Lokren 20

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Lokren 20 (Lokren)
20 mg, film-coated tablets
Betaxololi hydrochloridum
Lokren 20 and Lokren are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Lokren 20 is and what it is 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 Lokren 20 is and what it is 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. Administered once daily, the drug provides long-lasting antihypertensive effect.
Indications:

• Arterial hypertension
• Ischaemic 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 asthma or 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 second- or third-degree atrioventricular block (except in patients with a pacemaker implanted),
• as the sole treatment if the patient has pure Prinzmetal's angina (variant angina),
• if the patient has sinoatrial node dysfunction (including sinoatrial block),
• if the patient has bradycardia (heart rate below 45–50 beats per minute),
• if the patient has severe Raynaud's disease or severe peripheral arterial disorders,
• if the patient has untreated pheochromocytoma,
• if the patient has hypotension,
• if the patient has previously experienced anaphylactic reactions (severe allergic reactions),
• if the patient has metabolic acidosis,
• when treating with floctafene or sultopride.

Warnings and precautions
Never abruptly stop taking this medicine, especially in patients with angina pectoris (ischaemic heart disease), as this may lead to serious cardiac arrhythmias, myocardial infarction, or sudden death. The doctor will recommend gradually reducing the dose, for example over a period of 1 to 2 weeks. At the same time, if necessary, to avoid worsening of angina, the doctor may decide to introduce a substitute medication. The decision on whether to discontinue the medicine and how to end the therapy must be made by the doctor.
You must inform the doctor if the patient has bronchial asthma or other chronic respiratory diseases. Beta-adrenergic receptor blocking agents may only be administered to patients with mild forms of these conditions, and treatment should be initiated with low doses of these drugs.
Patients with compensated heart failure treated with betaxolol hydrochloride should remain under continuous medical supervision.
Exercise caution when using this medicine in patients with a heart rate below 55 beats per minute, as well as in patients with first-degree atrioventricular block.
Betaxolol hydrochloride may be used in milder forms of Prinzmetal's angina and in mixed forms of angina, provided that a vasodilator is administered concomitantly.
Exercise caution when using beta-adrenergic blocking agents in patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic peripheral arterial occlusion). Inform the doctor about such conditions.
In patients with pheochromocytoma, blood pressure should be monitored regularly.
You must inform the doctor if the patient has renal dysfunction, diabetes (requiring more frequent monitoring of blood glucose concentration at the beginning of treatment), psoriasis (possible exacerbation of symptoms during treatment with beta-blocking agents), or a tendency to allergies (especially those caused by iodine-containing contrast agents or floctafene, or in patients undergoing desensitization therapy).
In the case of planned or emergency surgery, inform the anaesthesiologist about the use of Lokren 20 prior to anaesthesia.
Inform the doctor if the patient has glaucoma or thyroid disorders.
Athletes should not take this medicine, as it contains an active substance that may affect the result of anti-doping tests (positive result).

Lokren 20 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of betaxolol hydrochloride with floctafene (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used in the treatment of certain psychiatric disorders) is contraindicated.
Concomitant use of betaxolol hydrochloride with amiodarone (an antiarrhythmic medicine), digitalis glycosides (used in heart failure), or fingolimod (used in multiple sclerosis) is not recommended.
When diltiazem and betaxolol hydrochloride are used concomitantly, there may be an increased risk of depression.
Exercise caution when using concomitantly with:

• halogenated inhaled anaesthetic agents,
• calcium antagonists (bepridil, diltiazem, verapamil),
• antiarrhythmic drugs (propafenone, quinidine, hydroquinidine, disopyramide),
• baclofen (a muscle relaxant),
• insulin and blood glucose-lowering sulfonylureas,
• lidocaine,
• iodine-containing contrast agents,
• non-steroidal anti-inflammatory drugs,
• calcium antagonists (dihydropyridine derivatives, e.g. nifedipine),
• antidepressants (imipramine derivatives),
• neuroleptics (medicines used in the treatment of psychotic disorders),
• corticosteroids, tetracosactide,
• mefloquine (a medicine used in malaria),
• sympathomimetic agents,
• clonidine.

