Lokren 20

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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, so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lokren 20 is and what it is used for
2. What you need to know 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 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 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),
• 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 undergoing treatment with floctafenic 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 severe 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. During this time, if necessary to prevent worsening of angina, the doctor may decide to initiate a substitute treatment. The decision on whether to discontinue the medicine and how to stop therapy must be made by the doctor.
It is essential to inform the doctor if the patient has bronchial asthma or any other chronic respiratory disease. Beta-adrenergic blocking agents may be administered only to patients with mild forms of these conditions, 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 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.
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.
Inform the doctor 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-blocking agents), or a tendency to allergies (especially those caused by iodine-containing contrast agents or floctafenic, or in patients undergoing allergen immunotherapy).
In 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 outcome of anti-doping tests (positive result).

Lokren 20 and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concomitant use of betaxolol hydrochloride with floctafenic (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 agent), 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 oral hypoglycaemic agents (sulfonylureas),
• 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 (an antimalarial medicine),
• 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 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 an intolerance to certain sugars, the patient should consult their doctor before taking Lokren 20.

3. How to use Lokren 20

This medicine should always be used 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 drug reaches a steady concentration in the blood (on average, within 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 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 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.

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 (disturbances in cardiac impulse conduction), heart failure, bronchospasm, and hypoglycemia (low blood glucose levels).

If you have taken too much of the 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 package with you so that it is clear which drug has been taken and what action should be taken.

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 the 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 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 the adverse reactions listed below is 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, slowing of atrioventricular conduction 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:

• paresthesia (tingling or numbness), visual disturbances, hallucinations, confusion, nightmares;
• hypoglycemia (reduced blood glucose concentration) or hyperglycemia (increased blood glucose concentration).

Frequency not known:

• urticaria, itching, excessive sweating;
• lethargy;
• slowing or stopping of heartbeat, dizziness, feeling of marked fatigue, difficulty breathing – these symptoms may occur particularly 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 of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lokren 20

Store below 30°C.
Keep in the original packaging to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via sewage 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, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
  Coating ingredients: 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 division line on one side and the imprint «KE 20» on the other side.
The tablet can be divided into halves.
The pack of Lokren 20 contains 28 coated tablets in 2 PVC/Aluminium blisters, packed in a cardboard box.
For further information about the medicinal product, 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:
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 Number in Hungary, country of export: OGYI-T-2169/01
Parallel Import Authorisation Number: 9/24