Kerlon

Patient Information Leaflet

Kerlon 20 mg film-coated tablets

betaxolol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Kerlon is and what it is used for
2. What you need to know before taking Kerlon
3. How to take Kerlon
4. Possible side effects
5. How to store Kerlon
6. Contents of the pack and other information

1. What Kerlon is and what it is used for

Kerlon contains the active substance betaxolol, which belongs to a class of medicines called
"beta-blockers, antianginal and antihypertensive agents", and works by lowering blood pressure
(antihypertensive).
Kerlon is indicated for the treatment of:

• high blood pressure (arterial hypertension) of any type and severity;
• chest pain occurring during physical exertion, caused by reduced blood flow in the vessels supplying the heart (stable exertional angina pectoris).

2. What you need to know before taking Kerlon

Do not take Kerlon

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing problems (bronchial asthma and chronic obstructive pulmonary disease),
• if you have serious heart problems (uncontrolled heart failure, cardiogenic shock, second- or third-degree atrioventricular block in patients without a pacemaker, Prinzmetal's angina, or sinoatrial dysfunction including sinoatrial block),
• if your heart rate is slow (less than or equal to 45–50 beats per minute),
• if you have circulatory problems (severe forms of Raynaud’s phenomenon or peripheral arterial disease),
• if you have a tumor of an adrenal gland called "pheochromocytoma" that is untreated (not being treated),
• if you have low blood pressure (hypotension),
• if you have had allergic reactions (anaphylactic reactions),
• if you have excessive acidity in the blood (metabolic acidosis),
• if you are taking medicines containing "floctafénine" (medicines used to treat inflammation),
• if you are taking medicines containing "sultopride" (used to treat psychiatric disorders),
• if you are taking medicines used to treat depression (monoamine oxidase inhibitors, MAOIs),
• if you are taking medicines containing verapamil (used to treat high blood pressure),
• if you have severe kidney problems (severe renal failure).

Warnings and precautions
Take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Do not stop treatment with Kerlon abruptly, especially if you suffer from certain heart diseases (coronary artery disease), as this may lead to serious disturbances in heart rhythm, heart attack, or sudden death (severe cardiac arrhythmias, myocardial infarction, or sudden death). The dose will be gradually reduced over one to two weeks, and if necessary, an alternative therapy will be prescribed to prevent worsening of your condition.
• If you have severe respiratory problems (bronchial asthma or chronic obstructive pulmonary disease), be cautious when taking Kerlon, as it may have negative effects on the lungs and bronchi. Your doctor will perform respiratory function tests before starting treatment with Kerlon.
• If you have a heart condition called "controlled heart failure," Kerlon will be prescribed starting at a low dose, gradually increased under close medical supervision.
• If your resting heart rate drops below 50–55 beats per minute (bradycardia and associated symptoms), your doctor will reduce the recommended dose.
• If you have a heart condition called "first-degree atrioventricular block," Kerlon should be administered with caution.
• If you suffer from a heart condition called "Prinzmetal's angina," Kerlon and all medicines of the same class (beta-blockers) may worsen this condition.
• If you have circulatory disorders (Raynaud’s disease or syndrome, chronic occlusive arteritis of the lower limbs), be cautious when using Kerlon, as it may worsen these conditions.
• The use of Kerlon, like all medicines of the same class (beta-blockers), in treating high blood pressure (hypertension) caused by a specific type of tumor called "pheochromocytoma," requires close monitoring of blood pressure values.
• Administration of Kerlon in elderly patients must be done with particular care; your doctor will start treatment with low doses and ensure close monitoring of the patient.
• If you have kidney problems (renal insufficiency), Kerlon will be prescribed with attention to the degree of kidney impairment (dosage must be adjusted based on serum creatinine or creatinine clearance).
• If you have diabetes, increase blood glucose monitoring at the beginning of treatment. The use of Kerlon may mask warning signs of low blood sugar (hypoglycemia), particularly: increased heart rate (tachycardia), awareness of your heartbeat (palpitations), and sweating.
• If you have a skin condition called "psoriasis," be cautious when using Kerlon and other medicines of the same class (beta-blockers), as this condition may worsen.
• If you suffer from severe allergic reactions (anaphylactic reactions) of any origin (especially from iodine-containing contrast agents, use of a medicine called "floctafénine," or during desensitization therapy for allergies), be cautious when using Kerlon and other medicines of the same class (beta-blockers), as their use may lead to worsening of reactions. This worsening could result in increased resistance to treatment of allergic reactions, requiring higher doses of medicines used in therapy (such as adrenaline).
• If you are scheduled for general anesthesia, your doctor must consider that Kerlon and all medicines of the same class (beta-blockers) reduce the reflex increase in heart rate (reflex tachycardia) and increase the risk of low blood pressure (hypotension). Continuing treatment with Kerlon and other beta-blockers reduces the risk of heart complications (arrhythmias, myocardial ischemia, and hypertensive crises). Inform your anesthesiologist if you are taking Kerlon or other beta-blockers, because:
  - If the anesthesiologist considers it necessary to discontinue treatment, a 48-hour interruption is considered sufficient (to restore sensitivity to catecholamines).
  - In some cases, treatment with Kerlon or other medicines of the same class cannot be interrupted, such as in patients with certain heart conditions (coronary insufficiency) where discontinuation poses risks, or when suspension is not possible due to emergency situations; in these cases, treatment with Kerlon will continue, and the anesthesiologist may administer specific medicines (premedication with atropine) and use anesthetics with minimal depressive effect on heart function.
• If you suffer from an eye condition called "glaucoma," inform your ophthalmologist before any eye examination, because the use of Kerlon and other medicines of the same class (beta-blockers) lowers intraocular pressure (altering glaucoma screening tests). Your doctor must carefully evaluate the administration of Kerlon if you are already taking beta-blockers for eye pressure control, as the effects of the medicines may be additive and thus excessive.
• If you suffer from conditions affecting thyroid gland function (thyrotoxicosis), be cautious when using Kerlon and other medicines of the same class (beta-blockers), as they may mask circulatory and cardiac signs related to this dysfunction.

