Suprefact Nasal Spray - Summary of Product Characteristics (SPC) - History

Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK Telephone: +44 (0)1483 505 515 Fax: +44 (0)1483 535 432 Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 01/12/2009

SPC	Suprefact Nasal Spray

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 01/12/2009 and displayed until Current

Reasons for adding or updating:
Change to section 4.1 - Therapeutic indications 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
Date of revision of text on the SPC: 12-Nov-2009
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
In section 4.1 "hormone dependent" has been specified for the prostate cancer indication. "however, not after bilateral orchiectomy (no further reduction of testosterone level by buserelin to be expected)." has also been added. In section 4.4 (risk of recurrence or worsening of depression) - has been added following warning regarding use in patients with depression (risk of deterioration of blood pressure levels) - has been added following warning about use in patients with hypertension The following section has replaced special warning advice for diabetic patients and monitoring advice: The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture (see section 4.8). Particular caution is necessary in patients with additional risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long-term therapy with anticonvulsants or corticosteroids or a family history of osteoporosis) it is recommended to periodically monitor bone mineral density (BMD) and use preventative measures during therapy to prevent osteopenia/osteoporosis. In some patients treated with GnRH-agonists, change in glucose tolerance is observed (see section 4.8). In diabetic patients blood glucose levels must be checked regularly (risk of deterioration of metabolic control). The effect can be monitored clinically and by determination of prostate specific antigen (PSA) and testosterone in the serum. Testosterone levels increases in the beginning of the treatment and thereafter decreases during two weeks. After two to four weeks, the testosterone levels have decreased to castration level. Disease flare (temporary deterioration of patient's condition) has been reported at the beginning of treatment. The incidence is variable, but of the order of 10%. Symptoms are usually confined to transient increase in pain, but the exact nature depends on the site of the lesions. In the special warning about neurological sequelae (see section 4.8) has been added at the end of the text In section 4.5 (see section 4.8) has been added at the end of the text. In section 4.8 "section 4.4" has been inserted into paragraph 4 about avoiding secondary reactions to treatment Occasional oedema (of face and extremities) and hot flushes. has been added to the vascular disorders section atrophy of the testes, and (in most patients; result of hormone deprivation) has been added to the Reproductive system and breast disorders section

Updated on 11/09/2008 and displayed until 01/12/2009

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 17-Jul-2008
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
4.4 Special warnings and special precautions for use Addition of the following: Patients known to suffer from depression should be carefully monitored and treated if necessary during treatment with Suprefact. In patients with hypertension, blood pressure must be monitored regularly. In diabetic patients blood glucose levels must be checked regularly. Disease flare is prevented by the prophylactic use of an anti-androgen so it is strongly recommended that administration of an anti-androgen be started as adjunctive therapy (e.g. cyproterone acetate, 300 mg daily) about 5 days before starting treatment. This adjunctive therapy must be continued in parallel with buserelin therapy for 3 to 4 weeks. Neurological sequelae have been reported where secondary deposits impinge upon the spinal cord or CNS. In patients with known metastases, e.g. of the spinal column, this adjunctive therapy with an anti-androgen is indispensable to prevent initial complications up to and including , for example, spinal compression and paralysis, arising from a transient activation of the tumour and metastases. 4.6 Pregnancy and lactation Addition of the following: Buserelin passed into breast milk in small amounts. Although negative effects on the infant have not been observed, it is recommended that breast-feeding be avoided during treatment with Suprefact in order to prevent the infant from ingesting small quantities of buserelin with breast milk. 4.8 Undesirable effects Addition of the following: Psychiatric disorders – Frequent nervousness, emotional instability. Occasional anxiety, depression or worsening of existing depression. Nervous system disorders –,Dizziness, headache , sleep disturbances, tiredness, drowsiness. Occasional paraesthesia (especially in the arms or legs), disturbances of memory and concentration. Musculoskeletal and bone disorders – Frequent musculoskeletal discomfort and pain (including shoulder pain/stiffness). The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture. The risk of skeletal fracture increases with the duration of therapy. Reproductive system and breast disorders – Occasional gynaecomastia (increase in breast size) which is usually painless, decrease in libido and potency.

Updated on 20/09/2007 and displayed until 11/09/2008

Reasons for adding or updating:
Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC: 12/2006
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change in MA Holder's address

Updated on 29/08/2006 and displayed until 20/09/2007

Reasons for adding or updating:
Change to section 4.3 - Contra-indications Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC: 06/2006
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contraindications): revised wording: Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation or after surgical removal of the testes. It is contraindicated in cases of known hypersensitivity to LHRH or buserelin. It should not be used during pregnancy or lactation. Section 4.6 (Pregnancy and lactation):new wording: Suprafact is contraindicated in pregnancy. It is intended for the treatment of advanced prostatic carcinoma, it should not be used in pregnant or lactating women (see 4.3 Contraindications). Detectable levels of buserelin are found in breast milk. Section 4.8 (Undesirable effects): Re-arrangement of existing data and addition of following data: Neoplasms bening and malignant - Very rare cases of pituitary adenomas were reported during treatment with LH-RH agonists, including buserelin. Blood disorders - Very rare cases of thrombocytopenia or leucopenia. Metabolism and nutrition disorders – Frequent increase or decrease in weight Occasional changes in appetite and increased thirst. Rarely increase or decrease in blood lipid levels. Very rarely, reduction in glucose tolerance which may lead to the worsening of metabolic control in diabetics. Psychiatric disorders – Frequent emotional instability. Occasional anxiety, depression or worsening of existing depression. Nervous system disorders – Frequent nervousness, dizziness, headache, sleep disturbances, tiredness, drowsiness. Occasional paraesthesia, disturbances of memory and concentration. Eye disorders – Occassional dry eyes (possibly leading to eye irritations in people who wear contact lenses), impaired vision (eg blurred vision), feeling of pressure behind the eyes. Ear and labyrinth disorders – Rare cases of tinnitus, hearing disorders found. Cardiac disorders – Frequent palpitations. Vascular disorders – Occassional oedema (of face and extremities) and hot flushes. Very rare cases of a deterioration of blood pressure levels in patients with hypertension. Gastrointestinal disorders – Frequent lower abdominal pain, stomach ache, nausea, vomiting, diarrhoea, constipation. Hepato-biliary disorders – Occasional , increase in serum liver enzyme levels (e.g. transaminases), increase in serum bilirubin. Skin and subcutaneous tissue disorders – Frequent dry skin, acne, increase or decrease in scalp hair (alopecia, hirsutism). Occasional increase or decrease in body hair, splitting nails. Musculoskeletal and bone disorders – Frequent musculoskeletal discomfort and pain (including shoulder pain/stiffness). Reproductive system and breast disorders – increase in breast size, decrease in libido and potency.