Patentex Oval N (Suppositories) Instructions for Use

Marketing Authorization Holder

Merz Pharma, GmbH & Co. KGaA (Germany)

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Nonoxinol (Rec.INN registered by WHO)

Dosage Form

Patentex Oval N

Vaginal suppositories 75 mg: 3, 6, or 12 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white, cylindrical, on a longitudinal section without inclusions, the presence of an air core or a funnel-shaped depression is allowed.

Excipients: polyethylene glycol (macrogol) 1500, polyethylene glycol (macrogol) 1000, tartaric acid, sodium bicarbonate, sodium lauryl sulfate.

3 pcs. – blisters (1) – carton packs.
6 pcs. – blisters (1) – carton packs.
6 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Contraceptive agent for topical application

Pharmacological Action

Vaginal contraceptive with spermicidal action.

Patentex Oval N suppositories melt at body temperature and, regardless of the amount of vaginal secretion, form a foam.

The drug reduces the surface tension of the lipid membrane of spermatozoa and irreversibly paralyzes their ability to move.

The drug has a mechanical action, because the spermicidal substance, evenly distributed in the vagina, forms a stable barrier that prevents the penetration of spermatozoa into the uterus.

Patentex Oval N has a preventive effect against sexually transmitted infections.

Pharmacokinetics

Data on the pharmacokinetics of Patentex Oval N are not provided.

Indications

Contraception

• For episodic protection against pregnancy (including with irregular sexual activity);
• With an irregular menstrual cycle;
• When a woman wishes to use a contraceptive independently of her partner;
• When it is necessary to stop (for a short or long time) the use of oral hormonal contraceptives;
• With the simultaneous use of drugs that reduce the effectiveness of oral hormonal contraceptives;
• In the presence of contraindications to the use of oral contraceptives or to the use of intrauterine contraception.

ICD codes

Dosage Regimen

A mandatory condition for the effectiveness of Patentex Oval N is its correct application.

Before use, the suppository is removed from the blister at the marked place. Before each sexual intercourse, the suppository is inserted deep into the vagina. The drug becomes active 10 minutes after insertion. During this time, the active spermicidal substance is evenly distributed throughout the vagina and forms a stable barrier that prevents the passage of spermatozoa into the uterus.

In case of prolonged sexual intercourse (more than 1 hour), repeated administration of another suppository is necessary.

Before each new sexual intercourse, repeated administration of a suppository is necessary, even in cases where the time interval between two sexual acts is less than 1 hour.

Patentex Oval N can be used for a long period of time.

Adverse Reactions

The drug is well tolerated by both partners. In rare cases, a feeling of warmth may occur. If the vaginal microflora is disturbed, a sensation of itching and burning in the vagina (or penis) may occur.

Contraindications

• Developmental anomalies of the genital organs;
• Cervical erosion;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the safety and efficacy of the drug during lactation (breastfeeding) are not provided.

Overdose

To date, no cases of overdose with Patentex Oval N have been reported.

Drug Interactions

Patentex Oval N is practically not subject to systemic absorption, so interaction with other drugs is unlikely.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2.5 years. The drug should not be used after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.