Active ingredients: Atenolol
SELES BETA 100 mg tablets
Why is Seles beta used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Unassociated selective beta-blockers.
THERAPEUTIC INDICATIONS
- Arterial hypertension including that of renal origin.
- Angina pectoris.
- Arrhythmias.
- Early intervention in acute myocardial infarction.
Contraindications When Seles beta should not be used
- Like other beta-blockers, Seles Beta should not be administered to patients with: known hypersensitivity to the active substance or to any of the excipients;
- bradycardia;
- cardiogenic shock;
- hypotension;
- metabolic acidosis;
- severe disorders of peripheral arterial circulation;
- 2nd or 3rd degree atrioventricular block;
- diseases of the sinus node;
- untreated pheochromocytoma;
- uncontrolled heart failure.
Seles Beta should not be combined with verapamil or diltiazem therapy.
Precautions for use What you need to know before taking Seles beta
Although Seles Beta is contraindicated in uncontrolled heart failure (see section "Contraindications") it can be administered to patients whose signs of heart failure are controlled and, with due caution, to patients with poor cardiac reserve.
In patients with Prinzmetal's angina, Seles Beta may increase the number and duration of anginal seizures through alpha receptor mediated coronary arterial vasoconstriction.
However, although with the utmost caution, its use in these patients can be considered, as Seles Beta is a selective beta-blocker beta-1.
As already indicated (see "Contraindications" section), Seles Beta must not be administered to patients with severe peripheral arterial circulation disorders.
During its use in patients with peripheral vascular disorders of modest entity, an aggravation of these disorders may also occur.
Particular caution in the administration of Seles Beta should be given to patients with 1st degree atrioventricular block, due to its negative effect on conduction time.
Seles Beta can change the signs of hypoglycemia, such as rapid heartbeat, heartbeat and sweating.
Seles Beta can mask the cardiovascular signs of thyrotoxicosis.
The reduction of heart rate is a "pharmacological action induced by Seles Beta.
Dosage reduction should be considered in the rare cases where symptoms attributable to excessive reduction in heart rate appear.
It is important not to abruptly stop treatment with Seles Beta, especially in patients with ischemic heart disease.
Seles Beta can cause a hypersensitivity reaction including angioedema and urticaria.
In patients treated with Seles Beta and with a history of anaphylactic reactions to various allergens, there may be an aggravation of allergic reactions on the occasion of repeated stimuli by the allergen.
These patients may not respond adequately to the doses of adrenaline commonly used in the treatment of allergic reactions.
Patients with bronchospasm should, in general, not receive beta-blockers, due to increased airway resistance. Atenolol is a selective beta-blocker beta1; however this selectivity is not absolute. Therefore the lowest possible dose of Seles Beta should be used in these patients and extreme caution should be exercised.
In the event of increased respiratory tract resistance, the administration of Seles Beta should be discontinued and, if necessary, therapy with bronchodilator preparations (such as salbutamol) initiated.
The systemic effects of oral beta-blockers may be potentiated when used concomitantly with ophthalmic beta-blockers.
In patients with pheochromocytoma Seles Beta should only be given after blocking of alpha receptors. Blood pressure must be closely monitored.
Caution should be exercised in case of concomitant administration of anesthetic agents and Seles Beta. The anesthetist should be informed of this and an anesthetic with the lowest possible negative inotropic activity should be used. The use of beta-blockers and anesthetic drugs may lead to attenuation of reflex tachycardia and increase the risk of hypotension. The use of anesthetics which can cause myocardial depression should be avoided.
As with all beta-blockers in patients who are to undergo surgery it is advisable to gradually reduce the treatment with Seles Beta until it is stopped at least 48 hours before surgery. Any signs of vagal hyperactivity can be corrected by intravenous injection of 0, 5 - 1 mg of atropine sulphate possibly repeated.
Interactions Which drugs or foods can modify the effect of Seles beta
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Concomitant use of beta-blockers and calcium channel blockers with negative inotropic effect (eg verapamil, diltiazem) may cause an excess of these effects, particularly in patients with impaired ventricular function and / or sinus or atrial conduction abnormalities. ventricular This can lead to severe hypotension, bradycardia and heart failure.
