Package leaflet: Information for the patient

REACTIFARGAN 2g/100g Cream

Promethazine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

What REACTIFARGAN is and what it is used for
What you need to know before using REACTIFARGAN
How to use REACTIFARGAN
Possible side effects
How to store REACTIFARGAN
Contents of the pack and other information

1. What REACTIFARGAN is and what it is used for

REACTIFARGAN contains promethazine, which blocks histamine, a substance involved in allergic reactions, and reduces pain sensitivity at the site of application.
REACTIFARGAN is indicated for the treatment of insect bites and skin irritations such as redness, burning, itching, and sun erythema (skin irritation caused by excessive exposure to sunlight).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using REACTIFARGAN

Do not use REACTIFARGAN:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
on skin lesions known as eczema, characterized by itching, redness, and blisters that may rupture with leakage of fluid;
on skin lesions presenting with fluid discharge. Do not use REACTIFARGAN in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using REACTIFARGAN.
With prolonged treatment, REACTIFARGAN may cause allergic reactions leading to worsening of the condition. If this occurs, discontinue treatment and consult your doctor or pharmacist.
REACTIFARGAN may delay the wound healing process; if you use this medicine on healing lesions, do not apply it for more than 3–4 consecutive days.
When applied to large areas of skin, REACTIFARGAN may cause drowsiness (see section on driving and use of machines).
In case of sunburn, do not expose the skin to sunlight after applying this medicine.
Discontinue use and contact your doctor if symptoms persist, worsen, or new symptoms appear.

Other medicines and REACTIFARGAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between REACTIFARGAN and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use REACTIFARGAN only if clearly needed.

Driving and using machines
Abundant application of REACTIFARGAN on large areas of skin may cause drowsiness.
Exercise particular caution before driving vehicles or operating machinery.

REACTIFARGAN contains methyl-para-hydroxybenzoate and propyl-para-hydroxybenzoate
These may cause allergic reactions (including delayed reactions).

3. How to use REACTIFARGAN

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply REACTIFARGAN to the affected area 3–4 times a day. Do not exceed the recommended number of daily applications.
Avoid applying on large areas of the body.
If you use more REACTIFARGAN than you should
In case of accidental ingestion/overdose of REACTIFARGAN, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects listed below are derived from post-marketing experience and have unknown frequency
(frequency cannot be estimated from the available data).
The following may occur during treatment:

dermatitis (skin inflammation);
edema (swelling),
redness (erythema),
blisters,
light sensitivity reactions (photosensitivity)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store REACTIFARGAN

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What REACTIFARGAN contains
The active substance is: promethazine.
100 grams of cream contain: 2 grams of promethazine.
The other components are: polyacrylamide isoparaffin laureth-7, octyl methoxycinnamate, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, lavender compound oil, purified water.
Description of the appearance of REACTIFARGAN and contents of the pack
Tube containing 20 or 50 grams of cream.
Marketing Authorization Holder and Manufacturer
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba – Pomezia, ROMA.
Manufacturer:
Famar Orléans, 5 avenue de Concyr - 45071 ORLEANS Cedex 2, France.