Lomexin vaginal capsules 600mg per 2

In this manual :

1. WHAT IS LOMEXIN 600 mg, vaginal softgel and WHAT IS IT USED FOR?

2. WHAT DO YOU NEED TO KNOW BEFORE USING LOMEXIN 600 mg, vaginal softgels?

3. HOW DO I USE LOMEXIN 600 mg, vaginal softgel?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE LOMEXIN 600 mg, vaginal softgel?

6. ADDITIONAL INFORMATION

1. WHAT IS LOMEXIN 600 mg, vaginal softgel and WHAT IS IT USED FOR?

Synthetic antifungal agent belonging to the imidazole class.

This medicine is recommended for the local treatment of genital candidiasis (disorders caused by microscopic fungi) whether or not superinfected by Gram-positive bacteria.

2. WHAT DO YOU NEED TO KNOW BEFORE USING LOMEXIN 600 mg, vaginal softgels?

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Never use LOMEXIN 600 mg, vaginal softgel in the following cases:

- Hypersensitivity to any of the components (or cross-sensitivity to other members of the imidazole group),

- If used with male condoms or latex diaphragms.

- If you are allergic (hypersensitive) to peanuts or soya, due to the presence of soya lecithin.

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

Take care with LOMEXIN 600 mg, vaginal softgel:

Special warnings

Local treatment of the fungus is only one part of the treatment. To avoid relapses, it is essential that your doctor check for contributing factors.

This medicine contains parahydroxybenzoate and may cause allergic reactions.

Precautions for use

- Do not use acidic soap for local hygiene (acidity promotes the growth of fungi) (See practical advice in the section: How to use this medicine).

- This treatment may cause local burning and increased itching. Generally, these phenomena cease spontaneously with continued treatment. If the symptoms persist beyond 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 medicines:

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

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

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.

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Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor, as only he or she can judge whether it is necessary to continue the treatment.

In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.

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List of excipients with a notorious effect : sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217), soya lecithin.

3. HOW TO USE LOMEXIN 600 mg, vaginal softgel?

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Dosage

One 600 mg capsule at bedtime, as a single administration.

Practical advice:

- In the case of Candidiasis, washing should be done with a neutral or alkaline pH soap.

- In gynaecology, the treatment should be accompanied by hygiene advice (wear cotton underwear, avoid vaginal showers, etc.) and, as far as possible, the elimination of favourable factors. Do not interrupt the treatment during menstruation.

- To treat vulvar or perianal extensions of the mycosis, it is recommended to combine gynaecological ova with a locally applied antifungal milk or cream.

Method and route of administration

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

Treatment of the partner (prepuce and glans) should be discussed on a case-by-case basis.

Frequency and timing of administration

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

In case of recurrent or resistant mycosis, the administration can be renewed after three days.

IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S PRESCRIPTION.

Duration of treatment

The treatment consists of a single administration.

IN ALL CASES STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, LOMEXIN 600 mg, vaginal softgel is likely to have undesirable effects, although not everyone is subject to them:

- possible occurrence of local burning, itching and possible allergy.

If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO CONSERVE LOMEXIN 600 mg, vaginal softgels?

Keep out of the reach and sight of children.

Do not use LOMEXIN 600 mg, vaginal softgel after the expiry date stated on the outer packaging.

No special storage conditions.

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does LOMEXIN 600 mg, vaginal softgel contain?

The active substance is:

Fenticonazole nitrate .................................................................................................................. 600.0 mg

Amount corresponding to fenticonazole base ................................................................................... 527.1 mg

For one vaginal softgel.

The other components are:

Liquid paraffin, light liquid paraffin, soya lecithin, gelatine, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217).

What is LOMEXIN 600 mg, vaginal softgel and what does it contain?

This medicine is presented as a vaginal softgel. Box of 1 or 2 vaginal softgels.

Holder

EFFIK

9/11, RUE JEANNE BRACONNIER

LE NEWTON" BUILDING

92366 MEUDON LA FORET

Operator

EFFIK

LE NEWTON" BUILDING

9-11, RUE JEANNE BRACONNIER

92366 MEUDON LA FORET

Manufacturer

EFFIK

LE NEWTON" BUILDING

9-11, RUE JEANNE BRACONNIER

92366 MEUDON LA FORET

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The last date on which this package insert was approved was {date}.

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

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