Non-hormonal local contraception with Pharmatex 18.9 mg vaginal ovules. A simple, effective solution for punctual protection, offering peace of mind without affecting the menstrual cycle.
Pharmatex 18.9 mg, in the form of vaginal ovules, is a local contraceptive solution designed to offer an effective, non-hormonal alternative to traditional contraceptive methods. This product is ideal for women looking for a punctual, reliable solution, particularly in cases of temporary or permanent contraindication to hormonal or intrauterine contraceptives. With its active ingredient, benzalkonium chloride, Pharmatex acts as a spermicide, destroying spermatozoa before they reach the ovum, thus reducing the risk of pregnancy.
This local contraceptive is particularly suitable for specific situations: after childbirth, during breastfeeding, during the premenopause, or for those who prefer episodic contraception. Pharmatex can also be used as a complement to intrauterine devices (IUDs) or other local methods such as diaphragms and cervical capes, particularly in the case of prolonged drug treatment with anti-inflammatories.
Unlike hormonal contraceptives, Pharmatex does not alter the menstrual cycle or libido, offering peace of mind without altering the natural hormonal balance. It does not interfere with beneficial vaginal flora, respecting the microbiome and ensuring optimum comfort of use for the user. Its ease of application and effectiveness make it a popular choice for women seeking a convenient, non-invasive alternative to other forms of contraception.
Pharmatex protection lasts for four hours, providing several hours of coverage without the need for reapplication in the event of multiple intercourse. However, to ensure maximum effectiveness, a new egg is recommended for each intercourse. Thanks to its rapid action, it provides almost immediate contraceptive protection when applied a few minutes before intercourse.
Pharmatex 18.9 mg also has a unique profile which, over and above its contraceptive role, takes into account concerns linked to comfort and respect for vaginal flora. Thanks to its non-hormonal composition, this local contraceptive can be used in a variety of situations without interfering with the body's natural cycle. It therefore meets the expectations of users looking for punctual, alternative solutions to conventional contraceptive methods, while maintaining a balance that respects the specific needs of each individual.
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Pharmatex 18.9 mg is taken vaginally, by inserting an ovule deep into the vagina five minutes before intercourse. If repeated intercourse is planned within the same four-hour protection period, another egg must be inserted to ensure continuous protection. Only external cleansing with pure water is recommended after application; avoid internal washing or the use of soap, which could impair the product's efficacy.
Give your opinion on the advice for use and dosage of Pharmatex 18,9 mg with our partner Verified opinions after your purchase.
Precautions for use
Pharmatex 18.9 mg contains the following ingredients: Benzalkonium Chloride, Hydroxypropylcellulose, Hemi-Synthetic Solid Glycerides.
Packaging
Boxes of 10 or 20 ovules.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: June 21, 2024
PHARMATEX 18.9 mg, vaginal suppository
Benzalkonium chloride
You should always use this medication exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this package insert. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See Section 4.
What is in this package insert?
1. What is PHARMATEX 18.9 mg, vaginal suppository, and what is it used for?
2. What should you know before using PHARMATEX 18.9 mg, vaginal suppository?
3. How should you use PHARMATEX 18.9 mg, vaginal suppository?
4. What are the possible side effects?
5. How should you store PHARMATEX 18.9 mg vaginal suppositories?
6. Package contents and other information.
1. WHAT IS PHARMATEX 18.9 mg, vaginal suppository, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: LOCAL CONTRACEPTIVE (G: genitourinary system) - ATC code: G02BB.
This medication is a local contraceptive:
· it contains a spermicide (a chemical that kills sperm);
· it reduces the risk of pregnancy but does not eliminate it entirely. Effectiveness depends on following the instructions for use.
When should PHARMATEX be used?
This local contraceptive is intended for all women seeking contraception, and in particular:
· If you cannot use hormonal contraception (see Section 6) or an intrauterine device (IUD), also known as a coil.
· If you have recently given birth, are breastfeeding, or are in perimenopause.
· If you are looking for occasional contraception.
· As a supplement to contraception using a diaphragm, a cervical cap, or an IUD (especially if you are taking certain medications long-term, such as nonsteroidal anti-inflammatory drugs).
· If you forgot to take a pill from your oral contraceptive or if you took it late.
In these cases, review the package insert for your oral contraceptive and use both methods of contraception for the remainder of your menstrual cycle.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING PHARMATEX 18.9 mg, vaginal suppository?
· If you are allergic to the active ingredient or any of the other ingredients in this medication. You will find the list of ingredients in Section 6.
· If you use male condoms made of polyurethane.
Warnings and Precautions
· Before using PHARMATEX, be sure to read and understand the instructions for use.
· Always insert PHARMATEX deep into the vagina before each sexual intercourse, regardless of where you are in your menstrual cycle.
· Soapy water destroys the active ingredient in this local contraceptive. Therefore, you must not wash your genital area with soap 2 hours before or 2 hours after intercourse. Only external cleansing with plain water is permitted for both partners.
