Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets
- Name:
Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- 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: 06/10/20
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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 6 October 2020
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Inserted Text; Deleted Text
4.3 Contraindications
Crestor is contraindicated:
[..]
- in patients receiving concomitant combination of sofosbuvir/velpatasvir/voxilaprevir (see section 4.5)
[..]
4.5 Interaction with other medicinal products and other forms of interaction
[..]
If medicinal product is observed to increase rosuvastatin AUC less than 2-fold, the starting dose need not be decreased but caution should be taken if increasing the Crestor dose above 20 mg.
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Table 1. Effect of co-administered medicinal products on rosuvastatin exposure (AUC; in order of decreasing magnitude) from published clinical trials |
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2-fold or greater than 2-fold increase in AUC of rosuvastatin |
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Interacting drug dose regimen |
Rosuvastatin dose regimen |
Change in rosuvastatin AUC* |
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Sofosbuvir/velpatasvir/voxilaprevir (400 mg-100 mg-100 mg) + Voxilaprevir (100 mg) once daily for 15 days |
10 mg single dose |
7.4 -fold |
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[..] |
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Darolutamide 600 mg BID, 5 days |
5 mg, single dose |
5.2-fold |
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[..] |
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Less than 2-fold increase in AUC of rosuvastatin |
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Interacting drug dose regimen |
Rosuvastatin dose regimen |
Change in rosuvastatin AUC* |
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[..] |
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Decrease in AUC of rosuvastatin |
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Interacting drug dose regimen |
Rosuvastatin dose regimen |
Change in rosuvastatin AUC* |
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[..] |
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The following medical product/combinations did not have a clinically significant effect on the AUC ratio of rosuvastatin at coadministration: Aleglitazar 0.3 mg 7 days dosing; Fenofibrate 67 mg 7 days TID dosing; Fluconazole 200mg 11 days OD dosing; Fosamprenavir 700 mg/ritonavir 100 mg 8 days BID dosing; Ketoconazole 200 mg 7 days BID dosing; Rifampin 450 mg 7 days OD dosing; Silymarin 140 mg 5 days TID dosing.
[..]
4.8 Undesirable effects
[..]
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Updated on 6 October 2020 PIL
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 - how to report a side effect
- Change to section 6 - date of revision
Updated on 26 September 2019
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8 Undesirable effects, Lupus-like syndrome and Muscle rupture have been added as Rare side effects in Table 2. Adverse reactions based on data from clinical studies and post-marketing experience. Revision date has been updated form February 2019 to September 2019.
Updated on 26 September 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Added text
Deleted text
4) Possible side effects
…..
Also, stop taking Crestor and talk to your doctor immediately:
- If you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.
- If you experience muscle rupture.
- If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
If you experience muscle rupture.
…..
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):
- …..
- Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
This leaflet was last revised in February May 2019.
Updated on 6 February 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 6 February 2019
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Update to section 4.5 Update to table 1, effect of co-administrered medicinal products on rosuvastatin exposure
Update to section 7 – Change of MAH
Update to section 8 – Update to marketing authorisation numbers
Update to section 10 – Update to date of revision of text
Updated on 1 November 2018 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 1 November 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Update to section 4.8 – Update to adverse reaction reporting details.
Update to section 5.1 – Update to paediatric population section
Update to section 10 – Update to date of revision of text.
Updated on 4 May 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 3 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 3 October 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Improved presentation of PIL
Updated on 23 February 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 February 2017 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Correction of spelling/typing errors
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 4.1 – inclusion of indication and posology details regarding Homozygous familial hypercholesterolaemia
Change to section 4.3 – editorial and formatting changes
Change to section 4.4 – inclusion of paragraph regarding fusidic acid warning/contraindication
Change to section 4.5 - inclusion of paragraph regarding fusidic acid warning/contraindication
Change to section 5.1 – inclusion of summary of HYRDA study results
Minor editorial and formatting changes made throughout.
