Package leaflet: Information for the patient

metronidazolo same 1% gel

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

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 weeks of treatment.

Contents of this leaflet:

What Metronidazolo Same is and what it is used for
What you need to know before using Metronidazolo Same
How to use Metronidazolo Same
Possible side effects
How to store Metronidazolo Same
Contents of the pack and other information

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

Metronidazolo Same is a topical gel containing the active ingredient metronidazolo. Metronidazolo is an antimicrobial and antiprotozoal agent. Metronidazolo Same is indicated for the treatment of papules (red spots), inflammatory pustules (red spots filled with pus), and erythema (redness) caused by a skin condition called rosacea.
Consult 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 to 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 eyes and mucous membranes. In case of contact with the eyes, remove the gel thoroughly with water. Be aware that tearing (lacrimation) has been reported when metronidazole is applied to the face.
If you experience skin irritation, use this medicine less frequently or temporarily discontinue treatment and inform your doctor.
Avoid exposure to ultraviolet light (sunlight, UV lamps, tanning devices) during treatment with Metronidazolo Same.
Use this medicine with caution if you have or have had blood disorders (haematological dyscrasias).
Always follow your doctor's instructions. Do not exceed the recommended doses.
Use, especially prolonged use, of topical skin products may lead to sensitization reactions (allergy to one or more components) (see section 4 “Possible side effects”).

Children
Metronidazolo Same must not be used in children, as there are insufficient data on efficacy and safety of this medicine.

Other medicines and Metronidazolo Same
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to the low systemic absorption of metronidazole following topical application, interactions with other medicines are unlikely.
However, if you are taking blood-thinning medicines (anticoagulants) such as coumarins and warfarin, be aware that oral metronidazole increases their effect (prolongation of prothrombin time). It is not known what effect topical metronidazole may have on blood coagulation.

Metronidazolo Same and alcohol
In a small number of patients who took metronidazole and alcohol simultaneously, reactions such as nausea, vomiting, skin flushing, rapid heartbeat, and breathing difficulties (disulfiram-like reactions) have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Metronidazolo Same during the first trimester of pregnancy.
You may use Metronidazolo Same during the second and third trimesters 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 stop breastfeeding or the treatment with the medicine, taking into account the importance of the therapy for you.

Driving and using machines
Metronidazolo Same does not affect the ability to drive or operate machinery.

Metronidazolo Same contains methyl 4-hydroxybenzoate
Methyl 4-hydroxybenzoate may cause allergic reactions (including delayed-type reactions).

3. How to use Metronidazolo Same

Use this medicine 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 daily to the affected skin areas, as directed by your doctor, after cleaning the areas. After applying Metronidazolo Same, you may use cosmetics.
You should observe significant improvement within 3 weeks of starting treatment.
Clinical studies have shown that continuing treatment up to 9 weeks leads to progressive improvement.
Do not swallow this medicine. If Metronidazolo Same is accidentally ingested, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported in no more than 2% of patients treated with topical metronidazole applications:

Skin and subcutaneous tissue disorders: allergic reaction (contact dermatitis), dryness, increased redness (erythema), itching, rash with numerous small spots, discomfort (burning and stinging sensation), irritation, transient redness, and worsening of rosacea.

Eye disorders: lacrimation.

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Metronidazole Same

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 packaging after "Exp". The
expiry date refers to the last day of that month. The expiry date applies to the product in its
original, unopened packaging, correctly stored.
Do not freeze or refrigerate.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metronidazolo Same contains

The active substance is metronidazole. 100 g of gel contain 1.0 g of metronidazole.
The other components 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 30-gram tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)