Neither beta-blockers nor calcium channel blockers should be administered intravenously within 48 hours of stopping the others.
Concomitant use with dihydropyridines (eg nifedipine) may increase the risk of hypotension and cases of heart failure may occur in patients with latent heart failure.
Concomitant use of baclofen may potentiate the antihypertensive effect, thus requiring dose adjustments.
Glycoside digitalis drugs, associated with beta-blockers, can cause an increase in atrioventricular conduction time.
Beta-blockers can aggravate the sharp rise in blood pressure that can occur after discontinuation of clonidine. If the two drugs are administered at the same time, the beta-blocker must be discontinued several days before stopping the clonidine therapy. If beta-blocker therapy is to replace clonidine therapy, initiation of beta-blocker therapy should occur several days after stopping clonidine therapy.
Class I antiarrhythmic drugs (eg disopyramide) and amiodarone may potentiate the effect on atrial conduction time and induce negative inotropic effects. Sympathomimetic drugs, such as adrenaline, can counteract the effect of beta blockers when used simultaneously.
Concomitant use of prostaglandin synthetase inhibitor drugs (eg ibuprofen, indomethacin) may reduce the hypotensive effects of beta-blockers.
Particular caution should be exercised in the use of anesthetic agents in patients treated with Seles Beta (see section "Precautions for use").
Concomitant use of insulin or oral antidiabetic drugs may intensify the hypoglycemic effect of these drugs.
Warnings It is important to know that:
Pregnancy and breastfeeding
Pregnancy
Seles Beta crosses the placental barrier and blood levels have been found in the umbilical cord.
No studies have been performed on the use of Seles Beta in the 1st trimester of pregnancy and therefore the possibility of fetal harm cannot be excluded.
Seles Beta has been used, under strict medical supervision, for the treatment of hypertension in the 3rd trimester.
The use of Seles Beta in pregnant women for the treatment of mild to moderate hypertension has been associated with intra-uterine growth retardation. The use of Seles Beta in women who are pregnant or who may start it requires a careful evaluation of the benefits induced by the therapy compared to the possible risks, particularly in the 1st and 2nd trimester of gestation.
Feeding time
There is a significant accumulation of Seles Beta in breast milk. Caution should be exercised when Seles Beta is administered to breastfeeding women.
Babies born to mothers who have taken Seles Beta shortly before giving birth or while breastfeeding may be at risk of hypoglycaemia and bradycardia. Care should be taken when Seles Beta is taken during pregnancy or breastfeeding.
Effects on ability to drive and use machines: Taking Seles Beta is unlikely to affect your ability to drive and use machines. However, dizziness may sometimes occur in some patients taking Seles Beta. and fatigue; in case of these symptoms it is advisable not to carry out these activities.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Seles beta: Dosage
You must follow your doctor's instructions regarding the dose, method and frequency of taking the tablets.
The tablets should be taken with water, preferably always at the same time and in a single administration.
Improved health status should not lead to discontinuation of treatment, unless requested by the physician. Discontinuation of treatment should be gradual.
Adults
Arterial hypertension, including that of renal origin
½-1 tablet (50-100 mg) per day The full antihypertensive effect is usually achieved after one or two weeks of therapy. If necessary, it is possible to obtain a further reduction in blood pressure by combining Seles Beta with other antihypertensive drugs.
The simultaneous administration of Seles Beta with a diuretic results in an antihypertensive effect superior to that produced by the single drugs.
Angina pectoris
Most patients respond to administration of 1 tablet (100 mg) per day.
Increasing the dosage generally does not provide additional benefit.
Arrhythmias
After controlling for arrhythmias with an injectable formulation of atenolol, an oral maintenance dose of 50-100 mg / day is recommended.
Early intervention in acute myocardial infarction
Treatment should be started within 12 hours of the onset of precordial pain in acute myocardial infarction with an injectable formulation of atenolol. 15 minutes after the bolus injection, administer 50 mg of Seles Beta orally followed by another 50 mg 12 hours after the injection. Subsequently, oral maintenance therapy is recommended at a dose of 100 mg / day which should be started after another 12 hours.