Updated on 22 February 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 4 January 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 August 2016 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 29 March 2016 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- 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 5.2 update to special population – age and sex
Section 10 date of revision
Updated on 8 April 2015 SPC
Reasons for updating
- 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 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 4.5 Drug interaction – new protease inhibitor information
Section 4.8 SE reproting – update to HPRA address
Section 10 – date of revision
Updated on 31 March 2015 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 7 November 2014 SPC
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 4.1 Treatment age group changed to 6 years of older for treatment of hypercholesterolaemia
- Section 4.2 Change to Paediatric population age range – 10years changed down to 6 years
- Section 4.4 Update to Paediatric population age range
- Section 5.1 Addition of information to paediatric studies
- Section 5.2 Update to Paediatric population
- Section 10 date of revision
Updated on 4 November 2014 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Change to warnings or special precautions for use
Updated on 4 August 2014 SPC
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 - how to report a side effect
- 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 addition of Fusidic acid interaction
- Section 4.5 addition of clopidogrel information and addition of fusidic acid information
- Section 4.8 updating AE address for IMB
- Section 10 date of revision
Updated on 29 July 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 4 February 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.8 addition of Peripheral neuropathy and change in frequency of side effect
- Section 4.8 section 4.8 AE reporting statement
- Section 5.1 updating of subheading (improving readability)
- Section 10 date of revision
Updated on 29 January 2014 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 19 April 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- 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 4.2 addition of genetic polymorphism
- Section 4.2 addition on concomitant therapy
- Section 4.3 clarification of immune-mediated necrotising myopathy occurrence
- Section 4.3 exposure effects during use with protease inhibitors
- Section 4.5 effect of co-administered medicinal products on rosuvastatin clarified.
- Section 4.5 explanations on interactions requiring rosuvastatin dose adjustments
- Section 4.8 adverse events table re-formatted and section update
- Section 5.2 addition of information related to genetic polymorphism
- Section 6.4 storage precautions clarified regarding storage to prevent ingress of moisture
- Section 6.6 clarification of disposal mechanism
- Section 10 Updated date of revision
Updated on 9 April 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
- Change of special precautions for disposal
- Change of distributor details
- Improved electronic presentation
Updated on 17 September 2012 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Information re necrotizing myopathy added.
Update to Diabetes Mellitus information.
Section 4.8
Footnote 1 re diabetes mellitus updated.
Post Marketing Experience updated re necrotizing myopathy.
Section 10
Date of revision amended to 5th September 2012
Updated on 11 September 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 3 May 2012 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Addition of imposed amended wording for new onset diabetes mellitus.
Section 4.8
Addition of imposed wording for gynaecomastia.
Section 10
Date of revision amended to 27th April 2012.
Updated on 1 May 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 5 January 2012 SPC
Reasons for updating
- Change to joint SPC covering all presentations
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 and 4.4 - Addition of reference ‘(see Section 4.3)'
Section 4.8 - Add Tendon disorder
Section 10 Date of revision changed to 20th December 2011
Updated on 22 December 2011 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to marketing authorisation holder
Updated on 8 October 2010 PIL
Reasons for updating
- Addition of manufacturer
Updated on 15 June 2010 PIL
Reasons for updating
- Change of manufacturer
Updated on 2 June 2010 SPC
Reasons for updating
- Joint SPC superseded by SPCs for individual presentations
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 4.1
Includes paediatric information.
Additional text:
Prevention of Cardiovascular Events
Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors.
Section 4.2
Additional text:
Crestor may be given at any time of day, with or without food.
Additional text:
Prevention of Cardiovascular Events
In the cardiovascular events risk reduction study, the dose used was 20 mg daily (see Section 5.1).
Section 4.2 includes Paediatric information
Section 4.4
New indication for use in adult patients.
Additional text
Interstitial lung disease
Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see Section 4.8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Diabetes Mellitus
In patients with fasting glucose 5.6 to 6.9 mmol/L, treatment with rosuvastatin has been associated with an increased risk of diabetes mellitus (see Section 4.8).
Section 4.4 includes Paediatric information
Section 4.8
New indication for use in adult patients.
Additional side effect:
Endocrine disorders
Common: diabetes mellitus1
Additional adverse events under heading ‘Post marketing Experience
Section 4.8 includes Paediatric information
Section 5.1
Deletion of text:
Rosuvastatin has not been proven to prevent the associated complications of lipid abnormalities, such as coronary heart disease as mortality and morbidity studies with Crestor have not yet been completed.
Additional text – JUPITER study
Section 5.1 includes Paediatric information
Section 5.2
Additional text
Special populations:
Age and sex: There was no clinically relevant effect of age or sex on the pharmacokinetics of rosuvastatin in adults. The pharmacokinetics of rosuvastatin in children and adolescents with heterozygous familial hypercholesterolaemia was similar to that of adult volunteers (see “Paediatric population” below).
