Zoladex 3.6mg

  • Name:

    Zoladex 3.6mg

  • Company:
    info
  • Active Ingredients:

    Goserelin Acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/04/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 8/3/2019

Click on this link to Download PDF directly

AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name Losec MUPS 40mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
Medicine Name Lynparza 50 mg hard capsules Active Ingredients Olaparib
Medicine Name NEXIUM 20 mg Tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name NEXIUM 40 mg Tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Nexium I.V. 40mg Powder for solution for injection/infusion Active Ingredients Esomeprazole sodium
Medicine Name NIFTEN Active Ingredients Atenolol, Nifedipine
Medicine Name Nolvadex D 20mg Tablets Active Ingredients Tamoxifen Citrate
Medicine Name Onglyza 2.5 mg & 5 mg film-coated tablets Active Ingredients Saxagliptin hydrochloride
Medicine Name Oxis Turbohaler 12mcg Active Ingredients Formoterol fumarate dihydrate
Medicine Name Oxis Turbohaler 6mcg Active Ingredients Formoterol fumarate dihydrate
Medicine Name Plendil 2.5mg, 5mg & 10mg Tablets Active Ingredients Felodipine
Medicine Name Pulmicort Respules 0.5mg Active Ingredients Budesonide
Medicine Name Pulmicort Respules 1mg Active Ingredients Budesonide
Medicine Name Pulmicort Turbohaler 100 Active Ingredients Budesonide
Medicine Name Pulmicort Turbohaler 200 Active Ingredients Budesonide
Medicine Name Pulmicort Turbohaler 400 Active Ingredients Budesonide
Medicine Name Seroquel Tablets 25mg, 100mg, 200mg and 300mg Active Ingredients Quetiapine fumarate
Medicine Name Seroquel XR 50mg, 150mg, 200mg, 300mg, 400mg prolonged-release tablets Active Ingredients Quetiapine fumarate
Medicine Name Symbicort Turbohaler 100/6 Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Symbicort Turbohaler 200/6 Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Symbicort Turbohaler 400/12 Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name TAGRISSO 40 mg and 80mg film-coated tablets Active Ingredients Osimertinib mesylate
Medicine Name Tenoret 50 Active Ingredients Atenolol, Chlortalidone
Medicine Name Tenoretic Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Tenormin Tablets 25mg, 50mg & 100mg Active Ingredients Atenolol
26 - 50 of 56 items.Total: 3 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 24 April 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 8 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 8 March 2019 SmPC

Reasons for updating

  • 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 not be renewed (A)

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 February 2017 SmPC

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.2 – change of wording from ‘older’ to ‘elderly’

Section 6.5 – addition of text that syringe can also be moulded from styrene-butadiene copolymer

Section 10 – updated date of revision

Updated on 13 October 2015 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 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

3.6mg and 10.8mg (same changes):

Section 4.2 – addition of information on how to administer Zoladex and extra care to be taken when administering to patients with low BMI and/or who are receiving full anticoagulation medication

Section 4.4 – infomration on injection site injury added

Section 10 – updated date of revision

Updated on 12 October 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on reporting a side effect.
  • Change to side-effects

Updated on 23 March 2015 SmPC

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 4.6 - 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 6.3 - Shelf life
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company



SmPC changes:

Section 2 – Editorial update in line with latest QRD template

Section 4.2 – Editorial update in line with latest QRD template

Section 4.3 – Editorial update in line with latest QRD template

Section 4.4 – Addition of warnings and precautions around Androgen Deprivation Therapy and effect on the QT interval. Editorial update in line with latest QRD template

Section 4.5 – Addition of information on interactions following addition of information around Androgen Deprivation Therapy and effect on the QT interval.

Section 4.6 – Editorial update in line with latest QRD template

Section 4.7 – Editorial update in line with latest QRD template

Section 4.8 – amendment of ADR wording details from IMB to HPRA

Section 4.8 – Addition of QT interval as side effect

Section 5.1 – Editorial update in line with latest QRD template

Section 6.3 - Editorial update in line with latest QRD template

Section 6.6 – Editorial update in line with latest QRD template

Section 9 – Editorial update in line with latest QRD template

Section 10 – Update to "Date of Revision"

Updated on 20 March 2015 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
  • Improved electronic presentation

Updated on 15 May 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 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 4.8 – Addition of PRAC recommended wording “Hyperhidrosis and hot flushes may continue after stopping Zoladex.” after footnote (b) of the table.

