectoris, or irregular heart rhythm (calcium antagonists, such as verapamil or diltiazem),
• certain antihypertensive medicines, such as clonidine, methyldopa, moxonidine, or rilmenidine. However, the patient should not stop taking these medicines without prior consultation with their doctor.

Before taking any of the following medicines concurrently with Sobycombi, the patient should consult their 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 antagonists, 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-adrenolytics used locally (such as timolol eye drops 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 that cause loss of contact with reality (phenothiazines, such as levomepromazine),
• mefloquine, used to prevent or treat malaria,
• medicines used to treat depression, known as 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 cholesterol levels in the blood),
• 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 they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The safety of amlodipine during pregnancy in humans has not been established. If the patient is pregnant or thinks they may be pregnant, or plans to have a child, they should consult their 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 the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Sobycombi is one tablet per day.
The tablets should be taken in the morning, with water, with or without food. The tablets should not be chewed or crushed.
It is important to take the medicine regularly. The patient should visit their doctor for the next appointment before using 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 the patient has taken more tablets of Sobycombi than prescribed by their doctor, they should contact their doctor immediately. Taking too many tablets may cause low or even dangerously low blood pressure. The patient may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. If the blood pressure drop is significant, it may lead to shock. The patient's skin may become cold and sweaty, and they may lose consciousness. Symptoms of overdose may also include slow heart rate, severe breathing difficulties, or tremors (due to low blood sugar). If the patient has taken too many tablets of Sobycombi, they should seek medical help immediately.
Even 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

The patient should not worry if they miss a dose. They should skip the missed dose and take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping Sobycombi treatment

The patient should not stop taking Sobycombi without consulting their doctor. Otherwise, their condition may return to what it was before treatment started or may worsen.
If the patient has any further doubts about taking this medicine, they should consult their 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 of 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 the patient experiences any of the following very rare, severe side effects after taking the medicine, they should contact their 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 breathing difficulties,
• severe skin reactions, including severe rash, hives, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), 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 the patient experiences dizziness, weakness, or breathing difficulties, they should contact their doctor immediately.

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

• dizziness, headache,
• feeling of coldness or numbness in the 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 the patient or last longer than a week, they should consult their 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 beginning 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,
• vision disturbances, double vision,
• muscle cramps,
• edema of the ankles.

Other reported side effects are listed below. If any of these worsen or if the patient experiences any side effects not listed in this leaflet, they should inform their 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 in the 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, redness of the skin, skin discoloration, skin peeling,
• urination disorders, increased need to urinate at night, increased frequency of urination,
• erectile dysfunction, discomfort or enlargement of the breasts in men,
• pain, poor general condition,
• 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

• reduced white blood cell count, reduced platelet count, which may lead to the formation of atypical bruises and easy bleeding,
• increased blood sugar levels (hyperglycemia),
• nerve disorders that may cause weakness, numbness, or tingling,
• gum swelling,
• abdominal distension (gastritis),
• liver function disorders, liver inflammation, yellowing of the skin (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 of posture, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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.
Reporting side effects will help gather more information on the safety of the 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 (in the form of amlodipine besylate). Sobycombi, 5 mg + 5 mg, tablets Each tablet contains 5 mg of bisoprolol fumarate and 5 mg of amlodipine (in the form of amlodipine besylate). Sobycombi, 5 mg + 10 mg, tablets Each tablet contains 5 mg of bisoprolol fumarate and 10 mg of amlodipine (in the form of amlodipine besylate). Sobycombi, 10 mg + 5 mg, tablets Each tablet contains 10 mg of bisoprolol fumarate and 5 mg of amlodipine (in the form of amlodipine besylate). Sobycombi, 10 mg + 10 mg, tablets Each tablet contains 10 mg of bisoprolol fumarate and 10 mg of amlodipine (in the form of amlodipine besylate).
• Other ingredients (excipients) are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous 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:

To obtain more detailed information on this medicine, the patient should contact their 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