NADIXA 1% CREAM

2. What you need to know before using Nadixa 1% cream

Do not use Nadixa 1% cream

If you are allergic to Nadifloxacin 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 between Nadixa and your eyes and other mucous membranes (mouth and nose). If, despite this, the cream comes into 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 to avoid accidentally applying the medication to unwanted areas.

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

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

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 in this age group.

Other medications and Nadixa 1% cream:

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

The absorption of Nadifloxacin after applying Nadixa cream to the skin is very low, and therefore, interaction with other medications administered orally is unlikely. There is no evidence to suggest that the efficacy of systemically administered medications may be affected by the topical use of Nadixa cream.

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

Pregnancy and Breastfeeding:

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

There are no clinical study data available on the effects of Nadifloxacin in pregnant women.

In animal studies, it has been shown that there is no risk of teratogenicity or other negative effects on fetal development.

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

It is known that Nadifloxacin is excreted in breast milk, so Nadixa cream should not be used during breastfeeding. Breastfeeding women should not apply Nadixa to the breast under any circumstances.

Driving and Using Machines:

No special precautions are necessary.

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

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

This medication contains 0.4 mg of benzalkonium chloride per 1 g 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.

3. How to use Nadixa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Nadixa is a cream for topical use only. Place a small amount of cream (the size of a pea) on a cotton swab to avoid infections. Apply a thin layer of the cream to the acne lesions twice a day, once in the morning and once before bedtime. Before applying the cream, clean and dry the area carefully. Avoid getting the cream in your eyes and lips (see also "Warnings and Precautions"). Nadixa cream should not be used under occlusive conditions (under a tight bandage).

The normal treatment duration is 8 weeks.

If you use more Nadixa cream than you should

It may cause redness and skin discomfort.

In case of accidental oral ingestion, a suitable method of gastric lavage should be considered, unless the amount of Nadixa accidentally ingested is small.

If you forget to use Nadixa cream

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

If you interrupt treatment with Nadixa cream

To achieve the desired effect, carefully follow the instructions on the duration of treatment indicated in the "How to use Nadixa" section or as indicated by your doctor. Do not interrupt or suspend treatment without consulting your doctor.

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

4. Possible Side Effects

Like all medications, Nadixa can have side effects, although not everyone will experience them.

The following is an indication of the frequency with which possible side effects 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:

• Papules, skin dryness, contact dermatitis, skin irritation, warmth in the skin, redness, rash.
• Burning sensation at the application site.
• Redness

Rare:

• Urticaria

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nadixa Cream

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date indicated on the box and 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 wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Nadixa Composition

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

The other components are: soft white paraffin, light liquid paraffin, stearyl alcohol, cetyl alcohol, macrogol 5 cetostearyl ether, macrogol 20 cetostearyl 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 Package 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

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

This package leaflet was approved in: December 2023

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