DEXPANTHENOL 5% BIOGARAN Ointment for Irritated Skin promotes skin repair, particularly in cases of diaper rash.
VANILLA PLANIFOLIA 5CH, 7CH, 9CH, 15CH, 30CH Boiron Homeopathic Granules
This ointment is recommended for treating skin irritation, particularly in cases ofdiaper rash (red bottom) in infants and for tattoo healing.
Skinirritation is caused by external factors that damage the skin and trigger local inflammatory reactions. These external factors can include cold temperatures, detergents, a razor blade, or even a runny nose.Moisturization plays an essential role in preventing skin irritation. Skin irritation can be a sign of inflammation: redness, warmth, swelling, tingling, and itching.
If you’re looking for an alternative for sensitive skin, check out a product similar to our DEXPANTHENOL 5% BIOGARAN Ointment by lookinginto Bayer’s Bepanthen 5% for Babies, available online.
During the first year of life, very few children escape “red bottom” or diaper rash. Friction from the diaper, skin maceration, and infrequent diaper changes are all factors that contribute to the development of this irritation—which, while mild, can quickly become frustrating for both the baby and the mother.
To soothe your baby’s irritation,it is recommended to apply adexpanthenolointment. Dexpanthenol is rapidly converted into pantothenic acid, which plays an important role as a component of coenzyme A, involved in thecellular repair process; thereby promoting cellregenerationand therepairof the skin’s epithelium.
Apply by gently massaging the area once or several times a day.
Method and Route of Administration
Topical use.
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This restorative ointment is a medication indicated for the treatment of skinirritation, particularly in casesof diaper rash (red bottom) in infants.
Diaper rash occurs when your baby’s skin is irritated by wet or soiled diapers. A baby’s skin is particularly delicate in this area, and the proximity to natural orifices is a constant source of irritation and infection.
Dexpanthenom 5% Biogaran Ointment for Irritated Skin is formulated with:
Dexpanthenol ............................................ 5.0 g
Per 100 g of ointment.
Excipients with known effects: lanolin (wool fat), cetyl alcohol, and stearyl alcohol.
For the complete list of excipients, see Section 6.1.
What are the side effects and contraindications?
If symptoms persist for more than 5 days, worsen, or if new symptoms appear, consult your pharmacist or doctor.
Presentation and Packaging
Dexpanthenom 5% Biogaran Ointment for Irritated Skin is available in a 100-gram tube.
1. MEDICATION NAME
DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexpanthenol ............................................ 5.0 g
Per 100 g of ointment.
Excipients with known effects: lanolin (wool fat), cetyl alcohol, and stearyl alcohol.
For the complete list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Ointment.
Pale yellow ointment.
4. CLINICAL DATA
4.1. Therapeutic Indications
Skin irritations, particularly in cases of diaper rash (red buttocks) in infants.
4.2. Dosage and Administration
Topical use.
Apply by gently massaging into the skin once or several times a day.
4.3. Contraindications
4.4. Special Warnings and Precautions for Use
This medication contains lanolin (wool fat), cetyl alcohol, and stearyl alcohol and may cause local skin reactions (e.g., eczema).
Avoid contact with the eyes.
4.5. Interactions with Other Medications and Other Forms of Interaction
Currently available data do not suggest the existence of any clinically significant interactions.
4.6. Pregnancy and Breastfeeding
Use with caution in pregnant or breastfeeding women, as there are no reliable clinical data available. In breastfeeding women, if applied to the breasts, clean the skin before each feeding.
4.7. Effects on the ability to drive and operate machinery
No effects on the ability to drive or operate machinery have been observed.
4.8. Adverse Reactions
Rare allergic skin reactions.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse drug reactions after the drug’s approval is important. It allows for continuous monitoring of the drug’s benefit-risk profile. Healthcare professionals should report any suspected adverse reactions through the national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: www.ansm.sante.fr.
4.9. Overdose
No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: SKIN PROTECTANT, ATC Code: D03AX.
(D: dermatology).
Dexpanthenol: a component of coenzyme A.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Not applicable.
6. PHARMACEUTICAL INFORMATION
6.1. List of Excipients
Protegin XN*, petroleum jelly, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.
*Composition of Protegin XN: liquid paraffin, petroleum jelly, 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 the opened tube for more than 6 months.
6.5. Nature and contents of outer packaging
30 g or 100 g aluminum tube. Box of 1.
100-g aluminum tube. Box of 2.
Not all pack sizes may be marketed.
6.6. Special Precautions for Disposal and Handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
BIOGARAN 15 Boulevard Charles de Gaulle, 92700 Colombes 8. MARKETING AUTHORIZATION NUMBER(S) · 34009 279 477 7 3: 30 g in a tube (aluminum). Box of 1.· 34009 279 478 3 4: 100 g in a tube (aluminum). Box of 1.9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION [To be completed later by the marketing authorization holder]10. DATE OF TEXT UPDATE [To be completed later by the marketing authorization holder]11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS FOR PRESCRIBING AND DISPENSING This medication is not subject to a medical prescription.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated: 15/05/2015
Name of the drug
DEXPANTHENOL BIOGARAN TIP 5%, Ointment
dexpanthenol
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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.
Summary notice
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?
Pharmacotherapeutic class
SKIN PROTECTOR.
Therapeutic indications
This drug is indicated for the treatment of skin irritation, especially in cases of diaper rash (red buttocks) of the infant.
2. BEFORE YOU USE DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment?
List of information needed before taking the medication
Not applicable.
Cons-indications
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.
Interactions with other drugs
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
Pregnancy and breast feeding
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.
Sport
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?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
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.
Risk of withdrawal syndrome
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
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.
Expiration date
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.
Storage conditions
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.
6. ADDITIONAL INFORMATION
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.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
Holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
exploiting
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
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.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
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.
