Nolvadex D 20mg Tablets

  • Name:

    Nolvadex D 20mg Tablets

  • Company:
    info
  • Active Ingredients:

    Tamoxifen Citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/08/17

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Summary of Product Characteristics last updated on medicines.ie: 1/3/2017
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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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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 23 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 23 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2017 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 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the 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 4.2 – QRD related changes, older to elderly

Section 4.5 – removal of pharmacokinetic interaction with CYP2D6 inhibitors (repititve) – related to QRD updates

Section 4.8 – amendment of adverse events table and text underneath the table, QRD related changes

Section 6.6 – wording related to disposal of unused product – QRD related changes

Section 9 – QRD related changes

Section 10 – updated date of revision

Updated on 1 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 9 June 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

section 2 updated in line with QRD

section 4.1 updated in line with QRD

section 4.2 updated in line with QRD

section 4.3 updated in line with QRD

section 4.4 updated in line with QRD

section 4.6 updated in line with QRD

section 4.7 updated in line with QRD

section 4.8 updated in line with QRD

section 4.8 addition of radiation recall as a very rare side effect (in table and as additional text in section 4.8)

section 5.1 updated in line with QRD

section 6.6 updated in line with QRD

section 9 updated in line with QRD

section 10 updated date of revision

Updated on 4 June 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 12 August 2013 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 To include fatigue as an Adverse Event
Section 10 Updated date of revision

Updated on 8 August 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 February 2013 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

-       icrovasvascular flap complications – Section 4.4 & 4.8

-       Sensory disturbance  - Section 4.8

Updated on 29 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 16 March 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 November 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • 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

 

Table 1


Common
        Musculoskeletal and connective tissue

 

Addition of:      Myalgia

 

Rare

 

Addition of:      Vaginal polyps

 

Very Rare

 

Addion of:       Skin and subcutaneous tissue                    ●  Cutaneous lupus erythematosusb

 

                     Congenital, familial and genetic disorders     ●  Porphyria cutanea tardab

 

 

Addition of footer

 
     The event was not observed in other major clinical studies. The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate (based on 3/X, where X represents the total sample size of 13,357 patients in the major clinical studies). This is calculated as 3/13,357 which equates to a frequency category of ‘very rare’.

 

 

Paragraphs inserted before last paragraph.

 

Vaginal polyps have rarely been observed in women receiving Nolvadex.

 

Cutaneous lupus erythematosus has been observed very-rarely in patients receiving Nolvadex.

 

Porphyria cutanea tarda has been observed very-rarely in patients receiving Nolvadex.

 


Secton 6.4

 

Special precautions for storage

Text updated to:            Store in the original container in order to protect from light.


 

Section 10

 

Date of Revision changed to 11th November 2011

Updated on 15 November 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 21 October 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to dosage and administration

Updated on 8 August 2011 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 5.1 - 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 4.4

 

Text Added

 

In the literature it has been shown that CYP2D6 poor metabolisers have a lowered plasma level of endoxifen, one of the most important active metabolites of tamoxifen (see section 5.2).

 

Concomitant medications that inhibit CYP2D6 may lead to reduced concentrations of the active metabolite endoxifen. Therefore, potent inhibitors of CYP2D6 (e.g. paroxetine, fluoxetine, quinidine, cinacalcet or bupropion) should whenever possible be avoided during tamoxifen treatment (see section 4.5 and 5.2).

 

Section 4.5


Text Removed

 

The relevance of this to clinical practice is not known.

 

Text Added

 

Pharmacokinetic interaction with CYP2D6 inhibitors, showing a 65-75% reduction in plasma levels of one of the more active forms of the drug, i.e. endoxifen, has been reported in the literature. Reduced efficacy of tamoxifen has been reported with concomitant usage of some SSRI antidepressants (e.g. paroxetine) in some studies. As a reduced effect of tamoxifen cannot be excluded, co-administration with potent CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine, cinacalcet or bupropion) should whenever possible be avoided (see section 4.4 and 5.2).

 

Section 4.8

 

Text and Table Added

 

Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal women patients with operable breast cancer treated for 5 years and unless specified, no account was taken of the frequency within the comparative treatment group or whether the investigator considered it to be related to study medication.

