Active ingredients: Metronidazole
Metronidazole same 1% gel
Why is Metronidazole Gel - Generic Drug used? What is it for?
Metronidazole Same is a skin-applied gel that contains the active ingredient metronidazole. Metronidazole is an active substance against microbes and protozoa.
Metronidazole Same is indicated for the treatment of papules (red spots), inflammatory pustules (red pus-filled spots) and redness (erythema) caused by a skin condition called rosacea.
Talk to your doctor if you do not feel better or if you feel worse after 3 weeks of treatment.
Contraindications When Metronidazole Gel - Generic Drug should not be used
Do not use Same Metronidazole
- if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding" section).
Precautions for use What you need to know before taking Metronidazole Gel - Generic Drug
Talk to your doctor or pharmacist before using Metronidazole Same.
- Avoid contact of this medicine with the eyes and mucous membranes. In case of contact with the eyes, remove the gel carefully with water. Note that metronidazole applied to the face has been reported to cause tearing.
- If you experience skin irritation, use this medicine less often or temporarily stop treatment and tell your doctor.
- Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) while being treated with Same Metronidazole.
- Use this medicine with caution if you have or have ever had blood disorders (blood dyscrasias).
- Always follow your doctor's instructions. Do not exceed the recommended dose.
- 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) (see paragraph 4 "Possible side effects").
Children
Metronidazole Same should not be used in children as there are no adequate data on the efficacy and safety of this medicine.
Interactions Which drugs or foods can modify the effect of Metronidazole Gel - Generic Drug
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
In view of the poor passage into the blood of metronidazole following application to the skin, interactions with other medicinal products are unlikely.
However, if you are taking blood-thinning medicines (anticoagulants) such as coumarins and warfarin, be aware that metronidazole given by mouth increases their effect (prolongation of prothrombin time). It is not known what the effect of metronidazole on coagulation is when applied to the skin.
Same metronidazole with alcohol
Reactions such as nausea, vomiting, redness of the skin, rapid heartbeat, difficulty in breathing (disulfiram-like reactions) have been reported in a small number of patients taking metronidazole and alcohol at the same time.
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.
Do not use Metronidazole Same during the first trimester of pregnancy.
You can use Metronidazole Same during the middle trimester and during the last trimester of pregnancy only if other treatments are not effective.
Same metronidazole is not recommended if you are breastfeeding. In this case, ask your doctor who will decide whether to stop breastfeeding or treatment with the medicine, appropriately evaluating the importance of the therapeutic treatment for you.
Driving and using machines
Metronidazole Same does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Metronidazole Gel - Generic Drug: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply a thin layer of Metronidazole Same 1-2 times a day on the skin, according to the doctor's instructions, after cleaning the affected areas. After the application of Same Metronidazole can use cosmetics.
You should see significant improvement within 3 weeks of starting treatment.
Clinical studies have shown that continuing treatment for up to 9 weeks leads to progressive improvement.
Do not swallow this medicine. In case of accidental ingestion / intake of Metronidazole Same, notify your doctor immediately or go to the nearest hospital.
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 Metronidazole Gel - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following undesirable effects have been reported in no more than 2% of patients treated with metronidazole applications on the skin:
- Affecting the skin and underlying tissue: allergic reaction (contact dermatitis), dryness, marked redness (erythema), itching, rash with numerous spots (rash), discomfort (burning and stinging sensation), irritation, transient redness and worsening of rosacea
- At the expense of the eye: tearing. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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 after EXP. The expiry date refers to the last day of that month. The expiry date refers to the unopened, correctly stored product.
Do not freeze or refrigerate.
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.
What Metronidazole Same contains
- The active ingredient is metronidazole. 100 g of gel contains 1.0 g of metronidazole.
- The other ingredients are: octyldodecanol, caprilocaproil macrogol-8 glycerides, carbomer, methyl parahydroxybenzoate, sodium hydroxide, sodium edetate, purified water.
What Metronidazole Same looks like and contents of the pack
Metronidazole Same is a gel contained in a 30 gram 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
METRONIDAZOLE SAME 1% GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gel contain:
Active ingredient: METRONIDAZOLE 1.0 g.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Gel.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
METRONIDAZOLE SAME is indicated for topical application in the treatment of papules, inflammatory pustules and rosacea erythema.
04.2 Posology and method of administration
Apply a thin layer of METRONIDAZOLO SAME 1-2 times a day, according to medical indications and after cleansing the affected areas.
