Active ingredients: Erythromycin, Zinc (Zinc acetate dihydrate)
Zineryt 4% + 1.2% powder and solvent for skin solution
Why is Zineryt used? What is it for?
Zineryt contains the active ingredients: erythromycin and zinc acetate dihydrate. Erythromycin is an antimicrobial antibiotic that works by killing the bacteria that cause acne (an inflammation of the skin that occurs with boils, with or without pus). Zinc acetate enhances the effect of erythromycin.
Zineryt is used for the local treatment of all forms of acne.
Contact your doctor if you do not notice any improvement after 12 weeks of treatment.
Contraindications When Zineryt should not be used
Do not use Zineryt
- if you are allergic to erythromycin, zinc acetate dihydrate or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other antibiotics belonging to the macrolide family (a class of medicines similar to Zineryt).
Precautions for use What you need to know before taking Zineryt
Only use Zineryt on the skin.
Do not use Zineryt on the eyes and / or mucous membranes. If Zineryt accidentally comes into contact with the eyes and / or mucous membranes, it must be rinsed immediately with plenty of water.
The use, especially if prolonged, of the products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components). In this case, stop the treatment and contact your doctor.
Children
In children this medicine should only be used when clearly needed and under medical supervision.
Your doctor will carefully weigh the benefit of erythromycin therapy against the potential risk of developing side effects (see section "Additional side effects in children").
Interactions Which drugs or foods can change the effect of Zineryt
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
- macrolide antibiotics (class of medicines similar to Zineryt)
- lincomycin or clindamycin (antibiotics).
Warnings It is important to know that:
Pregnancy and breastfeeding
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; use Zineryt only when clearly needed and under the direct supervision of your doctor.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
Dose, Method and Time of Administration How to use Zineryt: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Zineryt must be applied twice a day.
Apply the medicine to the skin of the face or other affected areas (not just the lesion) until the area to be treated is covered (approximately 0.5 ml for each application).
Use in children
In children this medicine should only be used when clearly needed and under medical supervision.Your doctor will carefully weigh the benefit of erythromycin therapy against the potential risk of developing side effects (see section "Additional side effects in children").
Instructions for Use
Instructions for preparing the solution
- Remove the cap from both bottles of Zineryt and save the cap of the bottle with the powder.
- Pour the liquid into the bottle containing the Zineryt powder.
- Screw the cap previously stored on the bottle which now contains powder and liquid.
- Shake the bottle well for about one minute.
- Remove the cap, insert the applicator and screw the cap back on by exerting a slight pressure in order to position the applicator correctly.
- Check that the applicator is fully inserted (press if necessary).
- Once the solution is prepared, write the expiry date on the bottle (the prepared solution expires 8 weeks after preparation) (see section 5 "How to store Zineryt").
Instructions for applying the product
Zineryt is applied by tilting the container downwards and rubbing the applicator on the skin to be treated with a simultaneous light pressure.
The amount of flow of Zineryt can be controlled by increasing or decreasing the pressure against the skin. After application, allow to dry.
Warning: after application, use the container containing the medicine only for yourself. The container must not be used by others, this is to prevent the spread of infection.
Duration of treatment
The treatment period is generally 10-12 weeks. As a rule, after this treatment period, you should notice a satisfactory improvement.
If you do not notice visible improvement after 12 weeks of treatment, contact your doctor as there may be bacterial resistance (presence of bacteria against which erythromycin is not effective). In this case, your doctor will prescribe the appropriate therapy.
If you forget to use Zineryt
Do not use a double dose to make up for a forgotten dose.
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 Zineryt
There are no known cases of using an overdose of this medicine.
When used correctly, overdose is unlikely to occur.
In case of accidental ingestion of the contents of the package the symptoms that may have are due to the presence of alcohol in the medicine.
Side Effects What are the side effects of Zineryt
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If during the treatment you experience allergic phenomena, stop the treatment and contact your doctor immediately. These effects mainly occur with prolonged use of the medicine. In addition, the following side effects may occur at the following frequency.
Uncommon (may affect up to 1 in 100 people)
- itching - erythema (redness of the skin),
- skin irritation
- burning sensation,
- dryness of the skin
- skin exfoliation (detachment of thin and superficial layers of skin).