Adverse drug reactions (ADRs) can be classified as either due to the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge and pruritus vulvae, or as more general ADRs e.g. nausea, fluid retention and skin rash.  When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease.

 

Table 1                 Adverse Drug Reactions (ADR) seen with Nolvadex

Frequency

System Organ Class (SOC)

ADR

Very common

(³10%)

Gastrointestinal disorders

Nausea

 

Metabolism and nutrition

Fluid retention

 

Reproductive system and breast

Vaginal bleeding

 

 

Vaginal discharge

 

Skin and subcutaneous tissue

Skin Rash

 

Vascular

Hot flushes

Common

(³1% and <10%)

Blood and lymphatic system

Anaemia

 

Eye disorders

Cataracts

 

 

Retinopathy

 

Immune system disorders

Hypersensitivity reactions

 

Investigations

Elevated triglycerides

 

Musculoskeletal and connective tissue

Leg cramp

 

Neoplasms benign, malignant and unspecified

Uterine fibroids

 

Nervous system

Ischaemic cerebrovascular events

 

 

Headache

 

 

Light headedness

 

Reproductive system and breast

Pruritus valvae

 

 

Endometrial changes (including hyperplasia and polyps)

 

Skin and subcutaneous tissue

Alopecia

 

Gastrointestinal disorders

Vomiting

Diarrhoea

Constipation

 

Hepatobiliary disorders

Changes in liver enzymes

 

 

Fatty liver

 

Multiple SOC Terms

Thromboembolic events (including deep vein thrombosis and pulmonary embolism)

Uncommon

(³ 0.1% and <1%)

Blood and lymphatic system

Thrombocytopenia

Leukopenia

 

Eye disorders

Visual disturbances

 

Gastrointestinal disorders

Pancreatitis

 

Metabolism and nutrition

Hypercalaemia (in patients with bony metastases)

 

Neoplasms benign, malignant and unspecified

Endometrial cancer

 

Respiratory, thoracic and mediastinal disorders

Interstitial pneumonitis

 

Hepatobiliary disorders

Cirrhosis of the liver

Rare

(³ 0.01% and <0.1%)

Blood and lymphatic system disorders

Neutropeniaa

Agranulocytosisa

 

Eye disorders

Corneal changes

 

 

Optic neuropathya

 

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine Sarcoma (mostly malignant mixed Mullerian tumours)a

 

 

Tumour Flarea

 

Nervous system

Optic neuritis

 

Hepatobiliary disorders

Hepatitis

Cholestasisa

Hepatic failurea  

 

 

Hepatocellular injurya

 

 

Hepatic necrosisa

 

Skin and subcutaneous tissue

Angioedema

 

 

Steven-Johnsons syndromea

 

 

Cutaneous vasculitisa

 

 

Bullous pemphigoida

 

 

Erythema multiformea

 

Reproductive system and breast disorders

Endometriosisa

Cystic ovarian swellinga

a        This adverse drug reaction was not reported in the tamoxifen arm (n= 3094) of the above study; however, it has been reported in other trials or from other sources. The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate (based on 3/X, where X represents the total sample size e.g. 3094).  This is calculated as 3/3094 which equates to a frequency category of ‘rare’.

 

Text amended and new text added

 

Skin rashes (including rare reports of erythema multiforme, Stevens-Johnson syndrome, cutaneous vasculitis, and bullous pemphigoid) and commonly hypersensitivity reactions, including angioedema have been reported.

Uncommonly, patients with bony metastases have developed hypercalcaemia on initiation of therapy.

Cases of visual disturbances, including rare reports of corneal changes, and common reports of retinopathy have been described in patients receiving Nolvadex therapy. Cataracts have been reported commonly in association with the administration of Nolvadex.

 

Cases of optic neuropathy and optic neuritis have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.

 

Uterine fibroids and other endometrial changes including hyperplasia and polyps have been reported commonly with the use of Nolvadex.

 

Falls in platelet count, usually only to 80,000 - 90,000 per cu mm but occasionally lower, have been reported in patients taking Nolvadex for breast cancer.

Leucopenia has been observed following the administration of Nolvadex, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions; this can sometimes be severe, and rarely cases of agranulocytosis have been reported.

