Active ingredients: Neomycin (Neomycin sulphate), Bacitracin zinc, Glycine, L-Cysteine, DL-Threonine
CICATRENE cream
CICATRENE, dust
Why is Cicatrene used? What is it for?
CICATRENE contains five active ingredients:
- neomycin and bacitracin, antibiotics that fight bacterial skin infections;
- glycine, cysteine and threonine, amino acids that stimulate the tissue healing process.
This medicine is used for superficial skin infections, such as folliculitis (infection of the hair follicle, the structure that surrounds the hair root) or furunculosis (inflammation of the skin characterized by the presence of boils), small burns or infected wounds.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Cicatrene should not be used
Do not use CICATRENE
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- on infections that are close to the eye;
- on ear canal infections if you have a perforation of the eardrum.
Precautions for use What you need to know before taking Cicatrene
Talk to your doctor or pharmacist before using CICATRENE.
This is particularly important if you are allergic to other antibiotics belonging to the aminoglucoside class (such as for example kanamycin, gentamicin, framycetin), because you may also be allergic to CICATRENE.
Take care to use CICATRENE:
- if you have poor kidney function (kidney failure);
- if you are taking other medicines that have harmful effects on the kidney or ear;
- for a long time and / or on areas of extended or ulcerated skin and / or with an occlusive bandage that does not let air through; since these situations increase the risk of undesirable effects on the kidney and / or ear, due to a increased absorption of neomycin.
Stop therapy and consult your doctor if you notice signs of hypersensitivity (redness, itching) following repeated or prolonged use of CICATRENE.
Children
In premature babies and infants, kidney function is not developed. Do not use CICATRENE, as neomycin can cause kidney and / or ear problems.
In children, skin folds or nappies can act as an occlusive dressing.
Interactions Which drugs or foods can modify the effect of Cicatrene
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important if you are taking other antibiotics belonging to the aminoglucoside class (Kanamycin, Gentamicin, Framycetin, etc.).
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 taking this medicine.
Only use CICATRENE during pregnancy if necessary, under direct medical supervision.
Driving and using machines
CICATRENE does not affect the ability to drive and use machines.
CICATRENE cream contains:
- wool alcohol: can cause local skin reactions (eg contact dermatitis).
Dose, Method and Time of Administration How to use Cicatrene: 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 a thin layer of cream or a light spray of powder, twice a day each time you need to re-dress after cleaning the wound.
Do not use CICATRENE on large or ulcerated areas of skin.
After applying CICATRENE, do not use an occlusive bandage that does not let air through. In children, skin folds or diapers can act as an occlusive bandage.
Consult your doctor if the disorder occurs repeatedly, if you have noticed any change in its characteristics or if you do not obtain appreciable results after a short period of treatment.
Overdose What to do if you have taken too much Cicatrene
When used correctly, this medicine does not cause symptoms due to an overdose.
If you use CICATRENE for a long time and / or on large or ulcerated areas of skin and / or with an occlusive bandage that does not let air through, it could have undesirable effects on the kidney and / or ear.
In case of accidental ingestion, you may also experience symptoms in the stomach or intestines.
In case of accidental ingestion / intake of an overdose of CICATRENE, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Cicatrene
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking CICATRENE and see your doctor if you have any of the following conditions:
Uncommon side effects (likely to affect 1 to 10 in 1,000 patients)
- redness;
- itch;
- wheals (swelling of the skin);
- infection that persists and / or worsens (superinfection);
- allergy (rash, spots on the skin (hives), swelling of the face, eyes, lips, throat with difficulty in breathing).
Rare side effects (likely to affect 1 to 10 users in 10,000)
- anaphylaxis (more severe allergy symptoms which also include severe difficulty in breathing, increased heart rate, sharp drop in blood pressure until the heart stops).
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 "www.agenziafarmaco.gov.it/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 at a temperature not exceeding 25 ° C.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What CICATRENE contains
The active ingredients are: neomycin sulfate, bacitracin zinc, glycine, L-Cysteine, DL-Threonine.
Each gram of cream / powder contains: 3,300 IU of neomycin sulfate, 250 IU of bacitracin zinc, 10 mg of glycine, 2 mg of L-Cysteine and 1 mg of DL-threonine.
The other ingredients are:
Cream
BP wool alcohol; sorbitan trioleate; polyoxyethylene sorbitan trioleate; polyoxyethylene lauryl ether; solid paraffin; liquid paraffin; soft paraffin.
Dust
cornstarch; magnesium oxide.
Description of what CICATRENE looks like and contents of the pack
CICATRENE Cream is available in 15 g tube. CICATRENE Powder is available in a 15 g bottle.
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
CICATRENE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are: neomycin sulfate, bacitracin zinc, glycine, L-Cysteine, DL-Threonine.
Each gram of cream / powder contains: 3,300 IU of neomycin sulfate, 250 IU of bacitracin zinc, 10 mg of glycine, 2 mg of L-Cysteine and 1 mg of DL-threonine.
Excipients with known effects
CICATRENE CREAM: wool alcohol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
Dust.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Superficial skin infections (folliculitis, furunculosis, small burns and infected wounds).
04.2 Posology and method of administration
After cleaning the wound, apply a thin layer of cream or a light spray of powder twice a day to renew the dressing.
04.3 Contraindications
Known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Ailments of the ear canal in case of perforation of the tympanic membrane.
Do not use near the eyes.
