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Lomexin 600 mg, 2 Vaginal Capsules for Candidiasis
Over-the-counter medication

Lomexin 600 mg, 2 Vaginal Capsules for Candidiasis

Brand : Effik Effik
used for :

Lomexin 600 mg vaginal capsule is an antifungal indicated for the local treatment of genital candidiasis (infections caused by microscopic fungi), whether or not complicated by Gram-positive bacterial superinfection.

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What is Lomexin 600 mg 2 Vaginal Capsules for Candidiasis used for?

Lomexin 600 mg vaginal capsule is a synthetic antifungal agent belonging to the pharmacological class of imidazoles. This medication is indicated for the local treatment of genital candidiasis (infections caused by microscopic fungi), whether or not complicated by Gram-positive bacterial superinfection.

Lomexin 600 mg vaginal capsule is a synthetic antifungal agent belonging to the pharmacological class of imidazoles. This medication is indicated for the local treatment of genital candidiasis (infections caused by microscopic fungi), whether or not complicated by a secondary Gram-positive bacterial infection.

Genital candidiasis, more commonly known as genital yeast infections, most often affects women. What causes it? Specific circumstances such as menstruation, pregnancy, or taking antibiotics. Genital yeast infections cause redness and itching. Treatment is usually topical.

This is a fungal infection of the genital organs. It is extremely common, particularly among women. The fungus responsible is almost always Candida albicans. The infection most often occurs endogenously, linked to the growth of Candida already present in the vagina or on the skin. It can also occur exogenously, through sexual contact, swimming pools, beaches, and so on. However, vaginal candidiasis is not considered a sexually transmitted infection.

As a basic treatment, we recommendJailys Soothing and Restorative Balm, which is recommended for all women who want to protect their intimate area from external irritants, who are seeking comprehensive restoration, long-lasting relief, softer, more beautiful skin and mucous membranes, and who wish to maintain a healthy scent.

How should these vaginal capsules be used?

Dosage:

1 600-mg capsule at bedtime, as a single dose. Repeat 3 days later in case of recurrence or chronic conditions. To prevent recurrent vaginal infections, we recommend taking Gynophilus capsules.

Practical Tips:

  • In cases of candidiasis, wash the area with a pH-neutral or alkaline soap.
  • In gynecology, treatment will be accompanied by hygiene advice (wearing cotton underwear, avoiding vaginal douches, etc.) and, whenever possible, the elimination of contributing factors. Do not interrupt treatment during menstruation.
  • To treat vulvar or perianal spread of the fungal infection, it is recommended to combine the vaginal capsules with an antifungal lotion or cream applied topically.

Method and Route of Administration:

The capsule should be inserted deep into the vagina, preferably while lying down. Treatment of the partner (foreskin and glans) should be discussed on a case-by-case basis.

Frequency and timing of administration:

At bedtime, insert one capsule deep into the vagina, preferably while lying down.

In cases of recurrent or refractory yeast infection, treatment may be repeated after three days.

In all cases, strictly follow your doctor’s prescription.

Duration of treatment:

1 600-mg capsule at bedtime, as a single dose. Repeat 3 days later in cases of recurrence or chronic conditions.

Never use Lomexin 600 mg vaginal capsule in the following cases:

  • Hypersensitivity to any of the ingredients (or cross-sensitivity with other members of the imidazole group),
  • When used with male condoms or latex diaphragms,
  • If you are allergic (hypersensitive) to peanuts or soy, due to the presence of soy lecithin.
If in doubt, it is essential to consult your doctor or pharmacist.

Take special care with LOXEMIN 600 mg, vaginal soft capsule:

Special Warnings:

Local treatment of yeast infections is only one part of the overall treatment. To prevent recurrence, it is essential that your doctor identify any contributing factors.
This medication contains para-hydroxybenzoate and may cause allergic reactions.

Precautions for use:

  • Do not use acidic soap for local hygiene (as acidity promotes fungal growth).
  • This treatment may cause a local burning sensation and increased itching. These symptoms usually subside on their own as treatment continues. If symptoms persist for more than 24 to 48 hours, consult your doctor.
If in doubt, do not hesitate to ask your doctor or pharmacist for advice.

Taking or using other medications:

Do not use with spermicides (risk of inactivation).
To avoid potential interactions between multiple medications, always inform your doctor or pharmacist of any other treatments you are currently taking.

Pregnancy and Breastfeeding:

It is best not to use this medication during pregnancy.
If you discover that you are pregnant while taking this medication, consult your doctor, as only he or she can determine whether it is necessary to continue treatment.
In general, during pregnancy and while breastfeeding, you should always consult your doctor or pharmacist before taking any medication.

