NADIXA 1% Cream

Зміст інструкції

1. Nadixa 1% Crema
   1. WHAT IS NADIXA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NADIXA
   3. HOW TO TAKE NADIXA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NADIXA
   6. OTHER INFORMATION

Nadixa 1% Crema

Active ingredient:Nadifloxacina

Read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Nadixa 1% crema is and what it is used for
• 2. What you need to know before you use Nadixa 1% crema
• 3. How to use Nadixa 1% crema
• 4. Possible side effects
• 5. How to store Nadixa 1% crema
• 6. Further information

1. WHAT IS NADIXA AND WHAT IS IT USED FOR

Nadixa is an anti-infective agent belonging to the quinolone group.
Nadixa cream is used for the topical treatment of mild to moderate inflammatory forms of acne
vulgaris (papulo-pustular acne, grade I-II).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NADIXA

Do not take Nadixa

• If you are allergic to nadifloxacin or any of the other ingredients of Nadixa.

Warnings and precautions

• Avoid contact with eyes or other mucous membranes. If Nadixa cream accidentally comes into contact with the eyes and mucous membranes, rinse immediately with lukewarm water.
• After using Nadixa cream, wash your hands with warm water and soap to avoid unintentional contact of Nadixa cream with other areas.
• Photosensitivity reactions develop during therapy with other quinolones administered systemically. While numerous studies conducted on animals and humans have not highlighted any phototoxic or photoallergic potential of the active ingredient nadifloxacin, the cream base may determine increased photosensitivity. Furthermore, there is no data available regarding prolonged exposure to sunlight or artificial UV light under treatment with Nadixa. Therefore, patients undergoing treatment with Nadixa should generally avoid irradiation with artificial UV light (UV lamps, tanning beds, solariums) and, when possible, exposure to sunlight.
• If signs of hypersensitivity reactions (manifesting as itching, erythema, papules, vesicles) or severe skin irritation appear, the use of Nadixa cream should be discontinued.
• The product should not be applied to damaged, cracked or eroded skin.

Children
The safety and efficacy of Nadixa cream have not been sufficiently studied in children under the age of
14 years. Therefore, Nadixa should not be used in patients belonging to this age group.

Other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.
The absorption of nadifloxacin after application of Nadixa to human skin is very poor and, therefore, it is
unlikely to interact with drugs administered simultaneously orally. There is no evidence
to suggest that the effectiveness of systemically administered drugs is affected by the topical use of
Nadixa cream.
Nadixa cream can cause skin irritation and therefore it is possible that the simultaneous use of exfoliants,
astringents or products containing irritating substances, such as aromatic and alcoholic substances, may cause an
increase in skin irritation.

Pregnancy and breastfeeding
There are no clinical data on the use of nadifloxacin in pregnancy.
Studies conducted in animals do not indicate teratogenic effects or harmful effects on fetal development.
However, Nadixa cream should only be used during pregnancy after an evaluation by
a doctor of the benefits and risks to the mother and the development of her baby.
It is known that the active ingredient nadifloxacin is excreted in breast milk and, therefore, Nadixa cream should not be
used during breastfeeding. In no case should breastfeeding women apply Nadixa to the breast.

Driving and operating machinery
No special precautions are necessary.

Important information about some ingredients contained in Nadixa cream
Cetyl alcohol and stearyl alcohol can cause local skin reactions (e.g. contact dermatitis).
Benzalkonium chloride can cause skin irritation.

3. HOW TO TAKE NADIXA

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Nadixa must be applied in a thin layer to the skin areas affected by acne twice a
day. Nadixa cream is only suitable for external use and must be applied in a thin layer to the
areas affected by acne in the morning and at night before going to bed, after cleansing the skin. The skin must
be thoroughly dry before use. Nadixa cream must not come into contact with the eyes and the
lips (see also warnings and precautions). To avoid infections, Nadixa cream must be applied
with a cotton swab. Nadixa should not be used with occlusive dressings.
In general, the duration of treatment is up to 8 weeks.
If you take more Nadixa cream than you should:
You may experience marked redness or an unpleasant sensation on the skin.
If a quantity of Nadixa cream is accidentally ingested, appropriate gastric lavage should be considered, unless the amount ingested is small.
If you forget to take Nadixa cream:
If you have forgotten to use Nadixa cream, continue with the applications as described in the
instructions or as indicated by your doctor.
If you stop taking Nadixa cream
To achieve the desired success of the treatment, carefully follow the instructions regarding the duration of
therapy described in the paragraph “How to take Nadixa” or as indicated by your doctor. Treatment should not
be interrupted or discontinued without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nadixa can cause side effects, although not everybody gets them.
The most commonly reported adverse reaction during clinical studies was itching (>1.8%).
Below are listed adverse reactions considered at least possibly related to the drug and more
commonly reported with nadifloxacina cream.
The frequencies correspond to:
Very common: >1/10
Common: >1/100, ≤ 1/10
Uncommon: >1/1,000, ≤ 1/100
Rare: >1/10,000, ≤ 1/1,000
Very rare: ≤ 1/10,000, including isolated cases

Skin and subcutaneous tissue disorders:
Common: itching
Uncommon :papules, dry skin, contact dermatitis, skin irritation, skin burning sensation,
redness, rash.
Rare: urticaria.

Systemic disorders and conditions related to the application site:
Uncommon: burning at the application site.

Vascular disorders:
Uncommon: redness.

Post-marketing data:
Isolated cases: skin hypopigmentation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE NADIXA

Keep this medicine out of the sight and reach of children.
Do not use Nadixa after the expiry date which is stated on the tube and the packaging. The expiry date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Nadixa contains

• The active ingredient is Nadifloxacin (1%). Each gram of Nadixa contains 10 mg of nadifloxacin.
• The other ingredients are: white petrolatum, light liquid paraffin, stearyl alcohol, cetyl alcohol, Ceteth 5, Ceteth 20, sodium hydroxide, glycerol, diethanolamine, disodium edetate, benzalkonium chloride and purified water.

Description of the appearance of Nadixa and contents of the pack
Cream from white to off-white, without a distinctive odour.
Tubes of 10 g, 20 g, 25 g, 30 g and 50 g
Tubes of 5 g (for samples only)
Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer
FERRER INTERNACIONAL, S.A.
Gran Vía Carlos III, 94
08028 Barcelona (Spain)

Distributor for sale
Elytra Pharma
Viale Monte Nero, 70 - 20135 Milan