Lokren 20

Package Leaflet: Information for the User

LOKREN 20, 20 mg, Film-Coated Tablets

Betaxolol Hydrochloride

Read the package 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, pharmacist, or nurse.
• 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 LOKREN 20 and what is it used for
• 2. Important information before taking LOKREN 20
• 3. How to take LOKREN 20
• 4. Possible side effects
• 5. How to store LOKREN 20
• 6. Contents of the pack and other information

1. What is LOKREN 20 and what is it used for

LOKREN 20 is available as film-coated tablets and contains the active substance betaxolol hydrochloride. Betaxolol blocks beta-adrenergic receptors in the heart. The medicine taken once a day provides long-lasting antihypertensive action.

Indications:

• Hypertension
• Angina pectoris

2. Important information before taking LOKREN 20

When not to take LOKREN 20:

Warnings and precautions

Never stop taking the medicine abruptly, especially in patients with angina pectoris (coronary heart disease), as this may cause severe heart rhythm disturbances, myocardial infarction, or sudden death; the doctor will recommend gradual dose reduction, e.g. over a period of 1 to 2 weeks. At the same time, if necessary, to avoid exacerbation of angina, the doctor may decide to introduce a substitute medicine. The decision to discontinue the medicine and the method of ending therapy is made by the doctor.
It is essential to inform the doctor if the patient has bronchial asthma or other chronic respiratory diseases. Beta-adrenergic receptor blockers may only be administered to patients with mild forms of these diseases, and treatment should be started with small doses of these medicines.
Patients with compensated heart failure treated with betaxolol hydrochloride should be under constant medical supervision.
Caution should be exercised when using the medicine in patients with a heart rate below 55 beats per minute, as well as with first-degree atrioventricular block.
Betaxolol hydrochloride may be used in cases of milder Prinzmetal's angina and mixed angina, provided that a vasodilating medicine is used at the same time.
Caution should be exercised when using beta-adrenergic receptor blockers in patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic obstruction of the arteries of the lower limbs). The doctor should be informed about such conditions.
In patients with pheochromocytoma of the adrenal gland, blood pressure should be regularly monitored.
It is essential to inform the doctor if the patient has kidney dysfunction, diabetes (need for more frequent blood glucose monitoring at the beginning of treatment), psoriasis (possibility of exacerbation of symptoms during treatment with beta-adrenergic blockers) and a tendency to allergies (especially those caused by contrast agents containing iodine or floctafenine, or in patients undergoing desensitization treatment).
In the event of planned or emergency surgery, the anesthesiologist should be informed about the use of LOKREN 20 before anesthesia.
The doctor should be informed if the patient has glaucoma or thyroid diseases.
Athletes should not take this medicine, as it contains an active substance that may affect the result of a doping test (positive result).

LOKREN 20 and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Concomitant use of betaxolol hydrochloride with floctafenine (non-steroidal anti-inflammatory medicine) or sultopride (a medicine used to treat certain mental disorders) is contraindicated.
Concomitant use of betaxolol hydrochloride with amiodarone (an antiarrhythmic medicine), digitalis glycosides (a medicine used in heart failure), or fingolimod (a medicine used in multiple sclerosis) is not recommended.
When diltiazem and betaxolol hydrochloride are used concomitantly, there may be an increased risk of depression.
Caution should be exercised when using the following medicines concomitantly:

• halogenated inhalational anesthetics,
• calcium antagonists (bepridil, diltiazem, verapamil),
• antiarrhythmic medicines (propafenone, quinidine, hydroquinidine, disopyramide),
• baclofen (a medicine that reduces muscle tension),
• insulin and sulfonylureas that reduce blood glucose levels,
• lidocaine,
• contrast agents containing iodine,
• non-steroidal anti-inflammatory medicines,
• calcium antagonists (dihydropyridine derivatives, e.g. nifedipine),
• medicines with antidepressant action (imipramine derivatives),
• neuroleptics (medicines used to treat psychotic disorders),
• corticosteroids, tetracosactide,
• mefloquine (a medicine used to treat malaria),
• sympathomimetic medicines,
• clonidine.

