Alotendin

Leaflet attached to the packaging: information for the user

Alotendin, 5 mg + 5 mg, tablets

Alotendin, 5 mg + 10 mg, tablets

Alotendin, 10 mg + 5 mg, tablets

Alotendin, 10 mg + 10 mg, tablets

Bisoprolol fumarate + Amlodipine

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Alotendin and what is it used for
• 2. Important information before taking Alotendin
• 3. How to take Alotendin
• 4. Possible side effects
• 5. How to store Alotendin
• 6. Contents of the packaging and other information

1. What is Alotendin and what is it used for

Alotendin is indicated for the replacement treatment of hypertension in patients whose blood pressure is well controlled during the simultaneous administration of the individual active substances in the same dose as in the combination drug, but in separate tablets.

2. Important information before taking Alotendin

When not to take Alotendin

If the patient suspects that they have any of the above-mentioned diseases, they should ask their doctor if they can take this medicine.

Warnings and precautions

Before starting to take Alotendin, the patient should discuss it with their doctor or pharmacist. In the following cases, Alotendin must be administered with special caution. Before starting to take Alotendin, the patient should discuss it with their doctor if they:

• are elderly,
• have heart failure,
• have diabetes with large fluctuations in blood sugar levels,
• do not eat solid foods or follow a strict diet,
• are receiving allergy treatment (desensitization) at the same time, e.g. to prevent allergic rhinitis, as Alotendin may increase the likelihood of an allergic reaction or worsen its severity,
• have minor conduction disorders (first-degree atrioventricular block),
• have certain heart diseases, such as arrhythmias or coronary artery spasms that can cause circulatory disorders in the coronary vessels (Prinzmetal's angina),
• have less severe circulatory disorders in the limbs,
• have (or have had) a flaking skin rash (psoriasis),
• have hyperthyroidism,
• have liver or kidney disease,
• have a treated pheochromocytoma, which is a rare tumor of the adrenal gland,
• have less severe respiratory diseases, such as asthma or other chronic obstructive pulmonary disease,
• are to be anesthetized (e.g. for surgery), as bisoprolol may alter the body's response to anesthesia.

If any of the above conditions apply to the patient, the doctor may recommend special procedures (e.g. additional pharmacological treatment).

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age, as its efficacy and safety have not been studied in this age group.

Alotendin and other medicines

The therapeutic and unwanted effects of medicines can change under the influence of other medicines taken at the same time. Interactions between medicines are possible, even if another medicine is taken only for a short time. 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. The following medicines should not be taken with Alotendin:

• -Calcium channel blockers of the verapamil and diltiazem type (medicines used to treat high blood pressure and chronic stable angina pectoris).
• -Clonidine, methyldopa, moxonidine, rilmenidine (so-called antihypertensive drugs acting centrally): these drugs should not be discontinued without consulting a doctor.

The following medicines can be taken with Alotendin only in certain situations, with special caution and under medical supervision:

• Felodipine and nifedipine (medicines from the group of so-called calcium channel blockers, dihydropyridine derivatives, used to treat hypertension or angina pectoris).
• Quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone (some medicines regulating heart rhythm: used to treat irregular or abnormal heart rhythm).
• Beta-adrenergic blockers with local action (e.g. eye drops used to treat glaucoma).
• Parasympathomimetics: (enhancing the activity of smooth muscles in stomach, intestine, bladder, and glaucoma diseases).
• Insulin and oral antidiabetic drugs.
• Sedatives, anesthetics.
• Cardiac glycosides (digitalis preparations used to treat heart failure).
• Non-steroidal anti-inflammatory drugs (NSAIDs: used to treat pain and joint inflammation).
• Isoprenaline, dobutamine, noradrenaline, adrenaline: (so-called sympathomimetics, used to treat severe circulatory disorders, in emergency situations).
• Any medicines that lower blood pressure as a therapeutic or unwanted effect (e.g. antihypertensive drugs, tricyclic antidepressants, barbiturates, phenothiazines).
• Dantrolene (used in infusion in severe body temperature disorders).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the activity of the immune system).
• Simvastatin (a medicine that reduces cholesterol levels).
• Cyclosporine (an immunosuppressive medicine).

