Agerdex 1mg Film Coated Tablets

  • Name:

    Agerdex 1mg Film Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Anastrozole

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/04/20

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Summary of Product Characteristics last updated on medicines.ie: 29/4/2020

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Gerard Laboratories

Gerard Laboratories

Company Products

Medicine NameActive Ingredients
Medicine Name Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Active Ingredients Abacavir hydrochloride, Lamivudine
Medicine Name Agerdex 1mg Film Coated Tablets Active Ingredients Anastrozole
Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atazanavir Mylan 300 mg hard capsules Active Ingredients Atazanavir sulfate
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azacitidine Mylan 25 mg/mL powder for suspension for injection Active Ingredients azacitidine
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
1 - 0 of 117 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 29 April 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 April 2020

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 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Updated on 11 October 2016

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 October 2016 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life
30 48 months.

Updated on 26 August 2014 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 2  - 'with known effect' added
section 4.3 - hypersensitivity to anastrazole - wording changed
section 4.4 - spelling of estorgen chanhed to oestrogen, caps lock removed from Anaztrazole, luteinizing changed to luteinising
section 4.5 - oestrogen spelling correction
section 4.8 - refer to table 1
section 5.1 - Hormone Antagonists and Related Agents Aromatase added instead of 'Enzyme' and spelling of estorgen chanhed to oestrogen, caps lock removed from Anaztrazole
section 5.2 - underline added on sub headings
section 10 - Date of revision changed

 

 

Updated on 21 August 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 August 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of manufacturer

Updated on 20 August 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of manufacturer

Updated on 25 September 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration

Updated on 25 September 2012 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Harmonisation of the product information in line with Article 30 Referral.

Sections 4 & 5 updated.
New text added.

Updated on 10 August 2011 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC updated to remove Patented Indication

4.1            Therapeutic indications

Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.

Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.



5.1            Pharmacodynamic properties

Pharmacotherapeutic group: Enzyme inhibitors

ATC Code: L02B G03

Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, oestradiol is produced primarily by the conversion of androstenedione to oestrone through the aromatase enzyme complex in peripheral tissues. Oestrone is subsequently converted to oestradiol. Lowering circulating oestradiol levels has been shown to produce a beneficial effect in women with breast cancer.

In postmenopausal women, a daily dose of 1 mg of anastrozole produced oestradiol suppression of greater than 80% using a highly sensitive assay.

Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity.

Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore not needed.

Primary adjuvant treatment of early breast cancer

In aA large phase III study showed that anastrozole is an effective treatment conducted in 9366 for postmenopausal women with operable breast cancer treated for 5 years, anastrozole was shown to be statistically superior to tamoxifen in disease free survival. A greater magnitude of benefit was observed for disease-free survival in favour of anastrozole versus tamoxifen for the prospectively defined hormone receptor positive population Anastrozole was statistically superior to tamoxifen in time to recurrence. The difference was of even greater magnitude than in disease free survival for both the Intention To Treat (ITT) population and hormone receptor positive population. Anastrozole was statistically superior to tamoxifen in terms of time to distant recurrence. The incidence of contralateral breast cancer was statistically reduced for anastrozole compared to tamoxifen. Following 5 years of therapy, anastrozole is at least as effective as tamoxifen in terms of overall survival. However, due to low death rates, additional follow-up is required to determine more precisely the long-term survival for anastrozole relative to tamoxifen. With 68 months median follow-up, patients in the ATAC study have not been followed up for sufficient time after 5 years of treatment, to enable a comparison of long-term post treatment effects of anastrozole relative to tamoxifen.


ATAC endpoint summary: 5- year treatment completion analysis

Efficacy endpoints

Number of events (frequency)

Intention to treat population

Hormone-receptor-positive tumour status

anastrozole (n=3125)

tamoxifen (n=3116)

anastrozole (n=2618)

tamoxifen (n=2598)

Disease-free survivala

575 (18.4)

651 (20.9)

424 (16.2)

497 (19.1)

Hazard ratio

0.87

0.83

2-sided 95% CI

0.78 to 0.97

 

0.73 to 0.94

p-value

0.0127

 

0.0049

Distant disease-free survivalb

500 (16.0)

530 (17.0)

370 (14.1)

394 (15.2)

