Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets

  • Name:

    Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Rosuvastatin Calcium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/09/19

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Summary of Product Characteristics last updated on medicines.ie: 26/9/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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Medicine Name Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen Active Ingredients Exenatide
Medicine Name Casodex 50mg Tablets Active Ingredients Bicalutamide
Medicine Name Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets Active Ingredients Rosuvastatin Calcium
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Medicine Name Forxiga 10 mg Film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name Forxiga 5 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name IMFINZI 50 mg/mL concentrate for solution for infusion Active Ingredients durvalumab
Medicine Name IRESSA 250 mg film-coated tablets Active Ingredients gefitinib
Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Komboglyze 2.5mg-850mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Losec MUPS 10mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
Medicine Name Losec MUPS 20mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
1 - 0 of 56 items.Total: Infinity pages

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 26 September 2019 SmPC

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

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 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

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 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 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 - 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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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

 

 

 

 

 

 

 

 

 

 

 

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 SmPC

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 2009

Updated on 7 August 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 August 2008 SmPC

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

Section 4.8
1st paragraph new text added : Not known (cannot be estimated from the available data).
 
Last paragraph under the heading post marketing experience following new text added:
G
astrointestinal disorders: Not known: diarrhoea.
Skin and subcutaneous tissue disorders: Not known: Stevens-Johnson syndrome.
 
Section 10
Date updated to 17th July 2008

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 SmPC

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

Section 6.1 Change from Glycerol Triacetate to Triacetin
 
Section 6.4 Change in wording for storage conditions
 
Section 6.5 Change wording from HDPE bottles to HDPE containers

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 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 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 SmPC

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 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 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 SmPC

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 SmPC

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