Section 4.8 – Addition of ADR statement.

Section 10 – Update to "Date of Revision"

Updated on 12 May 2014 PIL

Reasons for updating

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

Updated on 23 January 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.6 (undesirable effects) Acne has been added to females only.

Section 10
Date of revision has been updated to 9th January 2013

Updated on 22 January 2013 PIL

Reasons for updating

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

Updated on 25 October 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2

 

Additional information regarding Endometriosis, Endometrial thinning, Uterine fibroids and Assisted reproduction.

 

Section 4.4

 

Addition of wording on depression and Myocardial infarction and cardiac failure

 

Section 4.8

 

Psychiatric disorders updated re depression.

 

Section 10

 

Date of revision amended to 18th October 2012.

Updated on 22 October 2012 PIL

Reasons for updating

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

Updated on 5 September 2011 PIL

Reasons for updating

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

Updated on 27 July 2011 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

 

Text added to table - Skin and subcutaneous tissue disorders

 

Column 4         In Common section - alopeciag  added  

Column 2         Not Known added

Column 3         Alopeciah   added

Column 4         (see Common) added

 

Text added to table – Investigations

 

Column 2 - weight increased added

Column 3- weight increased added

 

 

Additional footnotes added to table

 

g        Loss of head hair has been reported in females, including younger patients treated for benign conditions.  This is usually mild but occasionally can be severe.

 

h        Particularly loss of body hair, an expected effect of lowered androgen levels.

 

 

Section 10

 

Date of Revision of Text changed to 27th June 2011

Updated on 25 July 2011 PIL

Reasons for updating

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

Updated on 18 January 2011 PIL

Reasons for updating

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

Updated on 18 January 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8

Update to Table under cardiac disorders, now row reads as,

 

Cardiac disorders

Common

Cardiac failuref, myocardial infarctionf

N/A

 

Section 10

10th December 2010

Updated on 29 July 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

Text changes to first paragraph, now reads, “The following frequency categories for adverse drug reactions (ADRs) were calculated based on reports from Zoladex clinical trials and post-marketing sources. The most commonly observed adverse reactions include hot flushes, sweating and injection site reactions.

Text changes to table, now reads,

 

”Table: Zoladex 3.6 mg adverse drug reactions presented by MedDRA System Organ Class

SOC

Frequency

Males

Females

 

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

Very rare

Pituitary tumour

Pituitary tumour

Not known

N/A

Degeneration of uterine fibroid

Immune system disorders

Uncommon

Drug hypersensitivity

Drug hypersensitivity

Rare

Anaphylactic reaction

Anaphylactic reaction

Endocrine disorders

Very rare

Pituitary haemorrhage

Pituitary haemorrhage

Metabolism and nutrition disorders

Common

Glucose tolerance impaireda

N/A

 

Uncommon

N/A

Hypercalcaemia

Psychiatric disorders

Very common

Libido decreasedb

Libido decreasedb

Common

(see Not known)

Mood altered, depression

Very rare

Psychotic disorder

Psychotic disorder

Not known

Mood altered, depression

(see Common)

Nervous system disorders

Common

Paraesthesia

Paraesthesia

Spinal cord compression

N/A

N/A

Headache

Cardiac disorders

Common

Cardiac failuref

N/A

Vascular disorders

Very common

Hot flushb

Hot flushb

Common

Blood pressure abnormalc

Blood pressure abnormalc

Skin and subcutaneous tissue disorders

Very common

Hyperhidrosisb

Hyperhidrosisb

Common

Rashd

Rashd

Musculoskeletal, connective tissue and bone disorders

Common

Bone paine

N/A

(see Uncommon)

Arthralgia

Uncommon

Arthralgia

(see Common)

Renal and urinary disorders

Uncommon

Ureteric obstruction

N/A

Reproductive system and breast disorders

Very common

Erectile dysfunction

N/A

N/A

Vulvovaginal dryness

N/A

Breast enlargement

Common

Gynaecomastia

N/A

Uncommon

Breast tenderness

N/A

Rare

N/A

Ovarian cyst

N/A

Ovarian hyperstimulation syndrome (if used concomitantly with gonadotrophins)

