Package Insert: Information for the User

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

Hydrocortisone acetate/ Chloramphenicol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contains as active principles 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 infections caused by germs sensitive to chloramphenicol.

Do not use Cortison Chemicetina:

• If you are allergic to hydrocortisone, chloramphenicol, or any of the other components of this medication (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes).
• If you have rosacea (a condition that causes redness and inflammation in the skin), ulcers, or skin diseases with skin thinning (atrophy).
• In areas of the skin that show a vaccine reaction, that is, redness or inflammation after the vaccine.
• In specific inflammation of the skin around the upper lip and chin (perioral dermatitis).
• In case of fungal infections (see "Warnings and precautions" section).
• Do not use it in the eyes or open deep wounds.
• Children under 2 years, as its safety has not been established.
• If you have or have a history of bone marrow insufficiency or any blood disease.

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 medication should not be used more than necessary in infections caused by sensitive bacteria to this antibiotic when other less toxic ones are ineffective.
• Corticosteroids, such as hydrocortisone, have significant effects on the body. Do not apply the ointment to large areas of the body or for prolonged periods, as this increases the risk of adverse effects.
• If you have or your doctor diagnoses a fungal infection, you must use the specific treatment prescribed for it.
• This medication should not come into contact with the eyes, open wounds, or mucous membranes (for example, the genital area).
• Do not apply the treatment with occlusive dressings, such as some diapers, or in skin folds, such as the groin or armpits.
• If you have kidney or liver insufficiency, you should be cautious.

• If you use this medication for diseases other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.

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

Children and adolescents

In children under 2 years, this medication 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 in them it is more likely that the corticosteroid will pass through the skin and cause adverse effects in other areas of the body, such as growth delay, obesity, etc. (see section 4).

Use of Cortison Chemicetina with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions of Cortison Chemicetina with other medications are known.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

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

This medication will 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 Cortison Chemicetina on large areas of the skin, for prolonged periods, or with occlusive dressings.

This medication will 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 medication to the breasts; do not put the child in contact with treated areas.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Cortison Chemicetina contains lanolin

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Cutaneous use.

• Adults and children over 12 years:

Generally, apply the ointment 2 to 4 times a day to the affected area over the first 4 days, on clean skin, spreading it smoothly, and then reduce the applications to 1-2 times a day.

The treatment duration is generally not more than 7-10 days.

Use in children and adolescents

If used in children between 2 and 12 years, under medical indication, administration should be done during short periods of time and with the minimum amount of medication 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 cutaneous application of an overdose (application to a large 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 Toxicological Information Service, Telephone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Cortison Chemicetina

Do not use a double dose to compensate for the missed doses and continue with your regular schedule according to the instructions indicated by your doctor or those described in this prospectus.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication can produce adverse effects, although not all people may experience them.

Due to the presence of chloramphenicol, in very rare cases, serious blood disorders (dyscrasias) such as aplastic or hypoplastic anemia, thrombocytopenia, and granulocytopenia may occur; they are normally reversible and are much more frequent with high doses and in other routes of administration.

Other effects include: Allergic reaction to one of the components, with symptoms on the skin and others of greater importance.

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

• Acne
• Fungal skin infection
• Easy bruising
• Redness (erythema)
• Thinning of the skin (atrophy)
• Excessive hair growth
• Striae cutaneous
• Facial skin inflammation, usually red or pink (rosacea)
• Perioral dermatitis (inflammation around the mouth)
• Increased sweating
• Dilated blood vessels in the skin (telangiectasias)
• Itching or burning

Unknown frequency (cannot be estimated from available data):

• Blurred vision

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30º C. Store in the original packaging.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cortison Chemicetina

• The active principles are Hydrocortisone acetate and Chloramphenicol. Each gram of ointment contains 5 mg of hydrocortisone acetate (0.5%) and 10 mg of chloramphenicol (1%).
• The other components (excipients) are: petrolatum, petroleum jelly, and lanolin.

Appearance of the product and content of the packaging

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

It is presented in a 5 g tube.

• -Other presentations

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

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Last review date of this leaflet:04/ 2015.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es