Betaxomyl

Package leaflet: Information for the patient

Betaxomyl, 20 mg, coated tablets
Betaxololi hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Betaxomyl is and what it is 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 Betaxomyl is and what it is used for

Betaxomyl belongs to a group of medicines called beta-blockers. These medicines reduce blood pressure, slow down heart rate, and reduce the heart's oxygen consumption.
Betaxomyl is used to treat high blood pressure (hypertension) in adults, mild to moderate in severity.
The medicine is also used for long-term treatment to prevent episodes 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 using Betaxomyl

When not to use Betaxomyl:

• if the patient is allergic to betaxolol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe bronchial asthma or other serious breathing difficulties known as chronic obstructive pulmonary disease (COPD), which causes shortness of breath during exertion, cough with sputum, and frequent chest infections,
• if the patient has severe heart failure,
• if the patient has cardiogenic shock (heart failure that prevents effective blood pumping),
• if the patient has conduction disorders in the heart that impair normal heart function (second- or third-degree atrioventricular block, except in patients with a pacemaker),
• if the patient has Prinzmetal's angina, a type of angina pectoris (chest pain occurring at rest),
• if the patient has sick sinus syndrome, including sinoatrial block (skipped heartbeats),
• if the patient has significantly slowed heart rate,
• if the patient has severe Raynaud's syndrome or peripheral arterial disorders (causing poor blood circulation in the upper and lower limbs),
• if the patient has untreated adrenal gland tumour (pheochromocytoma),
• if the patient has low blood pressure,
• if the patient has a history of severe allergic reactions causing breathing difficulties and swelling of the nasal, lip, and eyelid mucous membranes (anaphylactic reactions),
• if the patient has increased blood acid levels (metabolic acidosis),
• if the patient is taking floctafene (a medicine used for mild to moderate pain) or sultopride (a medicine used to treat schizophrenia).

Warnings and precautions
Before starting treatment with Betaxomyl, discuss with a doctor or pharmacist:

• if the patient has milder forms of chronic obstructive pulmonary disease or asthma – lung function tests are recommended before starting treatment,
• if the patient has kidney function disorders,
• if the patient has heart failure and is being treated with medicines for this condition,
• if the patient has other heart conduction disorders (first-degree atrioventricular block),
• if the patient has a milder form of Raynaud's disease, vasculitis, or vascular obstruction (reduced blood flow in blood vessels),
• if the patient is being treated for an adrenal gland tumour called pheochromocytoma, which causes high blood pressure – treatment of high blood pressure requires special management, and the doctor will regularly monitor the patient's blood pressure,
• if the patient has diabetes with a tendency to hypoglycaemia (low blood sugar) – this medicine may mask warning signs of low blood sugar such as rapid or irregular heartbeat and sweating; diabetic patients should monitor blood sugar levels more frequently, especially at the beginning of treatment,
• if the patient has glaucoma (increased intraocular pressure) – inform the ophthalmologist or optician before an eye examination that the patient is taking Betaxomyl,
• if the patient or a relative has a history of psoriasis,
• if the patient has thyrotoxicosis (a condition caused by overactive thyroid) – this medicine may mask symptoms.

During treatment
Before starting allergy treatment (called desensitisation therapy), consult a doctor or pharmacist, as betaxolol may increase the risk of allergic reactions and may reduce the effectiveness of certain medicines used to treat allergic reactions.
Consult a doctor if, during treatment with this medicine, the patient experiences a significant slowing of heart rate (less than 50–55 beats per minute).
During fasting/diet or intense exercise, this medicine may increase the risk of low blood sugar. The medicine may also mask warning signs of low blood sugar. If in doubt, the patient should consult a doctor or pharmacist.
If a computed tomography (CT) scan or radiological examination requiring intravenous contrast administration is planned, inform the doctor or medical staff about the use of this medicine. The doctor may decide to discontinue the medicine.
Before undergoing surgery and anaesthesia, inform the anaesthesiologist or medical staff about the use of 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 currently or recently taken, and any medicines the patient plans to take.
Do not use Betaxomyl if the patient is taking floctafene, a medicine used to reduce pain and swelling, or sultopride, a medicine used to treat schizophrenia.
Concomitant use of Betaxomyl is not recommended 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 conditions),
• certain antidepressants (called MAO inhibitors, e.g. moclobemide).

The doctor may recommend regular tests and monitoring to ensure the medicine is working properly and that there is no adverse effect on the heart when used concomitantly with any of the following medicines:

• calcium channel blockers (medicines used to treat high blood pressure, 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 anaesthesia),
• iodine-containing contrast agents (dyes that may be injected before certain imaging tests such as MRI, CT scan, or X-ray to visualise internal organs),
• medicines used to treat diabetes, e.g. insulin, glimepiride – the patient may not notice low blood sugar (hypoglycaemia), as this medicine may mask warning signs such as rapid or irregular heartbeat and sweating; frequent blood sugar monitoring is necessary, especially at the beginning of treatment,
• certain general anaesthetics used during surgical procedures – inform the anaesthesiologist or medical staff about taking this medicine,
• cimetidine (used for gastrointestinal disorders),
• hydralazine (used to treat high blood pressure).