There is evidence of ischaemic cerebrovascular events and thromboembolic events, including deep vein thrombosis and pulmonary embolism, occurring commonly during Nolvadex therapy. When Nolvadex is used in combination with cytotoxic agents, there is increased risk of thromboembolic events occurring.

 

Leg cramps have been reported commonly in patients receiving Nolvadex.

 

Uncommonly, cases of interstitial pneumonitis have been reported.

 

Nolvadex has been associated with changes in liver enzyme levels and with a spectrum of more severe liver abnormalities which in some cases were fatal, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis, and, hepatocellular injury (including hepatic necrosis).

 

Commonly, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Nolvadex.

 

Cystic ovarian swellings have rarely been observed in women receiving Nolvadex.

 

Uncommonly incidences of endometrial cancer and rare instances of uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with Nolvadex treatment.

Section 5.1

 

Text added

 

CYP2D6 polymorphism status may be associated with variability in clinical response to tamoxifen. The poor metaboliser status may be associated with reduced response. The consequences of the findings for the treatment of CYP2D6 poor metabolisers have not been fully elucidated (see sections 4.4, 4.5 and 5.2)

 

CYP2D6 genotype

Available clinical data suggest that patients who are homozygote for non-functional CYP2D6 alleles, may experience reduced effect of tamoxifen in the treatment of breast cancer.

 

The available studies have mainly been performed in postmenopausal women (see sections 4.4 and 5.2).

 

 

Section 5.2

 

Text added

 

Tamoxifen is metabolised mainly via CYP3A4 to N-desmethyl-tamoxifen, which is further metabolised by CYP2D6 to another active metabolite endoxifen. In patients who lack the enzyme CYP2D6 endoxifen concentrations are approximately 75% lower than in patients with normal CYP2D6 activity. Administration of strong CYP2D6 inhibitors reduces endoxifen circulating levels to a similar extent.

 

Section 10

 

Date of Revision

 

Changed to 1st June 2011

 

Updated on 4 August 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 15 June 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 June 2010 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

Addition to table, last entry

 

Frequency - Unassigned     ADR - Cutaneous vasculitisa; Agranulocytosisa

Footnote: a The frequencies are unassigned

 

 

Section 10

New revision date of text: 27th May 2010

Updated on 15 December 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • 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)

Free text change information supplied by the pharmaceutical company

Changes to Nolvadex 20mg SmPC

 

Section 1

New text:

“Nolvadex D 20 mg Film-coated Tablets”

Section 2
New text in 2nd paragraph,
” Excipients: Each tablet contains 234 mg lactose monohydrate.  For a full list of excipients, see section 6.1”

Section 4.4
New text, final paragraph,

This product contains lactose.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.”

Section 4.5
New text, 3rd paragraph,
The use of tamoxifen in combination with anastrozole as adjuvant therapy has not shown improved efficacy compared with tamoxifen alone.”

Section 4.8
New table and text,

                              Adverse Drug Reactions (ADR) seen with Nolvadex

Frequency

System

ADR

Very common

Vascular

Hot flushes

Common

Vascular

Ischaemic cerebrovascular events

Thromboembolic events, including deep vein thrombosis and pulmonary embolism

 

Reproductive and breast

Vaginal bleeding

Vaginal discharge

Pruritus vulvae

Endometrial changes (including hyperplasia and polyps)

 

Gastrointestinal

Gastrointestinal intolerance

 

Dermatologic

Alopecia

Skin rash

 

Nervous

Headache

Light-headedness

 

General

Tumour flare

Fluid retention

 

Musculoskeletal

Leg cramps

Uncommon

Ophthalmologic

Cataracts

Retinopathy

 

Reproductive and breast

Uterine fibroids

Endometrial cancer

 

General

Hypersensitivity, including angioedema

 

Investigations

Thrombocytopenia

Leukopenia

Neutropenia

Anaemia

Changes in liver enzymes

Elevated triglycerides

Rare

Ophthalmologic

Corneal changes

Optic neuropathy

Optic neuritis

 

Reproductive and breast

Uterine sarcoma (mostly malignant mixed Mullerian tumours)

Endometriosis

Ovarian cysts

 

Gastrointestinal

Pancreatitis

 

Hepatic and biliary

Fatty liver

Cholestasis

Hepatitis

 

Investigations

Hypercalcaemia  (not including tumour flare)

Very rare

Pulmonary

Interstitial pneumonitis

 

Dermatologic

Erythema multiforme

Stevens-Johnson syndrome

Bullous pemphigoid

 

The frequency definitions are:

Very common (>10%); Common (>1 - £10%); Uncommon (>0.1 - £1%), Rare (>0.01 - £0.1%); Very rare (£0.01%)

 

Side effects can be classified as either due to the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge and pruritus vulvae, or as more general side effects, e.g. gastrointestinal intolerance, headache, tumour flare, lightheadedness, and occasionally, fluid retention and alopecia.  When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease.

