Betaxomil

Leaflet attached to the packaging: patient information

Betaxomyl, 20 mg, coated tablets

Betaxolol hydrochloride

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

• Keep this leaflet, you may need to read it again.
• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Betaxomyl and what is it used for

Betaxomyl belongs to a group of medicines called beta-blockers. These medicines lower blood pressure, slow down the heart rate, and reduce the heart's oxygen consumption.
Betaxomyl is used to treat high blood pressure (hypertension) in adults, with mild to moderate severity.
The medicine is also used for long-term treatment to prevent the occurrence of stable angina pectoris (chest pain caused by insufficient blood flow to the heart muscle due to physical exertion or stress) in adults.

2. Important information before taking Betaxomyl

When not to take Betaxomyl:

• if you are allergic to betaxolol or any of the other ingredients of this medicine (listed in section 6),
• if you have severe asthma or other severe breathing difficulties, known as chronic obstructive pulmonary disease (COPD), which causes shortness of breath during exertion, coughing with expectoration, and frequent chest infections,
• if you have severe heart failure,
• if you have cardiogenic shock (heart failure that does not allow effective blood pumping),
• if you have conduction disorders in the heart that prevent normal heart function (second or third degree atrioventricular block, except for patients with a pacemaker),
• if you have Prinzmetal's angina, a variant of angina pectoris (chest pain at rest),
• if you have sick sinus syndrome, including sinoatrial block (skipped heartbeats),
• if you have significantly slowed heart rate,
• if you have severe Raynaud's syndrome or peripheral arterial disorders (causing poor blood circulation in the upper and lower limbs),
• if you have an untreated pheochromocytoma (a tumor of the adrenal gland),
• if you have low blood pressure,
• if you have a history of severe allergic reactions, causing breathing difficulties and swelling of the mucous membranes of the nose, lips, and eyelids (anaphylactic reactions),
• if you have increased blood acid levels (metabolic acidosis),
• if you are taking floctafenine (a medicine used to reduce pain and swelling) or sultopride (a medicine used to treat schizophrenia).

Warnings and precautions

Before starting treatment with Betaxomyl, discuss it with your doctor or pharmacist:

• if you have milder forms of chronic obstructive pulmonary disease or asthma - before starting treatment, it is recommended to perform a lung function test,
• if you have kidney function disorders,
• if you have heart failure and are being treated with medicines for this condition,
• if you have other conduction disorders in the heart (first degree atrioventricular block),
• if you have a milder form of Raynaud's disease, vasculitis, or obstruction (reduced blood flow) of blood vessels,
• if you are being treated for a pheochromocytoma, a tumor that causes high blood pressure - treatment of high blood pressure requires special care, and your doctor will regularly check your blood pressure,
• if you have diabetes with a tendency to hypoglycemia (low blood sugar) - this medicine may mask the warning signs of low blood sugar, such as rapid, irregular heartbeat and sweating; diabetic patients should check their blood sugar levels more frequently, especially at the beginning of treatment,
• if you have glaucoma (increased intraocular pressure) - you should inform your ophthalmologist or optometrist before the examination that you are taking Betaxomyl,
• if you or a family member has a history of psoriasis,
• if you have hyperthyroidism (a condition caused by an overactive thyroid) - this medicine may mask the symptoms.

During treatment
Before starting allergy treatment (desensitization), consult your doctor or pharmacist, as betaxolol may increase the risk of an allergic reaction and may reduce the effectiveness of some medicines used to treat allergic reactions.
Consult your doctor if, while taking this medicine, you notice a significant slowing of your heart rate (less than 50-55 beats per minute).
In case of fasting/diet or intense exercise, this medicine may increase the risk of low blood sugar. The medicine may also mask the warning signs of low blood sugar. In case of doubt, the patient should consult a doctor or pharmacist.
If a computer tomography or radiological examination is planned, which requires intravenous administration of a contrast agent, inform your doctor or medical staff about taking this medicine. The doctor may decide to discontinue the medicine.
In case of surgery, before anesthesia, inform your anesthesiologist or medical staff about taking this medicine.