· Wait at least 2 hours if you wish to perform a vaginal rinse with plain water.
· Avoid taking a bath or swimming in the ocean or a pool. This could reduce the effectiveness of PHARMATEX.
· If a genital lesion develops or worsens, stop treatment and consult your doctor.
· If vaginal treatment or the use of any other vaginal product is necessary, wait until the end of that treatment before (re)starting contraception with PHARMATEX.
Warning: This method of contraception does not protect against sexually transmitted infections or AIDS. To date, only condoms provide effective protection.
Why is it important to follow the instructions for use exactly?
The effectiveness of this local contraceptive method is lower than that of other forms of contraception, such as:
· hormonal contraception: oral contraceptives, subcutaneous implants, contraceptive patches, hormone-releasing IUDs, vaginal rings,
· the copper IUD,
· the diaphragm and cervical cap,
· condoms.
Therefore, it is very important that your doctor or pharmacist explain the instructions for use to you in detail.
If you do not understand how to use this medication, do not hesitate to ask your pharmacist or doctor again.
To ensure the most effective contraception possible, it is important to follow the instructions for use.
Use a vaginal suppository every time before sexual intercourse, regardless of where you are in your menstrual cycle, including during your period.
Other Medications and PHARMATEX 18.9 mg, Vaginal Suppository
· It is generally not recommended to use PHARMATEX at the same time as other vaginal medications or soaps. These products may reduce PHARMATEX’s contraceptive effectiveness.
· If your doctor has prescribed a vaginal treatment, wait until the treatment is finished before using PHARMATEX.
If you wish to use a condom with PHARMATEX 18.9 mg vaginal suppository, be sure to check the condom’s ingredients beforehand and refer to the “Practical Advice” section in Section 3 before use.
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications.
PHARMATEX with food and beverages
Not applicable.
Pregnancy
Using PHARMATEX early in an unrecognized pregnancy does not pose a specific risk to the fetus.
Breastfeeding
Breastfeeding is possible.
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medication.
Driving and operating machinery
Not applicable.
PHARMATEX contains
Not applicable.
3. HOW TO USE PHARMATEX 18.9 mg, vaginal suppository?
· Insert one ovule before every sexual intercourse, regardless of where you are in your menstrual cycle, including during your period.
· If you have sex more than once, use a new ovule before each additional instance of sex.
Method and Route of Administration
This medication is for vaginal use only. Do not swallow it.
It is necessary to follow the instructions for use below, as effectiveness depends on proper use:
· Always insert a vaginal suppository deep into the vagina 5 minutes before each sexual intercourse, regardless of where you are in your menstrual cycle, including during your period.
· Insert the ovule preferably while lying down, as this makes it easier to place it deep inside the vagina.
· Insert another ovule before each sexual intercourse if you have repeated intercourse.
· Protection lasts for 4 hours.
· Immediately before or after intercourse, only external cleansing with plain water is permitted for both partners. Do not wash your genital area with soap.
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Practical Tips
This contraceptive method iscompatiblewith:
· silicone diaphragms
· silicone cervical caps
· latex and polyisoprene male condoms.
This contraceptive method is contraindicated for use with male condoms made of polyurethane.
If you have used more PHARMATEX than you should have
Consult your doctor or pharmacist immediately
If you forget to use PHARMATEX
If you stop using PHARMATEX
Not applicable.
If you have any other questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Rare side effects (affecting 1 to 10 out of 10,000 patients)
· itching, burning sensations, or local irritation in one or both partners.
Side effects of unknown frequency (cannot be estimated based on available data)
· Allergy to any of the drug’s ingredients.
You can recognize the signs of an allergic reaction by redness, itching, and, very rarely, sudden swelling of the neck and face causing difficulty breathing. If these signs occur, consult a doctor immediately.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package insert. You can also report side effects directly through the national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: https://signalement.social-sante.gouv.fr/.
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD PHARMATEX 18.9 mg, vaginal suppository, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date printed on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding +25°C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What PHARMATEX 18.9 mg, vaginal suppository contains
· The active ingredient is:
Benzalkonium chloride.............................................................................................. 18.9 mg
Per vaginal suppository
· The other ingredients are:
Hydroxypropylcellulose and solid semi-synthetic glycerides (Witepsol S51 type).
What is PHARMATEX 18.9 mg, vaginal suppository, and contents of the outer packaging
This medication comes in the form of a vaginal suppository.
Each box contains 10 or 20 ovules.
Marketing Authorization Holder
LABORATOIRE INNOTECH INTERNATIONAL
22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
Marketing Authorization Holder
INNOTECH INTERNATIONAL LABORATORY
22 ARISTIDE BRIAND AVENUE
94110 ARCUEIL
Rene Chantereau Street, Chouzy-sur-Cisse
41150 VALLOIRE-SUR-CISSE
Drug names in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Detailed information about this medication is available on the ANSM (France) website.
BASIC INFORMATION ABOUT THE MENSTRUAL CYCLE AND CONTRACEPTION
What is the menstrual cycle?