Not known

N/A

Withdrawal bleeding (see section 4.4)

General disorders and administration site conditions

Very common

(see Common)

Injection site reaction

Common

Injection site reaction

(see Very common)

N/A

Tumour flare, tumour pain (on initiation of treatment)

Investigations

Common

Bone density decreased (see section 4.4)

Bone density decreased (see section 4.4)

a              A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus.

b              These are pharmacological effects which seldom require withdrawal of therapy.

c              These may manifest as hypotension or hypertension, have been occasionally observed in patients administered Zoladex. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with Zoladex. Rarely, such changes have been sufficient to require medical intervention, including withdrawal of treatment from Zoladex.

d              These are generally mild, often regressing without discontinuation of therapy.

e              Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically.

f               Observed in a pharmaco-epidemiology study of LHRH agonists used in the treatment of prostate cancer. The risk appears to be increased when used in combination with anti-androgens.”

 

Section 10

10th May 2010

Updated on 6 July 2010 PIL

Reasons for updating

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

Updated on 16 April 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

IR Zoladex 3.6mg updates

 

Section 4.3

Addition of the word ‘severe’ after the first word Known, paragraph now reads,

 

“Known severe hypersensitivity to the active substance or to any of the excipients of this product.”

Section 4.4

Re-wording in first paragraph, now reads,

“Zoladex 3.6 mg is not indicated for use in children, as safety and efficacy have not been established in this patient group.”

Re-wording in sub paragraph ‘Males’, now reads,

Males

The use of Zoladex 3.6 mg in men at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. Consideration should be given to the initial use of an anti-androgen (e.g. cyproterone acetate 300 mg daily for 3 days before and 3 weeks after commencement of Zoladex) at the start of LHRH analogue therapy, since this has been reported to prevent the possible sequelae of the initial rise in serum testosterone. If spinal cord compression or renal impairment due to ureteric obstruction are present or develop, specific standard treatment of these complications should be instituted.

The use of LHRH agonists may cause reduction in bone mineral density. In men, preliminary data suggest that the use of a bisphosphonate in combination with an LHRH agonist may reduce bone mineral loss. Particular caution is necessary in patients with additional risk factors for osteoporosis (e.g. chronic alcohol abusers, smokers, long-term therapy with anticonvulsants or corticosteroids, family history of osteoporosis).

Mood changes, including depression have been reported. Patients with known depression and patients with hypertension should be monitored carefully.

 Reduction in glucose tolerance has been observed in men receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in patients with pre-existing diabetes mellitus. Thus, monitoring of blood glucose levels should be considered.”

Re-wording in sub paragraph ‘Females’, now reads,

“Females

Breast cancer indication

Reduced bone mineral density:

The use of LHRH agonists may cause reduction in bone mineral density.  Following two years treatment for early breast cancer, the average loss of bone mineral density was 6.2% and 11.5% at the femoral neck and lumbar spine respectively.  This loss has been shown to be partially reversible at the one year off treatment follow-up with recovery to 3.4% and 6.4% relative to baseline at the femoral neck and lumbar spine respectively, although this recovery is based on very limited data. In the majority of women, currently available data suggest that recovery of bone loss occurs after cessation of therapy.

 

Preliminary data suggest that the use of Zoladex in combination with tamoxifen in patients with breast cancer may reduce bone mineral loss.

 

Benign indications

Loss of bone mineral density:

The use of LHRH agonists is likely to cause reduction in bone mineral density averaging 1% per month during a six month treatment period. Every 10% reduction in bone mineral density is linked with about a two to three times increased fracture risk. In the majority of women, currently available data suggest that recovery of bone loss occurs after cessation of therapy.

 

In patients receiving Zoladex for the treatment of endometriosis, the addition of hormone replacement therapy has been shown to reduce bone mineral density loss and vasomotor symptoms.

