ATENOLOLO 100 mg Tablet

Зміст інструкції

1. ATENOLOLO ALMUS 100 mg tablets
2. ATENOLOL ALMUS has been used, under strict medical supervision, for the treatment

ATENOLOLO ALMUS 100 mg tablets

Equivalente medicinale
PHARMACOTHERAPEUTIC CATEGORY
Selective beta-blockers not associated with other drugs.

THERAPEUTIC INDICATIONS

• Arterial hypertension, including that of renal origin.
• Angina pectoris.
• Arrhythmias.
• Early intervention in acute myocardial infarction.

CONTRAINDICATIONS
As with other beta-blockers, ATENOLOLO ALMUS should not be administered to patients with:
hypersensitivity to the active ingredient or to any of the excipients; bradycardia; cardiogenic shock;
hypotension; metabolic acidosis; severe disorders of peripheral arterial circulation; atrioventricular
block of 2nd and 3rd degree; sinus node disease; untreated pheochromocytoma; uncontrolled
heart failure with inadequate therapy.
ATENOLOLO ALMUS should not be associated with therapy with verapamil or diltiazem.

PRECAUTIONS FOR USE
Although ATENOLOLO ALMUS is contraindicated in uncontrolled heart failure with adequate
therapy (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, ATENOLOLO ALMUS may increase the number and duration
of angina attacks through alpha receptor-mediated coronary artery vasoconstriction. However,
although with the utmost caution, its use in these patients can be considered, as
ATENOLOLO ALMUS is a beta-1 selective beta-blocker.
As already indicated in the section CONTRAINDICATIONS, ATENOLOLO ALMUS should not be
administered to patients with severe disorders of peripheral arterial circulation. During its
use, in patients with mild peripheral vascular disorders, a worsening of these disorders may also occur.
Particular caution in the administration of ATENOLOLO ALMUS should be given to patients with
1st degree atrioventricular block, due to its negative effect on conduction time.
ATENOLOLO ALMUS may modify tachycardia induced by hypoglycemia.
ATENOLOLO ALMUS may mask the signs of thyrotoxicosis.
The reduction of heart rate is a pharmacological action induced by ATENOLOLO ALMUS.
A reduction in dosage should be considered in the rare cases where symptoms attributable to
excessive reduction of heart rate appear.
It is important not to abruptly interrupt treatment with ATENOLOLO ALMUS, especially in
patients with ischemic heart disease.
In patients undergoing therapy with ATENOLOLO ALMUS and with a history of anaphylactic reactions to various
allergens, a worsening of allergic reactions may occur on repeated exposure to the allergen.
These patients may not respond adequately to commonly used doses of adrenaline in the
treatment of allergic reactions.
In asthmatic patients, ATENOLOLO ALMUS may induce an increase in airway resistance; however, although with the utmost caution, its use in these
patients can be considered, as ATENOLOLO ALMUS is a beta-1 selective beta-blocker. In case of increased
airway resistance, the administration of ATENOLOLO ALMUS should be discontinued and, if necessary, therapy with bronchodilator preparations (such as salbutamol) should be started.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available over the counter.
ATENOLOLO ALMUS should not be administered to patients undergoing therapy with calcium antagonists with
negative inotropic effect (e.g. verapamil, diltiazem); at least 48 hours must have elapsed since the
suspension of one of these drugs before starting the other therapy.
Concomitant use with dihydropyridines (e.g. nifedipine) may increase the risk of hypotension and cases of
heart failure may occur in patients with latent heart failure.
Digoxin glycosides, associated with beta-blockers, can cause an increase in atrioventricular conduction time.
Beta-blockers can worsen the abrupt increase in blood pressure values that may occur after
discontinuation of clonidine. If the two drugs are administered simultaneously, the beta-
blocker must be discontinued several days before interrupting therapy with clonidine. If therapy
with a beta-blocker is to replace that with clonidine, the start of treatment with a beta-
blocker must take place several days after the interruption of therapy with clonidine.
Particular caution is required in the administration of ATENOLOLO ALMUS to patients undergoing treatment with
antiarrhythmic drugs belonging to class I (e.g. disopyramide) or with amiodarone as they can
potentiate the effect on atrial conduction time and induce a negative inotropic effect.
Sympathomimetic drugs, such as adrenaline, can counteract the effect of beta-blockers when used
simultaneously.
Concomitant use of drugs that inhibit prostaglandin synthesis (e.g. ibuprofen, indomethacin) may
reduce the hypotensive effects of beta-blockers.
Particular caution is required when using anesthetic agents in patients treated with
ATENOLOLO ALMUS.
The anesthesiologist must be informed of this therapy and, in this case, an anesthetic agent with a minimal
negative inotropic activity must be used.
The use of beta-blockers with anesthetic agents can cause an attenuation of reflex tachycardia and
increase the risk of hypotension. The use of anesthetic agents that cause myocardial depression should be avoided.
The use of atenolol in diabetic patients undergoing treatment with insulin and/or oral antidiabetic drugs may mask the
symptoms of hypoglycemia, in particular tachycardia, sweating and tremors.
Atenolol can also accentuate the hypoglycemic effect of insulin and oral antidiabetic drugs.

