Package leaflet: Information for the user

Warning!
Keep this leaflet. Information on the immediate packaging is in a foreign language.
LOKREN 20
20 mg, film-coated tablets
Betaxololi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet. 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 them, even if their symptoms are the same.
If you experience any side effects, including any 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 film-coated tablets and contains the active substance betaxolol hydrochloride. Betaxolol blocks beta-adrenergic receptors in the heart. When 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 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 Prinzmetal's angina (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 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 sultopramide.

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. Your doctor will recommend gradually reducing the dose, for example over a period of 1 to 2 weeks. During this time, if necessary, your doctor may decide to introduce a substitute medicine to prevent worsening of angina. The decision on whether to discontinue the medicine and how to stop treatment must be made by your doctor.
You must inform your doctor if the patient has bronchial asthma or other chronic respiratory diseases. Beta-adrenergic blocking agents may be administered only to patients with mild forms of these diseases, and treatment should be initiated with low doses of these medicines.
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 your doctor about such conditions.
In patients with pheochromocytoma, blood pressure should be monitored regularly.
You must inform your 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 history of allergies (especially those caused by iodine-containing contrast agents or floctafene, or in patients undergoing allergen immunotherapy).
In case of planned or emergency surgery, inform the anaesthesiologist about the use of LOKREN 20 before anaesthesia.
Inform your 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, has recently taken, or plans to take.
Concomitant use of betaxolol hydrochloride with floctafene (a non-steroidal anti-inflammatory drug) or sultopramide (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 betaxolol hydrochloride concomitantly with:

halogenated inhaled anaesthetics,
calcium antagonists (bepridil, diltiazem, verapamil),
antiarrhythmic drugs (propafenone, quinidine, hydroquinidine, disopyramide),
baclofen (a medicine that reduces muscle tone),
insulin and blood glucose-lowering sulfonamides,
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 or without food.

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 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 once daily.
Dosing in patients with renal impairment
The physician will adjust the dose according to kidney function: in patients with creatinine clearance
greater than 20 ml/min, dose adjustment is not necessary. However, close medical monitoring is
recommended at the beginning of treatment until the drug concentration in blood reaches 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 required. 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
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, breathing difficulties, hypotension, heart block (conduction disturbances in the
heart), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).
If you take too much of this medicine, contact your doctor immediately or go to the emergency
department of the nearest hospital. 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 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 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 in patients with angina pectoris (ischemic heart
disease); your doctor will recommend gradually reducing the dose over 1 to 2 weeks.
The decision on whether to discontinue the medicine and how to stop treatment must be made by
the 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 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 available data)

Commonly observed:

dizziness and headache, fatigue, insomnia;
abdominal pain, diarrhoea, nausea and vomiting;
bradycardia (slowing of heart rate) – severe bradycardia and cold extremities may occur;
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 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 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 interruption of heartbeat, dizziness, marked 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 adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse effects helps to provide more information on the safety of 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. Such practices 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, sodium carboxymethyl starch (type A), microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate.
Coating composition: hypromellose, macrogol 400, titanium dioxide (E 171).

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 two equal parts.
The LOKREN 20 pack contains 28 coated tablets in PVC/aluminum blisters, packed in a cardboard box.
For further detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Romania, country of export: 7016/2014/01
7016/2014/03
Parallel Import Authorisation number: 705/15
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