Taking Lokren 20 with food and drink
Food does not affect the absorption of the medicine.
Lokren 20 may be taken with meals or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Driving and operating machinery
When driving vehicles or operating machinery, bear in mind that dizziness or fatigue may occur during treatment.

This medicine contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Lokren 20.

3. How to use Lokren 20

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor.

The usual dose of Lokren 20 is one tablet once daily.

Dosing in patients with renal impairment
Your doctor will adjust the dose according to kidney function: if creatinine clearance is greater than 20 ml/min, dose adjustment is not necessary. However, close medical monitoring is recommended at the beginning of treatment until the blood concentration of the drug reaches a steady state (on average, after 4 days).

In patients with severe renal impairment (creatinine clearance less than 20 ml/min), the recommended dose is 10 mg once daily.

In patients with hepatic impairment, dose adjustment is not required. However, close medical supervision, especially at the beginning of treatment, is recommended.

In elderly patients, treatment should be initiated with the lowest effective dose. Regular medical monitoring 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 this medicine is not recommended in children.

Taking more Lokren 20 than recommended
The most common symptoms of overdose include slow heart rate or cardiac arrest, feeling of fatigue, dizziness, difficulty breathing, hypotension, heart block (impairment of electrical conduction in the heart), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).

If you have taken too much medicine, contact your doctor immediately or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the doctor will decide on appropriate management.

Take the medicine packaging with you so that it is clear which drug has been taken and what treatment should be initiated.

Missed 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 a missed dose.

Stopping Lokren 20
Do not stop taking this medicine abruptly, especially if you have angina pectoris (ischemic heart disease). Your doctor will advise gradually reducing the dose over 1 to 2 weeks. The decision whether to discontinue the medicine and how to stop treatment must be made by your doctor.

If you have any further questions 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 will get them.
The frequency of the side effects listed below 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)

Very common side effects may include:

• dizziness and headache, fatigue, insomnia;
• abdominal pain, diarrhoea, nausea and vomiting;
• bradycardia (slowing of the heart rate) – severe bradycardia, cold extremities may occur;
• impotence.

Rare side effects may include:

• skin reactions, including psoriasiform eruptions or exacerbation of psoriasis;
• depressive disorders;
• heart failure, hypotension, atrioventricular conduction delay or worsening of existing atrioventricular block;
• Raynaud's syndrome (cold extremities due to disturbances in peripheral blood circulation), worsening of existing intermittent claudication;
• bronchospasm. In rare cases, development of antinuclear antibodies has been reported, which only exceptionally were associated with clinical symptoms such as systemic lupus erythematosus, which resolved after discontinuation of treatment.

Very rare side effects may include:

• paraesthesia (tingling or numbness), visual disturbances, hallucinations, confusion, nightmares;
• hypoglycaemia (decreased blood glucose concentration) or hyperglycaemia (increased blood glucose concentration).

Frequency not known:

• urticaria, pruritus, excessive sweating;
• lethargy;
• slowing or stopping of the heartbeat, dizziness, feeling of significant fatigue, breathing difficulties – these symptoms may particularly occur in patients over 65 years of age or in patients who have other heart disorders.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Side effects can also be reported to the marketing authorisation holder or the parallel importer.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Lokren 20

Do not store above 30°C.
Store in the original packaging to protect from moisture.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Lokren 20 contains

• The active substance is betaxolol hydrochloride. One coated tablet contains 20 mg of betaxolol hydrochloride.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate. Coating ingredients: 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 coated tablets, with a division line on one side and embossed «KE 20» on the other side.
The tablet can be divided into halves.
The pack of Lokren 20 contains 28 coated tablets in PVC/Aluminum blisters, packed in a cardboard box.
For more detailed information about the medicine, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Hungary, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
Poland
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel – 37100 Tours
France
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg
Germany
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Hungary, country of export: OGYI-T-2169/01
Parallel Import Authorisation Number: 68/25