KERLON 20 mg Коированная Таблетка

Содержание инструкции

1. Kerlon 20 mg film-coated tablets
   1. What is Kerlon and what is it used for
   2. What you need to know before taking Kerlon
2. Kerlon can mask the warning signs of low blood sugar
   1. How to take Kerlon
   2. Possible side effects
   3. How to store Kerlon
   4. Contents of the pack and other information

Kerlon 20 mg film-coated tablets

betaxolol

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Kerlon and what is it used for

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

• high blood pressure (arterial hypertension) of any type and severity;
• severe chest pain that occurs after exertion, due to a decrease in blood flow in the vessels that nourish 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 ingredient or 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 severe heart problems (uncontrolled heart failure, cardiogenic shock, second and third degree atrioventricular block in patients without a “pacemaker”, Prinzmetal's angina and sinoatrial dysfunction, including sinoatrial block),
• if you have a slowed heartbeat (less than or equal to 45-50 beats per minute),
• if you have circulation problems (severe forms of Raynaud's phenomenon and peripheral arterial vascular diseases),
• if you have a tumor of a gland called the adrenal gland called “pheochromocytoma” for which you are not receiving any treatment (untreated),
• if you have low blood pressure (hypotension),
• if you have had allergic reactions (anaphylactic reactions),
• if you have excessive acidity of the blood (metabolic acidosis),
• if you are taking medicines containing “floctafenine” (medicines used for the treatment of inflammation),
• if you are taking medicines containing “sultopride” (used for the treatment of psychiatric disorders),
• if you are taking medicines used for the treatment of depression (monoamine oxidase inhibitors, MAOIs),
• if you are taking medicines containing verapamil (used for the treatment of high blood pressure),
• if you have severe kidney problems (severe renal failure).

Warnings and precautions
Take this medicine exactly as your doctor or
pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.

• Do not suddenly stop taking Kerlon, especially if you suffer from certain heart diseases (coronary heart disease), as you may experience severe heart rhythm disturbances, heart attack, death (severe heart rhythm disturbances, myocardial infarction or sudden death). The dose will be gradually reduced over a one- to two-week period and, if necessary, alternative therapy will be prescribed to prevent worsening of your condition.
• If you have severe breathing problems (bronchial asthma and chronic obstructive pulmonary disease), be careful when taking Kerlon as it may have negative effects on the lungs and bronchi. Your doctor will perform tests on your respiratory function before starting treatment with Kerlon.
• If you have a heart problem called “controlled heart failure”, Kerlon will be prescribed starting from a low dose which will be gradually increased, always under strict medical control.
• If the number of heartbeats at rest drops below 50-55 per minute (bradycardia and in the presence of symptoms referable to bradycardia) your doctor will reduce the recommended dose.
• If you have a heart problem called “first-degree atrioventricular block”, Kerlon should be administered with caution.
• If you suffer from circulation problems in the heart (Prinzmetal's angina) Kerlon and all medicines of the same class (beta-blockers) can worsen this disorder.
• If you suffer from circulatory disorders (Raynaud's disease or syndrome, arteritis or chronic occlusive arteriopathies of the lower limbs) be careful when using Kerlon as it may worsen these disorders.
• The use of Kerlon, like all medicines of the same class (beta-blockers) in the treatment of increased blood pressure (hypertension) caused by a particular type of tumor called “pheochromocytoma”, requires strict control of blood pressure values.
• The administration of Kerlon in the elderly must be carried out with particular attention; the doctor will start treatment with low doses ensuring close monitoring of the patient.
• If you have kidney problems (renal failure) Kerlon will be prescribed taking care of kidney impairment (the dosage must be adjusted according to creatinine levels or creatinine clearance).
• If you suffer from diabetes, increase blood glucose monitoring at the beginning of treatment. The use of

Kerlon can mask the warning signs of low blood sugar

(hypoglycemia), in particular: increased heart rate (tachycardia), awareness of your own heartbeat (palpitations) and sweating.

• If you have a skin condition called “psoriasis”, be careful when using Kerlon and all medicines of the same class (beta-blockers), because this condition may worsen.
• If you suffer from severe allergic reactions (anaphylactic reactions) of any origin (especially from contrast agents containing iodine or due to the use of a medicine called “floctafenine” or during allergy desensitization therapies), be careful when using Kerlon and all medicines of the same class (beta-blockers) because their use can lead to a worsening of the reactions. This worsening could lead to increased resistance to the treatment of allergic reactions with a consequent increase in the doses of medicines used for therapy (such as adrenaline).
• If you are to undergo general anesthesia, the doctor will be aware that Kerlon and all medicines of the same class (beta-blockers) attenuate the increase in heart rate (reflex tachycardia) and increase the risk of reduced blood pressure (hypotension). Continuing therapy with Kerlon and medicines of the same class (beta-blockers) reduces the risk of heart complications (arrhythmia, myocardial ischemia and hypertensive crises). Tell the anesthesiologist if you are taking Kerlon or other beta-blockers, because:  If the anesthesiologist deems it necessary to discontinue treatment, they should be aware that an interruption of 48 hours is considered sufficient (for the reappearance of 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 disorders (coronary insufficiency) where interruption of treatment carries risks, or when suspension is not possible in emergency situations; in these situations, therapy with Kerlon will be continued and the anesthesiologist may administer specific medicines (premedication with atropine) and use anesthetics whose effect on heart activity is minimal.
• If you suffer from a condition affecting the eye called “glaucoma”, inform your ophthalmologist before undergoing any eye examinations, because the use of Kerlon and all medicines of the same class (beta-blockers) lowers the pressure inside the eye (modifying glaucoma screening tests). The doctor must carefully evaluate the administration of Kerlon if you are already taking medicines of the same class (beta-blockers) to control eye pressure, as the effects of the medicines can add up (additive effect) and therefore be excessive.
• If you suffer from a disease affecting the thyroid gland (thyrotoxicosis), be careful when using Kerlon and all medicines of the same class (beta-blockers) because they can mask the signs affecting the circulatory and heart system due to this malfunction.

