Active ingredients: Promethazine
REACTIFARGAN 2g / 100g Cream
Why is Reactifargan used? What is it for?
REACTIFARGAN is a cream based on promethazine, an active ingredient belonging to the class of antihistamines. Promethazine works by blocking histamine, a substance involved in allergic reactions. Promethazine also decreases local sensitivity.
REACTIFARGAN calms itching, redness, burning and other skin disorders due to irritation, caused for example by insect bites or excessive exposure to the sun (sunburn).
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Reactifargan should not be used
Do not use REACTIFARGAN:
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- on skin lesions called eczema, characterized by itching, redness and blisters that can rupture with fluid leaking;
- on skin lesions that occur with leakage of liquid.
Do not use REACTIFARGAN in children under 2 years of age.
Precautions for use What you need to know before taking Reactifargan
Talk to your doctor or pharmacist before using REACTIFARGAN.
Like other medicines for local (topical) use, especially in case of prolonged therapy, REACTIFARGAN can cause redness and itching (possible sensitization phenomena) at the application site. In this case, stop the treatment and contact your doctor or pharmacist.
REACTIFARGAN can delay the wound healing process; if you use this medicine on healing wounds, do not apply it for more than 3-4 consecutive days.
If applied on very large areas of the skin REACTIFARGAN can cause drowsiness in particularly sensitive patients. This can be avoided by using a thin layer of cream.
If you have sunburn, do not expose your skin to the sun after applying this medicine.
Interactions Which drugs or foods can modify the effect of Reactifargan
There are no known interactions between REACTIFARGAN and other drugs. However, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
The application of REACTIFARGAN on very large areas of the skin may cause drowsiness in particularly sensitive patients. Take special care before driving or using machines.
REACTIFARGAN contains: methyl-para-hydroxybenzoate and propyl-para-hydroxybenzoate which can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Reactifargan: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply REACTIFARGAN to the affected area 3-4 times a day. Use a thin layer of cream, in case of application on very large areas of the skin.
In healing wounds, do not use REACTIFARGAN for more than 3-4 consecutive days.
Avoid contact with eyes or other mucous membranes.
Do not exceed the recommended dose. Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Overdose What to do if you have taken too much Reactifargan
In case of accidental ingestion / intake of an overdose of REACTIFARGAN, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Reactifargan
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice: rash, irritation, burning, redness, spots on the skin, blisters after sun exposure (photosensitivity). REACTIFARGAN contains a sunscreen which can limit these effects.
When applied to very large areas of the skin, REACTIFARGAN can cause drowsiness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at “http://www.aifa.gov.it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Unused product and waste resulting from this medicine must be disposed of in accordance with local legal requirements.
Deadline "> Other information
What REACTIFARGAN contains
The active ingredient is: promethazine.
100 grams of cream contain: 2 grams of promethazine.
The other ingredients are: polyacrylamide isoparaffin laureth-7, octyl methoxycinnamate, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, lavender compound oil, purified water.
Description of what REACTIFARGAN looks like and contents of the pack
REACTIFARGAN is available in a tube containing 20 or 50 grams of cream.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
REACTIFARGAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Cream
100 g of cream contain:
Active principle: promethazine 2.00 g
Emulsion
100 g of emulsion contain:
Active principle: promethazine 2.00 g
03.0 PHARMACEUTICAL FORM -
Cream.
Emulsion.
TOPICAL USE.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Local symptomatic treatment for insect bites and other localized skin irritations such as redness, burning, itching and sunburn.
04.2 Posology and method of administration -
Apply 3-4 times a day. Do not exceed the recommended dose.
04.3 Contraindications -
REACTIFARGAN is contraindicated in subjects hypersensitive to the components or to other closely related substances from a chemical point of view, in eczema, in all secreting lesions.
The medicine is contraindicated in children under 2 years of age
04.4 Special warnings and appropriate precautions for use -
Prolonged and incongruous use of the product can give rise to allergic sensitization phenomena with consequent worsening of symptoms.
If this occurs, the treatment must be suspended and the doctor consulted in order to establish a suitable therapy.
Since the application of REACTIFARGAN can delay the healing process, it should not be used more than 3-4 consecutive days on lesions in which this phenomenon is taking place.
In the case of sunburn, apply the product and avoid further exposure to the sun of the irritated skin.
If skin rashes, irritation and burning phenomena occur, the treatment must be suspended
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
There are no known drug interactions between locally applied promethazine and other topical drugs.
04.6 Pregnancy and breastfeeding -
In pregnant women, the product should be used only in case of real need and under medical supervision.
04.7 Effects on ability to drive and use machines -
Too abundant application of the product on very large areas of the skin can cause the drug to be absorbed and cause drowsiness in particularly sensitive patients.
04.8 Undesirable effects -
The topical application of promethazine can in some cases cause skin photosensitization. The presence of a sun filter in the REACTIFARGAN formula allows to avoid or limit these effects in those who are exposed to the sun after applying the product.
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Promethazine is a phenothiazine which, in addition to the typical properties of this class, possesses particular antihistamine (anti-H1) and membrane stabilizing activities (on which a certain local anesthetic power depends).
05.2 "Pharmacokinetic properties -
For local application on limited areas and on non-excoriated skin, promethazine is usually not absorbed in appreciable quantities. The amount eventually entered into the circulation is metabolized in the liver and its metabolites slowly eliminated in the urine and bile.
05.3 Preclinical safety data -
Doses of 6.25 to 12.5 mg / kg of promethazine administered in food did not show teratogenic effects in the rat.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Cream
Polyacrylamide isoparaffin laureth-7, octyl methoxycinnamate methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate-lavender compound oil, purified water.
Emulsion
Polyacrylamide isoparaffin laureth-7, octyl-methoxycinnamate, polyoxycetylstearyl ether, cetostearyl alcohol, diethylene glycol stearate, liquid paraffin, glycerin, isopropyl alcohol, methyl-p-hydroxybenzoate, propyl-para-hydroxybenzoate-lavender compound oil, purified water.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
Cream: 36 months.
Emulsion: 36 months.
06.4 Special precautions for storage -
They are not required.
06.5 Nature of the immediate packaging and contents of the package -
Cream
Aluminum tube internally coated with epoxy phenolic resins, painted externally.
20 g and 50 g tube.
Emulsion
Aluminum nebulizer coated internally with epoxy resin, painted externally and closed with a pressure-applied plastic pump.
30 g nebulizer.
06.6 Instructions for use and handling -
...
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Johnson & Johnson SpA Via Ardeatina km 23,500 - 00040 Santa Palomba - Pomezia ROME
08.0 MARKETING AUTHORIZATION NUMBER -
Cream 20 g - AIC n. 002516060
Cream 50 g - AIC n. 002516045
Emulsion 30 g - AIC n. 002516072
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
June 1995
10.0 DATE OF REVISION OF THE TEXT -
March 2011
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