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Gygel N-9 Spermicide

£19.50
VAT included

The NHS prescribed spermicide.

Hormone free contraception.

Ideal for diaphragms and cervical caps.

Large tube. Exp Feb’ 2021.

Highly effective N9 active ingredient.

Quantity

Description

Barrier contraceptives such as diaphragms (Milex and Caya for example) and cervical caps (such as FemCap, Beacup and Lea Contraceptive) must be used with a spermicide or contraceptive gel. Gygel has designed to fill that need.

Gygel MUST be used with a barrier contraceptive. It should not be used on its own. Even if a user applies the Gygel directly to the cervix within a short time their body temperature will warm up the gel, making it thinner and it will begin to move down the vagina, leaving no protection. Furthermore, the movement of intercourse and the excretion of bodily fluids will expedite it's movement. It is impossible to believe that Gygel could remain applied directly to the cervix for the 6 to 8 hours required after intercourse to reduce the risk of pregnancy. Advice on barrier contraceptives in the UK is available from your G.P. or the Family Planning Association (FPA). Midwives are always a great resource for barrier contraceptive advice as are private Gyno's and clinics.

Gygel: Technical Data

Trade Name of the Medicinal Product: GYGEL Contraceptive Jelly

Qualitative and Quantitative Composition: The gel contains 2.0% w/w of nonoxinol-9.

Pharmaceutical Form: Vaginal gel.

Important Information Regarding Gygel Spermicide:

Gygel should only be used by adult women with consent from their GP or gynecologist.

Gygel is intended for use in conjunction with barrier methods of contraception such as condoms, diaphragms and cervical caps such as FemCap.

This product does not protect against HIV or any other sexually transmitted diseases (STDs). You should use a latex condom or abstain from sex in order to protect yourself from STD transmission.

If irritation or discoloration occurs on the vagina or the penis, discontinue use. If symptoms worsen or continue for more than 48 hours, seek medical attention.

If consumed orally, the surfactant properties of Gygel may cause gastric irritation.

Pregnant women and those that may be pregnant should not use Gygel.

Do not store above 25ºC.

Clinical Particulars

Therapeutic Indications: For use as a spermicidal contraceptive in conjunction with barrier methods of contraception.

Method of Administration: For vaginal use. For use by adult females only.

Posology: The gel should be spread over the surface of the barrier that will be in contact with the cervix, and on the rim. The barrier and spermicide must be allowed to remain undisturbed for at least six to eight hours after intercourse. A fresh application of gel must be made prior to any subsequent acts of intercourse within this period of time, without removing the barrier (A vaginal applicator should be used for inserting more gel.)Douching is not recommended, but if desired it should be deferred for at least six hours after intercourse.

Contraindications: Sensitivity to nonoxynol-9 or to any component of the preparation. Patients with absent vaginal sensation e.g. paraplegics and quadriplegics.

Special warnings and special precautions for use: Spermicidal intravaginal preparations are intended for use in conjunction with barrier methods of contraception such as condoms, diaphragms and cervical 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 ofSTDs. High frequency use of nonoxynol-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, seek medical attention.

Interactions with other medicines or other forms of interaction: None known.

Pregnancy and Lactation: There is no evidence from animal and human studies that nonoxynol-9 is teratogenic.Human epidemiological studies have not shown any firm evidence of adverse effects on a fetus, however some studies have shown that nonoxynol-9 may be embryo toxic in animals. This product should not be used if pregnancy is suspected or confirmed. Animal studies have detected nonoxynol-9 in milk after intravaginal administration. Use by lactating women has not been studied.

Effects on ability to drive and to use machines: None known.

Undesirable effects: May cause irritation of the vagina or penis.

Overdose: SeIf 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.

Pharmacological Properties

Pharmacodynamic properties: The standard in vitro test (Sander-Cramer) evaluating the effect of nonoxynol-9 on animal sperm motility has shown the compound to be a potent spermicide.The site of action of nonoxynol-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.

Pharmacokinetic properties: The intravaginal absorption and excretion of radio labelled (14C) nonoxynol-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 nonoxynol-9 accounted for approximately 15-25% and faces approximately 70% of the administered dose as unchanged nonoxynol-9. Less than0.3% was found in the milk of lactating rats. No metabolites were detected in any of the samples analyzed.

Preclinical Safety Data: No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Pharmaceutical Particulars

List of excipients: Methyl parahydroxybenzoate (E 218)Sorbitol solution (E 420)Lactic acidPovidone K30Propylene glycolSodium carboxymethylcelluloseSorbic acid (E 200)Purified water.

Incompatibilities (major): Not applicable.

Shelf-life: 2 years.

Special precautions for storage: Do not store above 25ºC.

Nature and contents of containers: Epoxy resin lined aluminum tubes with polyethylene caps. Available in 81 gram packs; an applicator is available separately if required.

Instructions for use/handling: Not applicable.

Administrative Data

Name and Address of Marketing Authorisation Holder: Marlborough Pharmaceuticals Ltd35A High StreetMarlboroughWiltsSN8 1LWUK

Marketing Authorisation Number: PL 23138/0010

Date of First Authorisation/Renewal of Authorisation:12 September 1995/17 July 1996

Date of (Partial) Revision of the Text: 14th July 2007 Legal category GSL

Product Details

GYGEL

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