ALOTENDIN 10 mg/5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alotendin, 5 mg + 5 mg, tablets
3. Alotendin, 5 mg + 10 mg, tablets
4. Alotendin, 10 mg + 5 mg, tablets
5. Alotendin, 10 mg + 10 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
6. What is Alotendin and what is it used for
7. Important information before taking Alotendin
   1. When not to take Alotendin
   2. Warnings and precautions
   3. Children and adolescents
   4. Alotendin and other medicines
   5. Alotendin with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alotendin contains sodium
8. How to take Alotendin
   1. Taking a higher dose of Alotendin than recommended
   2. Missing a dose of Alotendin
   3. Stopping treatment with Alotendin
9. Possible side effects
   1. If you experience any of the following side effects, contact your doctor immediately:
   2. Other side effects:
   3. Reporting side effects
10. How to store Alotendin
11. Contents of the pack and other information
    1. What Alotendin contains
    2. What Alotendin looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturers
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the package leaflet: 21.11.2024

Package Leaflet: 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 package leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Alotendin and what is it used for

Alotendin is indicated for the replacement therapy 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 you are allergic to amlodipine or bisoprolol, dihydropyridine derivatives or any of the other ingredients of this medicine (listed in section 6),
• if you have a significant narrowing of the left ventricular outflow tract (e.g., due to a large aortic stenosis),
• if you have acute heart failure, unstable heart failure after a recent myocardial infarction, or severe heart failure requiring intravenous administration of drugs to increase heart muscle contraction,
• if you have cardiogenic shock (in which case the blood pressure is extremely low with a risk of circulatory collapse),
• if you have a heart condition characterized by a very slow heart rate or irregular heartbeats (second or third degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• if you have symptomatic, slow heart rate,
• in case of symptomatic, low blood pressure,
• in case of severe asthma,
• in case of severe circulatory disorders in the hands and feet, such as Raynaud's syndrome, characterized by numbness, pain, and pallor of the fingers and toes after exposure to cold,
• in case of untreated pheochromocytoma, a rare tumor of the adrenal gland,
• in case of metabolic disorders in which the blood pH becomes acidic.

If you suspect that you have any of the above conditions, you should ask your doctor if you can take this medicine.

Warnings and precautions

Before taking Alotendin, you should discuss it with your doctor or pharmacist. In the following cases, Alotendin must be administered with special caution. Before taking Alotendin, you should discuss it with your doctor if you:

• 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) (e.g., to prevent allergic rhinitis), as Alotendin may increase the likelihood of an allergic reaction or exacerbate it,
• have minor conduction disorders (first-degree atrioventricular block),
• have certain heart conditions, such as arrhythmias or coronary artery spasms that can cause disturbances in coronary blood flow (Prinzmetal's angina),
• have less severe circulatory disorders in the limbs,
• have (or have had) psoriasis (a chronic skin condition),
• 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 undergoing anesthesia (e.g., for surgery), as bisoprolol may alter the body's response to anesthesia.

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

Children and adolescents

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

Alotendin and other medicines

The therapeutic and unwanted effects of medicines can change under the influence of other medicines taken simultaneously. Interactions between medicines are possible, even if another medicine is used only for a short time. You should 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 should not be taken simultaneously 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 centrally acting antihypertensive drugs): you should not stop taking these medicines without consulting your doctor.

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

• Felodipine and nifedipine (medicines of the calcium channel blocker group, dihydropyridine derivatives, used to treat hypertension or angina pectoris).
• Quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone (certain antiarrhythmic drugs 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).
• Nonsteroidal 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 severe body temperature disorders).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system's activity).
• Simvastatin (a medicine that reduces cholesterol levels).
• Cyclosporine (an immunosuppressive medicine).

Your 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, such as:
• 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

Patients taking Alotendin should not consume grapefruit juice or grapefruits, as they may increase the levels 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyGiven the lack of sufficient clinical experience with pregnant women, the medicine can only be used after careful consideration of the benefits and risks by the doctor. In case of pregnancy or planned pregnancy, it is essential to inform your 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 affect your ability to drive or use machines, as it can cause dizziness, headache, fatigue, or nausea – especially at the beginning of treatment, during changes in treatment, and when consuming alcohol. Your doctor will determine the individual dose that will allow you to drive or operate machines.

Alotendin contains sodium

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

3. How to take Alotendin

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet of the prescribed strength. Usually, there is no need to adjust the dose 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 dose 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 score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. If you feel that the therapeutic effect of Alotendin is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Alotendin than recommended

If you have taken more Alotendin than recommended, you should contact your doctor 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 Alotendin

You should 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 dose, as it is impossible to make up for the missed dose, and there is a risk of overdose.

Stopping treatment with Alotendin

You should not stop taking this medicine suddenly or change the recommended dose without consulting your doctor, as the heart condition may worsen temporarily. Treatment should not be stopped abruptly, especially in patients with coronary artery disease. If it is necessary to stop treatment, the dose should be gradually reduced. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, contact your doctor immediately:

• Severe skin reactions, including intense rash, urticaria, redness of the skin all over the body, severe itching, blistering, and peeling, as well as 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:

You should inform your 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), visual disturbances (including double vision), palpitations, flushing, especially of the face, shortness of breath, abdominal pain, muscle cramps, fatigue, weakness, feeling of coldness or numbness in 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, alopecia, 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*.
*These symptoms occur especially at the beginning of treatment and are usually mild and often disappear within 1-2 weeks.
Rare(may occur in less than 1 in 1000 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 (which should be kept in mind when using contact lenses), hearing disorders, allergic rhinitis, hepatitis, hypersensitivity reactions, such as itching, flushing, rash, and 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), photosensitivity; medicines with a similar mechanism of action to bisoprolol (the active substance of the medicine) may cause or exacerbate psoriasis (a chronic skin condition) or cause psoriasis-like skin changes.
Unknown(cannot be estimated from the available data):
Tremor, rigidity, mask-like face, slow movements, and dragging of the feet while walking;

Reporting side effects

If you experience any side effects, including those not listed in this 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 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, you can help provide more information on the safety of this medicine.

5. How to store Alotendin

Do not store above 30°C. Store in the original package 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 you notice signs of deterioration (fading). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 contents of the pack

Alotendin, 5 mg + 5 mg, tablets: white or almost white, odorless, oblong, slightly convex tablets 9.5 mm with a score line on one side and MS embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Alotendin, 5 mg + 10 mg, tablets: white or almost white, odorless, round, flat, with beveled edges tablets 10 mm with a score line on one side and MS embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Alotendin, 10 mg + 5 mg, tablets: white or almost white, odorless, oval, slightly convex tablets 13 mm with a score line on one side and MS embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Alotendin, 10 mg + 10 mg, tablets: white or almost white, odorless, round, slightly convex tablets 10 mm with a score line on one side and MS embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Alotendin is available in packs of 28, 30, 56, or 90 tablets in a blister pack of 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 package leaflet: 21.11.2024