Betaxolol Medreg

Package Leaflet: Information for the Patient

Betaxolol Medreg, 20 mg, Tablets

Betaxolol Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Betaxolol Medreg and what is it Used for
• 2. Important Information Before Taking Betaxolol Medreg
• 3. How to Take Betaxolol Medreg
• 4. Possible Undesirable Effects
• 5. How to Store Betaxolol Medreg
• 6. Package Contents and other Information

1. What is Betaxolol Medreg and what is it Used for

Betaxolol Medreg Contains the Active Substance Betaxolol, which Belongs to a Group of Medications Called Beta-Adrenergic Blockers, which Lower Blood Pressure, Slow Heart Rate, and Reduce Oxygen Consumption by the Heart.
Betaxolol Medreg is Used to Treat High Blood Pressure (Hypertension) of Mild to Moderate Severity. In Severe Cases of Hypertension, it may be Combined with other Antihypertensive Medications.
Betaxolol Medreg is also Used for the Long-Term Treatment and Prevention of Stable Angina Pectoris (Chest Pain Caused by Insufficient Blood Flow to the Heart Muscle due to Effort or Stress).
Betaxolol Medreg is Indicated for the Treatment of Adults.

2. Important Information Before Taking Betaxolol Medreg

When not to Take Betaxolol Medreg:

• If the Patient is Allergic to Betaxolol or any of the other Ingredients of this Medication (listed in Section 6),
• If the Patient has Severe Asthma or Chronic Obstructive Pulmonary Disease,
• If the Patient has Severe Heart Failure,
• If the Patient has Cardiogenic Shock,
• If the Patient has Conduction Disorders in the Heart (Second or Third Degree Atrioventricular Block, except for Patients with a Pacemaker),
• If the Patient has Prinzmetal's Angina,
• If the Patient has Sinoatrial Node Dysfunction, including Sinoatrial Block (Disorder of Impulse Generation and Conduction in the Heart),
• If the Patient has a Slow Heart Rate (less than 45-50 beats per minute),
• If the Patient has Severe Raynaud's Disease and Peripheral Vascular Disease (Disorders of Blood Circulation in the Lower Extremities),
• If the Patient has an Untreated Pheochromocytoma (a Tumor of the Adrenal Gland),
• If the Patient has Low Blood Pressure,
• If the Patient has a History of Anaphylactic Reactions (a Condition resulting from Hypersensitivity to certain Foreign Substances),
• If the Patient has Metabolic Acidosis.

Warnings and Precautions

Before Starting Betaxolol Medreg, the Patient should Discuss the Following with their Doctor or Pharmacist:

• If the Patient has Mild Forms of Chronic Obstructive Pulmonary Disease. Before Starting Treatment, it is Recommended to Perform a Lung Function Test. The Risk of Undesirable Effects is Low.
• If the Patient has High Blood Pressure Caused by a Disease of the Adrenal Gland called Pheochromocytoma.
• If the Patient has Diabetes with a Tendency to Hypoglycemia (Low Blood Sugar). Patients with Diabetes should Monitor their Blood Sugar Levels more Frequently, especially at the Beginning of Treatment.
• If the Patient is to Undergo General Anesthesia during Surgery. The Anesthesiologist should be Informed that the Patient is Taking Betaxolol Medreg. In Patients with Severe Ischemic Heart Disease and High Blood Pressure, it is not Recommended to Discontinue Betaxolol Medreg due to the Risk associated with Abrupt Withdrawal of a Beta-Adrenergic Blocker.
• If the Patient has Glaucoma (Increased Intraocular Pressure). The Patient should Inform their Ophthalmologist before the Examination that they are Taking Betaxolol Medreg.
• If the Patient is an Athlete. Betaxolol Medreg Contains an Active Substance that may Cause a Positive Result in a Doping Test.
• If the Patient has Compensated Heart Failure, Slow Heart Rate, or Conduction Disorders in the Heart (First Degree Atrioventricular Block).
• If the Patient has Kidney Disease (Renal Insufficiency).
• If the Patient has a Skin Disease (Psoriasis).
• If the Patient has a Thyroid Disease (Thyrotoxicosis).