Paediatric population: The pharmacokinetic parameters in paediatric patients with heterozygous familial hypercholesterolaemia aged 10 to 17 years have not been fully characterised. A small pharmacokinetic study with rosuvastatin (given as tablets) in 18 paediatric patients demonstrated that exposure in paediatric patients appears comparable to exposure in adult patients. In addition, the results indicate that a large deviation from dose proportionality is not expected.
Section 10
Revision date of text: 14 May 2010
Section 5.2
Updated on 25 May 2010 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 16 April 2009 PIL
Reasons for updating
- Change to appearance of the medicine
- Change to MA holder contact details
Updated on 15 April 2009 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4
Addition of paragraph on Lactose Intolerance:
Lactose intolerance
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Section 5.3
Replacement of paragraph:
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity potential. Specific tests for effects on hERG have not been evaluated. Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels were as follows: In repeated-dose toxicity studies histopathologic liver changes likely due to the pharmacologic action of rosuvastatin were observed in mouse, rat, and to a lesser extent with effects in the gall bladder in dogs, but not in monkeys. In addition, testicular toxicity was observed in monkeys and dogs at higher dosages. Reproductive toxicity was evident in rats, with reduced litter sizes, litter weight and pup survival observed at maternally toxic doses, where systemic exposures were several times above the therapeutic exposure level.
Section 10
Change of date:
31st March 2009Updated on 7 August 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 1 August 2008 SPC
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
1st paragraph new text added : Not known (cannot be estimated from the available data).
Gastrointestinal disorders: Not known: diarrhoea.
Updated on 2 July 2008 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 20 March 2008 PIL
Reasons for updating
- Change of inactive ingredient
- Change to improve clarity and readability
- Change to date of revision
Updated on 19 March 2008 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 6 September 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 3 September 2007 SPC
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 5.1 - Pharmacodynamic properties
- 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
4.4 Special warnings and special precautions for use
Addition of text after the Race paragraph
Protease inhibitors
The concomitant use with protease inhibitors is not recommended (see Section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Addition of text after Gemfibrozil and other lipid-lowering products paragraph
Protease inhibitors: Although the exact mechanism of interaction is unknown, concomitant protease inhibitor use may strongly increase rosuvastatin exposure. In a pharmacokinetic study, co-administration of 20 mg rosuvastatin and a combination product of two protease inhibitors (400 mg lopinavir / 100 mg ritonavir) in healthy volunteers was associated with an approximately two-fold and five-fold increase in rosuvastatin steady-state AUC(0-24) and Cmax respectively. Therefore, concomitant use of rosuvastatin in HIV patients receiving protease inhibitors is not recommended (see also Section 4.4).
5.1 Pharmacodynamic properties
Addition of text last paragraph in section
In a multi-centre, double-blind, placebo-controlled clinical study (METEOR), 984 patients between 45 and 70 years of age and at low risk for coronary heart disease (defined as Framingham risk <10% over 10 years), with a mean LDL-C of 4.0 mmol/l (154.5 mg/dL), but with subclinical atherosclerosis (detected by Carotid Intima Media Thickness) were randomised to 40 mg rosuvastatin once daily or placebo for 2 years. Rosuvastatin significantly slowed the rate of progression of the maximum CIMT for the 12 carotid artery sites compared to placebo by -0.0145 mm/year [95% confidence interval -0.0196, -0.0093; p<0.0001]. The change from baseline was -0.0014 mm/year (-0.12%/year (non-significant)) for rosuvastatin compared to a progression of +0.0131 mm/year (1.12%/year (p<0.0001)) for placebo. No direct correlation between CIMT decrease and reduction of the risk of cardiovascular events has yet been demonstrated. The population studied in METEOR is low risk for coronary heart disease and does not represent the target population of Crestor 40mg. The 40mg dose should only be prescribed in patients with severe hypercholesterolaemia at high cardiovascular risk (see Section 4.2).
10 Date of revision of the text
16th August 2007
Updated on 19 February 2007 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 27 June 2006 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 May 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 6 April 2006 SPC
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 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 January 2006 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 December 2005 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 December 2005 PIL
Reasons for updating
- New PIL for new product