Children and adolescents

This medicine should not be used in children and adolescents, as safety and efficacy have not been established.

Betaxomyl and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do nottake this medicine if you are taking floctafenine, a medicine used to reduce pain and swelling, or sultopride, a medicine used to treat schizophrenia.
It is not recommendedto take Betaxomyl with the following medicines:

• amiodarone and digoxin (medicines used to treat heart rhythm disorders)
• fingolimod (a medicine used to treat multiple sclerosis)
• verapamil (used to treat high blood pressure and heart disease)
• certain medicines used to treat depression (called MAO inhibitors, e.g., moclobemide)

Your doctor may recommend regular tests and checks to ensure that the medicine is working properly and that, when taking any of the following medicines, there is no adverse effect on the heart:

• calcium antagonists (medicines used to treat high blood pressure - hypertension, e.g., bepridil, diltiazem, mibefradil),
• medicines used to treat heart rhythm disorders, e.g., propafenone, quinidine, hydroquinidine, disopyramide,
• baclofen (a medicine that reduces muscle tension),
• lidocaine (used for local anesthesia),
• contrast agents containing iodine (a dye that may be administered by injection before certain imaging tests, e.g., MRI, CT, and X-ray to visualize internal organs),
• medicines used to treat diabetes, e.g., insulin, glimepiride - the patient may not notice that the blood sugar level is too low (hypoglycemia), as this medicine may mask the warning signs, such as rapid, irregular heartbeat and sweating; it is necessary to check blood sugar levels frequently, especially at the beginning of treatment,
• certain general anesthetics used during surgical procedures - inform your anesthesiologist or medical staff about taking this medicine,
• cimetidine (used in case of stomach disorders),
• hydralazine (used to treat high blood pressure).

Tell your doctor about taking any of the following medicines, as they may affect the action of Betaxomyl:

• medicines used to treat pain and inflammation, called non-steroidal anti-inflammatory drugs (NSAIDs),
• medicines that help to dilate blood vessels (also called calcium antagonists), used to treat high blood pressure or certain circulation disorders, e.g., nifedipine, amlodipine,
• certain medicines used to treat depression and mental disorders, e.g., imipramine,
• corticosteroids and tetracosactide (a type of hormonal treatment),
• mefloquine (a medicine used to treat malaria),
• sympathomimetics (medicines that can increase heart rate, e.g., phenylephrine).

If you are taking a medicine called clonidine with Betaxomyl and need to stop taking clonidine, your doctor may stop betaxolol for a few days before stopping clonidine.

Betaxomyl with alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
There is a risk that treatment with betaxolol during pregnancy may be harmful to the child. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will decide whether you can take betaxolol during pregnancy.
Betaxolol passes into breast milk, so it is not recommended to take it while breastfeeding.

Driving and operating machinery

Due to possible side effects (feeling tired, dizzy), which occur especially at the beginning of treatment, this medicine may affect the performance of tasks that require concentration, coordination, and quick decision-making (e.g., driving vehicles, operating machinery, working at heights, etc.). In such cases, these activities can only be performed if the doctor agrees.

Betaxomyl contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Betaxomyl

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

Your doctor will determine the dose that is right for you.
In the treatment of mild hypertension, the recommended initial dose is 10 mg (½ tablet) once daily, usually in the morning. If the effect is insufficient, your doctor may increase the dose to 20 mg (1 tablet) once daily.
In the treatment of moderate hypertension, the recommended dose is 20 mg once daily, but your doctor may increase the dose to 40 mg (2 tablets) daily.
In stable angina pectoris, the recommended daily dose is 1 tablet. Your doctor may adjust the dose from 10 mg to 40 mg (½ tablet to 2 tablets) daily.
Patients with kidney function disorders
For patients with mild kidney function disorders, there is no need to adjust the dose. For patients with more severe kidney function disorders, your doctor may recommend reducing the dose. For patients undergoing dialysis, the recommended dose is 10 mg (½ tablet) daily, regardless of the time of dialysis.
Patients with liver function disorders
For patients with liver function disorders, there is usually no need to adjust the dose, but liver function tests are recommended, especially at the beginning of treatment.
Elderly patients
Your doctor may start treatment with a lower dose.
The tablet can be divided into equal doses.

