ADIZEM-XL Capsules
- Name:
ADIZEM-XL Capsules
- Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/03/17
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 23/5/2017
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Company Products
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 23 May 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 May 2017 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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
$0Text from the SPC: in italics$0$0Current text: in black$0$0Updated text: in red$0$0Added text: in bold$0$0Removed text: crossed through$0$0$0$0Section 2:$0More detail has been added to the description of the capsule.$0$0$0$0$0Each capsule contains 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride.$0$0For a full list of excipients, see section 6.1.$0$0$0$0$0$0Each prolonged release capsule contains 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride.$0$0For a the full list of excipients, see section 6.1.$0$0$0$0$0$0Section 3:$0$0The length of the capsules has been added to their descriptions.$0$0$0$0$0ADIZEM-XL capsules 120 mg are size 3, hard gelatin capsules with a pale pink body and a navy blue cap, marked DCR 120.$0$0ADIZEM-XL capsules 180 mg are size 2, hard gelatin capsules with a dark pink body and a royal blue cap, marked DCR 180.$0$0ADIZEM-XL capsules 240 mg are size 1, hard gelatin capsules with a dark red body and a blue cap, marked DCR 240.$0$0ADIZEM-XL capsules 300 mg are size 0, hard gelatin capsules with a dark maroon body and a pale blue cap, marked DCR 300.$0$0$0$0$0$0ADIZEM-XL capsules 120 mg are size 3, hard gelatin capsules, approximately 16 mm long with a pale pink body and a navy blue cap, marked 'DCR' 120.$0$0ADIZEM-XL capsules 180 mg are size 2, hard gelatin capsules, approximately 18 mm long with a dark pink body and a royal blue cap, marked 'DCR' 180.$0$0ADIZEM-XL capsules 240 mg are size 1, hard gelatin capsules, approximately 19 mm long with a dark red body and a blue cap, marked 'DCR' 240.$0$0ADIZEM-XL capsules 300 mg are size 0, hard gelatin capsules approximately 22 mm long with a dark maroon body and a pale blue cap, marked 'DCR' 300.$0$0$0$0$0Section 4.1:$0$0'ADIZEM-XL capsules are indicated for use in adults only' has been added.$0$0$0$0$0Section 4.2:$0$0The subtitle 'Posology' has been added to the start of this section.$0$0$0$0$0Information regarding method of administration has been moved to the end of this section:$0$0Oral. The capsules should be swallowed whole and not chewed.$0$0$0$0$0Oral. The capsules should be swallowed whole and not chewed.$0$0Method of administration$0$0Oral.$0$0To be taken at 24 hour intervals.$0$0The capsules should be swallowed whole and not chewed.$0$0$0$0$0'Paediatric population' has replaced 'Children' as a subtitle.$0$0$0$0$0Section 4.5:$0$0Information has been added regarding the effect of diltiazem on serum levels of phenytoin.$0$0$0$0$0Phenytoin: serum levels of diltiazem may be decreased by concomitant usage of CYP3A4 inducers.$0$0$0$0$0Phenytoin: serum levels of diltiazem may be decreased by concomitant usage of CYP3A4 inducers. Diltiazem may increase serum levels of phenytoin.$0$0$0$0$0Section 4.6:$0$0The title of this section has been updated to 'Fertility, pregnancy and lactation'.$0$0$0$0$0The subtitles 'Pregnancy' and 'Breast Feeding' have been added.$0$0$0$0$0A reference to section 5.3 has been added:$0$0$0$0$0Diltiazem has been shown to have reproductive toxicity in certain animal species (rat, mice, rabbit).$0$0$0$0$0Diltiazem has been shown to have reproductive toxicity in certain animal species (rat, mice, rabbit - see section 5.3).$0$0$0$0$0Section 4.8:$0$0'Hypersensitivity' has been added as an adverse event under 'Immune system disorders' with a frequency of uncommon.$0$0$0$0$0'Gastrointestinal disorder' has been removed.$0$0$0$0$0'Pruritus' has been added as an adverse event under 'Skin and subcutaneous tissue disorders' with a frequency of common.$0$0$0$0$0Information has been added regarding the reporting of suspected adverse reactions:$0$0$0$0$0Reporting of suspected adverse reactions$0$0Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continues monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacoviglance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie$0$0$0$0$0Section 4.9:$0$0Information regarding the symptoms/effects of overdose has been reworded.$0$0Information regarding treatment in a hospital has been updated.$0$0Information regarding proposed corrective treatments has been added.$0$0Information regarding the correction of hypotension has been removed.$0$0$0$0$0The clinical symptoms of acute intoxication may include pronounced hypotension or even collapse, and sinus bradycardia with or without atrioventricular conduction defects.