Instructions Pharmatex vaginal suppositories 18.9 mg No. 10
Composition
active ingredient: benzalkonium chloride (benzalkonium choride);
1 vaginal suppository (1.6 g) contains 18.9 mg of benzalkonium chloride;
excipients: hydroxypropylcellulose, semi-synthetic solid glyceride (type Witepsol S 51).
Dosage form
Vaginal suppositories.
Main physicochemical properties: white suppositories, cylindrical in shape with a conical end.
Pharmacotherapeutic group
Contraceptives for local use. Intravaginal contraceptives.
ATX code G02B B.
Pharmacological properties
Pharmacodynamics.
Benzalkonium chloride has both spermicidal and antiseptic properties.
The active substance causes the sperm membrane to rupture. The destruction of the sperm occurs in two stages: first the flagellum is destroyed, and then the head.
The effectiveness of the product varies depending on how closely the instructions for use are followed.
Does not affect saprophytic microflora (Doderlein sticks are preserved).
Since Pharmatex is not a hormonal drug, its use does not affect the menstrual cycle, libido, or fertility.
Experimental studies have established the antiseptic activity of benzalkonium chloride:
in vitro the drug is active against pathogens of sexually transmitted infections, in particular: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the drug is inactive against Mycoplasma spp. and has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum;
Some in vivo data suggest possible efficacy in preventing some sexually transmitted diseases, but there is no direct evidence of this preventive effect.
Pharmacokinetics.
Benzalkonium chloride is practically not absorbed by the vaginal mucosa.
Indication
Local contraception.
Pharmatex is a local contraceptive (spermicide) for preventing pregnancy, which, like other methods of contraception, does not completely eliminate it. The effectiveness of the spermicide depends on compliance with the instructions for medical use. Pharmatex can be used both separately and together with other contraceptives to enhance the contraceptive effect.
This method of contraception is intended for all women of reproductive age. It is especially advisable to use Pharmatex:
in case of temporary or permanent contraindications to the use of oral contraceptives or an intrauterine device (intrauterine device);
after childbirth, during breastfeeding, during premenopause;
if episodic pregnancy prevention is necessary;
as an adjunct to oral contraception in case of missing a pill or taking it later than required (in this case, Pharmatex must be additionally used until the end of the menstrual cycle);
as an aid in barrier contraception (vaginal diaphragm, cervical cap), when using an intrauterine device (especially with long-term simultaneous use of certain drugs, such as nonsteroidal anti-inflammatory drugs).
Contraindication
This medicine should not be used in case of hypersensitivity to benzalkonium chloride or excipients, vaginitis, ulcers and irritation of the vaginal and cervical mucosa.
Interaction with other medicinal products and other types of interactions
Combinations to avoid:
+ medical drugs with vaginal administration:
any intravaginal treatment is likely to inactivate the spermicidal effect of the local contraceptive;
+ soaps:
This spermicide is destroyed by soaps and detergents - any use of soap solutions should be avoided, because they, even in minimal quantities, destroy the active substance.
A vaginal suppository-latex compatibility study conducted with different brands did not reveal any changes in the physical characteristics of the tested condoms.
Application features
Pharmatex is an effective means of preventing pregnancy if used correctly during each act of intercourse. However, this method of contraception is somewhat inferior in effectiveness to such contraceptives as hormonal contraception, intrauterine device, diaphragm, cervical cap or condom. The effectiveness of spermicides is reduced if the rules of use are not followed.
The effectiveness of the contraceptive effect depends significantly on careful adherence to the rules of use, so it is important to clearly explain to the patient how to use the product and make sure that she understands everything correctly.
Individuals who cannot understand or accept the instructions for use should not use this contraceptive.
Conditions that must be met when using Pharmatex:
systematically insert the suppository deep into the vagina before each sexual act, regardless of the phase of the menstrual cycle;
it is necessary to postpone douching with clean water for at least 2 hours to avoid the risk of washing out the drug;
avoid taking a bath, swimming in a pond, pool, etc., because the effect of the contraceptive may be weakened;
discontinue use of Pharmatex if symptoms of genital lesions appear or worsen;
In case of treatment with intravaginal agents, discontinue use of Pharmatex until the end of treatment. During this period, another method of contraception should be chosen.
This contraceptive does not protect against sexually transmitted infections (STIs) or against the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS).
Use during pregnancy or breastfeeding
Clinical and epidemiological studies have not revealed any malformations associated with accidental use of this product in early pregnancy.
A very small amount of the drug can pass into breast milk without any harmful effects. Breastfeeding is possible.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect on the ability to drive or use machines was observed.
Method of administration and doses
Administer intravaginally.
Apply systematically before each sexual act, regardless of the phase of the menstrual cycle.
In a lying position, insert 1 vaginal suppository deep into the vagina 5 minutes before sexual intercourse.
In case of repeated sexual intercourse, insert another suppository.
The duration of contraceptive action is 4 hours.
Immediately before and after sexual intercourse, only external genital toileting with clean water is possible (excluding soaps).
Children.
Pharmatex should not be used in children.
Overdose
No cases of overdose have been identified.
Side effects
Reproductive system and breast disorders
Rare (≥1/10,000 to <1/1,000): itching, burning sensation or local irritation in one or both partners.
On the part of the immune system
Frequency unknown: allergic reactions.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package!
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 suppositories in a blister, 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
INNOTHERA CHOUZY, France.
Address
22 avenue Aristide Briand, 94110 Arcueil, France/22 avenue Aristide Briand, 94110 Arcueil, France.
Applicant
LABORATORY INNOTECH INTERNATIONAL, France/LABORATOIRE INNOTECH INTERNATIONAl, France.
