DEXPANTHENOL 5% BIOGARAN Irritated Skin Ointment promotes skin repair, especially in cases of diaper rash.
This ointment is recommended for the treatment of irritated skin, particularly in the case ofdiaper rash (red buttocks) in infants, and tattoo scarring.
Skinirritations are caused by external agents that attack the skin and provoke local inflammatory reactions. These external agents can include cold, detergents, razor blades or nasal discharge.Moisturization plays an essential role in preventing skin irritation. Skin irritation can be a sign of inflammation: redness, heat, swelling, tingling and itching.
In the first year of life, very few children can escape "red bottoms" or diaper rash. Diaper rubbing, maceration and too-frequent diaper changes are just some of the factors that can lead to the appearance of these irritations, which may be benign but are very quickly upsetting for both baby and mother.
To soothe baby's irritations, we recommend applying Dexpanthenol ointment. Dexpanthenol is rapidly converted into pantothenic acid, which plays an important role as a component of coenzyme A in the cell repair process, promoting cell regeneration and skin epithelial repair.
Apply with a gentle massage once or several times a day.
Method and route of administration
Apply to the skin.
Give your opinion on the advice for use and dosage of DEXPANTHENOL 5% BIOGARAN Pommade peau irritée with our partner Verified opinions after your purchase.
This reparative ointment is indicated for the treatment of skinirritation, particularlydiaper rash in infants.
Diaper rash occurs when your baby's skin is irritated by wet or dirty diapers. Baby's skin is particularly fragile in this area, and the proximity of natural orifices is a constant source of irritation and infection.
Dexpanthenom 5% Biogaran Pommade peau irritée is formulated with :
Dexpanthenol ............................................ 5.0 g
For 100 g of ointment.
Notable excipients: lanolin (wool fat), cetyl alcohol and stearyl alcohol.
For a full list of excipients, see section 6.1.
What are the side effects and contraindications?
If symptoms persist for more than 5 days, worsen or develop new symptoms, ask your pharmacist or doctor for advice.
Presentation-Packaging
Dexpanthenom 5% Biogaran Pommade peau irritée comes in a 100g tube.
1. DRUG NAME
DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexpanthenol ............................................ 5.0 g
Per 100 g of ointment.
Notable excipients: lanolin (wool grease), cetyl alcohol and stearyl alcohol.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pale yellow ointment.
Pale yellow ointment.
4. CLINICAL DATA
4.1 Therapeutic indications
Skin irritations, particularly diaper rash (red buttocks) in infants.
4.2. Dosage and administration
Apply to the skin.
Gently massage into the skin once or several times a day.
4.3. Contraindications
4.4 Special warnings and precautions for use
This product contains lanolin (wool fat), cetyl alcohol and stearyl alcohol and may cause local skin reactions (e.g. eczema).
Avoid contact with eyes.
4.5. Interactions with other drugs and other forms of interaction
The data available to date do not suggest the existence of clinically significant interactions.
4.6. Pregnancy and breast-feeding
Use with caution in pregnant or breast-feeding women, in the absence of usable clinical data. In the case of breast-feeding women, cleanse the skin before each feed.
4.7. Effects on ability to drive and use machines
No effect on the ability to drive vehicles and use machines has been observed.
4.8. Undesirable effects
Rare allergic skin reactions.
Reporting suspected adverse reactions
The reporting of suspected adverse reactions after drug approval is important. It enables continuous monitoring of the drug's benefit/risk ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
4.9. Overdosage
No cases of overdosage have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: SKIN PROTECTIVE, ATC code: D03AX.
(D: dermatology).
Dexpanthenol: constituent of coenzyme A.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Protegin XN*, vaseline, wool grease, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid kerosene, purified water.
*Protegin XN composition: liquid kerosene, vaseline, microcrystalline wax, glycerol monooleate, wool fat alcohols.
6.2 Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
After first opening: Do not store opened tube beyond 6 months.
6.5. Nature and contents of packaging
30 g or 100 g aluminum tube. Box of 1.
Aluminum tube of 100 g. Box of 2.
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
BIOGARAN15 BOULEVARD CHARLES DE GAULLE92700 COLOMBES8. MARKETING AUTHORIZATION NUMBER(S) - 34009 279 477 7 3: 30 g in tube (Aluminum). Box of 1 - 34009 279 478 3 4 : 100 g in tube (Aluminium). Box of 1.9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION [To be completed subsequently by the holder]10. DATE OF TEXT UPDATE[To be completed at a later date by the holder]11. DOSIMETRYNot applicable.12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALSNot applicable.CONDITIONS OF PRESCRIPTION AND DELIVERYMedication not subject to medical prescription.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated: 15/05/2015
DEXPANTHENOL BIOGARAN TIP 5%, Ointment
dexpanthenol
This is an authorized and controlled medicine (see Identification number on the outer packaging):
· This medicine can be
· If symptoms persist for more than 5 days, if they worsen or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is meant to help you use this medicine. Keep it there, you may need to read it again.