$0$0The patient should be closely monitored in hospital to exclude arrhythmias or atrioventricular conduction defects. Gastric lavage and osmotic diuresis should be undertaken when considered appropriate.$0$0Symptomatic bradycardia and high grade atrioventricular block may respond to atropine, isoprenaline or occasionally temporary cardiac pacing.$0$0Hypotension may require correction with plasma volume expanders, intravenous calcium gluconate and positive inotropic agents. The formulation employs a prolonged release system which will continue to release diltiazem for some hours.$0$0$0$0$0$0The clinical symptoms effects of acute overdose can involve intoxication may include pronounced hypotension or even possibly leading to collapse , and sinus bradycardia with or without isorhythmic dissociation and atrioventricular conduction disturbances defects.$0$0The patient should be closely monitored in hospital to exclude arrhythmias or atrioventricular conduction defects. Treatment in a hospital setting will include gastric lavage and/or osmotic diuresis should be undertaken when considered appropriate. Conduction disturbances may be managed by temporary cardiac pacing.$0$0Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.$0$0Symptomatic bradycardia and high grade atrioventricular block may respond to atropine and isoprenaline or occasionally temporary cardiac pacing.$0$0Hypotension may require correction with plasma volume expanders, intravenous calcium gluconate and positive inotropic agents. The formulation employs a prolonged release system which will continue to release diltiazem for some hours.$0$0$0$0$0Section 5.2:$0$0The subtitles 'Absorption', 'Biotransformation', 'Elimination' and 'Linearity/non-linearity' have been added.$0$0Information has been added about biotransformation, elimination and linearity/non-linearity.$0$0$0$0$0An oral dose of diltiazem is almost completely absorbed. Despite this, diltiazem has a low bioavailability owing to hepatic first-pass metabolism. Diltiazem is metabolised extensively and only 1.0-3.0% of the dose is excreted in urine as metabolised diltiazem.$0$0The release of the drug has been prolonged in the capsules by special pharmaceutical technology. The high peak concentrations of the absorption phase have been eliminated. This allows the capsules to be administered once daily.$0$0$0$0$0$0Absorption$0$0An oral dose of diltiazem is almost completely absorbed. Despite this, diltiazem has a low bioavailability owing to hepatic first-pass metabolism. $0$0$0$0$0Biotransformation$0$0Diltiazem is extensively metabolised by the liver. The desacetyl metabolite is considered to be approximately 25% to 50% as potent a coronary vasodilator as diltiazem and is present in plasma at concentrations of 10% to 20% of parent. extensively and only 1.0-3.0% of the dose is excreted in urine as metabolised diltiazem.$0$0$0$0$0Elimination$0$0The mean elimination half life of diltiazem is around 4 hours, but this is extended from prolonged-release formulations. Mean plasma concentrations in elderly subjects and patients with renal and hepatic insufficiency are higher than in young subjects.$0$0$0$0$0Linearity/non-linearity$0$0This process of first-pass metabolism process is saturable at higher doses of the drug. This results in a non-linear accumulation and higher blood concentrations at steady state than would be anticipated from those following a single dose. From modified-release preparations, the prolonged delivery of diltiazem can significantly reduce the degree of non-linearity associated with conventional formulations.$0$0The release of the drug has been prolonged in the capsules by special pharmaceutical technology. The high peak concentrations of the absorption phase have been eliminated. This allows the capsules to be administered once daily.$0$0$0$0$0Section 5.3:$0$0Information has been added regarding genotoxicity, carcinogenicity, reproductive and developmental toxicity.$0$0$0$0$0There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.$0$0$0$0$0There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC. $0$0Genotoxicity and Carcinogenicity$0$0Diltiazem was not genotoxic when tested in vitro in two bacterial mutation tests with and without metabolic activation, and in two clastogenicity assays.$0$0Diltiazem was not carcinogenic in two long term carcinogenicity studies, in rats and mice.$0$0$0$0$0Reproductive and developmental toxicity$0$0Diltiazem was toxic to the developing embryo in studies in mice, rats and rabbits when dosed to the mother at critical stages during organ development. Skeletal malformations occurred in the limbs, tail and ribs of all three species.$0$0Diltiazem had an adverse effect upon male fertility in rats, with decreases in sperm count, sperm motility and epididymal weight, although these effects were reversible on cessation of dosing.$0$0$0$0$0Section 10:$0$0The date of revision of the text has been updated to 21 March 2017.$0$0$0$0
