Lokren 20

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Lokren 20 (Lokren)

20 mg, coated tablets

Betaxolol hydrochloride
Lokren 20 and Lokren are different trade names for the same medicine.

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 a 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 side effects 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 package and other information

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

Lokren 20 comes in the form of coated tablets and contains the active substance betaxolol hydrochloride. Betaxolol blocks β-adrenergic receptors in the heart. The medicine taken once a day provides long-lasting antihypertensive action.

Indications:

• Hypertension
• Ischaemic 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 II and III 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 slow heart rate (heart rate below 45-50 beats per minute),
• if the patient has severe Raynaud's disease 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 case of treatment with floctafenine or sultopride.

Warnings and precautions

The medicine should never be stopped abruptly, especially in patients with angina pectoris (ischaemic 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. β-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 β-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 β-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 anaesthetist should be informed about the use of Lokren 20 before anaesthesia.
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 any 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 to treat heart failure), or fingolimod (a medicine used to treat 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 anaesthetics,
• calcium antagonists (bepridil, diltiazem, verapamil),
• antiarrhythmic medicines (propafenone, quinidine, hydroquinidine, disopyramide),
• baclofen (a medicine that reduces muscle tension),
• insulin and sulphonamides that lower 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, consult your doctor before taking this medicine.

Driving and using machines

When driving or using machines, remember that dizziness or fatigue may occur during treatment.

The medicine contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Lokren 20.

3. How to take Lokren 20

This medicine should always be taken as directed by your doctor. If you are unsure, consult 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 per 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, consult your doctor.

Use in children

The use of the medicine in children is not recommended.

Using a higher dose of Lokren 20 than recommended

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 hypoglycaemia (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 to take.

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 (ischaemic 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, this medicine 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 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
Frequency not known (cannot be estimated from the available data).
Common side effects may include:

• dizziness and headache, weakness, insomnia;
• abdominal pain, diarrhoea, nausea, and vomiting;
• bradycardia (slow heart rate) - severe bradycardia is possible, 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:

• paraesthesia (tingling or numbness), visual disturbances, hallucinations, confusion, nightmares;
• hypoglycaemia (low blood glucose levels) or hyperglycaemia (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 side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
e-mail: [email protected]
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 below 30°C, 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 that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Lokren 20 contains

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

What Lokren 20 looks like and what the package contains

Pink, round, biconvex 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 coated tablets in PVC/Al blisters in a cardboard box.
For more detailed information, contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Hungary, the country of export:

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
Poland
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Hungary, the country of export: OGYI-T-2169/01

Parallel import authorisation number: 123/25

Date of leaflet approval: 02.04.2025

[Information about the trademark]