When a pharmaceutical company changes an SPC or PIL, 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.
Section 2: (as estradiol hemihydrate) changed to (as hemihydrate) Section 4.1: at least 6 months since last menses added, with an intact uterus removed Section 4.2: the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours has passed, the tablet is to be discarded has been added. Section 4.3: Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency (see section 4.4)) added. Section 4.4: appropriate imaging tools, e.g. added. Section 4.4: Substantial additions of text to the following paragraphs: Endometial hyperplasia and carcinoma, Breast cancer, Ovarian cancer, Venous thromboembolism, Coronary artery disease, Other conditions. Section 4.5: Addion: Drugs that inhibit the activity of hepatic microsomal drug metabolising enzymes, e.g. ketoconazole, may increase circulating levels of the active substances in Novofem.Concomitant administration of cyclosporine may cause increased blood levels of cyclosporine, creatinine and transaminases due to decreased metabolism of cyclosporine in the liver. Section 4.6: Title changed to Fertility, pregnancy and lactation Section 4.7: Addition: Novofem has no known effect on the ability to drive and use machines. Deletion: No effects known. Section 4.8: Substantial additions to the sections on post-marketing experience, Breast cancer risk, Endometrial cancer risk, Ovarian cancer risk, Risk of venous thromboembolism, Risk of coronary artery disease, Risk of ischaemic stroke. Section 5.1: Synthetic progestagen added Section 10: Revision date changed to 09/2011
SmPC changes for Novofem
Gelatine Substitution
PREVIOUS WORDING
NEW WORDING
1 NAME OF THE MEDICINAL PRODUCT
(Formatted to all caps)
2. Qualitative and Quantitative Composition
Excipient: Lactose monohydrate 38.4 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipient: Lactose monohydrate
(Removed 38.4mg as not in the schedule)
3. Pharmaceutical Form
3. PHARMACEUTICAL FORM
4. Clinical Particulars
4. CLINICAL PARTICULARS
(Formatted to lower case for M and A)
4.4 Special Warnings and Precautions for Use
4.4 Special warnings and precautions for use
(Formatted to lower case for W, P and U)
Other conditions
Novofem® tablets contain lactose.
Novofem® tablets contain lactose monohydrate.
4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
4.5 Interaction with other medicinal products and other forms of interaction
(Formatted to lower case for O, M, P O, F and I)
5. Pharmacological Properties
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Oestrogen and progestogen, sequential combination for continuous treatment.
6. Pharmaceutical Particulars
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Gelatin
Hydroxypropylcellulose
(Formatted to lower case for P, D and H)
7. Marketing Authorisation Holder
7. MARKETING AUTHORISATION HOLDER
8. Marketing Authorisation Number
8. MARKETING AUTHORISATION NUMBER
9. Date of First Authorisation/Renewal of the Authorisation
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. Date of Revision of the Text
January 2009
10. DATE OF REVISION OF THE TEXT
May 2010
Excipient: Lactose monohydrate 38.4 mg (red-film-coated tablets) and 37.9 mg (white film-coated tablets)
Now reads:
Ovarian Cancer
Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer is some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than oestrogen–only products.
Has been replaced with the following text:
Long term (at least 5 or 10 years) use of oestrogen-only HRTs and oestrogen plus progestogen HRTs has been associated with an increased risk of ovarian cancer in some epidemiological studies.
5.1 Pharmacodynamic Properties
The following text has been added:
Pharmacotherapeutic group: Oestrogen and progestogen, sequential combination for continuous treatment.
6.4 Special precautions for use
Keep the container in the outer carton.
Keep the container in the outer carton in order to protect from light.
6.6 Instructions for Use and Handling
This heading has been amended to:
6.6. Special precautions for disposal and other handling of the product
10 Date of Revision of the Text
“For excipients, see 6.1” has been changed to:
“Excipient: Lactose monohydrate 38.4 mg (red film-coated tablet) and 37.9 (white film-
coated tablet).
For a full list of excipients see section 6.1”.
Other Conditions
Added:
Novofem® tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
9 Date of First Authorisation/Renewal of the Authorisation
Added: Date of last renewal: 27 September 2005
Date “November 2007” added.