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 this 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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 medicine provides long-lasting antihypertensive effect.
Therapeutic indications:

• Hypertension
• Ischaemic heart disease

2. Important information before using the medicine 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 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 (a variant form of angina pectoris),
• 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 undergoing treatment with floctafenic or sultopride.

Warnings and precautions
The medicine must never be discontinued abruptly, especially in patients with angina pectoris (ischaemic heart disease), as this may lead to severe cardiac arrhythmias, myocardial infarction, or sudden death; the physician will recommend a gradual reduction in dose, e.g. over a period of 1 to 2 weeks. During this time, if necessary, to prevent worsening of angina, the physician may decide to introduce a substitute medication. The decision whether to discontinue the medicine and how to stop therapy must be made by the physician.
It is essential to inform the physician if the patient suffers from bronchial asthma or other chronic respiratory diseases. Beta-adrenergic receptor blocking agents may be administered only to patients with mild forms of these conditions, and treatment should be initiated with low doses of such drugs.
Patients with compensated heart failure treated with betaxolol hydrochloride should remain under continuous medical supervision.
Caution is required when administering the medicine to patients with a heart rate below 55 beats per minute, as well as in those 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.
Caution is required when using beta-adrenergic blocking agents in patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic arterial occlusion of the lower limbs). The physician should be informed about such conditions.
In patients with pheochromocytoma, blood pressure should be monitored regularly.
It is essential to inform the physician if the patient has renal impairment, diabetes (requiring more frequent monitoring of blood glucose levels at the beginning of treatment), psoriasis (possible exacerbation of symptoms during treatment with beta-adrenergic blocking agents), or a tendency towards allergies (especially those caused by iodine-containing contrast agents or floctafenic, or in patients undergoing desensitization therapy).
In the case of planned or emergency surgery, the anaesthesiologist must be informed about the use of LOKREN 20 prior to anaesthesia.
The physician should be informed if the patient has glaucoma or thyroid disorders.
Athletes should not take this medicine, as it contains an active substance that may affect the outcome of anti-doping tests (positive result).

LOKREN 20 and other medicines
Inform the physician or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Concomitant use of betaxolol hydrochloride with floctafenic (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 agent), 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 is required during concomitant use with:

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

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

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

Driving and operating machinery
When driving vehicles or operating machinery, it should be remembered that dizziness or fatigue may occur during treatment.

The medicine contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the physician before taking LOKREN 20.

3. How to use LOKREN 20

This medicine should always be taken as directed by your doctor. In case of 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: in patients with creatinine clearance greater than 20 ml/min, dose adjustment is not required. However, close medical monitoring is recommended at the beginning of treatment until the blood concentration of the drug reaches a steady state (on average, 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 necessary. However, close medical monitoring, especially at the beginning of treatment, is recommended.

In elderly patients, treatment should be initiated with the lowest effective dose. Regular medical monitoring is required.

If you feel that the effect of LOKREN 20 is too strong or too weak, consult your doctor.

Use in children
LOKREN 20 is not recommended for use 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 of this 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.

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

Missing a dose of LOKREN 20
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

Stopping LOKREN 20
You should never suddenly stop taking this medicine, especially if you have angina pectoris (ischemic heart disease). Your doctor will recommend gradually reducing the dose over a period of 1 to 2 weeks.
The decision on whether to discontinue the medicine and how to end therapy should be made by your doctor.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of occurrence of the adverse effects listed below has been 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 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects fewer than 1 in 10,000 patients
Frequency not known (cannot be estimated from the available data)

Commonly observed:

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

Rarely observed:

• 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 circulatory disturbances in peripheral blood vessels), 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 rarely observed:

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

Frequency not known:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store LOKREN 20

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

6. Contents of the packaging and other information

What Lokren 20 contains

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

What Lokren 20 looks like and contents of the pack
White, 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 halves.
The pack contains 28 coated tablets in PVC/Aluminum blisters, packed in a cardboard box.
For further information, 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
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Hungary, country of export, Marketing Authorisation Number: OGYI-T-2169/01
Parallel Import Licence Number: 163/24
[Information protected by trademark]