Children and adolescents
Since safety and efficacy have not been established in pediatric patients, the use of Kerlon is not recommended in this population.

Other medicines and Kerlon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Kerlon may interact with or be affected by the following medicines.

Contraindicated combinations

• Do not use Kerlon or other medicines of the same class (beta-blockers) in case of shock or low blood pressure (hypotension) caused by a medicine with anti-inflammatory activity called "floctafénine," as compensatory reactions in the heart and circulatory system may be reduced.
• Concurrent use of Kerlon or other medicines of the same class (beta-blockers) with sultopride, used to treat psychiatric disorders, may lead to excessive slowing of the heart rate (excessive bradycardia).

Not recommended combinations

• Medicines used to regulate heart rhythm (such as amiodarone), when taken together with Kerlon or other medicines of the same class (beta-blockers), may lead to disturbances in heart function (contractility, automatism, conduction, and suppression of compensatory sympathetic mechanisms).
• Concurrent use of Kerlon or other medicines of the same class (beta-blockers) with other medicines used for heart conditions (digitalis glycosides) may lead to a reduced heart rate (bradycardia due to prolonged atrioventricular conduction time).
• Concurrent use of Kerlon or other medicines of the same class (beta-blockers) with a medicine called fingolimod, used to regulate the body's immune system, may cause a greater reduction in heart rate (bradycardia). If concurrent administration is considered necessary by your doctor, appropriate monitoring of heart rate is recommended, starting at the beginning of treatment and continuing at least until the following morning.
• Kerlon must not be used simultaneously with a medicine called verapamil, used for high blood pressure.

Combinations requiring precautions

• Concurrent use of Kerlon or other medicines of the same class (beta-blockers) with certain anesthetics (volatile halogenated anesthetics) may cause circulatory and heart problems (beta-blockers reduce cardiovascular compensatory responses; beta-adrenergic blockade can be counteracted during surgery using beta-stimulants). Inform your anesthesiologist if you are using Kerlon or other beta-blockers, as treatment should generally not be stopped, especially not abruptly.

• Concurrent use of Kerlon or other medicines of the same class (beta-blockers) with certain blood pressure medicines called calcium antagonists (bepridil, diltiazem, and mebefradil) may cause heart rhythm and function problems (excessive bradycardia, sinus arrest, atrioventricular conduction disturbances, and heart failure).

