Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Amlodipine 2mg/ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Amlodipine besilate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Amlodipine 2mg/ml Oral Solution (called Amlodipine in this leaflet). Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal's or variant angina. In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.
What you need to know before you take it
e Amlodipine Oral Solution Do not take Amlodipine if: n you are allergic to Amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing n you have severe low blood pressure (hypotension) n you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body) n you suffer from heart failure after a heart attack. Warnings and precautions Talk to your doctor or pharmacist before taking Amlodipine. You should inform your doctor if you have or have had any of the following conditions: n recent heart attack n heart failure n severe increase in blood pressure (Hypertensive crisis) n liver disease n you are elderly and your dose needs to be increased. Children and adolescents Amlodipine has not been studied in children under the age of 6 years. Amlodipine should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3). For more information, talk to your doctor. Other medicines and Amlodipine Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Amlodipine may affect or be affected by other medicines, such as: n ketoconazole, itraconazole (anti-fungal medicines) n ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV) n rifampicin, erythromycin, clarithromycin (antibiotics) n hypericum perforatum (St. John's Wort) n verapamil, diltiazem (heart medicines) n dantrolene (infusion for severe body temperature abnormalities) n tacrolimus, sirolimus, temsirolimus and everolimus (medicine used to alter the way your immune system works) n simvastatin (a cholesterol lowering medicine) n ciclosporin (an immunosuppressant). Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Amlodipine with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine. Pregnancy n The safety of amlodipine in human pregnancy has not been established. n If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine. Breast-feeding n Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breastfeeding you must tell your doctor before taking Amlodipine. n Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Amlodipine may affect your ability to drive or use machines. If this medicine makes you feel sick, dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately. Amlodipine Oral Solution contains liquid maltitol and glycerol. n Amlodipine contains liquid maltitol (E965) (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. n Amlodipine contains glycerol (E422). This may cause headache, stomach upset and diarrhoea.
How to take it
Amlodipine Oral Solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine n This medicine contains 2 milligram (2mg) of Amlodipine in each 1 millilitre (1ml) of solution. n Take this medicine by mouth. n This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. See "Taking this medicine via NG or PEG tubes ". Do not use with a tube which is made of latex. There is further information in the SmPC, ask your doctor, pharmacist or nurse for this information. n Do NOT shake the bottle before use. n Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Amlodipine with grapefruit juice. Measuring your dose using the oral syringe provided Instructions for use n Open the bottle: press the cap and turn it anticlockwise (Figure 1). n Separate the syringe adaptor from the syringe and insert the adaptor securely into the bottle neck (Figure 2). n Take the syringe and put it in the adaptor opening (Figure 3).
n n
n n n n n
Turn the bottle upside down (Figure 4). Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A). Then push the plunger upward in order to remove any possible bubbles (Figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor. The top flat edge of the plunger should be in line with the graduation mark you are measuring to (Figure 4C).
Turn the bottle the right way up (Figure 5A). Remove the syringe from the adaptor (Figure 5B). Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine. Wash the syringe with water and let it dry before you use it again (Figure 6). Close the bottle with the plastic screw cap – leave the syringe adaptor in the bottle.
Taking this medicine via NG or PEG tubes
- The minimum volume of water that is required to flush tube sizes 8 Fr is 10mL and for tube sizes 10 Fr and above it is 20mL. 1. Ensure the tube is clear before taking the medicine 2. Flush the tube with the minimum volume of water required. 3. Administer the medicine with a suitable measuring device, which will be provided by your doctor, pharmacist or nurse. Do not use the oral syringe provided in the pack. 4. Flush the tube again with the minimum volume of water. C4ED1RBJ8
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Pharmacode:
749
Amlodipine 2mg/ml Oral Solution (UK)
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150 x 500mm
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N/A
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150 x 33mm
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Adults The usual initial dose of Amlodipine is 5mg (2.5ml) once daily. The dose can be increased to 10mg (5ml) once daily. Use in children and adolescents For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5mg (1.25ml) a day. The maximum recommended dose is 5mg (2.5ml) a day. It is important to keep taking this medicine. Do not wait until you have finished this medicine before seeing your doctor. If you take more Amlodipine than you should Taking too much medicine may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If the blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too much medicine. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake. If you forget to take Amlodipine n Do not worry. If you forget to take a dose, leave out that dose completely. Take your next dose at the right time. n Do not take a double dose to make up for a missed dose. If you stop taking Amlodipine Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Amlodipine can cause side effects although not everybody gets them. Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine. n sudden wheeziness, chest pain, shortness of breath or difficulty in breathing n swelling of eyelids, face or lips n swelling of the tongue and throat which causes great difficulty breathing n severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions n heart attack, abnormal heart beat n inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell. The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor. Very common: may affect more than 1 in 10 people n oedema (fluid retention) The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor. Common: affects 1 to 10 users in 100 n headache, dizziness, sleepiness (especially at the beginning of treatment) n palpitations (awareness of your heart beat), flushing n abdominal pain, feeling sick (nausea) n altered bowel habits, diarrhoea, constipation, indigestion n tiredness, weakness n visual disturbances, double vision n muscle cramps n ankle swelling. Other side-effects that have been reported include the following list. If any of these get serious, or if you notice any sideeffects not listed in this leaflet, please tell your doctor or pharmacist. Uncommon: affects 1 to 10 users in 1,000 n mood changes, anxiety, depression, sleeplessness n trembling, taste abnormalities, fainting n numbness or tingling sensation in your limbs; loss of pain sensation n ringing in the ears n low blood pressure n sneezing/running nose caused by inflammation of the lining of the nose (rhinitis) n cough n dry mouth, vomiting (being sick) n hair loss, increased sweating, itchy skin, red patches on skin, skin discoloration n disorder in passing urine, increased need to urinate at night, increased number of times of passing urine n inability to obtain an erection, discomfort or enlargement of the breasts in men n pain, feeling unwell n joint or muscle pain, back pain n weight increase or decrease. Rare: affects 1 to 10 users in 10,000 n confusion. Very rare: affects less than 1 user in 10,000 n decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage) n excess sugar in blood (hyperglycaemia) n a disorder of the nerves which can cause weakness, tingling or numbness n bleeding and swelling of the gums n abdominal bloating (gastritis) n abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests n increased muscle tension n inflammation of blood vessels, often with skin rash n sensitivity to light n disorders combining rigidity, tremor, and/or movement disorders. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
How to store it
Amlodipine Oral Solution Keep out of the sight and reach of children. Store in a refrigerator (2-8°C). Keep the bottle stored upright. Do not use after the expiry date (month, year) stated on the label and carton after EXP. The expiry date refers to the last day of that month. Use within 30 days of opening. Do not use Amlodipine if you notice anything wrong with the medicine. Talk to your pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
n n n n n n
Contents of the pack and other information
What Amlodipine Oral Solution contains n The active substance is amlodipine besilate. This medicine contains 2mg of amlodipine (as besilate) in each 1ml of solution. n The other ingredients are glycerol (E422), liquid maltitol (E965) and purified water. What Amlodipine Oral Solution looks like and contents of the pack Your medicine is a clear, pale straw coloured viscous liquid. It comes in a brown glass bottle holding 150ml of solution with a 5ml purple oral syringe and adaptor. Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. This medicinal product is authorised in the Member States of the EEA under the following names: UK – Amlodipine 2mg/ml Oral Solution France – Amlodipine Cevidra 2 mg/ml, solution buvable This leaflet was last revised in 09/2022
C4ED1RBJ8
0
10
20
30
40
50
UKL460
Pharmacode:
749
Amlodipine 2mg/ml Oral Solution (UK)
Dimensions:
150 x 500mm
EAN Code:
N/A
Folded Size:
150 x 33mm
No. of Colours: 1
YES
Page Number:
Steve
–
2 of 2
2mg/ml
New Item Code:
C4ED1RBJ8
Tabbed:
Pack Size:
150ml
Previous Item Code:
C4ED1RBJ7
MAIN BODY TEXT
150ml
Supplier Code:
N/A
Font Type:
Font Size:
Change Control No.:
CR-00565
Univers Roman Univers Bold
8pt
COLOURS
–
APPROVALS
Strength:
Date: Operator:
100
JOB SPECIFICATION
Date: Operator:
90
Keyline Ref:
Bottle Size:
29/09/22
80
Product Name:
PREFLIGHT VERSION:
–
70
JOB INFORMATION
ARTWORK VERSION:
3
60
Design Icon: N/A
Third Party Approval Name: Sign: Date: Regulatory Approval Name: Sign:
Print Colours:
BLACK
PANTONE 7474
PANTONE 265
Non-print Colours:
KEYLINE
Date:
Frequently asked questions about Amlodipine 2mg/ml Oral Solution
How do I take Amlodipine 2mg/ml Oral Solution?
Amlodipine 2mg/ml Oral Solution comes as oral solution containing 2mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Amlodipine 2mg/ml Oral Solution?
The active substance in Amlodipine 2mg/ml Oral Solution is amlodipine besilate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Amlodipine 2mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Amlodipine 2mg/ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: amlodipine besilate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal's) angina
4.2. Posology and method of administration
Posology
Adults
For both hypertension and angina the usual initial dose is 5 mg (2.5 ml) of amlodipine once daily which may be increased to a maximum dose of 10 mg (5 ml) depending on the individual patient's response.
In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.
Special populations
Elderly
Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and 5.2).
Hepatic impairment
Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.
Renal impairment
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Paediatric population
Children and adolescents with hypertension from 6 years to 17 years of age.
The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg (1.25 ml) once daily as a starting dose, up-titrated to 5 mg (2.5 ml) once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in paediatric patients (see sections 5.1 and 5.2).
Children under 6 years old
No data are available.
Method of administration
For oral administration
Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes only. For further information see section 6.6.
This product should not be shaken prior to administration.
