Atenolol Oral Solution 25mg/5ml
- Revised
- September 2023
- Source updated
- 07 Sep 2023
- MA number
- PL 00427/0280
- ATC
- C07AB03
- Legal status
- Prescription only medicine
Indications
Concepts (33)
+Heart conditionsContraindicated
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • sev
Source SmPC ↗+Hormone disordersContraindicated
other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.
Source SmPC ↗+Heart rhythm blockContraindicated
ny of the excipients listed in section 6.1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.
Source SmPC ↗+Allergy to the medicineContraindicated
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third deg
Source SmPC ↗+Low blood pressureContraindicated
• cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.
Source SmPC ↗+Acid build-up in the bloodContraindicated
be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.
Source SmPC ↗+ShockContraindicated
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • sev
Source SmPC ↗+UnclassifiedContraindicated
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm)
Source SmPC ↗+Blood vessel conditionsContraindicated
ock • uncontrolled heart failure • sick sinus syndrome • second or third degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.
Source SmPC ↗+AlcoholWarning
on (possibly delayed). This medicine contains 32.8 mg sodium in each 20 ml (four 5 ml spoonfuls) solution, equivalent to 1.64% of the WHO recommended maximum daily intake of 2 g sodium for an adult This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Source SmPC ↗+Angioedema (deep swelling)Warning
lergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. • May cause a hypersensitivity reaction including angioedema and urticaria. • Should be used with caution in the elderly, starting with a lesser dose (see section 4.2). Since atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clea
Source SmPC ↗+Benzyl alcoholWarning
reditary fructose intolerance (HFI) should not take/be given this medicinal product. This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml. This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reaction (possibly delayed). This medicine contains 32.8 mg sodium in each 20 ml (four 5 ml spoonfuls) solution, equivalent to 1.64% of the WHO recommended maximum daily intake of 2 g sodium for an adult This medicine contains
Source SmPC ↗+Obstructed blood flow from the heartWarning
the elderly, starting with a lesser dose (see section 4.2). Since atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for their use. Where such reasons exist, atenolol may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients, this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline. The label and patient information leaflet for the product state the following warning: “If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor”. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Excipients: This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoo
Source SmPC ↗+Taken with other medicinesWarning
eaflet for the product state the following warning: “If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor”. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Excipients: This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be give
Source SmPC ↗+Older peopleWarning
h allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. • May cause a hypersensitivity reaction including angioedema and urticaria. • Should be used with caution in the elderly, starting with a lesser dose (see section 4.2). Since atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2. Although cardioselective (beta1) beta-blockers may have less
Source SmPC ↗+Intolerance to an ingredientWarning
less you have discussed these symptoms with the prescribing doctor”. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Excipients: This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml. This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may c
Source SmPC ↗+Sugar alcoholsWarning
less you have discussed these symptoms with the prescribing doctor”. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Excipients: This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml. This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may c
Source SmPC ↗+Propylene glycolWarning
ne contains 5.32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml. This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reaction (possibly delayed). This medicine contains 32.8 mg sodium in each 20 ml (four 5 ml spoonfu
Source SmPC ↗+Kidney conditionsWarning
n. In the rare instances when a treated patient develops symptoms which may be attributed to a slow heart rate and the pulse rate drops to less than 50-55 bpm at rest, the dose should be reduced. • May cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. • May cause a hypersensitivity reaction including angioedema and urticaria. • Should be used with caution in the elderly, starting with a lesser dose (see section 4.2). Since atenolol is excrete
Source SmPC ↗+Breathing conditionsWarning
the elderly, starting with a lesser dose (see section 4.2). Since atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for their use. Where such reasons exist, atenolol may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients, this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline. The label and patient information leaflet for the product state the following warning: “If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor”. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Excipients: This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoo
Source SmPC ↗+ThyroidWarning
its negative effect on conduction time, caution must be exercised if it is given to patients with first degree heart block. • May mask the symptoms of hypoglycaemia, in particular, tachycardia. • May mask the signs of thyrotoxicosis. • Will reduce the heart rate, as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributed to a slow heart rate and the pulse ra
Source SmPC ↗+Heart rhythm (QT interval)Interaction
g clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine). Class I anti-arrhythmic drugs (e.g. disopyramide, quinidine) and amiodarone may have a potentiating effect on atrial conduction time and induce negative inotropic effect. Concomitant use of sympathomimetic agents, e.g. adrenaline, may counteract the effects of beta-blockers. Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of
Source SmPC ↗+BreastfeedingPregnancy
rease in placental perfusion which may result in growth retardation, intra-uterine deaths, abortion, immature and premature deliveries. There is significant accumulation of atenolol in breast milk. Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia. Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding.
Source SmPC ↗+Liver conditionsPregnancy
ment of hypertension in the third trimester. Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation The use of atenolol in women who are or may become pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters, since beta-blockers, in general, have been associated with a decrease in placental perfusion which may result in growth retardation, intra-uterine deaths, abortion, immature and premature deliveries. There is significant accumulation of atenolol in breast milk. Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia.
Source SmPC ↗+ChildrenPregnancy
rease in placental perfusion which may result in growth retardation, intra-uterine deaths, abortion, immature and premature deliveries. There is significant accumulation of atenolol in breast milk. Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia. Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding.
Source SmPC ↗+PregnancyPregnancy
Atenolol crosses the placental barrier and appears in cord blood. No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation The use of atenolol in women who are or may become pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters, since beta-b
Source SmPC ↗+Contrast dyes used in scansNot in scanned sections
+Salt and mineral balanceNot in scanned sections
+FertilityNot in scanned sections
+Stomach and gutNot in scanned sections
+Sodium and potassium contentNot in scanned sections
+BlockageNot in scanned sections
+Eye conditionsNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
3 years.
Use within one month of first opening.
§6.4 — Special precautions for storage
Do not store above 25°C.
Store in the original container.