· The menstrual cycle is the period between the first day of one menstrual period and the start of the next.
· Usually, the cycle lasts 28 days, though it can vary significantly from one woman to another.
· Menstruation occurs when a woman is not pregnant.
What is ovulation, and when does it occur?
· Ovulation is when the ovary releases an egg, which is then picked up by the fallopian tube.
· Generally, ovulation occurs in the middle of the cycle, but it can occur at any time during the cycle, even during menstruation.
When does pregnancy begin?
· If sperm are near the egg in the fallopian tube, “fertilization” (that is, the union of the egg and a sperm to create an embryo) can occur.
· After a few days, the fertilized egg will attach (or “implant”) in the uterus, and pregnancy begins.
What are the main methods of contraception?
· Hormonal contraception: oral contraceptives, subcutaneous implant, contraceptive patch, hormone-releasing intrauterine device (IUD), vaginal ring.
· The copper IUD.
· Local contraception: spermicides, condoms, diaphragms, cervical caps.
· Female sterilization.
What are the ways to prevent sexually transmitted infections (STIs), including HIV infection and AIDS?
When used correctly during sexual intercourse, condoms (male or female) are the only form of contraception that also protects against STIs and the Human Immunodeficiency Virus (HIV), which causes AIDS (Acquired Immunodeficiency Syndrome).
Other methods of contraception do not protect against these sexually transmitted infections or against AIDS.
What should I do if I’ve had unprotected sex or if I forgot to use my usual method of contraception?
If you find yourself in this situation, seek advice from your doctor or pharmacist as soon as possible.
· You can use emergency contraception (also known as the morning-after pill). It must be taken as soon as possible.
· This type of contraception works by preventing pregnancy by blocking or delaying ovulation.
What should you do if your situation changes or if this method of birth control isn’t right for you or no longer works for you?
Consult your doctor so they can prescribe another method of contraception that is better suited to your situation.
This medication contains an antiseptic from the quaternary ammonium family that destroys sperm.
It is used as a local contraceptive.
The prices listed do not include the pharmacist’s “dispensing fee.”
The most recent update to the information contained in this medication fact sheet applies only to product forms still on the market.
| p caps | cream per 100 g | |
| Benzalkonium chloride | 18.9 mg | 1.2 g |
| p mini suppository | ovule | |
| Benzalkonium chloride | 18.9 mg | 18.9 mg |
To ensure the most effective contraception possible, it is important to follow the instructions for use.
If you are undergoing vaginal treatment with other topical products, it is best to wait until the treatment is complete before using this method of contraception.
Since this medication contains a substance that may be irritating, it should not be used if you have genital sores or ulcers (herpes, etc.).
This spermicide must not be used with polyurethane condoms: risk of condom breakage. However, it is compatible with silicone diaphragms and cervical caps, as well as latex and polyisoprene condoms.
Combining this spermicide with other antiseptics or soaps reduces its effectiveness: do not wash the genital area with soapy water 2 hours before or after intercourse, and use only plain water for your intimate hygiene after intercourse.
In cases of pregnancy that occurred despite the use of this spermicide, no abnormalities in the unborn child have been observed.
This contraceptive may be used by breastfeeding women.
After sexual intercourse, external cleansing is possible with plain water or with Pharmatex foaming bar only, as conventional soaps neutralize the spermicide’s effectiveness. Wait at least 2 hours before douching.
The cream and ovules do not damage latex condoms.
Allergic reaction.
A skin reaction (itching, hives, swelling) or general discomfort that occurs after contact with a specific substance, the use of a medication, or the ingestion of a food. The main forms of allergy are eczema, hives, asthma, angioedema, and allergic shock (anaphylactic shock). Food allergies can also cause digestive problems.
A class of antiseptics found in many topical medications. Generally well-tolerated, they can, however, rarely cause allergic reactions.
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also effective against microscopic fungi and viruses.
Something that prevents conception: oral contraceptives (the pill), local contraceptives (IUD, spermicide, diaphragm, and condoms).
See the article: Female Contraception
A dome-shaped muscle that separates the thorax from the abdomen. Its contraction (during inhalation) presses against the abdominal organs and creates a vacuum in the chest cavity, thereby drawing air into the lungs. The diaphragm has three openings through which the esophagus, the vena cava, and the aorta pass. When abdominal organs protrude into the chest through one of these openings, this is called a diaphragmatic hernia.
See the articles: Genital Herpes and Cold Sore (oral herpes)
A reaction caused by the body’s hypersensitivity to a medication. Allergic reactions can take many different forms: hives, angioedema, eczema, a rash resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes dizziness due to a sudden drop in blood pressure.
See the article: Can You Be Allergic to Medications?
A small ulcer.
Endometriosis is a condition affecting women of childbearing age. This pathology usually results in severe pain during menstruation and fertility problems. It is the presence, outside the uterus, of one or more clusters histologically similar to the endometrium (endometriomas) that define in particular the presence of endometriosis. These clusters are preferably located in the ovaries, the posterior cul-de-sac and the…
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