CORTISON CHEMICETINA 25mg/g + 20mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

CORTISON CHEMICETINA 25 mg/g + 20 mg/g Ointment

Hydrocortisone Acetate/ Chloramphenicol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Cortison Chemicetina 25 mg/g + 20 mg/g is and what it is used for
2. What you need to know before you use Cortison Chemicetina 25 mg/g + 20 mg/g
3. How to use Cortison Chemicetina 25 mg/g + 20 mg/g
4. Possible side effects
5. Storage of Cortison Chemicetina 25 mg/g + 20 mg/g
6. Contents of the pack and further information

1. What Cortison Chemicetina 25 mg/g + 20 mg/g is and what it is used for

It contains as active ingredients hydrocortisone acetate, an anti-inflammatory (a corticosteroid), and chloramphenicol, a broad-spectrum antibiotic, for use on the skin.

Cortison Chemicetina is indicated for:

Local treatment of skin conditions (dermatoses) that respond to corticosteroids with superficial infection caused by germs sensitive to chloramphenicol.

2. What you need to know before you use Cortison Chemicetina 25 mg/g + 20 mg/g

Do not use Cortison Chemicetina:

• If you are allergic to hydrocortisone, chloramphenicol, or any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (such as chickenpox or herpes).
• If you have rosacea (a condition that causes red/pink inflammation of the skin), ulcers, or skin diseases with thinning of the skin (atrophy).
• In areas of the skin that show a vaccination reaction, i.e., redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In case of fungal infections (see "Warnings and precautions").
• It must not be used in the eyes or on open deep wounds.
• Not to be used in children under 2 years of age, as its safety has not been established.
• If you have or have a history of bone marrow failure or a blood disorder.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cortison Chemicetina.

• Due to the potential toxic effect of chloramphenicol on the bone marrow (see section 4), this medicine should only be used when necessary in infections caused by germs sensitive to this antibiotic when other, less harmful ones are ineffective.
• Corticosteroids, such as hydrocortisone, have significant effects on the body. The ointment should not be applied to large areas of the body or for prolonged periods, as this increases the risk of side effects.
• If you have or your doctor diagnoses a fungal infection, you should use the specific treatment prescribed for it.
• This medicine should not come into contact with the eyes, open wounds, or mucous membranes (e.g., the genital area).
• The treatment should not be applied with occlusive dressings, such as some diapers, or in skin folds, such as the groin or armpits.
• If you have kidney or liver failure, you should be cautious.

• If you use this medicine for diseases other than those for which it has been prescribed, it may mask the symptoms and make the correct diagnosis and treatment more difficult.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

In children under 2 years of age, this medicine is contraindicated, and in children between 2 and 12 years, administration should be limited to short periods of time and the minimum effective amount of the product, as it is more likely that the corticosteroid will pass into the body through the skin and cause side effects in other areas of the body, such as growth retardation, obesity, etc. (see section 4).

Using Cortison Chemicetina with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions of Cortison Chemicetina with other medicines are known.

Do not apply together with other preparations in the same area.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

As a general rule, during the first trimester of pregnancy, this medicine should not be applied.

This medicine should not be used during pregnancy unless your doctor considers that the potential benefit of its use justifies the potential risk to the fetus.

Do not use this medicine on large areas of the skin, for prolonged periods, or use occlusive dressings.

This medicine should not be used during breastfeeding unless your doctor considers that the potential benefit of its use justifies the potential risk to the fetus.

Do not apply the drug to the breasts; do not let the child come into contact with treated areas.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Cortison Chemicetina contains lanolin

This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

3. How to use Cortison Chemicetina 25 mg/g + 20 mg/g

Follow exactly the instructions for administration of this medicine indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Topical use.

• Adults and children over 12 years:

Generally, the ointment will be applied 2 to 4 times a day to the affected area for the first 4 days, on clean skin, spreading it gently, and then reducing applications to 1-2 times a day.

The duration of treatment will generally not exceed 7-10 days.

Use in children and adolescents

If used in children between 2 and 12 years, under medical indication, administration should be for short periods and with the minimum amount of the medicine possible.

If you use more Cortison Chemicetina than you should

Due to the characteristics and mode of application of this preparation, acute intoxication phenomena are not expected after a single topical application of an overdose (application to an extensive area, under favorable conditions for absorption).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, Telephone 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Cortison Chemicetina

Do not use a double dose to make up for forgotten doses, and continue with your usual schedule as indicated by your doctor or as described in this leaflet.

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

4. Possible side effects

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

Due to the presence of chloramphenicol, very rare but serious blood disorders (discrasias) can occur, such as reduction of red blood cells (aplastic or hypoplastic anemia), reduction of platelets (thrombocytopenia), decrease of some types of white blood cells (granulocytopenia); these are usually reversible and are much more frequent with high doses and in other routes of administration.

Other effects are: Allergic reaction to any of the components, with symptoms on the skin and more serious ones.

The following side effects have been reported with the use of corticosteroids administered locally, especially with prolonged application, in extensive areas, with occlusive dressings or materials, and/or in children:

• Acne
• Fungal skin infection
• Easy bruising
• Redness (erythema)
• Thinning of the skin (atrophy)
• Increased hair growth
• Stretch marks
• Rosacea (a condition that causes red/pink inflammation of the skin of the face)
• Perioral dermatitis (inflammation around the mouth)
• Increased sweating
• Dilated small blood vessels in the skin (telangiectasias)
• Itching or burning

Frequency not known (cannot be estimated from the available data):

• Blurred vision

Side effects may occur not only in the treated area but also in completely different areas of the body, which happens if the active ingredient passes into the body through the skin. This, for example, can increase pressure in the eye (glaucoma) or could cause a condition characterized by a rounded face, weight gain, hump, delayed wound healing, etc. (Cushing's syndrome); growth retardation in children, increased blood pressure, cataracts.

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cortison Chemicetina 25 mg/g + 20 mg/g

Do not store above 30°C. Store in the original package.

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

Do not use this medicine after the expiry date which is stated on the package after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Cortison Chemicetina 25 mg/g + 20 mg/g

• The active ingredients are Hydrocortisone Acetate and Chloramphenicol. Each gram of ointment contains 25 mg of hydrocortisone acetate (2.5%) and 20 mg of chloramphenicol (2%).
• The other ingredients (excipients) are: petroleum jelly and lanolin.

Appearance of the product and contents of the pack

Cortison Chemicetina is a greasy ointment with a soft consistency, white or slightly yellowish in color.

It is presented in a tube with 10 g.

• Other presentations

CORTISON CHEMICETINA 5 mg/g + 10 mg/g ointment

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Date of last revision of this leaflet: 04/2015.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es