Lokren 20

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Lokren 20

20 mg, coated tablets

Betaxolol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 using Lokren 20
• 3. How to use Lokren 20
• 4. Possible side effects
• 5. How to store Lokren 20
• 6. Contents of the packaging 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 beta-adrenergic receptors in the heart. The medicine, given once a day, provides long-lasting antihypertensive action.

Indications:

• hypertension,
• ischemic heart disease.

2. Important information before using Lokren 20

When not to use 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 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 untreated pheochromocytoma of the adrenal gland,
• if the patient has 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 (ischemic heart disease), as this may cause severe heart rhythm disturbances, myocardial infarction, or sudden death; the doctor will recommend gradual reduction of the dose, 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 given to patients with mild forms of these diseases, and treatment should be started with small doses of these medicines.
Patients with controlled 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 start 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 case of a planned or emergency surgical procedure, 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

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as about medicines the patient plans to take.
Concomitant use of betaxolol hydrochloride with floctafenine (non-steroidal anti-inflammatory medicine) or with 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 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

When driving or operating machines, it should be remembered that dizziness or fatigue may occur during treatment.

The medicine contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Lokren 20.

3. How to use Lokren 20

This medicine should always be used as directed by the doctor. In case of doubts, the doctor should be consulted.
Usually, the recommended 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 start of treatment, until the plasma concentration of the medicine reaches a steady state (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 start 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 it is felt that the effect of Lokren 20 is too strong or too weak, the doctor should be consulted.

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 (disturbances of impulse conduction in the heart), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).
In case of taking too much medicine, the doctor or the emergency department of the nearest hospital should be contacted immediately. Based on the severity of the poisoning symptoms, the doctor will decide what action to take.
The medicine packaging should be taken along, so that it is known what medicine was taken and what action to take.

Missing a dose of Lokren 20

In case of missing a dose of the medicine, it should be taken as soon as possible, unless it is almost time for the next dose. A double dose should not be taken to make up for the missed dose.

Stopping the use of Lokren 20

The medicine should never be stopped abruptly, especially in patients with angina pectoris (ischemic heart disease); the doctor will recommend gradual reduction of the dose over 1 to 2 weeks. The decision to discontinue the medicine and the method of ending therapy is made by the doctor.
In case of any further doubts related to the use of this medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects listed below 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, 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 25°C, in the original packaging.
The medicine should be stored out of 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate; The coating contains: titanium dioxide (E 171), macrogol 400, hypromellose.

What Lokren 20 looks like and what the packaging contains

White, round, biconvex coated tablets, with a dividing line on one side and "KE 20" embossed on the other side.
The tablet can be divided into two halves.
The packaging of Lokren 20 contains 28 coated tablets in 2 PVC/Al blisters in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald, Germany

Manufacturer:

Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours, France

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Romania, the country of export: 7016/2014/01
7016/2014/02
7016/2014/03
Parallel import authorization number: 152/20

Date of leaflet approval: 02.04.2025

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