Active ingredients: Meclocycline
MECLODERM® 1% cream
Mecloderm package leaflets are available for pack sizes:- MECLODERM® 1% cream
- MECLODERM® 2% skin foam
- MECLODERM® 35 mg eggs
Indications Why is Mecloderm used? What is it for?
Mecloderm1% cream contains the active ingredient meclocycline sulfosalicylate which belongs to a class of antibiotics used to treat skin infections. Mecloderm1% cream is used for the treatment of skin infections of bacterial origin.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Mecloderm should not be used
Do not use Mecloderm 1% cream
- if you are allergic to meclocycline sulphosalicylate or any of the other ingredients of this medicine.
- if you are allergic to a class of antibiotics known as tetracyclines
Precautions for use What you need to know before you take Mecloderm
Talk to your doctor or pharmacist before using Mecloderm 1% cream.
- Do not use Mecloderm 1% cream for a prolonged treatment as it can cause increased sensitivity of the skin. Your doctor can make you stop the treatment and start a specific therapy.
- Avoid prolonged use of Mecloderm 1% cream as it can cause the development of resistant bacteria that do not respond to treatment. If this happens your doctor may decide whether to stop the treatment.
- The product may cause sensitivity to sulphites (sensitivity to the sulfur-based component of the medicine) which can lead to allergic-type reactions, such as anaphylactic symptoms and life-threatening or less severe asthma episodes.
Interactions Which drugs or foods may change the effect of Mecloderm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant treatment with topical aminolevulinic acid or methyl aminolevulinate and meclocycline sulfosalicylate may increase the sensitivity of the skin to light. Avoid exposure to sunlight or intense light during treatment with Mecloderm 1% cream.
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.
Pregnancy
In pregnant women you should use the medicine only in case of real need and under strict medical supervision.
Feeding time
There are no data on the passage of meclocycline into breast milk or on harmful effects on breast-fed infants.
Fertility
There are no data on the effect of Mecloderm 1% cream on fertility.
Driving and using machines
No effects on driving or using machines associated with the use of Mecloderm 1% cream have been reported.
Mecloderm 1% cream contains
- Propylene glycol: can cause skin irritation.
- Methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate: can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Mecloderm: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Method of application
For external use only.
The recommended dose is one application 2-4 times a day, unless otherwise prescribed by your doctor. The frequency of application will be adapted to the severity of the infection.
You should spread the cream evenly over the affected area, if possible, massaging it gently. Avoid occlusive bandages.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Mecloderm
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Mecloderm 1% cream and see a doctor urgently if you experience an allergic reaction.
The following undesirable effects have been reported with the use of Mecloderm 1% cream:
- frequency not known (frequency cannot be estimated from the available data): pain, itching, redness of the skin, dry and flaky skin, yellowing of the skin, especially around the hair.
Other side effects such as swelling, other signs of irritation and burning have also been observed during topical administration of other medicines of the same class.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 / responsible. 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.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not store above 30 ° C. Protect the medicine from moisture.
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
What Mecloderm 1% cream contains
- The active ingredient is anhydrous meclocycline sulfosalicylate. 100 g of cream contains 1,457 g of anhydrous meclocycline sulfosalicylate (equivalent to 1 g of meclocycline).
- The other components are: polyglycolic ester of fatty acids, propylene glycol, sodium metabisulphite, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, perfume, purified water.
What Mecloderm 1% cream looks like and contents of the pack
Cream. 30 g 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.
01.0 NAME OF THE MEDICINAL PRODUCT
MECLODERM 1% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principle:
meclocycline sulphosalicylate anhydrous 1,457 g
(equal to meclocycline base g 1)
Excipients with known effects: propylene glycol methyl-p-hydroxybenzoate, 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
Skin infections caused by tetracycline-sensitive bacteria.
04.2 Posology and method of administration
The recommended dose is 2-4 applications per day. The frequency of applications will be adapted to the severity of the infection. The cream must be spread evenly on the infected part accompanying the application, if possible, with a light massage. Occlusive bandages should be avoided.
