METRONIDAZOLO 1% Gel

Зміст інструкції

1. metronidazolo same 1% gel
   1. What is Metronidazolo Same and what it is used for
   2. What you need to know before using Metronidazolo Same
   3. How to use Metronidazolo Same
   4. Possible side effects
   5. How to store Metronidazolo Same
   6. Contents of the pack and other information

metronidazolo same 1% gel

metronidazolo

Read this leaflet carefully before you start using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not get better or if your symptoms worsen after 3 weeks of treatment.

Contents of this leaflet:

• 1. What Metronidazolo Same is and what it is used for
• 2. What you need to know before you use Metronidazolo Same
• 3. How to use Metronidazolo Same
• 4. Possible side effects
• 5. How to store Metronidazolo Same
• 6. Contents of the pack and other information

1. What is Metronidazolo Same and what it is used for

Metronidazolo Same is a gel to be applied to the skin that contains the active ingredient
metronidazole. Metronidazole is an active substance against microbes and protozoa.
Metronidazolo Same is indicated for the treatment of papules (red spots), pustules
(red spots filled with pus) and redness (erythema) caused by a
skin condition called rosacea.
See your doctor if you do not feel better or if you feel worse after 3 weeks of treatment.

2. What you need to know before using Metronidazolo Same

Do not use Metronidazolo Same

• 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 section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Metronidazolo Same.

• Avoid contact of this medicine with your eyes and mucous membranes. If it comes into contact with your eyes, remove the gel carefully with water. Keep in mind that metronidazole applied to the face has been reported to cause tearing.
• If you experience skin irritation, use this medicine less frequently or temporarily stop treatment and inform your doctor.
• Avoid exposure to ultraviolet light (sun, UV lamps, tanning equipment) during treatment with Metronidazolo Same.
• Use this medicine with caution if you have or have had blood disorders (blood dyscrasias).
• Always follow your doctor's instructions. Do not exceed the recommended doses.
• The use, especially if prolonged, of products to be applied to the skin can lead to sensitization (allergy to one or more components) (see section 4 “Possible side effects”).

Children
Metronidazolo Same should not be used in children because there is not enough data
on the efficacy and safety of this medicine.

Other medicines and Metronidazolo Same
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Due to the poor absorption of metronidazole into the bloodstream following application
to the skin, interactions with other medicines are unlikely.
However, if you are taking medicines that thin the blood (anticoagulants) such as coumarins and
warfarin, be aware that metronidazole administered orally potentiates their effect (prolongation of prothrombin time). The effect of metronidazole on coagulation when applied to the skin is unknown.

Metronidazolo Same with alcohol
In a small number of patients taking metronidazole and alcohol at the same time
reactions such as nausea, vomiting, skin flushing, rapid heartbeat, difficulty breathing (disulfiram-like reactions) have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use Metronidazolo Same during the first trimester of pregnancy.
You may use Metronidazolo Same during the second trimester and during the third trimester of
pregnancy only if other treatments have not been effective.
Metronidazolo Same is not recommended if you are breastfeeding. In this case, consult your
doctor who will decide whether to discontinue breastfeeding or treatment with the medicine
appropriately assessing the importance of therapeutic treatment for you.

Driving and using machines
Metronidazolo Same does not impair the ability to drive vehicles or use machinery.

Metronidazolo Same contains methyl parahydroxybenzoate
Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use Metronidazolo Same

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of Metronidazolo Same 1-2 times a day to the skin, as directed by your doctor, after cleaning the affected areas. After applying
Metronidazolo Same you can use cosmetics.
You should observe significant improvements within 3 weeks of starting treatment.
Clinical studies have shown that continuing treatment for up to 9 weeks leads to a
progressive improvement.
Do not ingest this medicine. In case of ingestion/accidental intake of Metronidazolo
Same, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In no more than 2% of patients treated with metronidazole applications on the skin, the following side
effects have been reported:
Affecting the skin and subcutaneous tissue: allergic reaction (contact dermatitis),
dryness, accentuated redness (erythema), itching, rash with numerous small spots
(rash), discomfort (burning and stinging sensation), irritation, transient redness and
worsening of rosacea
Affecting the eye: tearing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Metronidazolo Same

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Expiry. The
expiry date refers to the last day of that month. The expiry date refers to the
product in intact packaging, correctly stored.
Do not freeze or refrigerate.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment .

6. Contents of the pack and other information

What Metronidazolo Same contains

• The active substance is metronidazole. 100 g of gel contain 1.0 g of metronidazole.
• The other ingredients are: octyldodecanol, caprylocaproyl macrogol-8 glycerides, carbomer, methyl parahydroxybenzoate (E218), sodium hydroxide, sodium edetate, purified water.

Description of the appearance of Metronidazolo Same and contents of the pack
Metronidazolo Same is a gel contained in a tube of 30 grams.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)