If the Patient has an Allergy and needs to Undergo Desensitization Therapy, Betaxolol Medreg should be Replaced with an Antihypertensive Medication from a Different Group than Beta-Adrenergic Blockers.
Do not Discontinue Betaxolol Medreg without Consulting a Doctor. If Discontinuation is Necessary, the Doctor will Gradually Reduce the Dose.
In Elderly Patients, it is Recommended to Start Treatment with a Lower Dose.

Children and Adolescents

Betaxolol Medreg is not Recommended for Use in Children and Adolescents under 18 years of Age, as the Safety and Efficacy of the Medication in this Age Group have not been Established. In Children, the Hypoglycemic Effect of Beta-Adrenergic Blockers may Occur more Rapidly, leading to an Increased Risk of Seizures in this Age Group.

Betaxolol Medreg and other Medications

The Patient should Inform their Doctor or Pharmacist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take.
The Effect of Betaxolol Medreg and other Medications may Interact with each other. Therefore, the Doctor should be Aware of all Medications the Patient is Taking, including those Available without a Prescription. Before Taking any Medication without a Prescription, the Patient should Consult their Doctor.
Do not Take Betaxolol Medreg with Floctafenine or Sultopride.
It is not Recommended to Take Betaxolol Medreg with Amiodarone, Digoxin, and Verapamil (Medications Used to Treat Heart Diseases) or Fingolimod.
Particular Caution should be Exercised when Taking Betaxolol Medreg with:

• Calcium Channel Blockers (Bepridil, Diltiazem, Verapamil),
• Medications Used to Treat Heart Rhythm Disorders (Propafenone, Quinidine, Hydroquinidine, Disopyramide),
• Baclofen (a Muscle Relaxant),
• Lidocaine (a Local Anesthetic),
• Contrast Agents Containing Iodine.

Concomitant Use of Betaxolol Medreg and Antidiabetic Medications may Enhance their Effect. In Case of Hypoglycemia (Low Blood Sugar), Clinical Symptoms such as Rapid Heart Rate and Shivering may be Masked by the Effect of Betaxolol.
The Following Combinations of Medications should be Considered, as their Efficacy may also be Altered during Treatment with Betaxolol Medreg:

• Non-Steroidal Anti-Inflammatory Medications,
• Calcium Channel Blockers (Nifedipine),
• Medications Used to Treat Depression,
• Corticosteroids and Tetracosactide (a Type of Hormonal Treatment),
• Mefloquine (a Medication Used to Treat Malaria),
• Sympathomimetics (Medications that Increase Heart Rate),
• Clonidine (a Medication Used to Treat Glaucoma).

Sinoatrial Arrest may Occur when Beta-Adrenergic Blockers, including Betaxolol Medreg, are Used in Combination with other Medications known to Cause Sinoatrial Arrest.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, thinks they may be Pregnant or is Planning to have a Child, they should Consult their Doctor or Pharmacist before Taking this Medication.
Betaxolol Medreg is not Recommended during Pregnancy, unless the Potential Benefits of Treatment Outweigh the Risks.
Betaxolol Medreg Passes into Human Milk, therefore its Use is not Recommended during Breastfeeding.

Driving and Operating Machinery

Due to Possible Undesirable Effects (Fatigue, Dizziness), which Occur especially at the Beginning of Treatment, Betaxolol Medreg may Affect the Ability to Perform Tasks that Require Alertness, Coordination, and Quick Decision-Making (e.g., Driving, Operating Machinery, Working at Heights, etc.). In such Cases, these Activities can only be Performed if the Doctor has Given their Consent.

Betaxolol Medreg Contains Sodium

This Medication Contains less than 1 mmol (23 mg) of Sodium per Tablet, which means it is Considered "Sodium-Free".

3. How to Take Betaxolol Medreg

This Medication should always be Taken as Directed by the Doctor. In Case of Doubts, the Patient should Consult their Doctor or Pharmacist.
The Dosage should be Determined Individually for each Patient, depending on Tolerance and Therapeutic Effect.
The Recommended Daily Dose for Hypertension is 1 Tablet (20 mg) once a Day.
The Recommended Daily Dose for Stable Angina Pectoris is 1 Tablet (20 mg). The Doctor may Adjust the Dosage depending on the Patient's Clinical Condition, from ½ to 2 Tablets (10 to 40 mg) per Day. The Tablet can be Divided into Equal Doses.
Special Patient Groups
Patient with Renal Impairment
In Patients with Mild Renal Impairment, no Dosage Adjustment is Necessary. In Patients with Severe Renal Impairment or those Undergoing Dialysis, the Doctor may Recommend a Dose Reduction.
Patient with Hepatic Impairment
In Patients with Hepatic Impairment, no Dosage Adjustment is usually Necessary, but Close Clinical Monitoring is Recommended at the Beginning of Treatment.
Use in Children and Adolescents
Betaxolol is not Recommended for Use in Children and Adolescents.
Elderly Patients
In Elderly Patients, Treatment should be Started with a Lower Dose.