If bradycardia and / or hypotension (of such a magnitude as to require therapeutic intervention) or other serious undesirable effects appear, Seles Beta should be discontinued.
Special populations
Use in the elderly
Dosage may need to be reduced, particularly in patients with impaired renal function.
Use in children and adolescents (<18 years)
There is no clinical experience relating to the pediatric use of Seles Beta, therefore its administration to children and adolescents is not recommended.
Use in patients with renal insufficiency
As Seles Beta is excreted via the kidney, the dosage must be reduced in patients with severe renal impairment. There is no evidence of significant accumulation of Seles Beta in patients who have a creatinine clearance greater than 35ml / min / 1.73m2 (the normal limit is 100-150ml / min / 1.73m2). with creatinine clearance of 15-35 ml / min / 1.73m2 (equivalent to 3.4-6.8 mg / 100 ml of serum creatinine) the dosage should be 50 mg per day or 100 mg every other day.
For patients with creatinine clearance <15 ml / min / 1.73m2 (equivalent to 6.8 mg / 100 ml of serum creatinine) the dosage should be 50 mg every other day or 100 mg every 4 days.
Seles Beta should be administered orally to patients on hemodialysis at a dose of 50 mg after each session; Administration should be performed in a hospital setting as marked reductions in blood pressure may occur.
Omission of one or more doses
In the event that a dose is missed due to forgetfulness, it should be taken as soon as possible. Two doses should not be taken at the same time.
Overdose What to do if you have taken too much Seles beta
Symptoms of overdose can manifest as bradycardia, hypotension, acute heart failure and bronchospasm.
General supportive measures should include: close medical surveillance, hospitalization in the intensive care unit, gastric lavage, use of activated charcoal and a laxative to prevent absorption of the drug still present in the gastrointestinal tract, use of plasma or plasma substitutes to treat hypotension and shock.
The possibility of using hemodialysis or hemoperfusion should be considered.
Severe bradycardia can be corrected with 1-2 mg of atropine administered intravenously and / or with a cardiac pacemaker. If necessary, this can be followed by a 10 mg intravenous bolus dose of glucagon, which may be repeated or followed by 1-10 mg / h intravenous glucagon depending on response.
If there is no response to glucagon or if it is not available, a beta-adrenergic stimulant such as dobutamine can be used at a dose of 2.5-10 mcg / kg / min for intravenous infusion. Dobutamine, due to its positive inotropic effects, could also be used to treat hypotension and acute heart failure. In the event of a large overdose, these doses are likely to be inadequate to counteract the cardiac effects induced by beta-blockade. The Dobutamine dose should then be increased as needed to achieve the desired response based on the patient's clinical condition.
Bronchospasm can usually be resolved by administering bronchodilator preparations.
In case of accidental ingestion / intake of higher than recommended doses, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Seles Beta, ask your doctor or pharmacist.
Side Effects What are the side effects of Seles beta
Like all medicines, Seles Beta can cause side effects, although not everybody gets them.
In clinical studies, reported undesirable effects are generally attributable to the pharmacological action of atenolol.
The following undesirable effects, listed by MedDRA system organ class, have been reported with the following frequencies: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon ( ≥ 1 / 1,000 to <1/100), rare (≥ 1 / 10,000 to <1 / 1,000), very rare (<1 / 10,000), not known (cannot be estimated from the available data):
Cardiac disorders:
- Common: bradycardia
- Rare: worsening of heart failure; heart block
Vascular disorders:
- Common: cold in the extremities
- Rare: postural hypotension which may be associated with syncope; aggravation of intermittent claudication, if already present; Raynaud's phenomenon in predisposed patients.
Nervous system disorders:
- Rare: dizziness; headache; paresthesia
Psychiatric disorders:
- Uncommon: sleep disturbances, similar to what has been reported with other beta-blockers
- Rare: mood changes, nightmares, psychosis or hallucinations, aggravation of nerve syndromes with mental depression, catatonia, confusion and memory disturbances
Gastrointestinal disorders:
- Common: gastrointestinal disturbances
- Rare: dry mouth Not known: constipation
Immune system disorders:
- Not known: Hypersensitivity reactions
Diagnostic tests:
- Common: increases in transaminase levels
- Very rare: An increase in antinuclear antibodies has been observed, however the clinical relevance is unclear. Cases of systemic lupus erythematosus have also been reported.
