Pharmatex (Tablets, Capsules, Cream, Suppositories) Instructions for Use
ATC Code
G02BB (Intravaginal contraceptives)
Active Substance
Benzalkonium chloride (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Vaginal contraceptive with spermicidal action
Pharmacotherapeutic Group
Other agents used in gynecology; contraceptives for topical use; intravaginal contraceptives
Pharmacological Action
Antiseptic with spermicidal action. It is a quaternary ammonium compound and belongs to cationic surfactants.
Spermicidal action is due to the ability of the active substance to destroy sperm membranes (first the flagella, then the heads), which makes it impossible for the egg to be fertilized by a damaged sperm.
The effect develops within 5-10 minutes after insertion into the vagina.
It does not affect the normal vaginal microflora or the menstrual cycle.
In vitro, Benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus. It has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. It is not active against Mycoplasma spp.
Pharmacokinetics
Benzalkonium chloride is not absorbed into the vaginal mucosa; it is removed by simple washing with water and with normal physiological secretions. When applied topically, it is practically not absorbed.
Indications
- Local contraception.
ICD codes
| ICD-10 code | Indication |
| Z30.0 | General advice and consultation on contraception |
| ICD-11 code | Indication |
| QA21.1 | Encounter for general counseling and advice on contraception |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer intravaginally 5-10 minutes before sexual intercourse; the exact time depends on the specific dosage form used.
Apply the cream, insert the capsule, or place the suppository deep into the vagina. Use a single dose before every act of sexual intercourse.
For the tablet form, insert one tablet intravaginally prior to each coital act, ensuring it is placed correctly for optimal effect.
Adverse Reactions
Possible adverse reactions include localized allergic responses and contact dermatitis. Patients may experience a burning sensation or itching in the vagina, and the partner may report similar symptoms on the penis.
Dysuria, or painful urination, can also occur. Discontinue use and consult a healthcare provider if any of these reactions are severe or persistent.
Contraindications
- Hypersensitivity to benzalkonium chloride or any other component of the formulation.
- Presence of vaginitis, vaginal ulcerations, or any other acute inflammatory conditions of the vaginal or cervical mucosa.
- Irritation of the genital tract, as the product may exacerbate existing lesions or discomfort.
Use in Pregnancy and Lactation
Not used during pregnancy. It does not have a negative effect on the course of pregnancy. It is not excreted in breast milk and can be used during breastfeeding.
Special Precautions
The contraceptive effectiveness depends on the correct use of the drug containing Benzalkonium chloride.
In case of vaginal diseases, the use of benzalkonium chloride should be temporarily discontinued until the end of treatment with vaginal medications.
This method of contraception does not protect against sexually transmitted infections or those caused by HIV.
The use of soap for genital hygiene is prohibited 2 hours before and 2 hours after sexual intercourse, as soap destroys Benzalkonium chloride. Vaginal douching should be used 2 hours after sexual intercourse.
Drug Interactions
Concurrent intravaginal administration of other medications, such as creams or suppositories, can reduce the spermicidal effect of benzalkonium chloride.
Benzalkonium chloride is inactivated by soap and other anionic surfactants; avoid using soap for genital hygiene around the time of application.
Iodine-based solutions, including dilute preparations like 0.1% iodonate, chemically inactivate benzalkonium chloride upon contact.
Overdose
Overdose is unlikely due to the local route of administration and minimal systemic absorption. No specific antidote exists.
In case of accidental ingestion, symptomatic and supportive care is recommended. For local overexposure, such as intense irritation, discontinue use and rinse the affected area thoroughly with water.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Vaginal capsules 18.9 mg: 6 or 12 pcs.
Marketing Authorization Holder
Laboratoire Innotech International (France)
Manufactured By
Innothera Chouzy (France)
Or
Catalent France Beinheim, SA (France)
Packaging and Quality Control Release
INNOTHERA CHOUZY (France)
Dosage Form
 |
Pharmatex | Vaginal capsules 18.9 mg: 6 or 12 pcs. |
Dosage Form, Packaging, and Composition
Vaginal capsules soft, translucent, light yellow, oval in shape; capsule content is an emulsion from white to white with a yellowish tint; slight stratification of the capsule content is possible.
| 1 caps. | |
| Benzalkonium chloride 50% aqueous solution | 37.8 mg, |
| Equivalent to benzalkonium chloride content | 18.9 mg |
Excipients: dimethicone 1000, colloidal silicon dioxide (hydrophobic), hypromellose (hydroxypropylcellulose), PEG-7 glyceryl cocoate, macrogol 400, gelatin, glycerol.
6 pcs. – blisters (1) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.
Vaginal cream 1.2%: tube 72 g with dispenser
Marketing Authorization Holder
Laboratoire Innotech International (France)
Manufactured By
Laboratoires Chemineau (France)
Primary Packaging
LABORATOIRES CHEMINEAU (France)
Secondary Packaging
INNOTHERA CHOUZY (France)
Quality Control Release
INNOTHERA CHOUZY (France)
Dosage Form
|
Pharmatex | Vaginal cream 1.2%: tube 72 g with dispenser |
Dosage Form, Packaging, and Composition
Vaginal cream white, homogeneous, with a lavender scent.
| 100 g | |
| Benzalkonium chloride 50% aqueous solution | 2.4 g, |
| Equivalent to benzalkonium chloride content | 1.2 g |
Excipients: anhydrous citric acid – 0.002 g, disodium hydrogen phosphate dodecahydrate – to pH 3.5-5.5, macrogol and ethylene glycol palmitostearate (Tefose® 63) – 24 g, lavender oil – 0.05 g, purified water – up to 100 g.
72 g – aluminum tubes (1) with a dispenser – cardboard packs.
Vaginal suppositories 18.9 mg: 5 or 10 pcs.
Marketing Authorization Holder
Laboratoire Innotech International (France)
Manufactured By
Unither Liquid Manufacturing (France)
Packaging and Quality Control Release
INNOTHERA CHOUZY (France)
Dosage Form
|
Pharmatex | Vaginal suppositories 18.9 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories white, cylindrical in shape with a conical end.
| 1 supp. | |
| Benzalkonium chloride 50% aqueous solution | 37.8 mg, |
| Equivalent to benzalkonium chloride content | 18.9 mg |
Excipients: hypromellose – 9.1 mg, solid fat Witepsol S 51 – 1553.1 mg.
5 pcs. – blisters (1) – cardboard packs.
5 pcs. – blisters (2) – cardboard packs.
Vaginal tablets 20 mg: 12 or 24 pcs.
Marketing Authorization Holder
Laboratoire Innotech International (France)
Manufactured By
Innothera Chouzy (France)
Dosage Form
|
Pharmatex | Vaginal tablets 20 mg: 12 or 24 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets white, round, with a hole in the center.
| 1 tab. | |
| Miristalkonium chloride | 20 mg |
Excipients: sodium bicarbonate – 111 mg, anhydrous citric acid – 96 mg, hydrated colloidal silicon dioxide – 12 mg, microcrystalline cellulose – 172 mg, magnesium stearate – 5.3 mg, lactose monohydrate – 363 mg, macrogol 6000 – 20.7 mg.
12 pcs. – polypropylene tubes (1) – cardboard packs.
12 pcs. – polypropylene tubes (2) – cardboard packs.
![Pharmatex [Tablets, Capsules, Cream, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Pharmatex [Tablets, Capsules, Cream, Suppositories] 2")