Over-the-counter medication

ONCTOSE HYDROCORTISONE CREAM TUBE 30g

Name: ONCTOSE HYDROCORTISONE CREAM TUBE 30g
Brand: Procter & Gamble healthcare
SKU: 6231
Price: 8.65 EUR
Availability: InStock
Rating: 4.9333 (15 reviews)

Brand : Procter & Gamble healthcare

€7.86 EXCL. VAT €8.65 INCL. VAT

In stock

Reference : 3400934457548

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ONCTOSE HYDROCORTISONE CREAM TUB E 30g: The Onctose drug hydrocortisone is recommended in case of itching, especially insect bites.

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Presentation - How to use - Composition

ONCTOSE HYDROCORTISONE CREAM TUB E 30 G

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description of onctose hydrocortisone cream tube

Onctose hydrocortisone is a medication recommended in the event of itching, in particular insect bites.

Tingling, itching, slight inflammation, or edema can result from an insect bite. Generally not serious, bites are especially frequent in summer and in the countryside, when wasps and mosquitoes are out. First advice before reading our file: always take a first aid kit with you!

Using advice and opinion on hydrocortisone cream tube onctose

1 application 2 to 3 times a day. Wash hands thoroughly after each use.

Composition of onctose hydrocortisone cream tube

The active substances per 100g are:
- Lidocaine hydrochloride: 1.00 g
- Mefenidramium methyl sulfate: 2.00g

The other components are:

Self-emulsifying cetyl alcohol, diethylene glycol stearate, propylene glycol, pink fragrance 449 S, purified water.

Presentation of onctose hydrocortisone cream tube

A 30g tube.

Drug warnings

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 02/06/2014

Name of the medicinal product

ONCTOSE HYDROCORTISONE, cream

framed

Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult a physician.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. What is ONCTOSE HYDROCORTISONE, cream and in what cases is it used?

2. What should be known before using ONCTOSE HYDROCORTISONE, cream ?

3. How to use ONCTOSE HYDROCORTISONE, cream?

4. What are the possible side effects?

5. How to keep ONCTOSE HYDROCORTISONE, cream?

6. Additional information.

1. WHAT ONCTOSE HYDROCORTISONE, cream AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

CORTICOID OF LOW / ANESTHESIC ACTIVITY FOR TOPICAL USE

(D: Dermatology).

Therapeutic indications

This medication is recommended in case of itching, especially following insect bites.

2. BEFORE YOU USE ONCTOSE HYDROCORTISONE, cream?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not use ONCTOSE HYDROCORTISONE, cream in the following cases:

· Allergy (hypersensitivity) to local anesthetics, antihistamines or hydrocortisone,

· Wounds, a weeping or ulcerated lesion,

· Acne,

· rosacea,

· Infected skin, whether the origin is bacterial (eg impetigo ... ..), viral (herpes, shingles, varicella), mycotic (due to microscopic fungi) or parasitic.

Precautions for use; special warnings

Take special care with ONCTOSE HYDROCORTISONE, cream:

This medicine contains propylene glycol and may cause skin irritation.

Itching is only a symptom that can have multiple causes requiring the advice of your doctor especially if persistence or aggravation of the disorders.

Do not apply on a large area, under occlusive dressing, to injured skin, in infants or young children, because of the risk of the active substance passing through the blood.

Do not apply to mucous membranes. Avoid application of the product near the eyes.

In children, the application on the face should be limited, accidental contact with the eyes being possible.

If symptoms persist beyond 3 days of treatment, take the advice of your doctor.

Interaction with other medicines

Taking or using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy

No teratogenicity studies were performed with local corticosteroids.

Nevertheless, studies of oral corticosteroids did not demonstrate a higher risk of malformations than in the general population.

As a result, this medication can be used during pregnancy if needed.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

Do not apply on the breasts during breastfeeding, because of the risk of ingestion of the product by the newborn.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

The attention of athletes is drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction of the tests performed during doping controls.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of ONCTOSE HYDROCORTISONE, cream:

This medicine contains propylene glycol.

3. HOW TO USE ONCTOSE HYDROCORTISONE, cream?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

1 application 2 to 3 times a day.

Wash hands thoroughly after use.

Administration mode

Dermal.

Duration of treatment

Persistence of symptoms beyond 3 days requires medical advice.

Symptoms and Instructions for Overdose

Not applicable.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, ONCTOSE HYDROCORTISONE, cream is likely to have unwanted effects, although not everyone is subject to it:

· Allergy (hypersensitivity) to lidocaine or any of the other ingredients mentioned in "Additional Information";

· Thinning of the skin, dilation of small blood vessels, stretch marks, acne breakouts, redness and irritation around the mouth;

· Delayed wound healing, skin discoloration disorder, secondary infection especially during prolonged treatment, under occlusive dressing or in folds;

· Mydriase when applied near the eyes, especially in children. This accident is spontaneously resolved in less than 24 hours.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ONCTOSE HYDROCORTISONE, cream?

Keep this medicine out of the reach and sight of children.

Expiration date

Do not use after the expiry date stated on the outer packaging.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does ONCTOSE HYDROCORTISONE contain, cream?

The active substance is :

Hydrocortisone acetate .............................................. .................................................. ................. 0.250 g

Lidocaine Hydrochloride ............................................... .................................................. ............... 1,000 g

Mefenidramium methylsulfate ............................................... .................................................. ..... 2,000 g

For 100 g of cream.