Hepatobiliary disorders:
- Rare: hepatic toxicity, including intrahepatic cholestasis
Disorders of the blood and lymphatic system:
- Rare: purple; thrombocytopenia
Skin and subcutaneous tissue disorders:
- Rare: alopecia; psoriatic-type skin reactions; aggravation of psoriasis; skin erythema; atenolol can exacerbate depigmentation in people with vitiligo
- Not known: angioedema, urticaria
Eye disorders:
- Rare: dry eyes; visual disturbances
Reproductive system and breast disorders:
- Rare: impotence
Respiratory, thoracic and mediastinal disorders:
- Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthma problems
General disorders and administration site conditions:
- Common: fatigue Compliance with the instructions contained in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Deadline "> Other information
COMPOSITION
Each tablet contains:
- Active ingredient: atenolol 100 mg.
- Excipients: magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.
PHARMACEUTICAL FORM AND CONTENT
Tablet. Seles Beta 100 mg tablets - 50 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
SELES BETA 100 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One tablet contains:
Active ingredient: atenolol 100 mg
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM -
Tablet.
White, round, convex tablets with a score line on one side.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
• Arterial hypertension, including that of renal origin.
• Angina pectoris.
• Arrhythmias.
• Early intervention in acute myocardial infarction.
04.2 Posology and method of administration -
Adults
Arterial hypertension, including that of renal origin
½-1 tablet (50-100 mg) per day. The full antihypertensive effect is usually achieved after one or two weeks of therapy. If necessary, it is possible to obtain a further reduction in blood pressure by combining Seles Beta with other antihypertensive drugs.
The simultaneous administration of Seles Beta with a diuretic results in an antihypertensive effect superior to that produced by the single drugs.
Angina pectoris
Most patients respond to administration of 1 tablet (100 mg) per day.
Increasing the dosage generally does not provide additional benefit.
Arrhythmias
After controlling for arrhythmias with an injectable formulation of atenolol, an oral maintenance dose of 50-100 mg / day is recommended.
Early intervention in acute myocardial infarction
Treatment should be started within 12 hours of the onset of precordial pain in acute myocardial infarction with an injectable formulation of atenolol. 15 minutes after the bolus injection, administer 50 mg of Seles Beta orally followed by another 50 mg 12 hours after the injection. Subsequently, oral maintenance therapy is recommended at a dose of 100 mg / day which should be started after another 12 hours.
If bradycardia and / or hypotension (of such a magnitude as to require therapeutic intervention) or other serious undesirable effects appear, Seles Beta should be discontinued.
Special populations
Use in the elderly
Dosage may need to be reduced, particularly in patients with impaired renal function.
Use in children and adolescents (
There is no clinical experience relating to the pediatric use of Seles Beta, therefore its administration to children and adolescents is not recommended.
Use in patients with renal insufficiency
As Seles Beta is excreted via the kidney, the dosage must be reduced in patients with severe renal impairment. There is no evidence of significant accumulation of Seles Beta in patients who have a creatinine clearance greater than 35 ml / min / 1.73m² (the normal limit is 100-150 ml / min / 1.73m²). with creatinine clearance of 15-35 ml / min / 1.73m² (equivalent to 3.4-6.8 mg / 100 ml of creatinine) the dosage should be 50 mg per day or 100 mg every other day.
For patients with creatinine clearance
Seles Beta should be administered orally to patients on hemodialysis at a dose of 50 mg after each session; Administration should be performed in a hospital setting as marked reductions in blood pressure may occur.
04.3 Contraindications -
Like other beta-blockers, Seles Beta should not be given to patients with:
• known hypersensitivity to the active substance or to any of the excipients;
• bradycardia;
• cardiogenic shock;
• hypotension;
• metabolic acidosis;
• severe disturbances of peripheral arterial circulation;
• 2nd or 3rd degree atrioventricular block;
• sickness of the sinus node;
• untreated pheochromocytoma;
• uncontrolled heart failure.