The burning sensation or redness of the skin is due to the alcohol contained in Zineryt. These effects are transient and cease with the discontinuation of treatment or with a reduction in the frequency of application
Additional side effects in children
The following side effects have been reported with other medicines containing erythromycin (one of the active substances in Zineryt), but are unlikely to occur with Zineryt:
Frequency not known (cannot be estimated from the available data)
- hypertrophic pyloric stenosis (narrowing of the valve that connects the stomach to the intestine, which generates difficulty in emptying the stomach resulting in continuous vomiting)
- He retched.
If your doctor has prescribed Zineryt for your baby, tell him immediately if you notice any difficulty in breastfeeding (with both breast and formula milk) and / or vomiting.
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.
After the final preparation the solution is kept at room temperature for 8 weeks.
Store in the original packaging.
Do not use 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.
Deadline "> Other information
What Zineryt
- the active ingredients contained in the bottle with powder are: erythromycin 1302 mg and zinc acetate dihydrate 389 mg
- the other components contained in the bottle with solvent (liquid) are: diisopropylsebacate, ethanol.
1 ml of product obtained by mixing the powder with the solvent contains: 40 mg of erythromycin and 12 mg of zinc acetate.
What Zineryt looks like and what is in the box
Zynerit comes in powder and solvent for local use to be applied to the skin.
Each package of Zineryt contains:
- a bottle containing a powder of the active ingredients (erythromycin and zinc acetate dihydrate)
- a bottle containing the solvent with the other components of the medicine (diisopropylsebacate, ethanol)
- an applicator to be applied on the bottle with the medicine solution (for the preparation of the medicine solution see section "Instructions for preparing the solution").
The bottle with the reconstituted solution contains 30 ml of Zineryt.
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 -
ZINERYT 4% + 1.2% POWDER AND SOLVENT FOR SKIN SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
The package contains, in the powder bottle: erythromycin 1302 mg, micronized zinc acetate dihydrate 389 mg.
1 mL of solution obtained after mixing contains: erythromycin 40 mg, zinc acetate 12 mg.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM -
Powder and solvent for skin solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Topical treatment of all forms of acne vulgaris.
04.2 Posology and method of administration -
Zineryt should be applied twice daily to the skin of the face or other affected areas (not just the lesion) until the area to be treated is covered (approximately 0.5 mL for each application). Zineryt is applied by tilting the container towards the skin. low and rubbing the applicator on the skin with a simultaneous light pressure. The amount of flow of Zineryt can be controlled by increasing or decreasing the pressure against the skin. Allow to dry.
The usual treatment period is 10-12 weeks. A satisfactory improvement is observed in the majority of patients over this period of time.
After use, the container should not be used by other patients to prevent the spread of infection.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients or to other antibiotics belonging to the macrolide family.
04.4 Special warnings and appropriate precautions for use -
Zineryt is intended for topical skin treatment only and should not come in contact with eyes or mucous membranes.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment.
If no improvement is visible after 12 weeks of treatment, the possible occurrence of bacterial resistance should be considered.
Cases of infantile hypertrophic pyloric stenosis have been reported in children receiving erythromycin therapy. In particular, non-biliary vomiting was found in infants who had taken erythromycin for pertussis prophylaxis; they were subsequently diagnosed with pyloric stenosis which necessitated surgical pyloro-myotomy. Given that erythromycin is used in children for the treatment of conditions associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy should be carefully weighed against the potential risk of developing hypertrophic stenosis of the pylorus.
Parents should be advised to report any vomiting or difficulty breastfeeding of the infant to the physician.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
Cross-resistance with other macrolide antibiotics and with lincomycin or clindamycin is possible.
04.6 Pregnancy and breastfeeding -
Based on human data it is believed that oral administration of erythromycin can cause congenital malformations, such as cardiovascular malformations and pyloric stenosis, when administered during pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Zineryt should not be used during pregnancy unless the clinical condition of the woman requires treatment with erythromycin.
04.7 Effects on ability to drive and use machines -
The product does not affect the ability to drive and use machines.