SPECIAL WARNINGS
In the event of hospitalization, inform the medical staff of the ongoing treatment with ATENOLOLO ALMUS and, in particular, the anesthesiologist in case of surgery.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine

Pregnancy
ATENOLOLO ALMUS crosses the placental barrier and umbilical blood levels have been found.
Studies on the use of ATENOLOLO ALMUS in the 1st trimester of pregnancy have not been conducted and
therefore the possibility of fetal harm cannot be excluded.

ATENOLOL ALMUS has been used, under strict medical supervision, for the treatment

of hypertension in the 3rd trimester. The use of ATENOLOL ALMUS in pregnant women, for the treatment
of mild-to-moderate hypertension, has been associated with intrauterine growth retardation.
The use of ATENOLOL ALMUS, in women who are pregnant or who may become pregnant, requires
careful assessment of the benefits induced by therapy compared to the possible risks, particularly in the 1st and 2nd
trimester of gestation.

Breastfeeding
Caution should be exercised when ATENOLOL ALMUS is administered to breastfeeding women, in
as much as a significant accumulation of ATENOLOL ALMUS is found in breast milk.
Infants born to mothers who have taken ATENOLOL ALMUS shortly before delivery or during
breastfeeding may be at risk of hypoglycemia and bradycardia. Attention should be paid when
ATENOLOL ALMUS is taken during pregnancy or breastfeeding.

Effects on the ability to drive and operate machinery:it is unlikely that taking
ATENOLOL ALMUS will affect the ability to drive and operate machinery. However, in
some patients treated with ATENOLOL ALMUS, dizziness and
fatigue may sometimes occur; if these symptoms are present, it is advisable not to perform these activities.

For those who engage in sports:
The use of the drug without therapeutic need constitutes doping and may still result in positive
doping tests.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
It is necessary to follow your doctor's instructions regarding the dose, method and frequency of
tablet intake.
The tablets should be taken with water, preferably always at the same time and in a single
administration.
Improvement in health status should not lead to discontinuation of treatment unless
requested by the doctor. Discontinuation of treatment should occur gradually.

The daily dosage indicated is referred to an adult.

• Arterial hypertension including that of renal originHalf or one tablet a day. Usually the full antihypertensive effect is achieved after one or two weeks of therapy. If necessary, a further reduction in blood pressure values can be obtained by combining ATENOLOL ALMUS with other antihypertensive drugs. In particular, the simultaneous administration of ATENOLOL ALMUS with a diuretic determines an antihypertensive effect superior to that produced by the single drugs
• Angina pectorisMost patients respond to the administration of one tablet a day. Increasing the dosage generally does not provide further benefit.
• ArrhythmiasAfter controlling the arrhythmias with an injectable formulation of atenolol, a maintenance dosage by oral route of 50-100 mg/day is recommended.
• Early intervention in myocardial infarction

Treatment with an injectable formulation of atenolol should be started within 12 hours
from the onset of precordial pain in acute myocardial infarction. After 15 minutes from the bolus injection,
administer 50 mg of ATENOLOL ALMUS (½ tablet) orally followed by another 50 mg after
12 hours from the injection. Subsequently, maintenance therapy by oral route at a dose of
100 mg/day is recommended, which should be started after another 12 hours.
If bradycardia and/or hypotension (of such severity as to require therapeutic intervention) or other
serious side effects occur, ATENOLOL ALMUS should be discontinued.

• ElderlyIt may be necessary to reduce the dosage, particularly in patients with impairedrenal function.
• ChildrenThere is no clinical experience regarding the pediatric use of ATENOLOL ALMUS; thereforeits administration to children is not recommended.
• Renal insufficiency.Renal insufficiency. Since ATENOLOL ALMUS is excreted by the kidney, it is necessary to reduce thedosage in patients with severe impairment of renal function. No significantaccumulation of ATENOLOL ALMUS occurs in patients who have a creatinine clearance greater than 35 ml/min/1.73m2 (the normal limit is 100-150 ml/min/1.73m2). Inpatients with creatinine clearance of 15-35 ml/min/1.73m2 (equivalent to 3.4-6.8 mg% ofcreatinine) 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% ofcreatinine) the dosage should be 50 mg every other day or 100 mg every 4 days.
• Patients undergoing hemodialysisATENOLOL ALMUS should be administered orally at a dose of 50 mg after eachsession; administration should be carried out in a hospital setting, asmarked reductions in blood pressure may occur.