 

No specific data is available for patients with established osteoporosis or with risk factors for osteoporosis (e.g. chronic alcohol abusers, smokers, long-term therapy with drugs that reduce bone mineral density, e.g. anticonvulsants or corticosteroids, family history of osteoporosis, malnutrition, e.g. anorexia nervosa). Since reduction in bone mineral density is likely to be more detrimental in these patients, treatment with Zoladex should be considered on an individual basis and only be initiated if the benefits of treatment outweigh the risks following a very careful appraisal. Consideration should be given to additional measures in order to counteract loss of bone mineral density.

 

Withdrawal bleeding

During early treatment with Zoladex some women may experience vaginal bleeding of variable duration and intensity. If vaginal bleeding occurs it is usually in the first month after starting treatment. Such bleeding probably represents oestrogen withdrawal bleeding and is expected to stop spontaneously. If bleeding continues, the reason should be investigated.

 

There are no clinical data on the effects of treating benign gynaecological conditions with Zoladex 3.6 mg for periods in excess of six months.

 

The use of Zoladex may cause an increase in cervical resistance and care should be taken when dilating the cervix.

Zoladex 3.6 mg should only be administered as part of a regimen for assisted reproduction under the supervision of a specialist experienced in the area.

 

As with other LHRH agonists, there have been reports of ovarian hyperstimulation syndrome (OHSS) associated with the use of Zoladex 3.6 mg, in combination with gonadotrophin. The stimulation cycle should be monitored carefully to identify patients at risk of developing OHSS. If OHSS risk is present, human chorionic gonadotrophin (hCG) should be withheld, if possible.

It is recommended that Zoladex 3.6 mg is used with caution in fertilisation treatment of patients with polycystic ovarian syndrome as follicle recruitment may be increased.

Fertile women should use non-hormonal contraceptive methods during treatment with Zoladex and until reset of menstruation following discontinuation of treatment with Zoladex.

Patients with known depression and patients with hypertension should be monitored carefully.”

 

Section 4.5

Small update to text, now reads,

” Not known.”

 

Section 4.6

Re-wording to first and second paragraph, section now reads,

Pregnancy: Zoladex should not be used during pregnancy since concurrent use of LHRH agonists is associated with a theoretical risk of abortion or foetal abnormality. Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy. Non‑hormonal methods of contraception should be employed during therapy until menses resume (see also warning concerning the time to return of menses in section 4.4).

Pregnancy should be excluded before Zoladex 3.6 mg is used for fertilisation treatment. When Zoladex is used in this setting, there is no clinical evidence to suggest a causal connection between Zoladex and any subsequent abnormalities of oocyte development or pregnancy or outcome.

Lactation: The use of Zoladex during breast‑feeding is not recommended.”

 

Section 4.7

Small update to text, now reads,

“There is no evidence that Zoladex 3.6 mg would result in impairment of ability to drive or operate machinery.”

Section 4.8

Re-wording to section and table, now reads,

“The following frequency categories were based on all adverse reactions from clinical trials, post-marketing studies and spontaneous reports. The most commonly observed adverse reactions include hot flushes, sweating and injection site reactions.

The following convention has been used for classification of frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

Table: Zoladex 3.6 mg adverse drug reactions presented by MedDRA System Organ Class

SOC

Frequency

Males

Females

 

Neoplasm benign and malignant (including cysts and polyps)

Very rare

Pituitary tumour

Pituitary tumour

Not known

N/A

Degeneration of uterine fibroids in women with uterine fibroids

Immune system disorders

Uncommon

Hypersensitivity reactions

Hypersensitivity reactions

Rare

Anaphylaxis

Anaphylaxis

Endocrine disorders

Very rare

Pituitary apoplexy

Pituitary apoplexy

Metabolism and nutrition disorders

Common

Reduction in glucose tolerancea

N/A

 

Uncommon

N/A

Hypercalcaemia

Psychiatric disorders

Very common

Change in libidob

Change in libidob

Common

(see Not known)

Mood changes, including depression

Very rare

Psychotic disorders

Psychotic disorders

Not known

Mood changes, including depression

(see Common)

Nervous system disorders

Common

Paraesthesia

Paraesthesia

Spinal cord compression

N/A

N/A

Headache

Vascular disorders

Very common

Hot flushesb

Hot flushesb

Common

Fluctuations in blood pressurec

Fluctuations in blood pressurec

Skin and subcutaneous tissue disorders

Very common

Sweatingb

Sweatingb

Common

Rashd

Rashd

Musculoskeletal, connective tissue and bone disorders

Common

Bone paine

N/A

(see Uncommon)

