This information is intended for use by health professionals

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 such as diaphragms or caps.

4.2 Posology and method of administration

Method of Administration

For vaginal use.

For use by adult females only.

Posology

In order to prevent pregnancy, diaphragms and caps need to be used with a spermicide.

Diaphragms: Approximately two 2cm strips of Gygel should be put on each side of the diaphragm. Putting a little on the rim also makes the diaphragm easier to insert.

Caps: One-third of the cap should be filled with Gygel. The gel should also be placed in the groove between the dome and the rim of silicone caps. Gygel should not be put around the rim however as this will stop the cap from staying in place. Depending on the type of cap, extra Gygel may be required after the cap has been inserted.

Extra Gygel will need to be added if coitus takes place 3 hours or more after insertion of a diaphragm or cap. The diaphragm /cap and spermicide must be allowed to remain undisturbed for at least six 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 / cap.

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 diaphragms and caps. Gygel is not required for use with condoms as there is no evidence of any additional protection against pregnancy.

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.

A diaphragm should not be left in the vagina for longer than 24 hours.

4.5 Interaction with other medicinal products and other forms of interaction

Some vaginal products and lubricating agents may contain ingredients that can damage contraceptive diaphragms/caps made from latex rubber. As a result these may be less effective as a barrier against pregnancy and as a protection from sexually transmitted diseases including HIV.

The following products should NOT be used at the same time as a vaginal diaphragm or cap:

• Petroleum jelly (Vaseline);

• Mineral oil (baby oil);

• Oil-based vaginal and rectal preparations.

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.

*not all packs may currently be marketed

6.6 Special precautions for disposal and other handling

Not applicable.

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

06/02/2014