• Concurrent use of Kerlon with diltiazem (a "calcium antagonist" medicine used to lower high blood pressure) may increase the risk of depression (see "Undesired effects").

• Concurrent use of Kerlon with antiarrhythmic medicines (propafenone and class Ia: quinidine, hydroquinidine, and disopyramide) may lead to heart problems (disturbances in contractility, automatism, conduction, and suppression of compensatory sympathetic mechanisms).

• Concurrent use of Kerlon with baclofen (a medicine used to treat certain muscle disorders) may enhance Kerlon’s blood pressure-lowering effect. Your doctor will monitor your blood pressure and dosage.

• Kerlon, like all medicines of the same class (beta-blockers), when taken together with medicines for diabetes (insulin and hypoglycemic sulfonylureas), may mask symptoms of low blood sugar (hypoglycemia), such as awareness of heartbeat (palpitations) and increased heart rate (tachycardia). In case of concomitant use, your doctor will ask you to monitor blood glucose more frequently, especially at the beginning of treatment.

• Kerlon and medicines of the same class (beta-blockers, especially propranolol, metoprolol, and nadolol), when taken together with lidocaine (a local anesthetic and heart rhythm regulator), may increase the risk of adverse effects on the nervous system and heart. In such cases, your doctor will adjust the dose and timing of lidocaine administration and may prescribe appropriate monitoring.

• Treatment with Kerlon or other medicines of the same class (beta-blockers) should be suspended before undergoing radiographic examinations with iodine-based contrast agents, as in cases of shock or hypotension due to the contrast agent, cardiovascular complications may occur (reduced compensatory cardiovascular responses).

Combinations to be considered with caution

• Concurrent use of Kerlon with anti-inflammatory medicines (non-steroidal anti-inflammatory drugs - NSAIDs) may reduce its antihypertensive effect (due to inhibition of vasodilatory prostaglandins by NSAIDs and sodium and water retention with pyrazolone-type NSAIDs).
• Concurrent use of Kerlon with calcium antagonists (dihydropyridines such as nifedipine) may lead to excessive lowering of blood pressure (hypotension), heart problems (heart failure in patients with latent or uncontrolled heart failure), and circulatory issues.
• If Kerlon is used together with medicines used for depression and psychotropic drugs (tricyclic antidepressants like imipramine, neuroleptics), an increased antihypertensive effect and possible drop in blood pressure upon standing (postural hypotension) may occur.
• If Kerlon is used together with tetracosactide (a medicine used in laboratory tests) and corticosteroids, a reduction in blood pressure (antihypertensive effect) may be observed.
• Concurrent use of Kerlon with a medicine called "mefloquine" (an antimalarial drug) may lead to a reduced heart rate (bradycardia).
• If Kerlon or other medicines of the same class (beta-blockers) are taken together with medicines acting on the nervous system called "sympathomimetics," a reduction in the effect of Kerlon may be observed.
• If you are taking Kerlon or other beta-blockers together with clonidine (used to lower high blood pressure) and wish to discontinue clonidine, blood pressure must be closely monitored. It may be necessary to discontinue Kerlon several days before gradually reducing the dose of clonidine.
• Medicines known to induce heart rhythm disturbances: concomitant use with beta-blockers such as Kerlon may induce conduction block in the heart's electrical signal.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of Kerlon is not recommended during pregnancy; Kerlon should only be used if your doctor considers it necessary and under direct medical supervision.
Kerlon and medicines of the same class (beta-blockers) may reduce blood flow to the placenta (placental flow), thereby increasing the risk of fetal death in utero, premature or early delivery. Other adverse effects may also occur in the fetus, particularly low blood sugar (hypoglycemia) and slow heart rate (bradycardia).
If Kerlon or other medicines of the same class (beta-blockers) are taken at the time of delivery, there is an increased risk that the newborn may experience heart and lung complications, even several days after birth. If heart function failure occurs, hospitalization of the newborn in an intensive care unit is required. The newborn may suffer from slow heart rate (bradycardia), breathing difficulties, and low blood sugar (hypoglycemia).