Do not let this medicine within the reach of children.
What does this booklet contain :
1. What is DEXPANTHENOL BIOGARAN 5% ADVICE, Ointment and in which cases is it used?
2. What information do you need to know before using DEXPANTHENOL BIOGARAN TIP 5%, ointment ?
3. How to use DEXPANTHENOL BIOGARAN TIP 5%, ointment ?
4. What are the possible side effects?
5. How to store DEXPANTHENOL BIOGARAN TIP 5 %, ointment ?
6. Additional information.
1. WHAT DEXPANTHENOL BIOGARAN TIP 5%, Ointment AND WHAT IT IS USED FOR?
2. BEFORE YOU USE DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment?
List of information needed before taking the medication
Not applicable.
NEVER use DEXPANTHENOL BIOGARAN 5% ADVICE, Ointment in the following cases:
· History of hypersensitivity to one of the components.
· Infected or oozing dermatosis.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Precautions for use; special warnings
Take care with DEXPANTHENOL BIOGARAN TIP 5%, Ointment :
Special warnings
· This medicine contains lanolin (wool fat), cetyl alcohol and stearyl alcohol and may cause local skin reactions (eg eczema).
· Avoid contact with the eyes, it could be irritating.
If there is no improvement beyond 5 days and despite the strict application of health education advice, consult a doctor or seek advice from a pharmacist.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
This medication should be used with caution during pregnancy and lactation. In breastfeeding women, when applied to the breasts, clean the skin before each feeding.
In general, consult your doctor or pharmacist before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment:
This medicine contains lanolin (wool fat), cetyl alcohol and stearyl alcohol.
3. HOW TO USE DEXPANTHENOL BIOGARAN TIP 5%, ointment?
Not applicable.
Dosage
Apply by massaging lightly one to several times a day.
Method and route of administration
Dermal
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr .
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE DEXPANTHENOL BIOGARAN TIP 5%, ointment?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of this month.
Do not keep the tube started beyond 6 months.
Store at a temperature not exceeding 25 ° C.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Complete list of active substances and excipients
What contains DEXPANTHENOL BIOGARAN 5% ADVICE, Ointment?
The active substance is:
Dexpanthenol ................................................. .................................................. ..................... 5.0 g
For 100 g of ointment.
The other components are:
Protegin XN *, petrolatum, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.
* Composition of Protegin XN: liquid paraffin, petrolatum, microcrystalline wax, glycerol monooleate, wool fat alcohols.
Pharmaceutical form and content
What is DEXPANTHENOL BIOGARAN TIP 5%, ointment and contents of the pack?
This medicine comes in the form of pale yellow ointment.
Tube of 30 g. Box of 1.
Tube of 100 g. Box of 1 or 2.
Not all presentations may be marketed.
Marketing Authorization Holder and Manufacturer
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
CHEMINEAU LABORATORIES
93 ROUTE OF CURRENCY
37210 VOUVRAY
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE
Skin irritations correspond to an alteration of the natural protective barrier of the skin resulting in redness, possibly associated with peeling or cracking skin. They are due to the action of irritating agents such as cold, mechanical friction, chemicals, ...
Diaper rash is an irritation of the skin in the areas covered by diapers. The skin is red and then crack.
"How to prevent diaper rash? "
To prevent diaper rash, keep your buttocks clean, dry and cool.
Change your baby's diaper often and let the buttocks look as much as possible. This allows the skin to dry.
At each change of diaper, clean the buttocks of your baby with warm water (but not hot) without forgetting the small folds.
Allow the buttocks to dry before putting on another layer, preferably in the open air or with a clean absorbent towel, without rubbing to avoid the risk of irritation.
"What to do in case of nappy rash of the infant? "
Avoid adjusting diapers too tight to let your baby's skin "breathe".
Leave your baby without a nappy as much as possible. Fresh air dries moist irritated skin and promotes healing of erythema.
Apply a protective and repairing ointment to the child's buttocks after each change.
Skin protector
vitamin B5
This medicine is a generic of BEPANTHEN Ointment.
. Presentations . Composition . Indications . Contraindications . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon
DEXPANTHENOL BIOGARAN TIP 5%: ointment; 30 g tube.
Not refunded - Free price -
DEXPANTHENOL BIOGARAN TIP 5%: ointment; tube of 100 g.
Not refunded - Free price -
Laboratory Biogaran
p 100 g | |
Dexpanthenol (vitamin B5) | 5 g |
Lanolin (wool fat) | + |
Usual dosage:
One or more applications per day.