Pediatric population
No data are available.
04.3 Contraindications
Hypersensitivity to meclocycline or to any of the excipients listed in section 6.1.
Hypersensitivity to tetracycline (see section 4.4).
04.4 Special warnings and appropriate precautions for use
• The use, especially if prolonged, of the product can cause manifestations of sensitization. If this occurs, treatment must be suspended and appropriate therapy instituted, if necessary. The same applies to the development of insensitive germs.
• The product may cause sensitivity to sulphites with allergic-type reactions, including anaphylactic symptoms and less severe or life-threatening asthma episodes.
• In patients who have developed hypersensitivity to tetracyclines, the application of the product can lead to allergic manifestations of various types and different sites (see section 4.3).
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant use of topical aminolevulinic acid or methyl aminolevulinate and meclocycline sulfosalicylate therapy may cause increased skin sensitivity to light. Exposure to sunlight or bright artificial lights should be avoided during therapy.
04.6 Pregnancy and breastfeeding
Pregnancy
In pregnant women, the product should be administered in cases of real need under the direct supervision of the doctor.
Studies in rabbits have shown that topical meclocycline causes a slight delay in ossification (see section 5.3).
Feeding time
No data are available.
Fertility
No data are available.
04.7 Effects on ability to drive and use machines
Mecloderm does not affect the ability to drive or use machines.
04.8 Undesirable effects
The following undesirable effects have been observed with the administration of Mecloderm 1% cream:
Frequencies are defined as follows: very common (≥1 / 10), common (≥1 / 100,
General disorders and administration site conditions
Not known: pain, exfoliation, itching, erythema and dryness. Yellowing of the skin especially near the hair roots.
During the administration of tetracyclines for topical use, other adverse events such as allergic reactions, redness, edema, burning, other signs of irritation have also been observed.
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
Overdose manifestations of the drug have never been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antimicrobials for the treatment of acne
ATC code: D10AF04
The antibacterial activity "in vitro" and "in vivo" of meclocycline on numerous bacterial strains, both Gram + and Gram-, is remarkable. Many authors have confirmed that the antibacterial activity "in vitro" of meclocycline was not only comparable to that of dimethylchlortetracycline and to that of oxytetracycline, but often superior.
Meclocycline, applied on different skin areas, does not enter the circulation in a quantity that can be determined by microbiological method, even though it penetrates into the deeper layers of the epidermis. This peculiarity, probably related to the high affinity of the bonds that are established between meclocycline and tissue macromolecules, allows the drug to exert an intense antibacterial action concentrated on site.
05.2 Pharmacokinetic properties
Meclocycline is not absorbed through the skin or, if it is absorbed, this occurs in quantities that cannot be determined by microbiological method. It does not cause any toxic or collateral effect and is practically not absorbed through the skin, which is instead adequately penetrated to the deeper layers of the epidermis. All this due to its very high ability to bind to the macromolecules present in the absorption surfaces.
05.3 Preclinical safety data
The acute, subacute and chronic toxicity of anhydrous meclocycline sulfosalicylate was extensively determined in mice, rats and rabbits by different routes of administration and compared to doxycycline.
None of the topically treated animals showed any apparent toxic manifestations. Blood chemistry tests did not reveal any substantial changes. Both at the macroscopic and microscopic examination in no case were alterations observed, both in the skin and in the organs taken.
Studies in rabbits have shown that topical meclocycline causes a slight delay in ossification.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polyglycol ester of fatty acids,
propylene glycol,
sodium metabisulfite,
methyl p-hydroxybenzoate,
propyl p-hydroxybenzoate,
scent,
purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
24 months in intact packaging.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C
06.5 Nature of the immediate packaging and contents of the package
30 g aluminum tube internally coated with epoxy resins, with polythene screw cap.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Amdipharm Ltd - 3 Burlington Road - Dublin 4 Temple Chambers - Ireland
08.0 MARKETING AUTHORIZATION NUMBER
30 g tube of A.I.C. n. 022839120
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 2009
10.0 DATE OF REVISION OF THE TEXT
26 August 2016
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