Hazard ratio

0.94

 

0.93

2-sided 95% CI

0.83 to 1.06

 

0.80 to 1.07

p-value

0.2850

 

0.2838

Time to recurrencec

402 (12.9)

498 (16.0)

282 (10.8)

370 (14.2)

Hazard ratio

0.79

 

0.74

2-sided 95% CI

0.70 to 0.90

 

0.64 to 0.87

p-value

0.0005

 

0.0002

Time to distant recurrenced

324 (10.4)

375 (12.0)

226 (8.6)

265 (10.2)

Hazard ratio

0.86

 

0.84

2-sided 95% CI

0.74 to 0.99

 

0.70 to 1.00

p-value

0.0427

 

0.0559

Contralateral breast primary

35 (1.1)

59 (1.9)

26 (1.0)

54 (2.1)

Odds ratio

0.59

 

0.47

2-sided 95% CI

0.39 to 0.89

 

0.30 to 0.76

p-value

0.0131

 

0.0018

Overall survivale

411 (13.2)

420 (13.5)

296 (11.3)

301 (11.6)

Hazard ratio

0.97

 

0.97

2-sided 95% CI

0.85 to 1.12

 

0.83 to 1.14

p-value

0.7142

 

0.7339

a  Disease-free survival includes all recurrence events and is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death (for any reason).

b  Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).

c  Time to recurrence is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death due to breast cancer.

d  Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.

e  Number (%) of patients who had died.

As with all treatment decisions, women with breast cancer and their physician should assess the relative benefits and risks of the treatment.

 

When anastrozole and tamoxifen were co-administered, the efficacy and safety were similar to tamoxifen when given alone, irrespective of hormone receptor status. The exact mechanism of this is not yet clear. It is not believed to be due to a reduction in the degree of estradiol suppression produced by anastrozole.

 

Adjuvant treatment of early breast cancer for patients being treated with adjuvant tamoxifen

In aA phase III trial (ABCSG 8) conducted in 2579 showed that anastrozole is an effective treatment of hormone receptor positive early breast in postmenopausal women with hormone receptor positive early breast cancer who had received surgery with or without radiotherapy and no chemotherapy, switching to anastrozole after 2 years adjuvant treatment with tamoxifen was statistically superior in disease-free survival when compared to remaining on tamoxifen, after a median follow-up of 24 months.


Time to any recurrence, time to local or distant recurrence and time to distant recurrence confirmed a statistical advantage for anastrozole, consistent with the results of disease-free survival. The incidence of contralateral breast cancer was very low in the two treatment arms with a numerical advantage for anastrozole. Overall survival was similar for the two treatment groups.

ABCSG 8 trial endpoint and results summary

Efficacy endpoints

Number of events (frequency)

 

anastrozole (n=1297)

tamoxifen (n=1282)

Disease-free survival

65 (5.0)

93 (7.3)

Hazard ratio

0.67

 

2-sided 95% CI

0.49 to 0.92

 

p-value

0.014

 

Time to any recurrence

36 (2.8)

66 (5.1)

Hazard ratio

0.53

 

2-sided 95% CI

0.35 to 0.79

 

p-value

0.002

 

Time to local or distant recurrence

29 (2.2)

51 (4.0)

Hazard ratio

0.55

 

2-sided 95% CI

0.35 to 0.87

 

p-value

0.011

 

Time to distant recurrence

22 (1.7)

41 (3.2)

Hazard ratio

0.52

 

2-sided 95% CI

0.31 to 0.88

 

p-value

0.015

 

New contralateral breast cancer

7 (0.5)

15 (1.2)

Odds ratio

0.46

 

2-sided 95% CI

0.19 to 1.13

 

p-value

0.090

 

Overall survival

43(3.3)

45 (3.5)

Hazard ratio

0.96

 

2-sided 95% CI

0.63 to 1.46

 

p-value

0.840

 


Two further similar trials (GABG/ARNO 95 and ITA), in one of which patients had received surgery and chemotherapy, as well as a combined analysis of ABCSG 8 and GABG/ARNO 95, supported these results.
The anastrozole safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal women with hormone receptor positive early breast cancer.

Updated on 6 July 2011 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 February 2011 PIL

Reasons for updating

  • New PIL for medicines.ie