List of excipients with known effects: Sodium ethyl parahydroxybenzoate (E 214), sodium propyl parahydroxybenzoate (E 217), soy lecithin.

What is its composition?

The active ingredient is: Fenticonazole nitrate : 600.0 mg per vaginal capsule, equivalent to 527.1 mg of fenticonazole base per capsule.

The other ingredients are: Liquid paraffin , light liquid paraffin, soy lecithin. Capsule shell: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 214), sodium propyl parahydroxybenzoate (E 217).

Excipients with known effects: Sodium ethyl parahydroxybenzoate (E 214), sodium propyl parahydroxybenzoate (E 217), soy lecithin.

Packaging

Box of two vaginal capsules

Summary of Product Characteristics (ANSM)

Medication Warnings

Warning: This medication is not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.

  • Please inform your online pharmacist of any current treatments to identify potential incompatibilities. The order confirmation form includes a custom message field for this purpose.
  • Click here to view the package insert for this medication on the website of the French National Agency for Medicines and Health Products Safety.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on: 29/07/2016

Name of the medicinal product

LOMEXIN 600 mg, soft vaginal capsule

Fenticonazole Nitrate

framed

Read all of this leaflet carefully before you start using this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult a physician.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS LOMEXIN 600 mg, soft vaginal capsule AND WHAT IT IS USED FOR?

2. BEFORE YOU USE LOMEXIN 600 mg, soft vaginal capsule?

3. HOW TO USE LOMEXIN 600 mg vaginal soft capsule?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE LOMEXIN 600 mg vaginal soft capsule?

6. ADDITIONAL INFORMATION

1. WHAT IS LOMEXIN 600 mg, soft vaginal capsule AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

A synthetic antifungal belonging to the class of imidazoles.

Therapeutic indications

This medication is recommended in the local treatment of genital candidiasis (diseases due to microscopic fungi) superinfected or not by Gram + bacteria.

2. BEFORE YOU USE LOMEXIN 600 mg, soft vaginal capsule?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use LOMEXIN 600 mg vaginal soft capsule in the following cases:

· Hypersensitivity to one component (or cross-sensitivity to other members of the imidazole group),

· For use with male condoms or latex diaphragms.

· If you are allergic (hypersensitive) to peanut or soybean, due to the presence of soy lecithin.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Precautions for use; special warnings

Take special care with LOMEXIN 600 mg, soft vaginal capsule:

Special warnings

Local treatment of mycosis is only one element of treatment. To avoid relapses, the search for factors favoring your doctor is essential.

This medicine contains parahydroxybenzoate and may cause allergic reactions.

Precautions for use

· Do not use acid soap for local hygiene (acidity promoting fungal growth) ( See practical tips in the section: How to use this medicine ).

· This treatment can cause local burning sensations and increased itching. Generally, these phenomena yield spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, consult your doctor.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Interaction with other medicines

Taking or using other medicines:

Do not use when using male condoms or latex diaphragms (risk of rupture).

Do not use with spermicidal products (risk of inactivation).

TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

It is best not to use this medication during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

List of excipients with known effect : Sodium parahydroxybenzoate, Sodium propyl parahydroxybenzoate (E 217), Soy lecithin.

3. HOW TO USE LOMEXIN 600 mg vaginal soft capsule?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

A capsule at 600 mg at bedtime, in single administration.

Practical advice:

· In the case of candidiasis, the toilet is to be performed with a soap at neutral or alkaline pH.

· In gynecology, treatment will be accompanied by hygiene advice (wearing cotton underwear, avoiding vaginal showers ...) and, as far as possible, the removal of favorable factors. Do not stop treatment during menstruation.

· To treat vulvar or perianal extensions of mycosis, it is recommended to associate with the gynecological ovules a milk or antifungal cream applied locally.

Method and route of administration

The capsule should be inserted deep into the vagina, preferably in the extended position.

The treatment of the partner (foreskin and glans) will be discussed according to each case.

Frequency and timing of administration of the drug

In the evening, at bedtime, a capsule will be inserted, placed deep in the vagina, preferably in the lying position.

In the case of recurrent or rebellious mycosis, administration may be repeated after three days.

IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.

Duration of treatment

The treatment consists of a single administration.

IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.

Symptoms and Instructions for Overdose

Not applicable.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, LOMEXIN 600 mg, soft vaginal capsule is likely to have side effects, although not everyone is subject to it:

· possible local burning sensation, itching and possible allergy.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE LOMEXIN 600 mg vaginal soft capsule?

Keep out of the reach and sight of children.

Expiration date

Do not use LOMEXIN 600 mg vaginal soft capsule after the expiry date which is stated on the outer packaging.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does LOMEXIN 600 mg contain, soft vaginal capsule?

