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, Coated Tablets

Betaxolol Hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 Packaging and Other Information

1. What is Lokren 20 and What is it Used For

Lokren 20 is available in the form of coated tablets and contains the active substance betaxolol hydrochloride. Betaxolol blocks beta-adrenergic receptors in the heart. The medication, taken once a day, provides long-lasting antihypertensive action.

Indications:

• Hypertension;
• Ischemic 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 medication (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 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 a 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 a history of anaphylactic reactions (severe allergic reactions),
• if the patient has metabolic acidosis,
• in the case of treatment with floctafenine or sultopride.

Warnings and Precautions

The medication 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 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 medication. The decision to discontinue the medication and the method of terminating 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 medications.
Patients with compensated heart failure treated with betaxolol hydrochloride should be under constant medical supervision.
Caution should be exercised when administering the medication to 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 medication 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 (the need for more frequent blood glucose monitoring at the beginning of treatment), psoriasis (the possibility of exacerbating 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 medication, as it contains an active substance that may affect the result of a doping test (positive result).

Lokren 20 and Other Medications

The doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Concomitant use of betaxolol hydrochloride with floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a medication used to treat certain mental disorders) is contraindicated.
Concomitant use of betaxolol hydrochloride with amiodarone (an antiarrhythmic medication), digitalis glycosides (a medication used to treat heart failure), or fingolimod (a medication 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 medications concomitantly:

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

Using Lokren 20 with Food and Drink

Food does not affect the absorption of the medication.
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 taking this medication.

Driving and Using Machines

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

Lokren 20 Contains Lactose Monohydrate

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

3. How to Take Lokren 20

This medication should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor.
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 monitoring is recommended at the beginning of treatment until the medication reaches a steady state in the blood (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 monitoring, especially at the beginning of treatment, is recommended.
In elderly patients, treatment should be started with the smallest effective dose of the medication.
Regular medical monitoring of the patient is necessary.
If you feel that the effect of Lokren 20 is too strong or too weak, consult a doctor.

Use in Children

The use of this medication in children is not recommended.

Overdose of Lokren 20

The most common symptoms of overdose are slow heart rate or cardiac arrest, fatigue, dizziness, difficulty breathing, hypotension, heart block (disturbances in the conduction of impulses in the heart), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).
In case of overdose, immediately contact a doctor or go to the emergency department of the nearest hospital. Based on the severity of the symptoms of poisoning, the doctor will decide what actions to take.
Take the medication packaging with you, so it is known what medication was taken and what actions to take.

Missing a Dose of Lokren 20

In case of missing 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

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

4. Possible Side Effects

Like all medications, Lokren 20 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 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 side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Lokren 20

Store in a temperature below 25°C, in the original packaging.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Lokren 20 Contains

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

What Lokren 20 Looks Like and What the Packaging Contains

Lokren 20 coated tablets are white, round, biconvex, with a dividing line on one side and engraved with «KE 20» on the other side.
The tablet can be divided into two halves.
The packaging of Lokren 20 contains 28 coated tablets in 2 blisters of PVC/Al foil in a cardboard box.

For More Detailed Information, Contact the Marketing Authorization Holder or the Parallel Importer.

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:

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
Authorization Number in Romania, the Country of Export:7016/2014/01
7016/2014/03
Parallel Import Authorization Number:190/14

Date of Approval of the Leaflet: 29.04.2024

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