The other components are :

Non-ionic emulsifiable wax to cetomacrogol 1000, diethylene glycol stearate, propylene glycol, purified water.

Pharmaceutical form and content

What is ONCTOSE HYDROCORTISONE cream and contents of the pack?

This medication is in the form of a cream in 30 g tube.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

MERCK MEDICATION FAMILIALE SAS

37 RUE SAINT-ROMAIN

69379 LYON CEDEX 08

exploiting

MERCK MEDICATION FAMILIALE

18 C BOULEVARD WINSTON CHURCHILL

21000 DIJON

Maker

FAMAR ORLEANS

5 AVENUE DE CONCYR

45071 ORLEANS CEDEX 2

FAMAR LYON

29, AVENUE DU GENERAL DE GAULLE

69230 SAINT-GENIS-LAVAL

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet 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 for health professionals only

Not applicable.

Other

Not applicable.

Vidal file

VIDAL OF THE FAMILY

ONCTOSE HYDROCORTISONE

Antipruritic local

hydrocortisone, mefenidramium, lidocaine

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

ONCTOSE HYDROCORTISONE: cream; 30 g tube.
-

Merck Family Medication Laboratory

COMPOSITION ^(summary)

	p 100 g
Hydrocortisone acetate	0.25 g
Mefenidramium methylsulfate	2 g
Lidocaine hydrochloride	1 g

INDICATIONS ^(summary)

This cream contains a dermocorticoid , an antihistamine and a local anesthetic .
It is used in the symptomatic treatment of itching due to insect bites and contact with certain plants (nettles ...). It should not be used without medical advice to treat other conditions.

CONTRAINDICATIONS ^(summary)

This medication should not be used in the following cases:

allergy to local anesthetics ,
infection and parasitosis of the skin (this drug has no anti-infectious effect),
oozing lesion,
ulcerated lesion,
acne and rosacea .

WARNING ^(Contents)

Do not use this cream in a child under 3 years of age without medical advice.
Follow your pharmacist's recommendations carefully and do not use this cream prolonged or repeated without the advice of your doctor.
Avoid exposing the treated areas to sunlight or ultraviolet rays: risk of skin reaction.
Sports: This drug contains a substance that may make certain anti-doping tests positive.

PREGNANCY AND BREAST-FEEDING ^(summary)

This medication may be used during pregnancy. If breast-feeding occurs, avoid application to the nipple.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

Spread the cream over the lesions and let it penetrate through a light massage.

Usual dosage:

2 or 3 applications per day.
Due to the limited indications of this product, the duration of treatment should not exceed 3 days.

TIPS ^(summary)

Remember to wash your hands after application.
Cortisone is a safe and effective drug when used wisely. This over-the-counter medication should not be used to treat skin lesions other than those mentioned under INDICATIONS.

POSSIBLE ADVERSE EFFECTS ^(summary)

Allergy to the skin.
Photosensitization .
In case of prolonged use:

atrophy with microhemorrhage of the skin ( purpura ), dilation of small vessels, stretch marks, eruption of pimples;
abnormal development of hair, drying, embrittlement and irregular discoloration of the skin;
redness around the mouth, appearance of rosacea ;
delayed healing.

GLOSSARY ^(summary)

acne
Skin disorders associated with sebum retention forming comedones (blackheads and microcysts). These are the site of a proliferation of bacteria and turn into pustules.

allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.

anesthetic
Medication that results in anesthesia. In addition to the general anesthetics that allow the patients to fall asleep before surgery, there are local anesthetics that can be injected in contact with a nerve to insensitize a region of the body. Local anesthetics are also called contact anesthetics.

antihistamine
Medication that opposes different effects of histamine. Two main types exist: antihistamines type H1 (antiallergic) and antihistamines type H2 (gastric antiulcer). Some antihistamines of type H1 are sedative, others do not alter vigilance.

atrophy
Decreased organ or limb volume due to aging, disease or lack of blood supply.

dermocorticoid
Preparation of corticosteroids for local use, intended to treat certain diseases of the skin.

photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.

purpura
Red or purplish skin patches due to small subcutaneous hemorrhages. Thrombocytopenic purpura is caused by a significant decrease in the number of platelets in the blood.

rosacea
Skin disease causing redness of the face. It is sometimes called acne rosacea, but has nothing to do with acne vulgaris. It prohibits the local use of dermocorticoids.

anti-doping tests
Athletes may be tested for the presence in their urine of doping substances or their derivatives. The International Olympic Committee and the Ministry of Health and Sports maintain a list of substances considered to be doping. These substances are very varied: anabolic hormones that develop muscles, excitants that increase vigilance, beta-blockers that slow down the heart and, for example, allow archery to unclip their arrow between two heartbeats, etc. Some medications such as creams, ear drops, contain substances considered to be doping, but the probability that these substances pass into the blood and are found in the urine is very low. When in doubt, the possibility of a positive reaction is mentioned for each drug when a doping substance is present in its composition. It is up to the athlete to decide with his doctor whether or not to use such a medicine.

symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.

ultraviolet
Ultraviolet rays are radiation emitted naturally by the sun or artificially by certain lamps. UV A and UVB are distinguishable. Short-wave UV B are stopped in the outermost layers of the skin. They are responsible for burns (sunburn). The UVA, of wider wavelength, penetrate deeply and reach the dermis. They induce pigmentation (tanning). Repeated intense UV exposure causes premature aging of the skin and increases the risk of skin cancer.
Abbreviation: UV.