Overdose of Betaxolol Medreg

In Case of Overdose or Accidental Ingestion by a Child, Medical Help should be Sought Immediately.

Missed Dose of Betaxolol Medreg

If a Dose is Missed, the Medication can be Taken during the Day and Treatment can be Continued the Next Day according to the Prescribed Dosage Schedule. A Double Dose should not be Taken to Make up for a Missed Dose.

Discontinuation of Betaxolol Medreg

Never Discontinue Betaxolol Medreg without Consulting a Doctor. If Discontinuation is Necessary, the Doctor will Gradually Reduce the Dose.
If the Patient has any Further Questions about the Use of this Medication, they should Consult their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Betaxolol Medreg can Cause Undesirable Effects, although not everybody gets them.
Frequent(may Occur in up to 1 in 10 Patients):

• Dizziness, Headache
• Weakness
• Insomnia
• Stomach Pain, Diarrhea, Nausea, and Vomiting
• Slow Heart Rate (Bradycardia)
• Cold Sensation in the Extremities
• Impotence

Rare(may Occur in up to 1 in 1,000 Patients):

• Psoriasis, Exacerbation of Existing Psoriasis or Psoriasis-like Rashes
• Depression
• Heart Failure, Low Blood Pressure, Slow Conduction, or Worsening of Existing Atrioventricular Block
• Discoloration of the Fingers (Raynaud's Syndrome), Exacerbation of Intermittent Claudication, caused by Circulatory Disorders in the Lower Extremities
• Breathing Difficulties due to Asthma or Exacerbation of Existing Asthma
• Appearance of Antinuclear Antibodies: only in Exceptional Cases associated with Clinical Symptoms, such as Systemic Lupus Erythematosus, which Disappeared after Treatment was Discontinued

Very Rare(may Occur in up to 1 in 10,000 Patients):

• Disturbances of Sensation (Tingling) in the Peripheral Extremities
• Visual Disturbances
• Hallucinations, Disorientation, Nightmares
• Decreased or Increased Blood Sugar Levels

Frequency not Known(Frequency cannot be Estimated from the Available Data):

• Hives, Itching
• Increased Sweating
• Lethargy
• Hair Loss
• Sinoatrial Arrest in Predisposed Patients.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they should Inform their Doctor or Pharmacist. Undesirable Effects can also be Reported Directly to the Department of Pharmacovigilance, 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Betaxolol Medreg

The Medication should be Stored out of Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Carton and Blister after: EXP.
The Expiration Date refers to the Last Day of the Specified Month.
Store in a Temperature below 25°C. Store in the Original Packaging to Protect from Moisture.
Medications should not be Disposed of via Wastewater or Household Waste. The Patient should Ask their Pharmacist how to Dispose of Medications they no longer Use. This will Help Protect the Environment.

6. Package Contents and other Information

What Betaxolol Medreg Contains

• The Active Substance of the Medication is Betaxolol Hydrochloride. Each Tablet of Betaxolol Medreg Contains 20 mg of Betaxolol Hydrochloride.
• The other Ingredients are Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Magnesium Stearate, Colloidal Silica, Anhydrous.

What Betaxolol Medreg Looks like and what the Package Contains

Betaxolol Medreg is a White, Round, Biconvex Tablet with a Diameter of 8 mm, with a Score Line on one Side. The Tablet can be Divided into Equal Doses.
Package Sizes: 10, 20, 28, 30, 50, 60, 84, 90, 98, 100 Tablets.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This Medication is Authorized in the Member States of the European Economic Area under the Following Names:

Czech Republic:
Betaxolol Medreg
Slovakia:
Betaxolol Medreg 20 mg
Poland:
Betaxolol Medreg
Romania:
Betaxolol Gemax Pharma 20 mg Comprimé

Date of Last Revision of the Package Leaflet: 04/2024