CORTAPAISYL 0.5% CREAM 15G TUBE

CORTAPAISYL 0.5% CREAM 15G TUBE View larger

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Apaisyl Apaisyl

Cortapaisyl 0.5% Cream Tube of 15 g on sale in our online pharmacy are just for adults and children over 6 years to relieve itching.

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CORTAPAISYL 0.5% CREAM 15G TUBE

For warnings, precautions for use and cons-indications, see the instructions for use.

Description Cortapaisyl 0.5% Cream Tube 15g

Cortapaisyl 0.5% Cream Tube 15g is a medicine indicated for adults and children over 6 years in case of:
- Nettle stings
- Insect bites
- Sunburn located

Using advice from Cortapaisyl 0.5% Cream Tube 15g

Apply the cream 2 times a day, morning and evening.
Depositing a thin layer and then spread it out and massage gently until completely absorbed.
Wash your hands after use.
The period of use is limited to 3 days.
The persistence of symptoms beyond three days requires taking medical advice.

Composition Cortapaisyl 0.5% Cream Tube 15g

The active substance is:

Hydrocortisone ................................................ .................. 0,500 g (for 100 g)

As hydrocortisone acetate ......................................... 0.558 g (for 100 g)

The other ingredients are:

Sorbitan stearate, polysorbate 60, synthetic spermaceti, cetostearyl alcohol, octyldodecanol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), imidurea, anhydrous citric acid, purified water.

Precaution of use

Never use Cortapaisyl 0.5% cream:
- If you are allergic to hydrocortisone or any component of the formula, on wounds,
- On acne,
- On rosacea,
- On an infected skin, the origin is bacterial (eg impetigo ...), viral (herpes zoster, chickenpox), fungal (caused by fungi) or parasitic.

When in doubt, it is essential to seek the advice of your doctor or pharmacist.


Do not leave this medicine out of reach of children.
If after a blistering sunburn, consult your doctor before applying the product.
Do not treat large areas.
Do not cover with a closed dressing (occlusion), as this may cause the passage of part of the active ingredient in the blood.
Do not apply other dermatological use products on the treated surface.
Do not exceed the prescribed doses.

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

In case of:

- Local intolerance,

- Irritation, skin superinfection,

Discontinue use and consult your doctor.

Introducing Cortapaisyl 0.5% Cream Tube 15g

Tube 15 g.

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

VIDAL OF THE FAMILY

CORTAPAISYL

dermocorticoid

hydrocortisone

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

PRESENTATIONS (summary)

CORTAPAISYL 0.5%: cream; 15 g tube.
-

CORTAPAISYL 0.5%: cream; box of 3 tubes of 15 g.
-

Merck Family Medication Laboratory

COMPOSITION (summary)
p 100 g
hydrocortisone 500 mg

INDICATIONS (summary)
It is a weakly active dermocorticoid . Like other cortisone derivatives for local use, it has a powerful anti-inflammatory effect.
It is used to treat the symptoms caused by insect or nettle stings, and to relieve sunburn, when they are small. It should not be used without medical advice to treat other conditions.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • ulcerative lesions, wounds;
  • acne , rosacea ;
  • cold sores, skin infection.
WARNING (Contents)
Cortisone (and its derivatives) 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.
The use of this cream on extended lesions or beyond the 3 days recommended can lead to a significant dermal absorption and a cortisone effect throughout the body.
During the treatment of sunburn, the relief provided by this medication should not lead to new untimely exposures without adequate protection.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
This medication may be used during pregnancy.

Breastfeeding:
Due to the risk of ingestion by the newborn, this drug should not be applied to the nipple in the breastfeeding woman.
DIRECTIONS FOR USE AND DOSAGE (summary)
Apply the cream with spaced keys, then spread it through a light massage until complete absorption.

Usual dosage:

  • Adult and child over 6 years: 2 applications per day.
Taking into account the limited indications of this product, the duration of the treatment must not exceed 3 days.
TIPS (summary)
Wash hands after application.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Adverse reactions that may occur mainly involve inadequate use or non-observance of precautions for use:
  • abnormal development of hair, drying, embrittlement and irregular discoloration of the skin;
  • perioral dermatitis , acne ;
  • retardation of wound healing;
  • very rarely: skin atrophy , telangiectasia (dilation of small vessels), purpura (microhemorrhages of the skin), stretch marks.


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.