A small number of patients with bony metastases have developed hypercalcaemia on initiation of therapy.

Falls in platelet count, usually only to 80,000 - 90,000 per cu mm but occasionally lower, have been reported in patients taking Nolvadex for breast cancer.

Cases of optic neuropathy and optic neuritis have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.

There is evidence of increased incidence of ischaemic cerebrovascular events and thromboembolic events, including deep vein thrombosis and pulmonary embolism, during Nolvadex therapy. When Nolvadex is used in combination with cytotoxic agents, there is increased risk of thromboembolic events occurring.

Leg cramps have been reported commonly in patients receiving Nolvadex.”

 

Section 5.1
New 1st paragraph,

“ATC Code: L02B A01”

Final sentence from second paragraph deleted

 

Section 6.1
Lactose now Lactose monohydrate

 

Section 6.6

Heading now,

“Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product”

 

Section 9

Text now,

10 May 1983/28 August 2009”

Section 10

21 September 2009”

Updated on 14 December 2009 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to appearance of the medicine

Updated on 11 April 2008 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 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 4.4

Addition of paragraph: This product contains lactose.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Section 4.8

Addition of Adverse Drug Reactions Table.  Update on the frequency definitions which are:

Very common (>10%); Common (>1 - £10%); Uncommon (>0.1 - £1%), Rare (>0.01 - £0.1%); Very rare (£0.01%)

 

Removal of following paragraphs:

 

Skin rashes (including isolated reports of erythema multiforme, Stevens-Johnson syndrome and bullous pemphigoid) and rare hypersensitivity reactions, including angioedema have been reported.

 

A number of cases of visual disturbance including infrequent reports of corneal changes and retinopathy have been described in patients receiving Nolvadex therapy. An increased incidence of cataracts has been reported in association with the administration of Nolvadex.

Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.

Cystic ovarian swellings have occasionally been observed in premenopausal women receiving Nolvadex.

Leucopoenia has been observed following the administration of Nolvadex, sometimes in association with anaemia and/or thrombocytopenia.  Neutropenia has been reported on rare occasions; this can sometimes be severe.

 

Very rarely, cases of interstitial pneumonitis have been reported.

Nolvadex has been associated with changes in liver enzyme levels and on rare occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis.

Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Nolvadex.

An increased incidence of endometrial cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with Nolvadex treatment. 

Section 5.1

Addition of: ATC Code: L02B A01

 

Section 10
New revision date of text: 28 March 2008

Updated on 15 October 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 October 2007 SmPC

Reasons for updating

  • 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 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

Additional New text

Children: The use of Nolvadex is not recommended in children, as safety and efficacy have not been established (see sections 5.1 and 5.2).

 

Section 4.4

Additional New text (last paragraph)

In an uncontrolled trial in 28 girls aged 2–10 years with McCune Albright Syndrome (MAS), who received 20 mg once a day for up to 12 months duration, mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study.  While this finding is in line with the pharmacodynamic properties of tamoxifen, a causal relationship has not been established (see section 5.1).

 

Section 4.5

Additional New text (last paragraph)

Pharmacokinetic interaction with CYP2D6 inhibitors, showing a reduction in plasma level of an active tamoxifen metabolite, 4-hydroxy-N-desmethyltamoxifen (endoxifen), has been reported in the literature. The relevance of this to clinical practice is not known.

 

Section 4.8

Additional New (6th paragraph)  text

Cases of optic neuropathy and optic neuritis have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.

 

Section 10

New revision date of text: 29th August 2007

Updated on 15 October 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 July 2006 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 27 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 2 June 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose

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

Updated on 25 March 2004 SmPC

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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