Amlodipine 1mg/ml Oral Solution
- Revised
- 14/12/2022
- Source updated
- 10 Jan 2023
- MA number
- PL 00427/0234
- ATC
- C08CA01
- Legal status
- Prescription only medicine
Indications
Concepts (25)
+Heart conditionsContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction
Source SmPC ↗+Obstructed blood flow from the heartContraindicated
ients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction
Source SmPC ↗+Allergy to the medicineContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart
Source SmPC ↗+Low blood pressureContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myoc
Source SmPC ↗+BlockageContraindicated
ients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction
Source SmPC ↗+ShockContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction
Source SmPC ↗+UnclassifiedContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction
Source SmPC ↗+Taken with other medicinesWarning
The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality. Use in patients with impaired hepatic function The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been
Source SmPC ↗+Older peopleWarning
ing range and caution should be used, both on initial treatment and when increasing the dose. Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment. Use in elderly patients In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2). Use in renal failure Amlodipine may be used in such patients at normal doses. Changes in amlodip
Source SmPC ↗+Intolerance to an ingredientWarning
omy (PEG) tubes. This could lead to under dosing due to medicine remaining in the tube. For accurate delivery the instructions in section 6.6 should be followed. Ingredients in the formulation • The product contains liquid maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. • The product contains glycerol (E422). This may cause headache, stomach upset and diarrhoea.
Source SmPC ↗+Stomach and gutWarning
nal failure Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. Administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes Due to the viscous nature of this medicine caution should be used when administering this medicine via a nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. This could lead to unde
Source SmPC ↗+Liver conditionsWarning
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality. Use in patients with impaired hepatic function The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be initia
Source SmPC ↗+Sugar alcoholsWarning
omy (PEG) tubes. This could lead to under dosing due to medicine remaining in the tube. For accurate delivery the instructions in section 6.6 should be followed. Ingredients in the formulation • The product contains liquid maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. • The product contains glycerol (E422). This may cause headache, stomach upset and diarrhoea.
Source SmPC ↗+Kidney conditionsWarning
l monitoring may be required in patients with severe hepatic impairment. Use in elderly patients In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2). Use in renal failure Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. Administrat
Source SmPC ↗+Breathing conditionsWarning
The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality. Use in patients with impaired hepatic function The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been
Source SmPC ↗+Salt and mineral balanceInteraction
m). Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects. Dantrolene (infusion): In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene. Due to risk of hyperkalemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia. Effects of amlodipine on other medicinal products The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+Heart rhythm blockInteraction
m). Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects. Dantrolene (infusion): In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene. Due to risk of hyperkalemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia. Effects of amlodipine on other medicinal products The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+CancerInteraction
m). Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects. Dantrolene (infusion): In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene. Due to risk of hyperkalemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia. Effects of amlodipine on other medicinal products The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+BreastfeedingPregnancy
was observed at high doses (see section 5.3). Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus. Breast-feeding Amlodipine has been identified in breastfed infants of treated women. Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an in
Source SmPC ↗+FertilityPregnancy
breast-feeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breast-feeding to the child and the benefit of amlodipine therapy to the mother. Fertility Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of
Source SmPC ↗+ChildrenPregnancy
igh doses (see section 5.3). Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus. Breast-feeding Amlodipine has been identified in breastfed infants of treated women. Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 – 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breast-feeding to the child and the benefit of amlodipine therapy to the mother. Fertility Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potentia
Source SmPC ↗+PregnancyPregnancy
Pregnancy The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Use in pregnancy is only recommende
Source SmPC ↗+AlcoholNot in scanned sections
+Sodium and potassium contentNot in scanned sections
+Propylene glycolNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
Unopened: 2 years
Once opened: use within 30 days.
§6.4 — Special precautions for storage
Store in a refrigerator (2-8°C).
Keep the bottle stored upright.