Arthralgia

Uncommon

Arthralgia

(see Common)

Renal and urinary disorders

Uncommon

Ureteric obstruction

N/A

Reproductive system and breast disorders

Very common

Decrease in potency

N/A

N/A

Vaginal dryness

N/A

Change in breast size

Common

Breast swelling

N/A

Uncommon

Breast tenderness

N/A

Rare

N/A

Ovarian cyst

Not known

N/A

Withdrawal bleeding (see section 4.4)

General disorders and administration site conditions

Very common

(see Common)

Injection site reactions (e.g. redness, pain, swelling, haemorrhage)

Common

Injection site reactions (e.g. redness, pain, swelling, haemorrhage)

(see Very common)

Investigations

Common

Bone mineral density loss (see section 4.4)

Bone mineral density loss (see section 4.4)

a              A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus.

b              These are pharmacological effects which seldom require withdrawal of therapy.

c              These may manifest as hypotension or hypertension, have been occasionally observed in patients administered Zoladex. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with Zoladex. Rarely, such changes have been sufficient to require medical intervention, including withdrawal of treatment from Zoladex.

d              These are generally mild, often regressing without discontinuation of therapy.

e              Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically.

Post-marketing experience

A small number of cases of changes in blood count, hepatic dysfunction, pulmonary embolism and interstitial pneumonia have been reported in connection with Zoladex.

In addition, the following adverse drug reactions have been reported in women treated for benign gynaecological indications:

Acne, change of body hairs, dry skin, weight gain, increase in serum cholesterol, ovarian hyperstimulation syndrome (if concomitantly used with gonadotrophins), vaginitis, vaginal discharge, nervousness, sleep disorder, tiredness, peripheral oedema, myalgias, cramp in the calves, nausea, vomiting, diarrhoea, constipation, abdominal complaints, alterations of voice.

Initially, breast cancer patients may experience a temporary increase in signs and symptoms, which can be managed symptomatically.

Rarely, breast cancer patients with metastases have developed hypercalcaemia on initiation of therapy. In the presence of symptoms indicative of hypercalcaemia (e.g. thirst), hypercalcaemia should be excluded.

Rarely, some women may enter the menopause during treatment with LHRH analogues and not resume menses on cessation of therapy. Whether this is an effect of Zoladex treatment or a reflection of their gynaecological condition is not known.”

 

Section 4.9

Re-wording to section, now reads,

” There is not much experience of overdose in humans. In cases where Zoladex has been given before the planned time of administration, or when a bigger dose of Zoladex than originally planned has been given, no clinically significant undesirable effects have been observed. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentrations and on the reproductive tract will be evident with higher doses of Zoladex. In case of overdosage, the condition should be managed symptomatically.”

Section 10

Date updated,

“23 March 2010”

 

 

 

Updated on 9 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Zoladex 3.6mg Implant SPC changes

 

Section 1

â symbol removed

 

Secton 2

Text change to second paragraph,

“For a full list of excipients, see section 6.1.”

Section 6.1

Additional text, “50/50”

 

Section 6.2

Changed text, “Not applicable”.

 

Section 9

Changed text, “02 February 1989/ 02 February 2009”

Section 10

Changed text, “13th November 2009”

Updated on 8 December 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 May 2008 PIL

Reasons for updating

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

Updated on 14 May 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 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 4.4

Change of text in third paragraph re: Reduction of Bone Mineral Density

And additional new text 4th paragraph: Addition of wording on Diabetes Mellitus and Alterered Glucose Metabolism

 

Section 4.8

Additional new text beginning of 7th paragraph and change of text in same paragraph re: Reduction of Bone Mineral Density

and Addition of wording on Diabetes Mellitus and Alterered Glucose Metabolism

 

Section 10

New revision date of text: 22 April 2008

Updated on 29 January 2007 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 23 November 2005 PIL

Reasons for updating

  • Change of active ingredient
  • Change of contraindications
  • Change to date of revision

Updated on 21 October 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

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

Updated on 13 June 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 July 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 30 March 2004 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 20 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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