Taking a higher dose of Betaxomyl than recommended

If you take more than the recommended dose of the medicine or if a child accidentally takes the medicine, contact your doctor or go to the emergency department of the nearest hospital immediately. You may experience weakness, dizziness, slow heart rate, chest pain, breathing difficulties, and occasionally seizures.

Missing a dose of Betaxomyl

If you miss a dose, you can take the medicine during the day and continue treatment the next day according to the prescribed dosage regimen. Do not take a double dose to make up for the missed dose.

Stopping treatment with Betaxomyl

Before stopping treatment with this medicine, always consult your doctor or pharmacist.
Do not stop taking betaxolol suddenly. If it is necessary to discontinue the medicine, your doctor may recommend gradually reducing the dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, contact your doctor or go to the emergency department of the nearest hospital immediately.

• Chest pain, feeling of very slow heart rate, feeling of fainting, shortness of breath, and dizziness, especially in patients with heart rate or rhythm disorders - these may be heart function disorders (slow conduction or worsening of existing atrioventricular block); cardiac arrest in predisposed patients (frequency not known)
• Shortness of breath, feeling tired, swelling of the ankles (heart failure).
• Joint swelling, feeling of exhaustion, rash on the cheeks and nose (systemic lupus erythematosus - a disease in which the immune system attacks parts of the body and can be confirmed by blood tests).

Other possible side effects

Common (may affect up to 1 in 10 people):

• fatigue, dizziness, headache, increased sweating
• weakness, sleep disturbances (insomnia)
• stomach pain, diarrhea, nausea, and vomiting
• slow heart rate (bradycardia)
• feeling cold in the limbs
• difficulty getting or maintaining an erection (impotence)

Uncommon (may affect up to 1 in 100 people):

• a skin disease characterized by thickened red skin patches, often covered with silver scales (psoriasis), worsening of existing psoriasis or psoriasis-like changes
• depression
• dizziness, feeling of "emptiness" in the head, fainting, unsteadiness due to a feeling of loss of balance (low blood pressure)
• discoloration of the fingers (Raynaud's syndrome), worsening of pain associated with circulation disorders in the lower limbs
• breathing difficulties, such as wheezing, which may be caused by bronchospasm

Rare (may affect up to 1 in 1,000 people):

• vision disturbances
• hallucinations (seeing, feeling, or hearing things that do not exist), disorientation, nightmares
• tingling of the hands and feet (distal paresthesia)
• low blood sugar (hypoglycemia), which can cause feelings of hunger, dizziness, fatigue, confusion, trembling, increased sweating, vision disturbances, and paleness of the skin
• high blood sugar (hyperglycemia), which can cause feelings of fatigue and thirst, as well as dryness of the mucous membranes of the mouth and the need to urinate more frequently, especially at night

Frequency not known (frequency cannot be estimated from the available data):

• lethargy
• hives
• itching
• excessive sweating
• hair loss

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49 21 301, fax: 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 Betaxomyl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Betaxomyl contains

The active substance of the medicine is betaxolol hydrochloride. Each tablet contains 20 mg of betaxolol hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose monohydrate (see section 2 "Betaxomyl contains lactose monohydrate"), sodium carboxymethylcellulose (type A) (see section 2 "Sodium"), colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400.

What Betaxomyl looks like and contents of the pack

Betaxomyl is a white, round, biconvex, film-coated tablet with a line on one side.
Betaxomyl is available in blisters containing 28 film-coated tablets.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

Delpharm Reims
10 Rue Colonel Charbonneaux
51100 Reims
France
or
Vetprom AD
The Vpharma site, 26 Otets Paisiy Str.
Radomir, 2400
Bulgaria

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

Czech Republic
Betaxolol Viatris 20 mg, film-coated tablets
Poland
Betaxomyl
To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:April 2025