The doctor will assess the possible effects of taking the following medicines with Alotendin:

• Mefloquine (used to prevent or treat malaria).
• Monoamine oxidase inhibitors (MAOIs), except for MAO-B inhibitors (used to treat depression).
• Medicines that affect the metabolism of amlodipine or bisoprolol, e.g.
• ketoconazole, itraconazole (antifungal medicines),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• ritonavir, indinavir, nelfinavir (used to treat HIV infection),
• St. John's wort (used to treat depression).
• Ergotamine derivatives (used to treat gynecological bleeding).

Alotendin with food, drink, and alcohol

Patient taking Alotendin should not consume grapefruit juice or grapefruits, as they may cause an increase in the concentration of the active substance, amlodipine, in the blood, which may result in an unexpected increase in the blood pressure-lowering effect of Alotendin. Alcohol may enhance the blood pressure-lowering effect of the medicine.

Pregnancy and breastfeeding

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. PregnancyConsidering that there is insufficient clinical experience with pregnant women, the medicine can be used only after careful consideration of the benefits and risks associated with treatment by the doctor. In case of pregnancy or planned pregnancy, it is necessary to inform the doctor. If the medicine is used during pregnancy, careful monitoring of the fetus and newborn may be necessary. BreastfeedingIt has been shown that small amounts of amlodipine pass into breast milk. Alotendin should not be used during breastfeeding.

Driving and using machines

Alotendin may impair the ability to drive vehicles or operate machines, as it may cause dizziness, headache, fatigue, or nausea – especially at the beginning of treatment, during changes in treatment, and when consuming alcohol – therefore, the doctor will determine individually what dose will be appropriate for the patient to drive a car or operate machines.

Alotendin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Alotendin

This medicine should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted. The recommended dose is one tablet of the prescribed strength. Usually, there is no need to adjust the dosage in patients with mild or moderate liver or kidney disease. In severe liver or kidney disease, the dose may be modified. Elderly patients There is no need to modify the dosage in elderly patients, however, caution is recommended when increasing the dose. Method of administration Alotendin should be taken in the morning, with or without food, with a small amount of liquid, without chewing. The dividing line on the tablet only facilitates its crushing, for easier swallowing, and not dividing into equal doses. If the patient feels that the therapeutic effect of Alotendin is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Alotendin than recommended

In case of taking a higher dose of Alotendin than recommended, the patient should contact their doctor immediately. Even 24-48 hours after taking the medicine, shortness of breath caused by excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Alotendin

The patient should take the missed dose as soon as possible. If the next dose is approaching, the patient should not take a double dose to make up for the missed dose, as making up for the missed dose is impossible, and there is a risk of overdose.

Stopping Alotendin treatment

The patient should not stop taking this medicine suddenly or change the recommended dose without consulting their doctor, as the heart disease may temporarily worsen. The treatment should not be stopped suddenly, especially in patients with coronary artery disease. If it is necessary to stop the treatment, the dose should be gradually reduced. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Alotendin can cause side effects, although not everybody gets them.

If any of the following side effects occur after taking Alotendin, the patient should contact their doctor immediately:

• Severe skin reactions, including intense rash, urticaria, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (very rare: may occur in less than 1 in 10,000 people)
• Acute swelling of the skin or mucous membranes, most often of the eyelids, lips, joints, genitals, larynx, and tongue (angioedema) (very rare: may occur in less than 1 in 10,000 people)
• Myocardial infarction (very rare: may occur in less than 1 in 10,000 people), arrhythmias (abnormal heart rhythm) (uncommon: may occur in less than 1 in 100 patients)
• Pancreatitis (which can cause severe abdominal pain, radiating to the back, with very poor general condition) (very rare: may occur in less than 1 in 10,000 people)

Other side effects:

The patient should inform their doctor if any of the following symptoms worsen or last longer than a few days. Very common(may occur in at least 1 in 10 patients):

• Edema (fluid retention).