Updated on 28 March 2017 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 8 November 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- 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 2 Qualatitative and Quantitative Composition
Deleted: Excipients also contains soya lecithin, trace quantaties per capsule
Section 4.3 Contra-indications
Deleted: Peanut or soya allergies
Section 6.1 List of excipients
Deleted: Soya lecithin
2-ethoxyethanol
Dimeticone changed to Simeticone
Deleted: Excipients also contains soya lecithin, trace quantaties per capsule
Section 4.3 Contra-indications
Deleted: Peanut or soya allergies
Section 6.1 List of excipients
Deleted: Soya lecithin
2-ethoxyethanol
Dimeticone changed to Simeticone
Updated on 7 November 2011 PIL
Reasons for updating
- Change of inactive ingredient
- Change of contraindications
- Change to date of revision
Updated on 26 October 2011 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 7. Marketing Authorisation Holder
Now Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8. Marketing Authorisation Number
Now reads PA 1688/1/4-7
Now Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8. Marketing Authorisation Number
Now reads PA 1688/1/4-7
Updated on 25 October 2011 PIL
Reasons for updating
- Change of licence holder
Updated on 21 July 2011 SmPC
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.3 Contra-indications, 4.4 Speical warnings and special precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.6 Pregnancy and lactation, 4.7 Effects on ability to drive and use machines, Section 4.8 Undersibale effects - have all been re-written
Updated on 23 June 2011 PIL
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 7 June 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Section 2
"Excipients : also contians soya lecithin, trace quantities per capsule" has been added
Section 6.1 Capsule shell
"Iron oxide black (E172) (180 mg capsule only)" has been added
"Iron oxide yellow (E172) (240 mg capsule only)" has been added
"Excipients : also contians soya lecithin, trace quantities per capsule" has been added
Section 6.1 Capsule shell
"Iron oxide black (E172) (180 mg capsule only)" has been added
"Iron oxide yellow (E172) (240 mg capsule only)" has been added
Updated on 17 November 2010 PIL
Reasons for updating
- Change of inactive ingredient
- Change to storage instructions
- Change to further information section
Updated on 8 June 2010 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 May 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 10 February 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 25 January 2010 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.3: Addition of contraindications in patients with peanut or soya allergies
4.6 Change of warning from 'Not recommended' in pregnancy to a contraindication in pregnant women or women of child bearing potential. Use in nursing mothers remains not recommended.
4.7 Advice changed from 'None know' to include text informing patients that some side effects of the tablets (such as dizziness) may impair their ability to drive.
4.8 Frequency of adverse events catergorised as common or uncommon. Adverse event 'rash' deleted.
4.6 Change of warning from 'Not recommended' in pregnancy to a contraindication in pregnant women or women of child bearing potential. Use in nursing mothers remains not recommended.
4.7 Advice changed from 'None know' to include text informing patients that some side effects of the tablets (such as dizziness) may impair their ability to drive.
4.8 Frequency of adverse events catergorised as common or uncommon. Adverse event 'rash' deleted.
Updated on 8 December 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 4 March 2009 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 January 2009 PIL
Reasons for updating
- Change of contraindications
- Change to date of revision
- Change to side-effects
- Change to drug interactions
Updated on 5 January 2009 SmPC
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
- 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
Section 4.4 Isolated cases of liver transaminases paragraph added as per CCDS
Section 4.5 - sectrion rewritten in line with CCDS
Section 4.8 rewritten in line with CCDS and classified by body system
Updated on 18 August 2008 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 6.3 - Shelife life changed to two years
Section 10 - Revision date updated
Updated on 2 March 2007 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 2 March 2007 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Sections 4.2 and 4.5 updated to include warnings and interactions with alcohol
Updated on 2 June 2005 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 May 2005 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 25 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)