04.8 Undesirable effects -
Disorders of the immune system
Very rare (
Hypersensitivity
Skin and subcutaneous tissue disorders
Uncommon (> 1 / 1,000, pruritus, erythema, skin irritation, burning sensation, dry skin, skin exfoliation.
The burning sensation or slight redness of the skin is due to the alcohol contained in Zineryt. These effects are transient and reversible with the interruption of treatment or with a reduction in the frequency of administration.
There have been reports of hypertrophic pyloric stenosis in infants who received erythromycin (see section 4.4).
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 -
No cases of overdose have been reported.
When used correctly, no cases of overdose are to be expected.
Ingestion of the contents of the entire package can induce symptoms related to the presence of ethyl alcohol.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: antimicrobial for the treatment of acne.
ATC: D10AF52.
The antibacterial activity of erythromycin eliminates Propionibacterium acnes and Staphylococcus epidermidis from the sebum of the sebaceous glands, resulting in the stopping of the decomposition of sebum by bacteria and a decrease in the quantity of free fatty acids. Consequently, the cause of the sebum also disappears. "inflammation. The presence of zinc improves the anti-acne effect of erythromycin, since zinc has its own anti-inflammatory activity.
The mechanism by which this occurs is not entirely known, but the ability of zinc to inhibit the release of mediators (interleukin 1 and 6) from inflammation cells is probably involved.
05.2 "Pharmacokinetic properties -
During the development of Zineryt it was shown that zinc acetate which is virtually insoluble in the diisopropylsebacate / ethyl alcohol carrier, solubilizes by complexing with erythromycin; this results in an increased penetration of zinc into the glands compared to zinc acetate alone. At the same time, however, there is no increased penetration of erythromycin. Absorption of Zineryt by the skin is minimal. The zinc erythromycin complex cleaves in the skin and the zinc is mostly bound or trapped in the epidermofollicular region of the epithelium, while erythromycin is minimally (0-10%) absorbed but rapidly eliminated within 24-72 hours.
05.3 Preclinical safety data -
Acute, subacute and chronic toxicity of Zineryt have been evaluated in various animal species.
Acute toxicity for oral administration showed an LD of 10.89 g / kg in the rat and over 10 ml / kg in the dog.
The minimal lethal dose for topical application in rabbits was greater than 2000 mg / kg.
In subacute and chronic toxicity tests, a daily topical dosage of 200 mg / kg of Zineryt for a period of 28 to 90 days in rabbits did not result in significant abnormalities, as did the topical dosage of 100 mg / kg for 5 days. week for thirteen weeks in the mouse.
Animal studies have not shown systemic toxicity after topical application (up to 200 times the usual dose).
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Diisopropylsebacate
Ethanol.
06.2 Incompatibility "-
Incompatibilities with other medicines are unknown.
06.3 Period of validity "-
Non-reconstituted product: 2 years.
After the final preparation the solution is kept at room temperature for 8 weeks.
06.4 Special precautions for storage -
Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package -
Each box contains a bottle with powder consisting of erythromycin and zinc acetate dihydrate and a second bottle containing the liquid carrier consisting of diisopropylsebacate in alcohol.
The bottle with the reconstituted solution and with the applicator contains 30 mL of Zineryt.
06.6 Instructions for use and handling -
Instructions for preparing the solution
1. Remove the cap from both bottles of Zineryt and save the bottle cap with the powder.
2. Pour the liquid into the bottle containing the Zineryt powder.
3. Screw the cap previously stored on the bottle which now contains powder and liquid.
4. Shake the bottle well for about one minute.
5. Remove the cap, insert the applicator and screw the cap back on by exerting slight pressure in order to position the applicator correctly.
6. Check that the applicator is fully inserted (press if necessary).
7. Record the expiration date on the bottle (8 weeks after preparation).
8. After use, keep the bottle closed at room temperature.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Astellas Pharma S.p.A. - Via del Bosco Rinnovato, 6 -U7 (Floor IV) - 20090 Assago (Milan)
08.0 MARKETING AUTHORIZATION NUMBER -
028734010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Registration: July 14, 1995 - Authorization renewal: August 3, 2010
10.0 DATE OF REVISION OF THE TEXT -
January 2015