Common(may occur in less than 1 in 10 patients):
Headache, dizziness, drowsiness (especially at the beginning of treatment), vision disturbances (including double vision), palpitations, flushing, especially of the face, shortness of breath, abdominal pain, muscle cramps, fatigue, weakness, feeling of coldness or numbness of the limbs, gastrointestinal disorders, such as nausea, vomiting, indigestion, and changes in bowel movements (including diarrhea and constipation).
Uncommon(may occur in less than 1 in 100 patients):
Insomnia, mood changes (including anxiety), depression, sleep disturbances, transient loss of consciousness (fainting), paresthesia, taste disturbances, tremors, tinnitus, hypotension, cough, rhinitis, dryness of the mucous membranes of the mouth, hair loss, minor bleeding into the skin and mucous membranes (petechiae), skin discoloration, increased sweating, itching, rash, eruption, urticaria, joint pain, muscle pain, back pain, frequent urination, urinary disorders, nocturia, impotence, gynecomastia in men, chest pain, pain, malaise, weight gain, weight loss, conduction disorders in the heart, worsening of existing heart failure, slow heart rate (bradycardia), bronchospasm in patients with asthma or obstructive pulmonary disease in their medical history, muscle weakness, exhaustion*.
*These symptoms occur especially at the beginning of treatment, are usually mild, and often disappear within 1-2 weeks.
Rare(may occur in less than 1 in 1,000 patients):
Confusion, increased triglyceride levels (fats) in the blood, nightmares, hallucinations, abnormal sensations without detectable stimuli, similar to real sensations and seeming real (illusions), decreased tear secretion (this should be kept in mind when using contact lenses), hearing disorders, allergic rhinitis, hepatitis, hypersensitivity reactions, such as itching, flushing, rash, increased activity of liver enzymes.
Very rare(may occur in less than 1 in 10,000 people):
Decreased white blood cell and platelet count, increased blood sugar levels, hypertension, peripheral neuropathy, vasculitis, gastritis, gingival hyperplasia, jaundice, severe skin or mucous membrane reactions with red blisters (erythema multiforme), widespread rash and skin peeling (exfoliative dermatitis), increased sensitivity to sunlight, conjunctivitis; medicines with a similar mechanism of action to bisoprolol (the active substance of the medicine) may cause or worsen psoriasis (a chronic skin disease characterized by areas of itchy, scaly, and red skin) or cause psoriasis-like skin changes.
Unknown(cannot be estimated from the available data):
Tremor, stiffness, mask-like face, slow movements, and dragging of the feet while walking;

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel: +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, more information can be collected on the safety of the medicine.

5. How to store Alotendin

Do not store above 30°C. Store in the original packaging to protect from light. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month. Do not use this medicine if signs of deterioration are visible (discoloration). Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Alotendin contains

• The active substances of the medicine are: Alotendin, 5 mg + 5 mg, tablets 5 mg bisoprolol fumarate and 5 mg amlodipine (in the form of besylate) Alotendin, 5 mg + 10 mg, tablets 5 mg bisoprolol fumarate and 10 mg amlodipine (in the form of besylate) Alotendin, 10 mg + 5 mg, tablets 10 mg bisoprolol fumarate and 5 mg amlodipine (in the form of besylate) Alotendin, 10 mg + 10 mg, tablets 10 mg bisoprolol fumarate and 10 mg amlodipine (in the form of besylate)
• The other ingredients are: colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Alotendin looks like and what the pack contains

Alotendin, 5 mg + 5 mg, tablets: white or almost white, odorless, elongated, slightly convex tablets 9.5 mm with a dividing line on one side and MS embossed on the other side. The dividing line on the tablet only facilitates its crushing, for easier swallowing, and not dividing into equal doses. Alotendin, 5 mg + 10 mg, tablets: white or almost white, odorless, round, flat, with beveled edges tablets 10 mm with a dividing line on one side and MS embossed on the other side. The dividing line on the tablet only facilitates its crushing, for easier swallowing, and not dividing into equal doses. Alotendin, 10 mg + 5 mg, tablets: white or almost white, odorless, oval, slightly convex tablets 13 mm with a dividing line on one side and MS embossed on the other side. The dividing line on the tablet only facilitates its crushing, for easier swallowing, and not dividing into equal doses. Alotendin, 10 mg + 10 mg, tablets: white or almost white, odorless, round, slightly convex tablets 10 mm with a dividing line on one side and MS embossed on the other side. The dividing line on the tablet only facilitates its crushing, for easier swallowing, and not dividing into equal doses. Alotendin is available in packs of 28, 30, 56, or 90 tablets in a blister pack with OPA/Aluminum/PVC/Aluminum in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC 1106 Budapest, Keresztúri út 30-38. Hungary

Manufacturers

Egis Pharmaceuticals PLC 1165 Budapest, Bökényföldi út 118-120. Hungary

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

Bulgaria Alotendin Czech Republic Bigital Hungary Opimol Latvia Alotendin Lithuania Alotendin Poland Alotendin Romania Alotendin Slovakia Bigital

Date of last revision of the leaflet: 21.11.2024