1. Name Of The Medicinal Product
GYGEL Contraceptive Jelly
2. Qualitative And Quantitative Composition
The gel contains 2.0% w/w of nonoxinol-9.
3. Pharmaceutical Form
Vaginal gel.
4. Clinical Particulars
4.1 Therapeutic Indications
For use as a spermicidal contraceptive in conjunction with barrier methods of contraception.
4.2 Posology And Method Of Administration
Method of Administration
For vaginal use.
For use by adult females only.
Posology
The gel should be spread over the surface of the diaphragm which will be in contact with the cervix, and on the rim. The diaphragm and spermicide must be allowed to remain undisturbed for at least six to eight hours after coitus. A fresh application of gel or other spermicides, must be made prior to any subsequent acts of coitus within this period of time, without removing the diaphragm. (A vaginal applicator should be used for inserting more jelly.)
Douching is not recommended, but if desired it should be deferred for at least six hours after intercourse.
4.3 Contraindications
Hypersensitivity to nonoxinol-9 or to any component of the preparation.
Patients with absent vaginal sensation e.g. paraplegics and quadriplegics.
4.4 Special Warnings And Precautions For Use
Spermicidal intravaginal preparations are intended for use in conjunction with barrier methods of contraception such as condoms, diaphragms and caps.
Where avoidance of pregnancy is important, the choice of contraceptive method should be made in consultation with a doctor or a family planning clinic.
This product does not protect against HIV (AIDS) or other sexually transmitted diseases (STDs). A latex condom should be used to protect against the spread of STDs. High frequency use of nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection. Therefore women at risk of HIV/STD infection and who have multiple daily acts of intercourse should be advised to choose another method of contraception. Sexually active women should consider their individual HIV/STD infection risk when choosing a method of contraception.
If vaginal or penile irritation occurs, discontinue use. If symptoms worsen or continue for more than 48 hours, medical advice should be sought.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There is no evidence from animal and human studies that nonoxinol-9 is teratogenic. Human epidemiological studies have not shown any firm evidence of adverse effects on the foetus, however some studies have shown that nonoxinol-9 may be embryotoxic in animals. This product should not be used if pregnancy is suspected or confirmed. Animal studies have detected nonoxinol-9 in milk after intravaginal administration. Use by lactating women has not been studied.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection.
It may cause hypersensitivity and application site reactions such as irritation, pain, discomfort, burning sensation, itching, dryness, rash and redness of the vulva, vagina or penis.
4.9 Overdose
If taken orally, the surfactant properties of this preparation may cause gastric irritation. General supportive therapy should be carried out. Hepatic and renal function should be monitored if medically indicated.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The standard in vitro test (Sander-Cramer) evaluating the effect of nonoxinol-9 on animal sperm motility has shown the compound to be a potent spermicide.
The site of action of nonoxinol-9 has been determined as the sperm cell membrane. The lipoprotein membrane is disrupted, increasing permeability, with subsequent loss of cell components and decreased motility. A similar effect on vaginal epithelial and bacterial cells is also found.
5.2 Pharmacokinetic Properties
The intravaginal absorption and excretion of radiolabelled (14C) nonoxinol-9 has been studied in non-pregnant rats and rabbits and in pregnant rats. No appreciable difference was found in the extent or rate of absorption in pregnant and non-pregnant animals. Plasma levels peaked at about one hour and recovery from urine as unchanged nonoxinol-9 accounted for approximately 15-25% and faeces approximately 70% of the administered dose as unchanged nonoxinol-9. Less than 0.3% was found in the milk of lactating rats. No metabolites were detected in any of the samples analysed.
5.3 Preclinical Safety Data
No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Methyl parahydroxybenzoate (E 218)
Sorbitol solution (E 420)
Lactic acid
Povidone K30
Propylene glycol
Sodium carboxymethylcellulose
Sorbic acid (E 200)
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
2 years.
6.4 Special Precautions For Storage
Do not store above 25ºC.
6.5 Nature And Contents Of Container
Epoxy resin lined aluminium tubes with polyethylene caps. Available in 30 and 81 gram packs; an applicator is available separately if required.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Marlborough Pharmaceuticals Ltd
35A High Street
Marlborough
Wilts
SN8 1LW
UK
8. Marketing Authorisation Number(S)
PL 23138/0010
9. Date Of First Authorisation/Renewal Of The Authorisation
12 September 1995/17 July 1996
10. Date Of Revision Of The Text
9th September 2009
11 LEGAL CATEGORY
GSL
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