The therapeutic indications of ALPAGELLE, cream, vaginal are limited to

· Local contraception: this method decreases considerably the pregnancy without completely eliminating the possibility: the effectiveness will be all the better, the better this mode of use will be respected.

Usage in general and more, especially

Where there is a temporary or definitive contraindication to oral contraception or D.I.U. (intrauterine device)

During contraception after childbirth, interruption of pregnancy or during pre-menopause

O when episodic contraception is desired.


Local application (vaginal route).

The protection obtained by ALPAGELLE is immediate. Renew application before each report

After the reports, an immediate external toilet is possible, but we will wait 1 hour at least if we want to do an intra-vaginal irrigation

The ALPAGELLE specialty can be used alone or possibly with any type of shutter (ALPAGELLE not altering the rubber)

Class: Pharmacotherapeutic: Contraceptive for use, local

(G: system, genitourinary and sex hormones)

Miristalkonium chloride is both a spermicide and an antiseptic.

The active principle causes the rupture of the spermatozoon membrane. On the physiological level, the destruction of the spermatozoon takes place in two stages: first the destruction of the flagellum and then the bursting of the head. This peculiarity guarantees the impossibility of fertilization by an altered spermatozoon. Clinical efficacy is assessed by a corrected Pearl rate of less than 1, if the product is correctly used, most failures are due to incorrect use or lack of use < Code>
The theoretical efficacy evaluated in the laboratory is 100 per cent because any spermatozoal life is impossible in the presence of the active ingredient, even in the trace state. >
The effectiveness of the method varies, according to the rigor of the observation of the indications and the precision of the dialogue preceding the prescription.

There is no modification of the flora, saprophyte: the bacillus of Döderlein is respected.

Miristalkonium chloride also possesses antiseptic activity

In vitro, the product is active on a number of infectious agents responsible for sexually transmitted diseases, including: Gonococci, Chlamydiae, Herpes virus type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. On the other hand, the activity is zero on Mycoplasma and low on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum
In vivo there is evidence of some activity in the prevention of certain diseases which is sexually transmitted without evidence of preventive action.

Hypersensitivity to the active substance or to any of the excipients, see section Composition.
Warnings

This specialty contains terpene derivatives, as excipients, which can lower the threshold, epileptogenic. In case of a history of epilepsy, take into account the presence of terpenic derivatives as excipients.Respect the dosages and duration of treatment recommended
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Precautions for use

Avoid vaginal injections and local use of soap between 12 hours before and 1 hour after the reports.

Due to the presence of miristalkonium chloride, discontinue treatment in the event of the occurrence or aggravation of a genital lesion.

Most of the vaginal or local treatments that can cancel the effect of ALPAGELLE, vaginal cream, wait until the end of treatment, to resume contraception by ALPAGELLE, cream, vaginal. Br>

No cases of overdose have been reported.

Pregnancy

In clinical studies, epidemiological studies have not revealed any malformative effect related to the adventitious use of this spermicide at the beginning of pregnancy.
Breastfeeding

In case of breast-feeding, it is preferable not to use this medicine because
· The absence of kinetic data on the passage of terpene derivatives in milk

· And their potential neurological toxicity in the infant

Due to the presence of terpene derivatives as excipients and in case of non-compliance with doses,
· Possibility of agitation and confusion in the elderly

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Pharmacovigilance Centers - Website: www.ansm. Sante.fr

The therapeutic indications of ALPAGELLE, cream, vaginal are limited to: · Local contraception: this method decreases, considerably the pregnancy without completely eliminating the possibility: the effectiveness will be all the better, Use in general and more, especially where there is a temporary or definite contraindication to oral contraception or to the IUD (intrauterine device); Childbirth, interruption of pregnancy or during pre-menopause, where episodic contraception is desired Contraceptive of local contraception by vaginal obturator (diaphragm) or intrauterine device