Aureomycin - Package Leaflet

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

Active ingredients: Chlortetracycline

Aureomycin 3% ointment

Aureomycin package inserts are available for pack sizes:
  • Aureomycin 3% ointment
  • Aureomycin 1% ophthalmic cream

Why is Aureomycin used? What is it for?

Aureomycin is a medicine based on chlorotetracycline hydrochloride, an antibiotic belonging to the tetracyclines class.

Aureomycin is indicated in adults for the treatment of pyoderma (skin infections caused by bacteria, which cause pus to form).

Talk to your doctor if you don't feel better or if you feel worse.

Contraindications When Aureomycin should not be used

Do not use Aureomycin

  • if you are allergic to chlortetracycline hydrochloride, any tetracycline or any of the other ingredients of this medicine (listed in section 6).

Precautions for use What you need to know before taking Aureomycin

Talk to your doctor or pharmacist before using Aureomycin.

Possible consequences of prolonged use of Aureomycin

Like other antibiotics, Aureomycin could cause uncontrolled growth of bacteria that are not sensitive to this antibiotic. If you develop a new infection in addition to the current one, your doctor will take appropriate measures.

Interactions Which drugs or foods can modify the effect of Aureomycin

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

Warnings It is important to know that:

Children and adolescents

Aureomycin should not be given to children and adolescents under the age of 18, as safety and efficacy have not been established in this patient group.

Pregnancy and breastfeeding

If you are pregnant, think you are pregnant or planning to become pregnant, or if you are breast-feeding, 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

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

Aureomycin contains lanolin

Lanolin can cause local skin reactions (e.g. contact dermatitis).

Dose, Method and Time of Administration How to use Aureomycin: Posology

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

The recommended dose is one application once or more times a day, according to the doctor's prescription.

Application procedure:

  1. spread the ointment on a sterile gauze
  2. apply the gauze to the part of the skin affected by the infection.

If you forget to use Aureomycin

Do not use a double dose to make up for a forgotten dose.

If you forget to apply the ointment at the scheduled time, you can arrange to apply it as soon as possible.

If you stop taking Aureomycin

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 Aureomycin

If you accidentally use large amounts of this medicine, contact your doctor or the nearest hospital.

Side Effects What are the side effects of Aureomycin

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

If during treatment with Aureomycin you experience the following side effects, STOP the treatment and contact your doctor immediately who will institute a suitable therapy:

  • allergic reactions that can occur with the following symptoms:
    • irritation
    • sense of burning If you are allergic to other medicines you may more easily develop an allergy to Aureomycin as well.

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.gov.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 25 ° C.

Do not take this medicine after the expiry date which is stated on the carton 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.

Other_information "> Other information

What Aureomycin contains

  • the active ingredient is chlorotetracycline hydrochloride 30 mg (tetracycline)
  • the other ingredients are: white petroleum jelly; anhydrous lanolin (See section 2 Aureomycin contains lanolin).

What Aureomycin looks like and contents of the pack

Aureomycin is presented as an ointment to be applied to the skin in a tube of 14.2 g

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 Aureomycin can be found 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 -

AUREOMYCIN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

1 g of ointment contains:

Active principle:

Chlortetracycline hydrochloride 30 mg

03.0 PHARMACEUTICAL FORM -

Ointment.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Aureomycin Ointment is indicated for the treatment of pyoderma (superficial cutaneous pyogenic infections) having proved effective against Gram-positive cocci (streptococci, staphylococci and pneumococci) and Gram-negative bacteria (including those of the coli-aerogenes group).

04.2 Posology and method of administration -

For local skin infections, apply Aureomycin Ointment directly on the affected part, preferably spreading it on sterile gauze, one or more times a day, as needed.

In severe local infections, in addition to topical treatment, Aureomycin should be administered orally.

04.3 Contraindications -

Known hypersensitivity to tetracyclines.

04.4 Special warnings and appropriate precautions for use -

A certain intolerance to Aureomycin has been found in patients who have shown a marked allergy to other drugs as well.

In pregnant women and in very early childhood, the product should be administered in cases of real need under the direct supervision of the doctor.

The use of the product, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy. Similarly, we will behave in case of development of resistant microorganisms including fungi.

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

There are no known drug interactions with other drugs.

04.6 Pregnancy and breastfeeding -

In pregnant women, the product should be administered only in cases of real need, under the direct supervision of the doctor.

04.7 Effects on ability to drive and use machines -

Aureomycin does not interfere with the ability to drive and use machines.

04.8 Undesirable effects -

Occasionally sensitization phenomena such as irritation and burning sensation.

04.9 Overdose -

No signs of overdose have been reported.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

The spectrum of action of chlortetracycline is substantially the same as that of all the other components of the tetracycline group. It includes Gram-positive and Gram-negative germs, Rickettsiae, cocci, actinomycetes, mycobacteria and generally protozoa. especially the spirochetes, the entamebas and the trichomonads.

The tetracyclines act as bacteriostatic, inhibiting the transport of the amino acid activated by the aminoacyl-t-RNA to the ribosomes, thus blocking the formation of the peptide chain and, ultimately, the synthesis of proteins.

05.2 "Pharmacokinetic properties -

In vivo, tetracyclines exhibit greater activity than in vitro and this refers both to a more difficult inactivation and to a "stimulating action on leukocytes.

05.3 Preclinical safety data -

The acute toxicity of tetracyclines is relatively low. The LD50 of chlortetracycline tested in mice by the intravenous and oral route was respectively 130 mg / kg and 1500 mg / kg. In rats, the intravenous LD50 was calculated to be 118 mg / kg, and by the oral route> 3000 mg / kg.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

White Vaseline, Anhydrous Lanolin.

06.2 Incompatibility "-

None.

06.3 Period of validity "-

Shelf life: 3 years.

The expiry date indicated refers to the product in intact packaging, correctly stored.

06.4 Special precautions for storage -

Do not store above 25 ° C

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

Aureomycin "3% Ointment" Tube of 14.2 g

06.6 Instructions for use and handling -

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07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Wyeth Lederle S.p.A.

Via Nettunense n. 90

04011 APRILIA (LT)

Aureomicina is a registered trademark owned by Alpharma, licensed to Wyeth Lederle S.p.A.

08.0 MARKETING AUTHORIZATION NUMBER -

A.I.C. n. 002039055.

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

6 April 1951 / June 2005

10.0 DATE OF REVISION OF THE TEXT -

01/05/2007

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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