Cortison Chemi Cetina 5 mg/g + 10 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Hydrocortisone acetate / Chloramphenicol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Cortison Chemicetina 5 mg/g + 10 mg/g is and what it is used for
2. What you need to know before using Cortison Chemicetina 5 mg/g + 10 mg/g
3. How to use Cortison Chemicetina 5 mg/g + 10 mg/g
4. Possible side effects
5. How to store Cortison Chemicetina 5 mg/g + 10 mg/g
6. Contents of the pack and other information

1. What Cortison Chemicetina 5 mg/g + 10 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 topical use on the skin.

Cortison Chemicetina is indicated for:

Local treatment of skin disorders (dermatoses) responsive to corticosteroids, associated with superficial infection caused by microorganisms sensitive to chloramphenicol.

2. What you need to know before using Cortison Chemicetina 5 mg/g + 10 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 (e.g., chickenpox or herpes).
• If you have rosacea (a condition causing red/pink skin inflammation), skin ulcers, or skin diseases with thinning of the skin (atrophy).
• On areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In fungal infections (see section “Warnings and precautions”).
• It must not be used in the eyes or on deep open wounds.
• Children under 2 years of age, as safety has not been established.
• If you have or have a history of bone marrow failure or any 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 for infections caused by germs sensitive to this antibiotic when other safer alternatives are ineffective.

• Corticosteroids, such as hydrocortisone, have significant effects on the body. The ointment should not be applied over 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 medicine must not come into contact with the eyes, open wounds, or mucous membranes (e.g., the genital area).

• The treatment should not be applied under occlusive dressings such as certain diapers, or in skin folds such as the groin or armpits.

• Exercise caution if you have renal or hepatic impairment.

• If you use this medicine for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.

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

Children and adolescents

Cortison Chemicetina is contraindicated in children under 2 years of age. In children between 2 and 12 years of age, treatment should be limited to short periods and the smallest effective amount of the product, as corticosteroids are more likely to be absorbed through the skin in children, potentially causing adverse effects in other parts of the body, such as growth retardation, obesity, etc. (see section 4).

Use of Cortison Chemicetina with other medicines

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

No interactions between Cortison Chemicetina and other medicines are known.

Do not apply together with other topical preparations on the same area.

Pregnancy, breastfeeding, and fertility

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

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

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

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

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

Do not apply the medicine on the breasts; avoid contact of treated areas with the infant.

Driving and using machines

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

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 5 mg/g + 10 mg/g

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Cutaneous use

• Adults and children over 12 years of age:

Generally, apply the ointment 2 to 4 times daily on the affected area for the first 4 days, on clean skin, gently spreading it, then reduce the applications to 1–2 times daily.

The duration of treatment should generally not exceed 7–10 days.

Use in children and adolescents

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

If you use more Cortison Chemicetina than you should

Due to the characteristics and method of application of this preparation, acute intoxication phenomena are not expected following a single cutaneous overdose (application over a large area, under conditions favorable for absorption).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 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 missed doses; continue with your usual schedule according to the instructions given by your doctor or those described in this leaflet.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Due to the presence of chloramphenicol, serious blood disorders (dyscrasias) may very rarely occur, such as a reduction in red blood cells (aplastic or hypoplastic anaemia), reduction in platelets (thrombocytopenia), or decreased levels of certain types of white blood cells (granulocytopenia); these are usually reversible and occur much more frequently with high doses and other routes of administration.

Other effects include: allergic reaction to one of the components, with skin symptoms and other more serious manifestations.

The following adverse effects have been reported with the use of corticosteroids administered locally, especially with prolonged application, over 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
• Stretch marks (striae)
• Skin condition with facial inflammation, usually red/pink (rosacea)
• Perioral dermatitis (inflammation around the mouth)
• Increased sweating
• Dilated small blood vessels in the skin (telangiectasias)
• Itching or burning sensation

Frequency not known (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, when the active substance passes through the skin into the body. This could, for example, increase eye pressure (glaucoma) or cause a condition characterised by a rounded face, weight gain, a hump on the back, delayed wound healing, etc. (Cushing's syndrome); growth retardation in children, increased blood pressure, cataracts.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cortison Chemicetina 5 mg/g + 10 mg/g

Do not store above 30°C. Keep in the original container.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Cortison Chemicetina

• The active substances are Hydrocortisone acetate and Chloramphenicol. Each g of ointment contains 5 mg of hydrocortisone acetate (0.5%) and 10 mg of chloramphenicol (1%).
• The other components (excipients) are: soft white paraffin, liquid paraffin, and lanolin.

Appearance of the product and contents of the container

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

It is presented in a tube containing 5 g.

• -Other presentations

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

Marketing Authorization Holder and Manufacturer

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Date of the most recent revision of this leaflet: 04/2015.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es