Children and adolescents
Since safety and efficacy have not been evaluated in pediatric age, the use of Kerlon is not
recommended in these subjects.

Other medicines and Kerlon
Tell your doctor or pharmacist if you are taking, have recently taken, or may
take any other medicine.
Kerlon can be affected by or affect the following medicines.

Contraindicated associations

• 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 “floctafenine” because the compensatory reactions on the heart and circulatory system may be reduced.
• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with sultopride, active in the treatment of psychiatric disorders, can lead to an excessive slowing of the heart rate (excessive bradycardia).

Associations not recommended

• Medicines used to regulate the heartbeat (such as amiodarone), if administered simultaneously with Kerlon or medicines belonging to the same class (beta-blockers), can lead to heart activity disorders (of contractility, automatism and conduction and suppression of sympathetic compensatory mechanisms).
• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with other medicines used for heart problems (digitalis glycosides) can lead to a decrease in heart rate (bradycardia due to prolongation of atrioventricular conduction time).
• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with a medicine called fingolimod, active in regulating the body's defense system, can cause a greater decrease in heart rate (bradycardia). If the concomitant administration of the two medicines is deemed necessary by the doctor, appropriate monitoring of the heart rate is recommended at the beginning of treatment and at least until the following morning.
• Kerlon should not be used simultaneously with a medicine called verapamil used for high blood pressure problems.

Associations requiring caution

• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with some medicines used for anesthesia (volatile halogenated anesthetics) can cause problems at the circulatory and heart level (beta-blockers determine a reduction in cardiovascular compensatory reactions and beta-adrenergic inhibition can be removed during

the intervention, using beta-stimulants). Inform the anesthesiologist if you are using Kerlon or medicines
of the same class (beta-blockers), because treatment should generally not be discontinued,
especially abruptly.

• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with medicines for high blood pressure called calcium antagonists (bepridil, diltiazem and mebefradil) can cause problems with the heartbeat and heart activity (excessive bradycardia, sinus arrest, altered atrioventricular conduction and heart failure).
• The use of Kerlon or medicines of the same class (beta-blockers) in conjunction with diltiazem (a “calcium antagonist” medicine used to lower high blood pressure) can increase the risk of depression (see “Undesirable effects”).
• The use of Kerlon in conjunction with antiarrhythmic medicines (propafenone and class Ia: quinidine, hydroquinidine and disopyramide) can lead to problems with the heart (disorders of contractility, automatism, conduction and suppression of sympathetic compensatory mechanisms).
• The use of Kerlon in conjunction with baclofen (a medicine to treat some muscle disorders) can cause an increase in the effect on lowering blood pressure from Kerlon. The doctor will monitor blood pressure and dosage.
• Kerlon, like all medicines of the same class (beta-blockers), if administered in conjunction with medicines for diabetes (insulin and sulfonamide hypoglycemic agents) can mask some disorders due to low blood sugar (hypoglycemia) such as perception of the heartbeat (palpitations) and increased heart rate (tachycardia). In case of concomitant intake, the doctor will ask you to perform blood sugar checks more frequently, especially at the beginning of treatment.
• Kerlon and medicines of the same class (beta-blockers and especially propranolol, metoprolol and nadolol) if administered in conjunction with lidocaine (local anesthetic and heart rate regulator) can lead to an increase in undesirable effects on the nervous system and heart. In this case, the doctor will adjust the dose and timing of lidocaine administration and assess whether to prescribe appropriate monitoring.
• Treatment with Kerlon or medicines of the same class (beta-blockers) should be discontinued before undergoing an X-ray examination with iodine-based contrast agents, because in case of shock or hypotension due to the contrast agent, there could be complications to the heart and blood vessels (reduction of cardiovascular compensatory reactions).