Seles Beta should not be combined with verapamil or diltiazem therapy.
04.4 Special warnings and appropriate precautions for use -
Although Seles Beta is contraindicated in uncontrolled heart failure (see section 4.3), it can be administered to patients whose signs of heart failure are controlled and, with due caution, to patients with poor cardiac reserve.
In patients with Prinzmetal's angina, Seles Beta may increase the number and duration of anginal seizures through alpha receptor mediated coronary arterial vasoconstriction. However, although with the utmost caution, its use in these patients can be considered, as Seles Beta is a selective beta-blocker beta-1.
As already indicated (see section 4.3), Seles Beta must not be administered to patients with severe disorders of the peripheral arterial circulation. During its use in patients with peripheral vascular disorders of modest entity, an aggravation of these disorders may also occur.
Particular caution in the administration of Seles Beta should be given to patients with 1st degree atrioventricular block, due to its negative effect on conduction time.
Seles Beta can change the signs of hypoglycemia, such as rapid heartbeat, heartbeat and sweating.
Seles Beta can mask the cardiovascular signs of thyrotoxicosis.
Reduction in heart rate is a pharmacological action induced by Seles Beta. A reduction in dosage should be considered in the rare cases where symptoms attributable to excessive reduction in heart rate appear.
It is important not to abruptly stop treatment with Seles Beta, especially in patients with ischemic heart disease.
Seles Beta can cause a hypersensitivity reaction including angioedema and urticaria.
In patients treated with Seles Beta and with a history of anaphylactic reactions to various allergens, an aggravation of allergic reactions may occur on the occasion of repeated stimuli by the allergen. These patients may not respond adequately to the doses of adrenaline commonly used in the treatment of allergic reactions.
Patients with bronchospasm should, in general, not receive beta-blockers, due to increased airway resistance. Atenolol is a selective beta-blocker beta1; however this selectivity is not absolute. Therefore, the lowest possible dose of Seles Beta should be used in these patients and extreme caution should be exercised. In case of increased airway resistance , the administration of Seles Beta should be discontinued and, if necessary, therapy with bronchodilator preparations (such as salbutamol) initiated.
The systemic effects of oral beta-blockers may be potentiated when used concomitantly with ophthalmic beta-blockers.
In patients with pheochromocytoma Seles Beta should only be given after blocking of alpha receptors. Blood pressure must be closely monitored.
Caution should be exercised in case of concomitant administration of anesthetic agents and Seles Beta. The anesthetist should be informed of this and an anesthetic with the lowest possible negative inotropic activity should be used. The use of beta-blockers and anesthetic drugs may lead to attenuation of reflex tachycardia and increase the risk of hypotension. The use of anesthetics which can cause myocardial depression should be avoided.
As with all beta-blockers in patients who are to undergo surgery it is advisable to gradually reduce the treatment with Seles Beta until it is stopped at least 48 hours before surgery. Any signs of vagal hyperactivity can be corrected by intravenous injection of 0, 5 - 1 mg of atropine sulphate possibly repeated.
04.5 Interactions with other medicinal products and other forms of interaction -
The concomitant use of beta-blockers and calcium channel blockers with negative inotropic effect (eg verapamil, diltiazem), may cause an excess of these effects, particularly in patients with impaired ventricular function and / or an abnormal sino-atrial or atrial conduction. ventricular This can lead to severe hypotension, bradycardia and heart failure.
Neither beta-blockers nor calcium channel blockers should be administered intravenously within 48 hours of stopping the others.
Concomitant use with dihydropyridines (eg nifedipine) may increase the risk of hypotension and cases of heart failure may occur in patients with latent heart failure.
Concomitant use of baclofen may potentiate the antihypertensive effect, thus requiring dose adjustments.
Glycoside digitalis drugs, associated with beta-blockers, can cause an increase in atrioventricular conduction time.