Breastfeeding
Kerlon passes into breast milk. Breastfeeding is not recommended during treatment with Kerlon.

Driving and using machines
Kerlon may occasionally cause dizziness and fatigue.
If you take Kerlon together with alcoholic beverages, your reaction abilities may be further reduced.
Take this into account if you need to drive vehicles or operate machinery.

Kerlon contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.

For those engaged in sports activities
The use of Kerlon without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Kerlon

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
1 tablet (20 mg) daily by mouth. The time and type of meals do not affect the administration of Kerlon.

If you suffer from severe chest pain occurring after exertion (exertional angina):
The recommended dose is: 1 tablet (20 mg) daily by mouth.
In some cases, your doctor may decide to start treatment with half a tablet (10 mg) daily.
If necessary, your doctor may consider increasing the dose to 2 tablets (40 mg) daily.

If you have kidney impairment:
Dose adjustment is usually not required if kidney disease is not severe (creatinine clearance of 20 ml per minute). Your doctor will monitor you for approximately 4 days.

If you are undergoing chronic dialysis (hemodialysis or peritoneal dialysis):
The recommended dose is:
1 tablet (10 mg) daily, taken regardless of the schedule or timing of dialysis sessions.

In case of liver impairment:
No changes in dosage are necessary. Your doctor will monitor you closely at the beginning of treatment.

Elderly patients:
Your doctor may start treatment with lower doses than normally recommended and will keep you under close supervision.

If you take more Kerlon than you should:
In case of accidental ingestion/overdose of Kerlon, inform your doctor immediately or go to the nearest hospital.
A disturbance in the electrical conduction of the heart may occur.

If you forget to take Kerlon:
Do not take a double dose to make up for the missed dose.

If you stop taking Kerlon:
Do not stop treatment abruptly if you suffer from a condition called angina: sudden discontinuation may cause serious disturbances in heart rhythm, heart attack, and sudden death.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common side effects (may affect up to 1 in 10 people)

• dizziness and headache,
• weakness (asthenia) and insomnia,
• stomach pain (gastralgia), diarrhoea, nausea and vomiting,
• reduction in heart rate (bradycardia), even severe,
• cold extremities,
• impotence.

Rare side effects (may affect up to 1 in 1,000 people)

• a skin reaction called psoriasis, with red patches covered by white scales, or worsening of pre-existing psoriasis (including psoriasiform rashes or worsening of psoriasis),
• depression,
• heart failure, drop in blood pressure, disturbances in heart rhythm (slowing of atrioventricular conduction or worsening of any existing atrioventricular block),
• constriction of blood vessels causing a bluish discoloration of the limbs (Raynaud's syndrome), or leg pain when walking (intermittent claudication),
• constriction of the bronchi (bronchospasm),
• alteration of the body's defence system (antinuclear antibodies), accompanied only in exceptional cases by clinical signs such as systemic lupus erythematosus, and which decrease upon discontinuation of treatment.

Very rare side effects (may affect up to 1 in 10,000 people)

• burning sensations and tingling (paraesthesiae) in the extremities,
• blurred vision,
• hallucinations, confusion, nightmares, emotional, behavioural and movement disorders (catatonia), and memory disturbances,
• reduction or increase in blood sugar levels (hypoglycaemia and hyperglycaemia).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• urticaria, itching, excessive sweating (hyperhidrosis),
• profound drowsiness (lethargy),
• your heartbeat becomes very slow or stops. You may also experience dizziness and feel unusually tired and short of breath. This condition may occur especially in people over 65 years of age or in people with other heart rhythm problems.

The doctor will discontinue treatment and take appropriate measures if, occasionally, changes in certain blood cells (thrombocytopenic purpura, granulocytopenia), skin redness (rash), or constriction of the bronchi (bronchospasm) occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kerlon

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kerlon contains

• The active substance is betaxolol. One film-coated tablet contains betaxolol hydrochloride 20 mg.
• The other ingredients are: lactose, sodium carboxymethylstarch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide.

Description of the appearance of Kerlon and pack contents
Kerlon is available as film-coated, divisible tablets.

• Carton containing 28 tablets

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel, Tours (France)