Associations to be considered with caution

• The use of Kerlon in conjunction with anti-inflammatory medicines (non-steroidal anti-inflammatory drugs - NSAIDs) can lead to a reduction in activity against high blood pressure (inhibition by NSAIDs of vasodilating prostaglandins and retention of sodium and water with pyrazolone NSAIDs).
• The use of Kerlon with medicines called calcium antagonists (dihydropyridines such as nifedipine) can lead to an excessive drop in pressure (hypotension), to heart problems (heart failure in patients with latent or uncontrolled heart failure) and to circulation.
• If you are using Kerlon in conjunction with medicines for depression and psychotropic drugs (imipramine-like antidepressants - “tricyclics”, neuroleptics), you may have an increased antihypertensive effect and a possible drop in blood pressure when standing up (postural hypotension).
• If you are using Kerlon in conjunction with tetracosactide (a medicine used for laboratory tests) and with medicines called corticosteroids, you may observe a reduction in blood pressure (antihypertensive effect).
• The use of Kerlon with a medicine called “mefloquine” (antimalarial drug) can lead to a decrease in heart rate (bradycardia).
• If you are taking Kerlon or medicines of the same class (beta-blockers) in conjunction with medicines for the nervous system called “sympathomimetics”, you may observe a reduction in the effects of Kerlon.
• If you are taking Kerlon or medicines of the same class (beta-blockers) with clonidine, used to lower high blood pressure, and you want to stop taking the latter, your blood pressure should be carefully monitored. It may be necessary to discontinue Kerlon several days before a gradual
• Medicines known to induce heart rhythm disturbances: concomitant use with beta-blockers, such as Kerlon, can induce arrest in the conduction of the electrical signal of the heart.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
The use of Kerlon is not recommended during pregnancy; Kerlon should only be used if the
doctor deems it necessary and under the direct supervision of the same doctor.
Kerlon and medicines of the same class (beta-blockers) can reduce blood in the placenta
(placental flow), thus increasing the probability of intrauterine fetal death, premature or
premature delivery. Other undesirable effects may also occur in the fetus, in particular a decrease in sugar in the blood (hypoglycemia) and a decrease in heart rate
(bradycardia).
If you take Kerlon or other medicines of the same class (beta-blockers) at the birth of the
child, the risk increases that the newborn may have complications to the heart and lungs
even many days after birth. If heart activity failure occurs, hospitalization of the newborn in an intensive care unit is necessary. The newborn may suffer from
reduced heart rate (bradycardia), breathing disorders and reduced blood sugar (hypoglycemia).

Breastfeeding
Kerlon passes into breast milk. Breastfeeding is not recommended during the period in which
Kerlon is used.

Driving and operating machinery
Kerlon can occasionally cause dizziness and fatigue,
If you take Kerlon together with alcoholic beverages, you may experience a reduction in
reaction capabilities.
Keep this in mind if you need to drive vehicles or operate machinery. .
Kerlon contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine

For those who play sports
The use of Kerlon without therapeutic necessity constitutes doping and may still
result in positive doping tests.

3. How to take Kerlon

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

If you suffer from severe chest pain that occurs after exertion (Exertional Angina pectoris):
The recommended dose is: 1 tablet (20 mg) daily by mouth.
In some cases, your doctor may decide to start therapy with half a tablet (10 mg) daily.
If necessary, your doctor may consider it necessary to increase the dose to 2 tablets (40
mg) daily.

If you suffer from kidney failure:
it is usually not necessary to adjust the dose if the kidney disease is not severe (creatinine clearance of 20 ml per minute). Your doctor will monitor you for about 4 days.

If you are undergoingchronic dialysis(hemodialysis or peritoneal):
The recommended dose is:
1 tablet (10 mg) daily, taken independently of the rhythm and timing of dialysis
(dialysis sessions).

In case of liver failure:
No dosage adjustments are necessary. Your doctor will monitor you carefully at the beginning
of treatment.

Elderly patients
Your doctor may start treatment by prescribing lower doses than normally
recommended and will keep you under control.

If you take more Kerlon than you should
In case of accidental ingestion/intake of Kerlon, immediately inform your doctor or go to the nearest hospital.
Cardiac electrical signal conduction block may occur.

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

If you stop taking Kerlon
Do not suddenly stop treatment if you suffer from a condition called angina: a
sudden discontinuation can cause serious heart rhythm disturbances (heart rate), heart attack and
sudden death.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• dizziness and headaches,
• weakness (asthenia) and insomnia,
• stomach pain (gastralgia), diarrhea, nausea and vomiting,
• slowing of the heartbeat (bradycardia), even severe,
• cold extremities,
• impotence.

Rare side effects (may affect up to 1 in 1000 people)

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

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

• burning and tingling (paresthesia) of the extremities,
• impaired vision,
• hallucinations, confusion, nightmares, emotional, behavioral and movement abnormalities (catatonia) and memory impairment,
• reduction or increase in blood sugar (hypoglycemia and hyperglycemia).

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

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

The doctor will stop treatment and take appropriate measures if alterations of some blood cells (thrombocytopenic purpura, granulocytopenia),
skin redness (rash) or bronchial constriction (bronchospasm) occur occasionally.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system
at the address. 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Scad”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Kerlon contains

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

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

• pack of 28 tablets

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Sanofi Winthrop Industrie – 30-36 Avenue Gustave Eiffel, Tours (France)