Inform the 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 dilate blood vessels (also called calcium channel blockers), used to treat high blood pressure or certain circulatory disorders, e.g. nifedipine, amlodipine,
• certain medicines used to treat depression and psychiatric disorders, e.g. imipramine,
• corticosteroids and tetracosactide (a type of hormonal treatment),
• mefloquine (a medicine used to treat malaria),
• sympathomimetics (medicines that may increase heart rate, e.g. phenylephrine).

If the patient is taking the medicine clonidine together with Betaxomyl and needs to discontinue clonidine, the doctor may discontinue betaxolol a few days before stopping clonidine.

Betaxomyl and alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is a risk that treatment with betaxolol during pregnancy may be harmful to the unborn child. Inform the doctor if the patient is pregnant or planning to become pregnant. The doctor will decide whether the patient can use betaxolol during pregnancy.
Betaxolol passes into breast milk; therefore, its use during breastfeeding is not recommended.

Driving and operating machinery
Due to possible adverse effects (feeling of fatigue, dizziness), especially at the beginning of treatment, this medicine may affect the ability to perform tasks requiring concentration, coordination, and quick decision-making (e.g. driving vehicles, operating machinery, working at heights, etc.). In such cases, these activities should only be performed if approved by a doctor.

Betaxomyl contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Betaxomyl

This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults
Your doctor will determine the appropriate dose for you.
For the treatment of mild hypertension, the recommended starting dose is 10 mg (½ tablet) once
daily, usually taken in the morning. If the effect is insufficient, your doctor may increase the dose
to 20 mg (1 tablet) once daily.
For the treatment of moderate hypertension, the recommended dose is 20 mg once daily; however,
your doctor may increase the dose up to 40 mg (2 tablets) per day.
For 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) per day.
Patients with impaired renal function
In patients with mild renal impairment, dosage adjustment is not usually necessary. In patients with
more severe renal impairment, your doctor may recommend a reduced dose. For patients undergoing
dialysis, the recommended dose is 10 mg (½ tablet) daily, regardless of the timing of dialysis.
Patients with impaired liver function
In patients with impaired liver function, dosage adjustment is generally not required; however,
liver function tests are recommended, especially at the beginning of treatment.
Elderly patients
Your doctor may start treatment with a lower dose.
The tablet may be divided into equal doses.
Taking more Betaxomyl than recommended
If you take more than the recommended dose or if the medicine is accidentally taken by a child,
contact your doctor immediately or go to the nearest hospital emergency department.
Symptoms may include weakness, dizziness, sensation of slow heartbeat, chest pain, breathing
difficulties, and occasionally seizures.
Missing a dose of Betaxomyl
If you miss a morning dose, you may take the medicine during the day and continue treatment
the next day according to the prescribed dosing schedule. Do not take a double dose to make up
for a missed dose.
Stopping Betaxomyl treatment
Before stopping this medicine, you must always consult your doctor or pharmacist.
Do not stop treatment with betaxolol suddenly. If discontinuation is necessary, your doctor may
recommend gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following symptoms, contact a doctor immediately
or go to the emergency department of the nearest hospital.

• Chest pain, sensation of very slow heartbeat, feeling of fainting, shortness of breath and dizziness, especially in patients with heart rate disorders or heart rhythm disorders – these may be disturbances in heart function (slowing of atrioventricular conduction or worsening of existing atrioventricular block); cardiac arrest in predisposed patients (frequency unknown)
• Shortness of breath, feeling of fatigue, swelling of the ankle area (heart failure).
• Joint swelling, feeling of exhaustion, rash on cheeks and nose (systemic lupus erythematosus – a disease in which the immune system attacks parts of the body and which can be confirmed by blood tests).

Other possible adverse reactions
Common (may affect less than 1 in 10 patients):

• fatigue, dizziness, headache, excessive sweating
• weakness, sleep disorders (insomnia)
• stomach pain, diarrhoea, nausea and vomiting
• slow heart rate (bradycardia)
• cold sensation in the limbs
• difficulties in achieving and maintaining erection (impotence)

Uncommon (may affect less than 1 in 1,000 patients):

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

Very rare (may affect less than 1 in 10,000 patients):

• vision disorders
• hallucinations (seeing, feeling or hearing things that do not exist), disorientation, nightmares
• tingling in hands and feet (distal paresthesia)
• low blood sugar (hypoglycemia), which may cause feeling of hunger, dizziness, fatigue, confusion, tremor, excessive sweating, blurred vision and paleness of the skin
• high blood sugar (hyperglycemia), which may cause feeling of fatigue and thirst, dryness of the oral mucosa, and increased need to urinate, especially at night

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

• lethargy
• urticaria
• itching
• excessive sweating
• hair loss

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Betaxomyl contains
The active substance 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 carboxymethyl starch (type A) (see section 2 "Sodium"), colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol 400.

What Betaxomyl looks like and contents of the pack
Betaxomyl is white, round, biconvex coated tablets with a break line on one side.
Betaxomyl is available in blisters containing 28 coated tablets.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Czech Republic Betaxolol Viatris 20 mg, potahované tablety
Poland Betaxomyl

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00