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


cortisone
Hormone secreted by the adrenal glands. It helps to regulate the body's sugars, fats and proteins, but also to the body's reaction to stress. Its powerful anti-inflammatory properties are used in therapeutics. The natural cortisone is called cortisol (assayed by blood tests). Hydrocortisone is the drug form that is closest to natural cortisone and is used primarily in the treatment of cortisone deficiency diseases. Other more potent chemical derivatives are used when looking for an anti-inflammatory effect: prednisone, prednisolone, betamethasone, dexamethasone, etc.


perioral dermatitis
Affection of the skin resulting in a red ring, possibly accompanied by pustules, which appears around the mouth. It is a frequent complication of the untimely and prolonged application of dermocorticoids on the face.


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


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.


telangiectasia
Small dilated vessels appearing transparently under the skin.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 21/05/2015

Name of the medicinal product

CORTAPAISYL 0.5%, cream

hydrocortisone

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 after 3 days, consult your doctor.

· 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 CORTAPAISYL 0.5%, cream AND IN WHAT CASES IS IT USED?

2. BEFORE YOU USE CORTAPAISYL 0.5%, cream?

3. HOW TO USE CORTAPAISYL 0.5%, cream?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE CORTAPAISYL 0.5%, cream?

6. ADDITIONAL INFORMATION

1. WHAT CORTAPAISYL 0.5%, cream AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

This medicine contains a corticosteroid.

Therapeutic indications

This medication is indicated for adults and children over 6 years of age in the following cases:

· stings of nettles

· Insect bites

· localized sunburns

2. BEFORE YOU USE CORTAPAISYL 0.5%, cream?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use CORTAPAISYL 0.5%, cream:

· in case of allergy to hydrocortisone or any of the components of the formula, on wounds,

· on an acne,

· on a rosacea,

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

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Precautions for use; special warnings

Take special care with CORTAPAISYL 0.5%, cream:

Warnings

DO NOT LEAVE THIS MEDICINE FOR CHILDREN.

If blistering occurs after sunburn, consult your doctor before applying the product.

Precautions for use:

This medication contains a corticosteroid, follow the directions for use. Indeed, an increase in the applied amount and / or the number of applications would not improve the activity or the speed of action of the product but could cause undesirable effects.

· Do not deal with large areas,

· do not cover with a closed dressing (occlusive dressing), as this may cause some of the active ingredient to pass through the blood,

· do not apply other dermatological products to the treated surface,

· do not use more than 2 times a day,

· do not exceed the recommended service life (3 days).

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

In case of :

· intolerance,

· irritation, skin superinfection,
discontinue treatment and see your doctor .

This medicinal product contains cetostearyl alcohol and may cause local skin reactions (eg eczema).

It also contains sodium parahydroxybenzoate (E219) and soda propyl parahydroxybenzoate (E217), which can cause skin allergies (urticaria, eczema).

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, including medicines obtained without a prescription, including dermatologic treatment.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

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

If needed, this medication may be used during pregnancy.

Breast-feeding is possible when treated with this medication.

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

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

List of excipients with known effect : cetostearyl alcohol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217).

3. HOW TO USE CORTAPAISYL 0.5%, cream?

Instructions for proper use

Not applicable.

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

Dosage / Administration Mode / Administration Frequency

Apply cream 2 times a day, morning and evening.

Apply the product in a thin layer, then spread it by massaging lightly until it is completely absorbed.

Wash your hands after application.

Duration of the treatment

The duration of use is limited to 3 days

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, CORTAPAISYL 0.5%, cream is likely to have undesirable effects, although not everyone is subject to it.

· risk of thinning of the skin, dilation of small blood vessels, stretch marks, acne outbreak, redness and irritation around the mouth;

· cases of exaggerated development of the hair system, skin discoloration disorder, secondary infection, particularly during prolonged treatment, under occlusive dressing or in folds, have been reported,

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via 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 CORTAPAISYL 0.5%, cream?

Keep out of the reach and sight of children.

Expiration date

Do not use CORTAPAISYL 0.5%, cream after the expiry date which is stated on the carton.

Storage conditions

No special storage conditions.

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 CORTAPAISYL 0.5% contain, cream?

The active substance is:

Hydrocortisone base ................................................ .................................................. ....................... 0.500 g

In the form of hydrocortisone acetate .......................................... .................................................. ... 0.558 g

For 100 g.

The other components are:

Sorbitan stearate, polysorbate 60, synthetic whale white, cetyltearyl alcohol, octyldodecanol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), imidurate, anhydrous citric acid, purified water.

Pharmaceutical form and content

What is CORTAPAISYL 0.5%, cream and contents of the pack?

This medication is in the form of a cream. Box of 1 tube of 15 g or 3 tubes of 5 g.

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 Winston Churchill Boulevard

21000 DIJON

(Registered office: 37, rue Saint Romain - 69008 LYON)

Maker

MERCK SANTE SAS

LACASSAGNE Production Center

115, avenue Lacassagne

69003 LYON

or

FAMAR LYON

29, avenue Charles 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 Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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