Lokren 20

Package Leaflet: Information for the User

Warning!

Please keep this leaflet. Information on the immediate packaging in a foreign language.

LOKREN 20 (Lokren)

20 mg, coated tablets

Betaxolol hydrochloride
LOKREN 20 and Lokren are different trade names for the same medicine.

Please read carefully the contents of this leaflet before taking this medicine, as it contains important information for the patient

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is LOKREN 20 and what is it 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 is LOKREN 20 and what is it used for

LOKREN 20 is available in the form of coated tablets and contains the active substance betaxolol hydrochloride. Betaxolol blocks beta-adrenergic receptors in the heart. The medicine taken once a day provides long-lasting antihypertensive action.

Indications:

• Hypertension
• Ischaemic heart disease

2. Important information before taking LOKREN 20

When not to take 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 and 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 atrioventricular block of second and third degree (except for patients with a pacemaker),
• as the only treatment if the patient has Prinzmetal's angina in its pure form (variant angina),
• if the patient has sinoatrial node dysfunction (including sinoatrial block),
• if the patient has slow heart rate (heart rate below 45-50 beats per minute),
• if the patient has severe Raynaud's phenomenon and severe peripheral arterial disorders,
• if the patient has untreated phaeochromocytoma of the adrenal gland,
• if the patient has hypotension,
• if the patient has a history of anaphylactic reactions (severe allergic reactions),
• if the patient has metabolic acidosis,
• in the case of treatment with floctafenine or sultopride.

Warnings and precautions

The medicine should never be stopped abruptly, especially in patients with angina pectoris (ischaemic heart disease), as this may cause severe heart rhythm disturbances, myocardial infarction, or sudden death; the doctor will recommend gradual dose reduction, e.g. over a period of 1 to 2 weeks. At the same time, if necessary, to avoid exacerbation of angina, the doctor may decide to introduce a replacement medicine. The decision to discontinue the medicine and the method of ending therapy is made by the doctor.
Please inform your doctor if you have bronchial asthma or other chronic respiratory diseases. Beta-adrenergic receptor blockers may only be administered to patients with mild forms of these diseases, and treatment should be started with small doses of these medicines.
Patients with controlled heart failure treated with betaxolol hydrochloride should be under constant medical supervision.
Caution should be exercised when using the medicine in patients with a heart rate below 55 beats per minute, as well as with first-degree atrioventricular block.
Betaxolol hydrochloride may be used in the case of a milder course of Prinzmetal's angina and in a mixed form of angina, provided that a vasodilating medicine is used at the same time.
Caution should be exercised when using beta-adrenergic receptor blockers in patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic occlusion of the arteries of the lower limbs). You should inform your doctor about such conditions.
In patients with phaeochromocytoma of the adrenal gland, blood pressure should be regularly monitored.
Please inform your doctor if you have kidney function disorders, diabetes (need for more frequent blood glucose monitoring at the start of treatment), psoriasis (possibility of exacerbation of symptoms during treatment with beta-adrenergic blockers) and a tendency to allergies (especially those caused by contrast agents containing iodine or floctafenine, or in patients undergoing desensitization treatment).
In the case of planned or emergency surgery, the anaesthesiologist should be informed about the use of LOKREN 20 before anaesthesia.
Please inform your doctor if you have glaucoma or thyroid diseases.
Athletes should not take this medicine, as it contains an active substance that may affect the result of an anti-doping test (positive result).

LOKREN 20 and other medicines

Please tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Concomitant use of betaxolol hydrochloride with floctafenine (non-steroidal anti-inflammatory medicine) or sultopride (a medicine used to treat certain mental disorders) is contraindicated.
Concomitant use of betaxolol hydrochloride with amiodarone (an antiarrhythmic medicine), digitalis glycosides (a medicine used in heart failure), or fingolimod (a medicine used in multiple sclerosis) is not recommended.
In the case of concomitant use of diltiazem and betaxolol hydrochloride, there may be an increased risk of depression.
Caution should be exercised when using the following medicines concomitantly:

• halogenated inhalation anaesthetics,
• calcium antagonists (bepridil, diltiazem, verapamil),
• antiarrhythmic medicines (propafenone, quinidine, hydroquinidine, disopyramide),
• baclofen (a medicine that reduces muscle tension),
• insulin and sulphonamides that reduce blood glucose levels,
• lidocaine,
• contrast agents containing iodine,
• non-steroidal anti-inflammatory medicines,
• calcium antagonists (dihydropyridine derivatives, e.g. nifedipine),
• medicines with antidepressant action (imipramine derivatives),
• neuroleptics (medicines used to treat psychotic disorders),
• corticosteroids, tetracosactide,
• mefloquine (a medicine used in malaria),
• sympathomimetic medicines,
• clonidine.