Using LOKREN 20 with food and drink

Food does not affect the absorption of the medicine.
LOKREN 20 can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.

Driving and using machines

When driving or operating machinery, remember that during treatment, dizziness or fatigue may occur.

LOKREN 20 contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking LOKREN 20.

3. How to take LOKREN 20

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The usual dose of LOKREN 20 is one tablet once a day.
The calendar strip attached to the packaging with the days of the week marked will help you take the medicine.
Dosing in patients with renal impairment
The doctor will adjust the dose according to kidney function: if the creatinine clearance is greater than 20 ml/minute, dose adjustment is not necessary. However, close medical supervision is recommended at the beginning of treatment, until the steady-state concentration of the medicine in the blood is reached (on average 4 days).
In patients with severe renal impairment (creatinine clearance less than 20 ml/minute), the recommended dose is 10 mg once a day.
In patients with liver impairment, dose adjustment is not necessary. However, close medical supervision, especially at the beginning of treatment, is recommended.
In elderly patients, treatment should be started with the smallest effective dose of the medicine.
Regular medical supervision of the patient is necessary.
If you feel that the effect of LOKREN 20 is too strong or too weak, ask your doctor.

Use in children

LOKREN 20 is not recommended for use in children.

Taking too much LOKREN 20

The most common symptoms of overdose are slow heart rate or cardiac arrest, fatigue, dizziness, difficulty breathing, hypotension, heart block (disturbances of impulse conduction in the heart), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).
If you have taken too much of the medicine, contact your doctor or go to the emergency department of the nearest hospital immediately. Depending on the severity of the symptoms of poisoning, the doctor will decide what action to take.
Take the packaging of the medicine with you, so that it is known what medicine was taken and what action should be taken.

Missing a dose of LOKREN 20

If you miss a dose of the medicine, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with LOKREN 20

Never stop taking the medicine abruptly, especially in patients with angina pectoris (coronary heart disease); the doctor will recommend gradual dose reduction over 1 to 2 weeks. As to whether the medicine should be discontinued and the method of ending therapy, the decision is made by the doctor.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, LOKREN 20 can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common: affects at least 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Frequency not known (cannot be estimated from the available data)
Common side effects may include:

• dizziness and headache, weakness, insomnia;
• abdominal pain, diarrhea, nausea, and vomiting;
• bradycardia (slow heart rate) - severe bradycardia, cold extremities;
• impotence.

Rare side effects may include:

• skin changes, including psoriasiform rashes or exacerbation of psoriasis;
• depressive disorders;
• heart failure, decreased blood pressure, slowed atrioventricular conduction or worsening of existing atrioventricular block;
• Raynaud's syndrome (cold extremities due to peripheral circulation disorders), worsening of existing intermittent claudication;
• bronchospasm. In rare cases, the development of antinuclear antibodies has been reported, which in exceptional cases were accompanied by clinical symptoms, such as systemic lupus erythematosus, which disappeared after the end of treatment.

Very rare side effects may include:

• paresthesia (tingling or numbness), visual disturbances, hallucinations, confusion, nightmares;
• hypoglycemia (low blood glucose levels) or hyperglycemia (high blood glucose levels).

Frequency not known:

• urticaria, itching, excessive sweating
• lethargy
• slow or interrupted heart rate, dizziness, feeling of extreme fatigue, difficulty breathing - these symptoms may occur especially in patients over 65 years of age or in patients with other heart disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store LOKREN 20

Store in a temperature not exceeding 30°C, in a dry place.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
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 LOKREN 20 contains

• The active substance of the medicine is betaxolol hydrochloride. One film-coated tablet contains 20 mg of betaxolol hydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate. The coating contains: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 400.

What LOKREN 20 looks like and contents of the pack

Pink, round, biconvex film-coated tablets, with a score line on one side and engraved «KE 20» on the other side.
The tablet can be divided into two halves.
The packaging of LOKREN 20 contains 28 film-coated tablets in 2 blisters of PVC/Aluminum in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Sanofi-Winthrop Industrie
30-36 Avenue Gustave Eiffel
37100 Tours
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg
Germany
Date of last revision of the leaflet:February 2024