Leaflet: information for the user

Nadixa 1% Cream

nadifloxacino

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What Nadixa cream is and for what it is used

2. What you need to know before starting to use Nadixa cream

3. How to use Nadixa cream

4. Possible side effects

5. Storage of Nadixa cream

6. Contents of the pack and additional information

Nadixa is an antimicrobial agent that belongs to the quinolone group.

Nadixa is used for the treatment of mild or moderate inflammatory forms of acne vulgaris(papulopustular acne, grade I-II).

Do not use Nadixa 1% cream

If you are allergic to Nadifloxacino or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nadixa 1% cream.

Avoid contact of Nadixa with the eyes and other mucous membranes (mouth and nose). If, despite this, the cream enters contact with your eyes or other mucous membranes, rinse the area with plenty of warm water.

After applying Nadixa cream, wash your hands with warm water and soap, so that you do not accidentally apply the medication to unwanted areas.

Phototoxicity reactions that develop during systemic treatment with other quinolones are known.While several studies in animals and humans have shown that Nadifloxacino lacks phototoxic and photoallergic potential, the cream base may have a potentiating effect on photosensitivity..Furthermore, there is no experience with prolonged exposure to sunlight or artificial UV light when using Nadixa. Therefore, patients treated with Nadixa should avoid, in principle, exposure to artificial UV radiation (UV lamps, sunbeds, solarium) and avoid, whenever possible, exposure to sunlight.

Discontinue use of Nadixa cream if a hypersensitivity reaction (itching, irritation, papules, vesicles) or severe irritation appears.

Do not apply Nadixa if you have open wounds in the application area.

Children:

The safety and efficacy of Nadixa have not been sufficiently evaluated in children under 14 years of age. Therefore, the medication should not be used in patients of this age group.

Other medications and Nadixa 1% cream:

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

The absorption of Nadifloxacino after applying Nadixa cream to the skin is very low and therefore, it is unlikely to interact with other medications administered concurrently by oral route. There is no evidence to indicate that the efficacy of medications administered systemically may be influenced by the topical use of Nadixa cream.

Nadixa may cause increased skin irritation if applied while using other products with peeling, astringent, and/or irritating substances (alcohols, aromatic agents).

Pregnancy and Breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

No data from clinical studies are available on the effects of Nadifloxacino on pregnant women.

Studies in animals have shown that there is no risk of teratogenicity or other adverse effects on fetal development.

However, Nadixa should only be used during pregnancy after careful evaluation by the doctor of the expected benefit for the mother versus the potential risks to the developing child.

Nadifloxacino is excreted in breast milk, so Nadixa cream should not be used during breastfeeding. Lactating women should not apply Nadixa to the breast under any circumstances.

Driving and operating machinery:

No special precautions are necessary..

Nadixa 1% cream contains alcohol stearate, cetyl alcohol, and benzalkonium chloride:

This medication may cause local skin reactions (such as contact dermatitis) because it contains alcohol stearate and cetyl alcohol.

This medication contains 0.4mg of benzalkonium chloride per 1g of cream. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes. Do not apply this medication to the breast during breastfeeding as it may pass to the baby.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Nadixa is a cream for topical use only.Deposit a small amount of cream (the size of a pea) on a cotton ball to prevent infections.Apply a thin layer of cream to acne lesions twice a day, once in the morning and once before bedtime. Before applying the cream, clean and dry the area carefully. Avoid contact with the eyes and lips. (see also “Warnings and precautions”). Nadixa cream should not be used in occlusive conditions (under a tight bandage).

The normal treatment duration is 8 weeks.

If you use more Nadixa cream than you should

You may experience skin redness and discomfort.

In case of accidental oral ingestion, consider an appropriate gastric emptying method, unless the amount of Nadixa accidentally ingested is small.

If you forgot to use Nadixa cream

If you have forgotten to use Nadixa, continue with the cream application following the instructions described in this leaflet or those indicated by your doctor.

If you interrupt the treatment with Nadixa cream

To achieve the desired effect, carefully follow the instructions on the treatment duration indicated in the “How to use Nadixa” section or those indicated by your doctor. Do not interrupt or discontinue treatment without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Nadixa may have adverse effects, although not everyone will experience them.

In the list of possible adverse effects, which is attached below, we provide an indication of the frequency with which they may occur:

Very Common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very Rare: may affect up to 1 in 10,000 people

Unknown: cannot be determined from available data

Common:

- Itching

Uncommon:

- Pustules, skin dryness, contact dermatitis, skin irritation, skin warmth, redness, hives.

- Burning sensation at the application site.

- Redness

Rare:

- Urticaria

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date indicated on both the box and the tube. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not refrigerate or freeze.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Nadixa Composition

The active ingredient is Nadifloxacino (1%). Each gram of Nadixa cream contains 10 mg of nadifloxacino.

The other components are: soft white paraffin, light liquid paraffin, stearic alcohol, cetyl alcohol, macrogol 5 cetoestearic ether, macrogol 20 cetoestearic ether, sodium hydroxide (E-524), sodium bicarbonate (E-500), sodium carbonate (E-500), glycerol (E-422), disodium edetate, benzalkonium chloride and purified water.

Product appearance and packaging contents

White or off-white cream without a characteristic odor.

Tubes containing 10 g, 20 g, 25 g, 30 g and 50 g.

Tubes containing 5 g (only for samples)

Not all formats may be marketed in all countries.

Marketing authorization holder and manufacturer responsible

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

This leaflet has been approved in:December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.