04.4 Special warnings and appropriate precautions for use
Repeated or prolonged use can give rise to hypersensitivity phenomena which require the suspension of therapy and consultation with the doctor.
It is possible that subjects presenting hypersensitivity to other aminoglucoside antibiotics (Kanamycin, Gentamicin, Framicetina, etc.) develop the latter also towards CICATRENE.
The systemic absorption of Neomycin can lead to renal and / or ear toxicity, especially in subjects with renal function disorders already present and / or treated simultaneously with other drugs harmful to the ear and kidney.
Avoid prolonged use, use of the product on extended or ulcerated skin areas, the occlusive bandage technique, since in these cases there is the possibility of greater absorption.
After a short period of treatment with no appreciable results, consult your doctor. Do not exceed the recommended dose.
Pediatric population
Use in premature babies and neonates is not recommended as they have undeveloped kidney function and, consequently, an increased risk of kidney and / or ear toxicity.
In children, skin folds or nappies can act as an occlusive dressing.
Important information about some of the ingredients
CICATRENE Cream contains:
- wool alcohol: can cause local skin reactions (eg contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
Simultaneous administration with other aminoglucoside antibiotics is not recommended.
04.6 Pregnancy and lactation
There is little information to demonstrate the possible effects of topical application of the combination neomycin sulphate / bacitracin zinc during pregnancy and lactation.
In pregnant women and in infancy use only in case of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
There are no known negative effects of CICATRENE on the ability to drive and use machines.
04.8 Undesirable effects
The following side effects have been observed.
The frequency of adverse reactions is defined by the following convention:
very common (≥ 1/10);
common (≥ 1/100,
uncommon (≥ 1 / 1,000,
rare (≥ 1 / 10,000,
very rare (
not known (it is impossible to provide an estimate based on the available data).
As these manifestations can worsen, it is necessary to stop treatment and consult a doctor at their first appearance.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
CICATRENE is only available in topical preparations and acute intoxication by systemic absorption is therefore unlikely unless large de-epithelialized areas are treated or if the product is applied with occlusive bandages. In case of systemic absorption, ototoxicity and / or nephrotoxicity could possibly occur.
In case of accidental ingestion, gastrointestinal symptoms could probably arise.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibiotics and chemotherapeutic agents for dermatological use.
ATC code: D06AX04.
Medicinal product containing Neomycin and Bacitracin.
Neomycin is an aminoglucoside antibiotic particularly active against Staphylococcus and numerous gram negative germs such as Proteus and Serratia through a bactericidal effect which results in the interruption of the cell's functioning by inhibiting the synthesis of peptides and proteins. It is less active against Streptococci while Pseudomonas is generally resistant.
Bacitracin is a polypeptide antibiotic active against many gram positive germs including Streptococci through a bactericidal effect of interference with the synthesis of the cell wall. The action of Bacitracin is not normally neutralized by clots, pus and necrosed tissues.
In the preparation there are also some amino acids (glycine, cysteine, threonine) which stimulate the repairing capacity of the injured tissues and the healing process.
05.2 Pharmacokinetic properties
Systemic absorption of the active ingredients following cutaneous use as recommended is unlikely.
Systemic absorption may be associated with prolonged use, particularly on large or markedly inflamed or damaged skin areas, or if the product is applied with occlusive bandages.
05.3 Preclinical safety data
Genetic toxicology
The available data do not reveal any risks on the genotoxic potential associated with neomycin and bacitracin.
Carcenogenicity
The available data reveal no risks on carcenogenicity associated with neomycin and bacitracin.
Teratogenicity
Neomycin: Studies available in the literature indicate that there is no evidence of maternal toxicity, foetotoxicity or teratogenicity in rats with doses up to 25 mg / kg bw / day and treated during gestation days 16-20.
Bacitracin: a teratogenesis study conducted on rats at dosages up to 500 mg / kg body weight / day, from 7 to 17 days of pregnancy, did not show any effect on embryo-fetal development, or any structural defects. Post-administration salivation, low feed consumption and increased water intake were observed in mothers, and a LOEL of 11 mg / kg / day was observed.
Fertility
Neomycin: In a 3-generation reproductive toxicity study performed in rats at doses of 0, 6.25, 12.5 or 25 mg / kg bw / day, no treatment effect was found in any generation on fertility parameters. Finally, a NOEL of 25 mg / kg / day was observed in the aforementioned study.
Bacitracin: a 1-year study was performed to determine the effect of bacitracin on fertility, this study did not reveal any toxic effects on reproductive capacity or any fertility parameters.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each gram of CICATRENE CREAM contains:
wool alcohol BP 61 mg; 66 mg sorbitan trioleate; polyoxyethylene sorbitan trioleate 32 mg; polyoxyethylene lauryl ether 54 mg; solid paraffin 30 mg; liquid paraffin mg 45; soft paraffin mg 688.
Each gram of CICATRENE POWDER contains:
corn starch 955 mg; magnesium oxide 21 mg.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
The stability of the product is 2 years.
In intact packaging, properly stored.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
CICATRENE CREAM: 15 g tube
CICATRENE POWDER: bottle of 15 g
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Johnson & Johnson SpA Via Ardeatina km 23,500 - 00040 Santa Palomba - Pomezia ROME
08.0 MARKETING AUTHORIZATION NUMBER
CICATRENE CREAM, 15 g tube: AIC n. 014160079
CICATRENE POWDER, 15 g bottle: AIC n. 014160081
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first marketing authorization: 13.08.1958
AIC renewal: May 2005