Beta-blockers can aggravate the sharp rise in blood pressure that can occur after discontinuation of clonidine. If the two drugs are administered at the same time, the beta-blocker must be discontinued several days before stopping the clonidine therapy. If beta-blocker therapy is to replace clonidine therapy, initiation of beta-blocker therapy should occur several days after stopping clonidine therapy.
Class I antiarrhythmic drugs (eg disopyramide) and amiodarone can potentiate the effect on atrial conduction time and induce negative inotropic effects.
Sympathomimetic drugs, such as adrenaline, can counteract the effect of beta-blockers when used concurrently.
Concomitant use of prostaglandin synthetase inhibitor drugs (eg ibuprofen, indomethacin) may reduce the hypotensive effects of beta-blockers.
Particular caution should be exercised in the use of anesthetic agents in patients treated with Seles Beta (see section 4.4).
Concomitant use of insulin or oral antidiabetic drugs may intensify the hypoglycemic effect of these drugs.
04.6 Pregnancy and breastfeeding -
Pregnancy
Seles Beta crosses the placental barrier and blood levels have been found in the umbilical cord.
No studies have been performed on the use of Seles Beta in the 1st trimester of pregnancy and therefore the possibility of fetal harm cannot be excluded.
Seles Beta has been used, under strict medical supervision, for the treatment of hypertension in the 3rd trimester. The use of Seles Beta in pregnant women for the treatment of mild to moderate hypertension has been associated with growth retardation. intra-uterine.
The use of Seles Beta in women who are pregnant or who may start it requires a careful evaluation of the benefits induced by the therapy compared to the possible risks, particularly in the 1st and 2nd trimester of gestation.
Feeding time
There is a significant accumulation of Seles Beta in breast milk. Caution should be exercised when Seles Beta is administered to breastfeeding women.
Babies born to mothers who have taken Seles Beta shortly before giving birth or while breastfeeding may be at risk of hypoglycaemia and bradycardia. Care should be taken when Seles Beta is taken during pregnancy or breastfeeding.
04.7 Effects on ability to drive and use machines -
Seles Beta is unlikely to affect the ability to drive and use machines. However, it should be taken into account that dizziness or fatigue may occasionally occur.
04.8 Undesirable effects -
In clinical studies, reported undesirable effects are generally attributable to the pharmacological action of atenolol.
The following undesirable effects, listed by MedDRA system organ class, have been reported with the following frequencies: very common (≥ 1/10), common (≥1 / 100,
Cardiac pathologies :
common: bradycardia
Rare: worsening of heart failure; heart block
Vascular pathologies :
common: cold at the extremities
Rare: postural hypotension which may be associated with syncope; aggravation of intermittent claudication, if already present; Raynaud's phenomenon in predisposed patients.
Nervous system disorders :
Rare: dizziness; headache; paresthesia
Psychiatric disorders :
Uncommon: sleep disturbances, similar to what has been reported with other beta-blockers
Rare: mood changes, nightmares, psychosis or hallucinations, aggravation of nerve syndromes with mental depression, catatonia, confusion and memory disturbances
Gastrointestinal disorders :
common: gastrointestinal disorders
Rare: dry mouth
Not known: constipation
Disorders of the immune system :
Not known: hypersensitivity reactions
Diagnostic tests :
common: increases in transaminase levels
Very rare: An increase in antinuclear antibodies was observed, however the clinical relevance is unclear. Cases of systemic lupus erythematosus have also been reported.
Hepatobiliary disorders :
Rare: hepatic toxicity, including intrahepatic cholestasis
Disorders of the blood and lymphatic system :
Rare: purple; thrombocytopenia
Skin and subcutaneous tissue disorders :
Rare: alopecia; psoriatic-type skin reactions; aggravation of psoriasis; skin rash; atenolol can exacerbate depigmentation in people with vitiligo
Not known: angioedema, urticaria
Eye disorders :
Rare: dry eyes; visual disturbances
Diseases of the reproductive system and breast :
Rare: impotence
Respiratory, thoracic and mediastinal disorders :
Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthma problems
General disorders and administration site conditions :
common: fatigue
If, according to clinical judgment, the patient's quality of life is negatively affected by the presence of any of the undesirable effects listed above, discontinuation of treatment should be considered.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
Symptoms of overdose can manifest as bradycardia, hypotension, acute heart failure and bronchospasm.
