Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Lokren 20
20 mg, coated tablets
Betaxololi hydrochloridum
Please read the entire leaflet carefully before using this 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, 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 reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Lokren 20 is and what it is used for
Important information before taking Lokren 20
How to take Lokren 20
Possible side effects
How to store Lokren 20
Contents of the pack and other information

1. What Lokren 20 is and what it is used for

Lokren 20 is available as 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.
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 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 form Prinzmetal's angina (variant 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
Never abruptly discontinue the use of this medicine, especially in patients with angina pectoris
(ischaemic heart disease), as this may lead to severe cardiac arrhythmias, myocardial infarction, or sudden death; the doctor will recommend gradually reducing the dose, e.g. over a period of 1 to
2 weeks. During this time, if necessary, to prevent worsening of angina, the doctor may decide to introduce a substitute medicine. The decision whether to discontinue the medicine and how to end the therapy must be made by the doctor.
It is essential to inform the doctor if the patient suffers from bronchial asthma or other chronic respiratory diseases. Beta-adrenergic receptor blocking agents may only be administered to patients with mild forms of these diseases, and treatment should be initiated with low doses of such medicines.
Patients with compensated heart failure treated with betaxolol hydrochloride should remain under continuous medical supervision.
Caution is required when using the medicine in 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 medicine is simultaneously administered.
Caution is required when using beta-adrenergic blocking agents in patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic lower limb arterial occlusion). Inform the doctor about such conditions.
In patients with pheochromocytoma, blood pressure should be monitored regularly.
It is essential to 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-adrenergic blocking agents), or a tendency towards allergies (especially those caused by iodine-containing contrast agents or floctafene, or in patients undergoing desensitization therapy).
In case of planned or emergency surgery, 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 any other medicines the patient is currently taking, has recently taken, or might take in the future.
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.
Caution is required when using Lokren 20 concomitantly with:

halogenated inhaled anaesthetic agents,
calcium antagonists (bepridil, diltiazem, verapamil),
antiarrhythmic medicines (propafenone, quinidine, hydroquinidine, disopyramide),
baclofen (a muscle relaxant),
insulin and oral antidiabetic sulfonylureas,
lidocaine,
iodine-containing contrast agents,
non-steroidal anti-inflammatory drugs,
calcium antagonists (dihydropyridine derivatives, e.g. nifedipine),
antidepressant medicines (imipramine derivatives),
neuroleptics (medicines used to treat 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 or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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.

Lokren 20 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 taken as prescribed 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 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 once daily.

In patients with hepatic impairment, dose adjustment is not required. However, close medical monitoring, especially at the beginning of treatment, is advised.
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
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, fatigue, dizziness, breathing difficulties, hypotension, heart block (impairment of electrical conduction in the heart), heart failure, bronchospasm, and hypoglycaemia (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 symptoms, the doctor will decide on appropriate management.
Bring the medicine package with you so that it is clear which medicine 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 your 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 (ischaemic heart disease). Your doctor will recommend gradually reducing the dose over 1 to 2 weeks.
The decision whether to discontinue the medicine and how to stop 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of occurrence 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 less than 1 in 10,000 patients
Frequency not known (cannot be estimated from the available data).

Commonly observed adverse reactions may include:

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 adverse reactions 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 circulatory disturbances in peripheral blood vessels), worsening of existing intermittent claudication;
bronchospasm. In rare cases, antinuclear antibodies have been reported, which only exceptionally were associated with clinical symptoms such as systemic lupus erythematosus, which resolved after discontinuation of treatment.

Very rarely observed adverse reactions may include:

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

Adverse reactions with unknown frequency:

urticaria, pruritus, excessive sweating;
lethargy;
slowing or arrest of heartbeat, dizziness, feeling of 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, pharmacist or nurse. Adverse reactions 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.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product and helps to improve the safety of using the medicine.

5. How to store Lokren 20

Store below 25°C in the original packaging.
Keep the medicine out of the 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. This will help 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, sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Coating ingredients: hypromellose, macrogol 400, titanium dioxide (E 171).

What Lokren 20 looks like and contents of the pack
Lokren 20 coated tablets are white, round, biconvex, with a score line on one side and the imprint «KE 20» on the other side.
The tablet can be divided into halves.
The pack contains 28 coated tablets in 2 blisters made of PVC/Al foil, contained in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation numbers in Romania, country of export: 7016/2014/01
7016/2014/03
Parallel import licence number: 190/14