The active substance is :

Fenticonazole Nitrate ............................................... .................................................. 600.0 mg

Quantity corresponding to fenticonazole base ............................................. ...................................... 527.1 mg

For a soft vaginal capsule.

The other components are :

Liquid paraffin, light liquid paraffin, soy lecithin, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, soda propyl parahydroxybenzoate (E 217).

Pharmaceutical form and content

What is LOMEXIN 600 mg, soft vaginal capsule and contents of the pack?

This medication is in the form of a soft vaginal capsule. Box of 1 or 2 soft vaginal capsules.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

EFFIK

9/11, RUE JEANNE BRACONNIER

BUILDING "THE NEWTON"

92366 MEUDON LA FORET

exploiting

EFFIK

BUILDING "LE NEWTON"

9-11, RUE JEANNE BRACONNIER

92366 MEUDON LA FORET

Maker

EFFIK

BUILDING "LE NEWTON"

9-11, RUE JEANNE BRACONNIER

92366 MEUDON LA FORET

LA FRANCE

or

CATALENT ITALY SPA

VIA NETTUNENSE, KM 20, 100

04011 APRILIA (LT)

ITALY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

VIDAL OF THE FAMILY

LOMEXIN capsule

antifungal

fenticonazole

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

LOMEXIN: vaginal capsule; box unit.
Refunded at 30%. - price: 3,29 euro (s).

LOMEXIN: vaginal capsule; box of 2.
-

Laboratory Effik

COMPOSITION (summary)
p caps
Fenticonazole nitrate 600 mg

INDICATIONS (summary)
This drug of local action contains an antifungal agent of the imidazole family.
It is used in the treatment of candidiasis of the vagina and the vulva.
CONTRAINDICATIONS (summary)
This medication should not be used if you are allergic to antifungal agents in the imidazole family.
WARNING (Contents)
Do not use a condom during treatment: risk of rupture by latex alteration.
If the infection does not go away after a few days, consult your doctor.
DRUG INTERACTIONS (summary)
Use of a condom is contraindicated during treatment (see WARNING).
Like any vaginal treatment, this drug may decrease the contraceptive effectiveness of spermicidal creams and ovules.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known: only your doctor can evaluate the possible risk of its use in your case.
DIRECTIONS FOR USE AND DOSAGE (summary)
The capsule should be inserted into the vagina.

Usual dosage:

1 capsule at bedtime, to be renewed 3 days later.
TIPS (summary)
Insert the capsule in the extended position, then lie down for 5 to 10 minutes. The capsule can be the cause of a disturbing flow: it is advisable to wear a protection.
During menstruation, do not stop treatment and avoid wearing tampons.
In case of recurrent gynecological fungi ( candidiasis ), it is useful to respect the usual advice to prevent the abnormal development of candida albicans and other microscopic fungi:
  • limiting the use of antibiotics to conditions requiring their use. Indeed, fungi are destroyed by certain bacteria , themselves killed by antibiotics;
  • fight against moisture, conducive to the development of mushrooms: dry well before putting on his underwear, prefer cotton panties that absorb better perspiration, do not keep his swimsuit after swimming in swimming pool, avoid the harbor clothing too tight;
  • change internal or external protections frequently during menstruation;
  • avoid using acid soaps: they promote the multiplication of fungi.
Your partner may be contaminated with no symptoms . If not treated together, recontamination is possible.
POSSIBLE ADVERSE EFFECTS (summary)
Aggravation of burns and itching at the beginning of treatment: these symptoms reflect the destruction of microscopic fungi that release an irritating substance. These manifestations do not usually recur in subsequent applications. If this is not the case, it may be an intolerance or an allergy to the medication: contact your doctor.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antibiotics
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .


antifungal
Medication that destroys fungi and microscopic yeasts. These can be present on the skin or the mucous membranes (digestive tract or genital organs). The most common yeast is Candida albicans.


bacteria
Microscopic organism that can cause infections. Unlike viruses, bacteria are usually susceptible to antibiotics.


candidiasis
Abnormal multiplication of a microscopic yeast, Candida albicans most often. This is a frequent and benign complication of antibiotic treatments. The main symptoms are digestive disorders, a brown or black color of the tongue, white spots on the palate or tongue (thrush), itching or burning of the vulva or glans.


imidazole
A family of medicines that includes antifungals, antibiotics and antiparasitics.


intolerance
Undesirable effect, most often digestive, when taking a drug. The irritation of the stomach due to aspirin is intolerance and not an allergy.


mycoses
Affection due to microscopic fungi, favored by the taking of antibiotics.


symptom
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.

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