Lokren 20

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. 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 taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 β-adrenergic receptors in the heart. When administered once daily, the drug provides long-lasting antihypertensive effect.
Therapeutic 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 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),
• 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 a slow heart rate (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 floctafene or sultopride.

Warnings and precautions
Do not stop taking this medicine suddenly, 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 medicine. The decision on whether to discontinue the medicine and how to stop treatment must be made by the doctor.
You must inform the doctor if the patient has bronchial asthma or any other chronic respiratory disease. Beta-adrenergic blocking agents should only be administered to patients with mild forms of these diseases, and treatment should be initiated with low doses.
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 arterial occlusion of the lower limbs). 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 impaired kidney function, diabetes (requiring more frequent monitoring of blood glucose levels at the beginning of treatment), psoriasis (possible exacerbation of symptoms during treatment with beta-blocking agents), or a tendency towards allergies (especially those caused by iodine-containing contrast agents or floctafene, or in patients undergoing desensitisation therapy).
In the case of planned or emergency surgical procedures, the anaesthesiologist must be informed 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 outcome of anti-doping tests (positive result).

Lokren 20 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of betaxolol hydrochloride with floctafene (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used to treat 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 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 to treat 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 food 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 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 consult a doctor before taking Lokren 20.

3. How to use Lokren 20

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
The usual dose of Lokren 20 is one tablet daily.
The calendar strip included in the packaging, with days of the week marked, will help the patient remember to take the medicine regularly.

Dosing in patients with renal impairment
The physician will adjust the dose according to kidney function: when 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 drug reaches steady-state blood concentration (on average, 4 days).
In patients with severe renal impairment (creatinine clearance less than 20 ml/min), the recommended dose is 10 mg daily.

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

In elderly patients, treatment should start 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
Lokren 20 is not recommended for use in children.

Overdose of Lokren 20
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 an excessive amount of medicine has been taken, 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 package with you so that it is clear which drug was taken and what treatment should be initiated.

Missed dose of Lokren 20
If a dose is missed, 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 Lokren 20
Do not stop taking this medicine abruptly, especially in patients with angina pectoris (ischemic heart disease). The doctor will recommend gradually reducing the dose over a period of 1 to 2 weeks. The decision whether to discontinue the medicine and how to end therapy must be made by the physician.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the adverse reactions 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 available data).

Commonly observed:

• dizziness and headache, fatigue, insomnia;
• abdominal pain, diarrhoea, nausea and vomiting;
• bradycardia (slowing of heart rate) – 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 disturbances or worsening of existing atrioventricular block;
• Raynaud's syndrome (cold extremities due to circulatory disturbances in peripheral 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 (reduced blood glucose concentration) or hyperglycaemia (increased blood glucose concentration).

Frequency not known:

• urticaria, itching, excessive sweating;
• lethargy;
• slowing or cessation of heartbeat, dizziness, marked 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 adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 49 21 301
faks: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lokren 20

Store below 30°C, 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 package 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: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
  Coating composition: hypromellose, titanium dioxide (E 171), iron oxide red (E 172), macrogol 400.

What Lokren 20 looks like and contents of the pack
Pink, round, biconvex coated tablets, with a break line on one side and the imprint «KE 20» on the other side.
The tablet can be divided into halves.
The Lokren 20 pack contains 28 coated tablets in PVC/Al blisters packed in a cardboard box.
For more detailed 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:
Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel
37100 Tours
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
Lubelska Street 52
35-233 Rzeszów
Poland
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg
Germany

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland

Marketing Authorisation Number in Hungary, country of export: OGYI-T-2169/01
Parallel Import Authorisation Number: 123/25