This product should not be mixed with food or beverages before use.
4.3. Contraindications
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.
4.4. Special warnings and precautions for use
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 established. Amlodipine should therefore be initiated at the lower end of the dosing 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 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 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.
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on amlodipine
CYP3A4 inhibitors: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure. The clinical translation of these PK variations may be more pronounced in the elderly. Clinical monitoring and dose adjustment may thus be required.
CYP3A4 inducers: Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
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 properties.
Tacrolimus
There is a risk of increased tacrolimus blood levels when co-administered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Mechanistic Target of Rapamycin (mTOR) Inhibitors
mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates. Amlodipine is a weak CYP3A inhibitor. With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.
Ciclosporine
No drug interaction studies have been conducted with ciclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% - 40%) of ciclosporine were observed. Consideration should be given for monitoring ciclosporine levels in renal transplant patients on amlodipine, and ciclosporine dose reductions should be made as necessary.
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin or warfarin.
Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
4.6. Fertility, pregnancy and lactation
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 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 potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. Caution is recommended especially at the start of treatment.
4.8. Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
Tabulated list of adverse reactions
The following adverse reactions have been observed and reported during treatment with amlodipine 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class
Frequency
Adverse reactions
Blood and lymphatic system disorders
Very rare
Leukocytopenia, thrombocytopenia
Immune system disorders
Very rare
Allergic reactions
Metabolism and nutrition disorders
Very rare
Hyperglycaemia
Psychiatric disorders
Uncommon
Insomnia, mood changes (including anxiety), depression
Rare
Confusion
Nervous system disorders
Common
Somnolence, dizziness, headache (especially at the beginning of the treatment)
Uncommon
Tremor, dysgeusia, syncope, hypoesthesia, paresthesia
Very rare
Hypertonia, peripheral neuropathy
Not Known
Extrapyramidal disorder
Eye disorders
Common
Visual disturbance (including diplopia)
Ear and labyrinth disorders
Uncommon
Tinnitus
Cardiac disorders
Common
Palpitations
Uncommon
Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)
Very rare
Myocardial infarction
Vascular disorders
Common
Flushing
Uncommon
Hypotension
Very rare
Vasculitis
Respiratory, thoracic and mediastinal disorders
Common
Dyspnoea
Uncommon
Cough, rhinitis
Gastrointestinal disorders
Common
Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation)
Uncommon
Vomiting, dry mouth
Very rare
Pancreatitis, gastritis, gingival hyperplasia
Hepatobiliary disorders
Very rare
Hepatitis, jaundice, hepatic enzymes increased*
Skin and subcutaneous tissue disorders
Uncommon
Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria
Very rare
Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity
Not known
Toxic Epidermal Necrolysis
Musculoskeletal and connective tissue disorders
Common
Ankle swelling, muscle cramps
Uncommon
Arthralgia, myalgia, back pain
Renal and urinary disorders
Uncommon
Micturition disorder, nocturia, increased urinary frequency
Reproductive system and breast disorders
Uncommon
Impotence, gynaecomastia
General disorders and administration site conditions
Very common
Oedema
Common
Fatigue, asthenia
Uncommon
Chest pain, pain, malaise
Investigations
Uncommon
Weight increase, weight decrease
*mostly consistent with cholestasis
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professional are asked to report any suspected adverse reactions via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In humans experience with intentional overdose is limited
Symptoms
Available data suggest that gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
Treatment
Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- NORVASC 10 mg prescriptionAMLODIPINUM · taken by mouth
- NORVASC 5 mg prescriptionAMLODIPINUM · taken by mouth
- AMLODIPINA GEMAX PHARMA 5 mg prescriptionAMLODIPINUM · taken by mouth
- AMLODIPINA GEMAX PHARMA 10 mg prescriptionAMLODIPINUM · taken by mouth
- AMLODIPINA HELCOR 5 mg prescriptionAMLODIPINUM · taken by mouth
- AMLODIPINA HELCOR 10 mg prescriptionAMLODIPINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- AmlozekAmlodipinum · taken by mouth
- NorvascAmlodipinum · taken by mouth
- CardilopinAmlodipinum · taken by mouth
- TenoxAmlodipinum · taken by mouth
- NormodipineAmlodipinum · taken by mouth
- AldanAmlodipinum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Amlodipine 2mg/ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Amlodipine besilate
- Amlodipine 1 mg/ml Oral Suspension (PL 00427/0277)
- Amlodipine 10 mg Tablets
- Amlodipine 10mg tablets
- Amlodipine 10mg tablet
- Amlodipine 10mg tablets
- Amlodipine 1mg/ml Oral Solution
- Amlodipine 2.5mg Tablets
- Amlodipine 5 mg tablets
- Amlodipine 5mg tablets
- Amlodipine Thame 10mg/5ml Oral Solution
- Amlodipine Thame 5mg/5ml Oral Solution
- Amlodipine Zentiva 2.5 mg Tablets
- ISTIN 10 mg tablets
- Istin 5 mg Tablets