Amlodipine Viatris 5mg & 10mg Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 June 2023
File name
ie-pl-ie0650-v040G-v041-maht-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 12 June 2023
File name
ie-smpc-ie0650-v040G-v041-maht-clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 September 2022
File name
ie-pl-ie0650-v039-clean.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 05 August 2022
File name
ie-pl-ie0650-v038-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Updated on 05 August 2022
File name
ie-spc-ie0650-v038-clean.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 October 2021
File name
ie-PIL-ie0650-p001-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 02 March 2021
File name
ie-spc-ie0650-v037-clean Feb 21.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 March 2021
File name
ie-spc-ie0650-v037-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 February 2021
File name
ie-pil-ie0650-v037-clean-2.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 18 September 2018
File name
UPDATE ie-pl-2746ib012.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 17 September 2018
File name
UPDATE ie-spc-2746ib012.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 May 2018
File name
SmPC Amlodipine.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 May 2018
File name
PACKAGE LEAFLET Amlodipine.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 26 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 July 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
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).
|
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 |
Depression, mood changes (including anxiety), insomnia |
|
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 |
|
|
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
Exceptional cases of extrapyramidal syndrome have been reported.
Updated on 19 July 2016
File name
PIL_14920_95.pdf
Reasons for updating
- New PIL for new product
Updated on 19 July 2016
Reasons for updating
- Change of inactive ingredient
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
Updated on 19 July 2016
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
Updated on 15 December 2015
Reasons for updating
- Correction of spelling/typing errors
Updated on 11 December 2015
Reasons for updating
- Change to further information section
Updated on 10 December 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 December 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 30 September 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Therapeutic indications
section 4.2
Patients with hepatic impairment
Patients with renal impairment
section 4.3
4.3 Contraindications
hypersensitivity to the active substanc,...
section 4.4-headers
section 4.5
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.
Ciclosporin
No drug interaction studies have been conducted with ciclosporin and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable
trough concentration increases (average 0% - 40%) of ciclosporin were observed.
Consideration should be given for monitoring ciclosporin levels in renal transplant patients on amlodipine, and ciclosporin dose reductions should be made as necessary.
Pharmacokinetic properties
Absorption
The bioavailability of amlodipine is not affected by food intake.
Distribution
The volume of distribution is approximately 21 l/kg. In vitro studies have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins.
Biotransformation
Amlodipine is extensively metabolised by the liver to inactive metabolites with 10% of the parent compound and 60% of metabolites excreted in the urine
The terminal plasma elimination half life is about 35-50 hours and is consistent with once daily dosing.[RTQ1]
Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment. Patients with hepatic insufficiency have decreased clearance of amlodipine resulting in a longer half-life and an increase in AUC of approximately 40-60%.[RTQ2]
section 6.1 -uppercase to lower case
Updated on 29 September 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 29 September 2015
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 July 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 11 August 2014
Reasons for updating
- Introduction of new pack/pack size
Updated on 31 July 2014
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 February 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 3:The tablet can be divided into equal doses.
Section 4.3: · hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1
Section 4.4:Calcium channel blockers, including amlodipine,
Section 4.5:Effects of other medicinal products on amlodipine CYP3A4 inhibitors: Concomitant use of amlodipine
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.
Section 6.6:Any unused medicinal product or waste material should be disposed of in accordance with local requirementsUpdated on 15 February 2013
Reasons for updating
- Correction of spelling/typing errors
Updated on 14 February 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 01 August 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.1,1.2,4.4,4.5,4.6,4.7,4.8,4.9,5.1,5.2,5.3
Changes made in-line with an Article 30 referral
Updated on 17 April 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to further information section
- Addition of manufacturer
Updated on 17 April 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 February 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 February 2012
Reasons for updating
- Change to date of revision
- Change to product name
Updated on 21 June 2011
Reasons for updating
- Change to date of revision
- Change to product name
Updated on 20 June 2011
Reasons for updating
- Change to date of revision
- Change to product name
Updated on 22 April 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 March 2011
Reasons for updating
- New PIL for new product