French pharmacy
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French pharmacy
ONCTOSE CREAM 48G TUBE: Onctose The drug is indicated for itching, especially insect bites.
The drug is indicated for Onctose itching, especially insect bites.
Dermal.
If the symptoms persist after 8 days of treatment, consult your doctor.
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 01/10/2019
Lidocaine hydrochloride, Mefenidramium methyl sulfate
You should always use this medicine strictly following the information given in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel less well after 8 days.
What does this booklet contain ?
1. What is ONCTOSE, cream and in which cases it is used?
2. What should I know before using ONCTOSE, cream?
3. How to use ONCTOSE, cream?
4. What are the possible side effects?
5. How to store ONCTOSE, cream?
6. Contents of the pack and other information.
1. WHAT ONCTOSE, cream IS AND WHAT IT IS USED FOR?
This medication is recommended in case of itching, in particular insect bites.
You should contact your doctor if you do not feel any improvement or if you feel less well.
2. WHAT YOU NEED TO KNOW BEFORE USING ONCTOSE, cream?
· If you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· In the event of a history of allergy to local anesthetics,
· If you have a history of allergy to antihistamines,
· In case of infected or irritated skin lesions,
· In case of oozing skin lesions.
Warnings and Precautions
Talk to your doctor or pharmacist before using ONCTOSE, cream .
Itching is only one symptom which can have multiple causes requiring the advice of your doctor, especially in the event of persistence or worsening of the disorders.
Do not apply over a large area, under an occlusive dressing, to damaged skin because of the risk of the active principle passing through the blood.
Do not use this medication in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (burns) without first informing your doctor or pharmacist.
Do not apply to mucous membranes or around the eyes.
The attention of athletes is drawn to the fact that this specialty contains an active principle which can induce a positive reaction from the tests carried out during doping controls.
Children and adolescents
Not applicable.
Other medicines and ONCTOSE, cream
The known interactions with lidocaine (antiarrhythmics, beta-blockers) in principle do not concern the local use on the anal mucosa. However, take into account a risk of systemic passage of lidocaine in the event of an injured mucosa.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
ONCTOSE, cream with food, drink and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
This drug should be used with caution during pregnancy or 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.
Driving and using machines
Not applicable.
ONCTOSE, cream contains propylene glycol and cetyl alcohol.
This medication contains 9 g of propylene glycol per 100 g of cream. Propylene glycol can cause skin irritation.
This medicine contains cetyl alcohol and may cause local skin reactions (eg contact dermatitis).
This medicine contains a fragrance containing limonene. Imonene can cause allergic reactions.
The recommended dose is 1 application 2 to 3 times per day via the skin.
Wash hands well after each use.
If symptoms persist after 8 days of treatment, consult your doctor.
If you use more ONCTOSE, cream than you should:
Not applicable.
If you forget to use ONCTOSE, cream:
If you stop using ONCTOSE, cream:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular risk of allergy to a component of the cream, risk of mydriasis (excessive dilation of the pupil) if applied too close to the eyes, risk of contact eczema (due to the presence of propylene glycol).
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ONCTOSE, cream?
Keep this medication out of the sight and reach of children.
Store at a temperature below 25 ° C.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
· The active substances are:
Lidocaine hydrochloride ............................................... .................................................. 1.00 g
Mefenidramium methyl sulphate ............................................... ........................................ 2.00 g
For 100 g of cream
· The other ingredients are:
Self-emulsifying cetyl alcohol, diethylene glycol stearate, propylene glycol, 449S rose fragrance, purified water.
What ONCTOSE, cream looks like and contents of the pack
This medication is in the form of a cream.
Tube of 30 g and 48 g.
Marketing authorization holder
163/165, QUAI AULAGNIER
92600 ASNIERES-SUR-SEINE
Marketing authorization operator
18C BOULEVARD WINSTON CHURCHILL
21000 DIJON
29, AVENUE CHARLES DE GAULLE
69230 SAINT GENIS LAVAL
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medication is available on the ANSM website (France).
Local antipruritic
mefenidramium, lidocaine
. Presentations . Composition . Indications . Contraindications . Be careful . Pregnancy and lactation . Instructions for use and dosage . Tips . Adverse effects . Lexicon
ONCTOSIS: cream; 48 g tube.
Not refunded - Free price -
P&G Health France Laboratory
| p 100 g | |
| Mefenidramium methyl sulfate | 2 g |
| Lidocaine hydrochloride | 1 g |
Usual dosage:
2 to 3 applications per day.