Using LOKREN 20 with food and drink

Food does not affect the absorption of the medicine.
LOKREN 20 can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

Driving and using machines

When driving vehicles or operating machines, remember that dizziness or fatigue may occur during treatment.

The medicine contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking LOKREN 20.

3. How to take LOKREN 20

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor.
The usual dose of LOKREN 20 is one tablet once a day.
Dosing in patients with renal impairment
The doctor will adjust the dose according to kidney function: if the creatinine clearance is greater than 20 ml/minute, dose adjustment is not necessary. However, close medical monitoring is recommended at the start of treatment, until the plasma concentration of the medicine reaches a steady state (on average 4 days).
In patients with severe renal impairment (creatinine clearance less than 20 ml/minute), the recommended dose is 10 mg per day.
In patients with liver impairment, dose adjustment is not necessary. However, close medical monitoring, especially at the start of treatment, is recommended.
In elderly patients, treatment should be started with the smallest effective dose of the medicine.
Regular medical monitoring of the patient is necessary.
If you feel that the effect of LOKREN 20 is too strong or too weak, you should consult your doctor.

Use in children

The use of this medicine in children is not recommended.

Using a higher dose of LOKREN 20 than recommended

The most common symptoms of overdose are slow heart rate or cardiac arrest, fatigue, dizziness, difficulty breathing, hypotension, heart block (conduction disturbances in the heart), heart failure, bronchospasm, and hypoglycaemia (low blood glucose levels).
If you have taken too much of this medicine, you should immediately contact your doctor or go to the emergency department of the nearest hospital. Based on the severity of the symptoms of poisoning, the doctor will decide what action to take.
You should take the medicine packaging with you, so it is known what medicine was taken and what action to take.

Missing a dose of LOKREN 20

If you miss a dose of the medicine, you should take it as soon as possible, unless it is almost time for the next dose. You should not take a double dose to make up for the missed dose.

Stopping treatment with LOKREN 20

You should never stop taking this medicine abruptly, especially if you have angina pectoris (ischaemic heart disease); your doctor will recommend gradual dose reduction over 1 to 2 weeks.
The decision to discontinue the medicine and the method of ending therapy is made by the doctor.
If you have any further doubts about the use of this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common: affects at least 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Frequency not known (cannot be estimated from the available data)
Common side effects may include:

• dizziness and headache, weakness, insomnia;
• abdominal pain, diarrhoea, nausea, and vomiting;
• bradycardia (slow heart rate) - severe bradycardia is possible, cold extremities;
• impotence.

Rare side effects may include:

• skin changes, including psoriasis-like rashes or exacerbation of psoriasis;
• depressive disorders;
• heart failure, decreased blood pressure, slowed atrioventricular conduction or worsening of existing atrioventricular block;
• Raynaud's syndrome (cold extremities due to peripheral circulation disorders), worsening of existing intermittent claudication;
• bronchospasm. In rare cases, the development of antinuclear antibodies has been reported, which in exceptional cases were accompanied by clinical symptoms, such as systemic lupus erythematosus, which disappeared after the end of treatment.

Very rare side effects may include:

• paraesthesia (tingling or numbness), vision disturbances, hallucinations, confusion, nightmares;
• hypoglycaemia (low blood glucose levels) or hyperglycaemia (high blood glucose levels).

Frequency not known:

• urticaria, itching, excessive sweating;
• lethargy;
• slow or interrupted heart rate, dizziness, feeling of extreme fatigue, difficulty breathing - these symptoms may occur especially in patients over 65 years of age or in patients with other heart disorders.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LOKREN 20

Do not store above 30°C. Store 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 month.
Medicines should 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 of the medicine is betaxolol hydrochloride. One coated tablet contains 20 mg of betaxolol hydrochloride.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. The coating contains: hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172).

What LOKREN 20 looks like and contents of the pack

White, round, biconvex coated tablets with a dividing line on one side and engraved with «KE 20» on the other side.
The tablet can be divided into two halves.
The packaging of LOKREN 20 contains 28 coated tablets in PVC/Aluminium blisters 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:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, country of export marketing authorisation number: OGYI-T-2169/01

Parallel import authorisation number: 163/24

Date of revision of the leaflet: 22.04.2024

[Information on the trademark]