Lokren 20

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lokren 20, 20 mg, Film-Coated Tablets

Betaxolol Hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 comes in the form of 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 (coronary heart disease)

2. Important information before taking Lokren 20

When not to take Lokren 20:

• if the patient is allergic to betaxolol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe bronchial asthma and severe chronic obstructive pulmonary disease,
• if the patient has heart failure that is not controlled by treatment,
• if the patient has cardiogenic shock,
• if the patient has atrioventricular block of second and third degree (except for patients with a pacemaker),
• as the only treatment if the patient has Prinzmetal's angina in its pure form (variant angina),
• if the patient has sinoatrial node dysfunction (including sinoatrial block),
• if the patient has a slow heart rate (heart rate below 45-50 beats per minute),
• if the patient has severe Raynaud's phenomenon and severe peripheral arterial disorders,
• if the patient has an untreated pheochromocytoma of the adrenal gland,
• if the patient has arterial hypotension,
• if the patient has had anaphylactic reactions (severe allergic reactions) in the past,
• if the patient has metabolic acidosis,
• in the case of treatment with floctafenine or sultopride.

Warnings and precautions

The medicine should never be stopped 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 replacement 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 given 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 the case of a milder course of Prinzmetal's angina and in a mixed form of 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 function disorders, 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 iodine-containing contrast agents or floctafenine, or in patients undergoing desensitization treatment).
In the case of planned, as well as 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 inhalation anesthetics,
• calcium antagonists (bepridil, diltiazem, verapamil),
• antiarrhythmic medicines (propafenone, quinidine, hydroquinidine, disopyramide),
• baclofen (a medicine that reduces muscle tension),
• insulin and sulfonylureas that lower blood glucose levels,
• lidocaine,
• iodine-containing contrast agents,
• 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, consult your doctor before taking this medicine.

Driving and using machines

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

Lokren 20 contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult 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, consult your doctor.
The usual dose of Lokren 20 is one tablet once a day.
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 lowest effective dose of the medicine.
Regular medical check-ups are necessary.
If you feel that the effect of Lokren 20 is too strong or too weak, consult your doctor.

Use in children

The use of Lokren 20 in children is not recommended.

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 (conduction disturbances 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. Based on the severity of the symptoms of poisoning, the doctor will decide what action to take.
Take the medicine packaging with you, so it is known what medicine was taken and what action to take.

Missing a dose of Lokren 20

If you miss a dose, 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.
The decision to discontinue the medicine and the method of ending therapy is made by the doctor.
If you have any further doubts about the use of this medicine, consult 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 psoriasis-like 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), vision 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 any not listed in this leaflet, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lokren 20

Store in a temperature below 30°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Lokren 20 contains

• The active substance of the medicine is betaxolol hydrochloride. One film-coated tablet contains 20 mg of betaxolol hydrochloride.
• 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 PVC/Aluminum blisters in a cardboard box.
For more detailed information on the medicine, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer:

Opella Healthcare Poland Sp. z o.o.
Rzeszów Branch
ul. Lubelska 52, 35-233 Rzeszów, Poland
Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel – 37100 Tours, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-2169/01

Parallel import authorization number: 9/24

Date of leaflet approval: 12.01.2024

[Information about the trademark]