General supportive measures should include: close medical surveillance, hospitalization in the intensive care unit, gastric lavage, use of activated charcoal and a laxative to prevent absorption of the drug still present in the gastrointestinal tract, use of plasma or plasma substitutes to treat hypotension and shock.
The possibility of using hemodialysis or hemoperfusion should be considered.
Severe bradycardia can be corrected with 1-2 mg of atropine administered intravenously and / or with a cardiac pacemaker. If necessary, this can be followed by a 10 mg intravenous bolus dose of glucagon, which may be repeated or followed by 1-10 mg / h intravenous glucagon depending on response.
If there is no response to glucagon or if it is not available, a beta-adrenergic stimulant such as dobutamine can be used at a dose of 2.5-10 mcg / kg / min for intravenous infusion. Dobutamine, due to its positive inotropic effects, could also be used to treat hypotension and acute heart failure. In the event of a large overdose, these doses are likely to be inadequate to counteract the cardiac effects induced by beta-blockade. The Dobutamine dose should then be increased as needed to achieve the desired response based on the patient's clinical condition.
Bronchospasm can usually be resolved by administering bronchodilator preparations.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Beta-blockers, selective, unassociated.
ATC code: C07AB03
Atenolol is a selective beta-blocker beta-1 (eg acts preferentially on cardiac beta-1 adrenergic receptors). Selectivity decreases with increasing dose.
Atenolol is devoid of intrinsic sympathomimetic activity and membrane stabilizing activity and, like other beta-blockers, has negative inotropic effects (it is therefore contraindicated in uncontrolled heart failure).
As with other beta-blockers, the mode of action of atenolol in the treatment of hypertension is unclear.
The efficacy of atenolol in eliminating or reducing symptoms in patients with angina is likely to be determined by the reduction in heart rate and contractility.
It is unlikely that any additional auxiliary properties possessed by S (-) atenolol, with respect to the racemic mixture, will give rise to different therapeutic effects.
Seles Beta is effective and well tolerated by most ethnicities, although a lower response may occur in black patients.
Seles Beta is compatible with diuretics, other antihypertensive and antianginal drugs (see 4.5)
05.2 "Pharmacokinetic properties -
After intravenous administration, blood levels of atenolol decline in a tri-exponential fashion with an elimination half-life of approximately 6 hours.
In the dose range of 5-10 mg intravenously the blood profile level responds to linear pharmacokinetics and the beta-blocker is still measurable 24 hours after a 10 mg intravenous dose.
After oral administration, absorption of atenolol is constant but incomplete (approximately 40-50%) with peak plasma concentrations 2-4 hours post dose.
Blood levels of atenolol are consistent and subject to slight variability.
There is no significant hepatic metabolism of atenolol and more than 90% of the absorbed atenolol reaches the systemic circulation unaltered.
The plasma half-life is approximately 6 hours, but may increase in patients with severe renal insufficiency, as the kidney is the major route of elimination.
Atenolol poorly penetrates tissues due to its low lipid solubility and its concentration in brain tissue is low. The amount of atenolol bound to plasma proteins is minimal (about 3%).
Seles Beta is effective for at least 24 hours after a single daily oral dose. The dosage simplicity facilitates compliance due to its acceptability by the patient.
05.3 Preclinical safety data -
Extensive clinical experience has been obtained with atenolol.
The various information regarding its administration are reported in the specific paragraphs.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.
06.2 Incompatibility "-
There are no known incompatibilities.
06.3 Period of validity "-
In intact packaging: 4 years
06.4 Special precautions for storage -
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Aluminum / PVC blister.
Seles Beta 100 mg tablets - 50 tablets
06.6 Instructions for use and handling -
No special precautions are required.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
UCB Pharma S.p.A. - Via Varesina 162 - 20156 Milan (Italy).
08.0 MARKETING AUTHORIZATION NUMBER -
A.I.C. n. 024325060 - "100 mg tablets" 50 tablets
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
A.I.C date: December 27, 1980 / Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT -
September 2015