OVERDOSAGE
Symptoms of overdose may manifest with bradycardia, hypotension, acute heart failure and
bronchospasm.
General supportive measures should include: close medical supervision, admission to the intensive care unit, gastric lavage, use of activated charcoal and a laxative to prevent absorption
of any drug still present in the gastrointestinal tract, use of plasma or blood derivatives to
treat hypotension and shock.
The possibility of using hemodialysis or hemoperfusion should be considered.
Marked bradycardia can be corrected with 1-2 mg of atropine administered intravenously and/or
with a cardiac pacemaker. If necessary, this may be followed by a dose of 10 mg of glucagon in
bolus intravenously, which may be repeated or followed by 1-10 mg/h of glucagon for intravenous infusion
depending on the response.
If there is no response to glucagon or this is not available, a beta-adrenoceptor stimulant such as dobutamine at a dose of 2.5-10 mcg/kg/min for intravenous infusion should be used. Dobutamine, due to its positive inotropic effects, could also be used to treat hypotension and
acute heart failure. These doses are likely to be inadequate to counteract the cardiac effects
induced by beta-blockade in case of extensive overdose. The dose of dobutamine should therefore
be increased, if necessary, to obtain the desired response based on the patient's clinical condition.
Bronchospasm can generally be resolved by administering bronchodilator preparations.
In case of accidental ingestion/intake of an excessive dose of ATENOLOL ALMUS, immediately notify
the doctor or go to the nearest hospital.
If you have any doubts about the use of ATENOLOL ALMUS, consult your doctor or pharmacist.

Omission of one or more doses
In case of forgetting, it is advisable to take the missed dose as soon as
possible. Two doses should not be taken at the same time.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ATENOLOL ALMUS, CONSULT
YOUR DOCTOR OR PHARMACIST

UNDESIRABLE EFFECTS
Like all medicines, ATENOLOL ALMUS can cause side effects, although not
everyone will experience them
The following undesirable effects, described according to MedDRA classification by systems and organs, have been
reported with the following frequencies: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000,
<1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (the frequency cannot be defined
based on available data)
Cardiac disorders
common: slowed heartbeats
rare: difficulty breathing and/or swelling of the ankles if you have heart failure; heart block (which can cause an abnormal heartbeat, dizziness, fatigue or fainting).
Vascular disorders:
common: cold hands and feet;
rare: possibility of sudden drop in blood pressure in the upright position with possibility of loss
of consciousness; worsening of intermittent claudication; numbness and cramping of the fingers followed by
a sensation of warmth and pain (Raynaud's phenomenon).
Nervous system disorders:
rare: dizziness; headache; tingling in the hands or feet;
Psychiatric disorders:
uncommon: sleep disturbances
rare: mood changes; nightmares; psychosis or hallucinations (mental disorders); worsening of nervous syndromes with mental depression, catatonia (apathy and reduction of motor activity), confusion and memory disturbances.
Gastrointestinal disorders:
common: gastrointestinal disturbances (nausea, diarrhea)
rare: dry mouth.
Laboratory tests:
common: alterations in liver function (transaminases).
very rare: an increase in antinuclear antibodies has been observed, however the clinical relevance is not clear.
not known: changes in blood levels of triglycerides and cholesterol.
Hepatobiliary disorders
rare: liver toxicity, including intrahepatic cholestasis (yellowing of the skin and eyes).
Blood and lymphatic system disorders:
rare: purpura (bruise-like spots on the skin); thrombocytopenia (reduction in the number of platelets).
Skin and subcutaneous tissue disorders:
rare: hair loss; skin rashes including worsening of psoriasis; redness of the skin;
in addition, atenolol may exacerbate depigmentation in subjects affected by vitiligo.
Eye disorders:
rare: dry eyes; visual disturbances.
Reproductive system and breast disorders
rare: impotence.
Respiratory, thoracic and mediastinal disorders;
rare: worsening of breathing difficulties if you have asthma or have suffered from asthma problems.
Systemic disorders and conditions related to the site of administration:
common: fatigue.
Metabolism and nutrition disorders
not known: hypoglycemia, hyperglycemia.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet

consult your doctor or pharmacist. Side effects can also be reported

directlythroughthenationalreportingsystemat:

www.agenziafarmaco.gov.it/it/responsabili.

Reporting side effects helps to provide more information on the

safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.

Caution: do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Keep the medicine out of the sight and reach of children
COMPOSITION
Each tablet contains:
Active ingredient: atenolol 100 mg.
Excipients: heavy magnesium carbonate, corn starch, sodium lauryl sulfate, magnesium stearate.

PHARMACEUTICAL FORM AND CONTENT
Tablets in packs of 42 divisible tablets.

MARKETING AUTHORISATION HOLDER
ALMUS S.r.l.
Via Cesarea, 11/10
16121 Genoa

MANUFACTURER
Laboratorio Farmaceutico CT
Via Dante Alighieri 71
18038 Sanremo (IM)

DRUG
August 2013