Cortidro - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Hydrocortisone (Hydrocortisone acetate)

Cortidro 0.5% Hydrocortisone acetate cream

Why is Cortidro used? What is it for?

Cortidro contains the active substance hydrocortisone, which belongs to a group of medicines called corticosteroids, used to reduce inflammation.

Cortidro is a cream used in adults and children over two years of age, in case of insect bites, itching, erythema or non-extensive burns, inflammation of the skin (eczema).

Contraindications When Cortidro should not be used

Do not use Cortidro if:

  • you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
  • you have an infection caused by viruses, bacteria or fungi.

Precautions for use What you need to know before taking Cortidro

Talk to your doctor or pharmacist before using this medicine. Cortidro is not indicated for the treatment of itching of the outermost part of the female genital organs (vulva), if this is associated with vaginal discharge. Cortidro is not for ophthalmic use, so do not use it around the eyes.

The use of this medicine, especially if prolonged and on large surfaces, can give rise to irritation and allergic reactions (sensitization phenomena). If this happens, stop the treatment and consult your doctor.

Children and adolescents

In children under the age of two, Cortidro should only be used when clearly needed and under direct medical supervision.

Interactions Which drugs or foods can modify the effect of Cortidro

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should be especially careful when using Cortidro together with the following medicines:

  • Amphotericin B medicines used in the treatment of fungal infections (mycosis): concomitant administration with Cortidro can cause further lowering of potassium levels in the blood (hypokalaemia).

The concomitant use of Cortidro with:

  • anticoagulant medicines (ie capable of slowing down or interrupting the blood clotting process): the action of Cortidro can counteract the effects of these medicines, especially in the case of coumarin anticoagulants;
  • barbiturates (medicines to treat conditions including insomnia and epilepsy): can reduce the effect of corticosteroids.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

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 using this medicine.

If you are pregnant, use this medicine only when clearly needed and under the direct supervision of your doctor.

Driving and using machines

Cortidro does not affect the ability to drive or use machines.

Cortidro contains:

  • methyl P-hydroxybenzoate, propyl P-hydroxybenzoate which can cause allergic reactions (even delayed);
  • cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis).

Dosage and method of use How to use Cortidro: Dosage

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Adults and children over two years of age

Take a small amount of cream and apply it on the affected area, massaging lightly to facilitate absorption, two or three times a day.

Only use Cortidro for short periods of treatment.

If you do not notice an improvement, please contact your doctor. Do not exceed the recommended dose.

If you forget to use Cortidro

If you have forgotten to apply the cream, do so as soon as you remember.

Do not apply a double dose to make up for the forgetfulness; then continue the application according to the usual scheme.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken too much Cortidro

In case of accidental ingestion / intake of an excessive dose of Cortidro, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Cortidro

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic side effects from local application of corticosteroids at the indicated doses are very unlikely. If you experience any side effects, stop therapy and contact your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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

Store at a temperature not exceeding 30 ° C.

Do not use this medicine after the expiry date which is stated on the package after "EXP." The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Cortidro contains

  • the active ingredient is hydrocortisone acetate. 100 g of cream contains 0.5 g of hydrocortisone acetate.
  • the other ingredients are: cetostearyl alcohol, sodium lauryl sulfate, vaseline oil, stringy vaseline, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.

Description of what Cortidro looks like and contents of the pack

Cortidro comes in the form of a cream, contained in a 20 g aluminum tube.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Cortidro is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

CORTIDRO 0.5% CREAM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 g of cream contains 0.5 g of Hydrocortisone acetate.

Excipients with known effects: cetostearyl alcohol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Cream.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

The product is used in case of insect bites, itching, erythema or limited burns, eczema.

04.2 Posology and method of administration -

For adults and children over two years of age: apply a small amount of cream on the part and rub lightly in order to facilitate its penetration. The application can be repeated two or three times a day for a few days. In case of failure to respond to therapy, it is advisable to contact a doctor.

Do not exceed the recommended dose.

04.3 Contraindications -

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

The use of hydrocortisone is contraindicated in the case of viral, bacterial or fungal diseases.

04.4 Special warnings and appropriate precautions for use -

The cream is not for ophthalmological use nor should it be applied in the periocular areas. Avoid use in the treatment of vulvar itching if associated with vaginal discharge. Avoid prolonged applications, especially on large surfaces. The use, especially if prolonged, of topical products can give rise to irritation or sensitization phenomena. In this case it is necessary to stop the treatment and consult the doctor in order to establish a suitable therapy.

Pediatric population

In children under two years, the product should be administered in cases of real need under the direct supervision of the doctor.

04.5 Interactions with other medicinal products and other forms of interaction -

It is necessary to observe caution in the association of corticosteroids with amphotericin B because they can add their hypokalemic actions. Corticosteroids antagonize the effects of anticoagulants, therefore simultaneous use with them is not recommended, especially if coumarin derivatives. Barbiturates accelerate the metabolism of corticosteroids by enzyme induction and reduce their effect, therefore their association is not recommended.

04.6 Pregnancy and breastfeeding -

The product should be administered in cases of real need and under the direct supervision of the doctor.

04.7 Effects on ability to drive and use machines -

Cortidro does not affect the ability to drive or use machines.

04.8 Undesirable effects -

The systemic side effects of corticosteroid preparations for topical use are extremely unlikely due to the low dosages used: in case of onset, discontinue therapy.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose -

At the indicated doses, no clinically unfavorable symptoms were detected; in case of emergency, the doctor intervenes according to the symptoms detected.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Therapeutic drug category: corticosteroids, dermatological preparations.

ATC code: D07AA02.

Hydrocortisone acetate (17-hydrocortisone 21-acetate) is a corticosteroid which for topical use has an anti-inflammatory, anti-allergic and vasoconstrictive activity. Various laboratory techniques, including analytical methods of vasoconstriction are used both to compare and to evaluate the potential and / or clinical efficacy of topical corticosteroids. There is evidence that suggests, in humans, the existence of a correlation between potency vasoconstrictive and therapeutic efficacy.

The topical application of corticosteroids produces a rapid suppression of cutaneous symptoms, where inflammation plays a predominant role, for example eczema, infantile eczema, atopic dermatitis, herpetiform dermatitis, contact dermatitis, veined dermatitis, seborrheic dermatitis, neurodermatitis, psoriasis and intertrigo . Despite this, skin disease may recur after discontinuation of corticosteroid treatment.

05.2 "Pharmacokinetic properties -

Hydrocortisone acetate is absorbed from the skin more slowly than other corticosteroids, but it has a longer action. Hydrocortisone is metabolized in the liver and almost all body tissues, in its hydrogenated and degraded forms such as, for example, tetrahydrocortisone and tetrahydrocortisol. These forms are excreted in the urine mainly conjugated as glucuronides together with a small portion of unmodified hydrocortisone. .

05.3 Preclinical safety data -

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Cetostearyl alcohol, sodium lauryl sulfate, petroleum jelly, stringy petroleum jelly, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.

06.2 Incompatibility "-

None.

06.3 Period of validity "-

5 years.

06.4 Special precautions for storage -

Do not store above 30 ° C.

06.5 Nature of the immediate packaging and contents of the package -

0.5% cream, 20 g tube.

06.6 Instructions for use and handling -

No special instructions.

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

SOFAR S.p.A., Via Firenze 40, Trezzano Rosa (MI)

08.0 MARKETING AUTHORIZATION NUMBER -

A.I.C. n. 010318032 - "0.5% cream" tube 20 g

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

June 2010

10.0 DATE OF REVISION OF THE TEXT -

13/10/2015

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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