Significant therapeutic results should be observed within three weeks of starting treatment. Clinical studies have shown progressive improvement up to nine weeks of therapy.
After the application of METRONIDAZOLE SAME it is possible to use cosmetics.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Contraindicated in pregnancy and lactation (see p.4.6).
04.4 Special warnings and appropriate precautions for use
However, due to the minimal absorption of metronidazole applied locally and, consequently, to negligible plasma concentrations, the undesirable effects reported following oral administration of the drug were not recorded following topical application.
Avoid contact with eyes and mucous membranes; Metronidazole applied to the face has been reported to cause lacrimation. In case of contact with the eyes, the gel must be carefully removed with water.
The patient should be advised that if irritation occurs, he should use Metronidazole Same less frequently or temporarily discontinue therapy and inform the physician.
Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during therapy with Same Metronidazole.
Since the drug is a nitroimidazole derivative it should be used with caution in patients presenting with blood dyscrasias or with anamnestic data relating to them.
The product must be used according to the instructions provided by the attending physician.
Do not exceed the recommended dose.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena.
There are no adequate clinical data on the efficacy and safety of Metronidazole Same in children, therefore Metronidazole Same should not be used in children.
Do not swallow.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
In consideration of the low blood levels consequent to the topical application of Metronidazole, interactions with other drugs are unlikely.
However, it should be remembered that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol at the same time and in case of treatment of patients receiving concomitant anticoagulation therapy, it should be borne in mind that metronidazole, following oral administration, determines an enhancement of the anticoagulant effects of coumarins and warfarin which occurs by inducing a prolongation of the prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
04.6 Pregnancy and lactation
The safety of use of metronidazole during pregnancy has not been sufficiently demonstrated. Contradictory reports are available, especially regarding early pregnancy. Some studies have indicated an increase in the rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified.
Same metronidazole is contraindicated during the first trimester of pregnancy. During the middle and last trimester of pregnancy, Metronidazole Same should only be given if other treatments have failed.
Following oral administration, metronidazole is secreted into breast milk in concentrations similar to those found in plasma. Following topical application, the drug reaches plasma levels significantly lower than those obtained after oral administration, therefore the treating physician will have to decide whether to stop breastfeeding or treatment with the drug by appropriately evaluating the importance of therapeutic treatment for the mother.
04.7 Effects on ability to drive and use machines
Metronidazole Same does not affect the ability to drive or use machines.
04.8 Undesirable effects
Following the use of topical metronidazole the following side effects have been reported:
Skin and subcutaneous tissue disorders:
contact dermatitis, dry skin, erythema, itching, rash, skin discomfort (burning and stinging sensation), skin irritation, transient redness and worsening of rosacea.
Eye disorders: lacrimation
None of these undesirable effects occurred in more than 2% of treated patients.
04.9 Overdose
No cases of overdose have been reported following topical application of Metronidazole.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
METRONIDAZOLE SAME gel is a preparation for external use based on Metronidazole, a substance with antimicrobial and antiprotozoal activity.
The mechanism of action by which Metronidazole determines a reduction of inflammatory lesions in rosacea is not well known, however it seems to include an antibacterial and / or anti-inflammatory action.
05.2 "Pharmacokinetic properties
Metronidazole is well absorbed by oral or parenteral administration, less absorbed by rectal and vaginal route, for topical applications, even if repeated, its absorption is negligible.
In bioavailability studies conducted by topical applications of METRONIDAZOLE SAME gel equal to an average quantity of active ingredient equal to 10 mg / day for a period of 7 days, the serum concentrations of the drug, determined by HPLC, were found to be below the limit of sensitivity of 0.3 mcg / ml.
05.3 Preclinical safety data
Acute toxicity:
LD 50 (rat i.v.) 1574-1575 mg / kg
LD 50 (mouse i.v.) 1169-1260 mg / kg
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Octyldodecanol, caprilocaproyl macrogol-8 glycerides, carbomer, methyl parahydroxybenzoate, sodium hydroxide, sodium edetate, purified water.
06.2 Incompatibility
Nothing to report.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not freeze or refrigerate.
06.5 Nature of the immediate packaging and contents of the package
Tube 30 g.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
SAVOMA MEDICINALI S.p.A. - Via Baganza N. 2 / A 43125 PARMA.
08.0 MARKETING AUTHORIZATION NUMBER
028523013
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
A.I.C renewal: May 2013
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of May 2013
