Package leaflet: Information for the user

SALICYLIC ACID MARCO VITI 20 mg/g ointment, 50 mg/g ointment, 100 mg/g ointment

Salicylic acid
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What ACIDO SALICILICO MARCO VITI is and what it is used for

ACIDO SALICILICO MARCO VITI contains the active substance acido salicilico, which belongs to a group of medicines called keratolytics that destroy excess keratin.
This medicine is indicated in adults and children for:

the treatment of psoriasis, acne vulgaris, seborrhea;
the removal of warts and calluses. In adults, ACIDO SALICILICO MARCO VITI is also indicated for the treatment of skin conditions such as eczema and ichthyosis.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using ACIDO SALICILICO MARCO VITI

Do not use ACIDO SALICILICO MARCO VITI

if you are allergic to salicylic acid, salicylates, or any of the other ingredients of this medicine (listed in section 6);
if the patient is a child under 2 years of age;
if you have diabetes;
if you have vascular diseases (peripheral vasculopathy).

Warnings and precautions
Consult your doctor or pharmacist before using ACIDO SALICILICO MARCO VITI.
Do not swallow the medicine and avoid contact of ACIDO SALICILICO MARCO VITI with the
mouth, eyes, genitals, and other mucous membranes.
ACIDO SALICILICO MARCO VITI is irritating and may cause skin inflammation (dermatitis).
If you are using this medicine to treat calluses or warts, protect the healthy skin surrounding the area to be treated.
Avoid using ACIDO SALICILICO MARCO VITI:

for prolonged periods;
in large quantities;
over extensive areas of the body;
on damaged or inflamed skin.

Excessive amounts of this medicine may cause very serious adverse reactions, especially in children (systemic salicylate poisoning), which may be fatal.
Children
This medicine should be administered with caution in children and under medical supervision.
Other medicines and ACIDO SALICILICO MARCO VITI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking or have recently taken the following medicines:

anticoagulants such as coumarins (acenocoumarol, dicoumarol, phenprocoumon, and warfarin), or other anticoagulants such as anisindione and phenidione, because they may increase the risk of bleeding;
activated coagulation factor X inhibitors (heparins and heparinoids), because, in case of neuraxial anaesthesia (spinal or epidural), concomitant use of salicylic acid may rapidly increase the risk of bleeding and hematoma;
gliburide, a medicine used to treat diabetes, because it may reduce blood sugar levels;
probenecid, a medicine used to treat gout, because salicylic acid may reverse its effects;
acetazolamide, a medicine used to treat high eye pressure (glaucoma), because the adverse effects of salicylic acid may increase;
varicella vaccine, because it may increase the risk of Reye's syndrome, a disease affecting the brain and liver.

Avoid using ACIDO SALICILICO MARCO VITI together with the following substances, as they may cause a rapid increase in medicine levels in the blood:

tamarind;
Salvia miltiorrhiza or Tan-Shen.

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.
Avoid using ACIDO SALICILICO MARCO VITI during pregnancy or while breastfeeding, unless absolutely necessary.
Do not use Acido Salicilico Marco Viti ointment during pregnancy, except for short-term treatment of a single small skin area/wart/callus/clavus.
Oral forms (e.g., tablets) of medicines in this class may cause adverse effects in the fetus. It is not known whether the same risks apply to Acido Salicilico Marco Viti ointment when used on skin/warts/calluses/clavi.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use ACIDO SALICILICO MARCO VITI

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the smallest amount of ointment to the affected area with gentle massage. Begin treatment by applying the medicine only to a small area of skin or just once daily, in order to avoid skin irritation.

If you use more ACIDO SALICILICO MARCO VITI than you should
There have been no reported cases of overdose with this medicine when applied locally to the skin.
However, with prolonged use or application over large areas of the body or on areas where the skin is damaged and inflamed, symptoms of salicylism may occur, such as nausea, vomiting, hearing disturbances (tinnitus), and dizziness.
Rarely, respiratory problems (asthma), stomach problems (gastric ulcer), liver (hepatotoxicity), kidneys (renal failure), and pancreas (pancreatic toxicity) may also occur.
In case of accidental ingestion/ingestion of ACIDO SALICILICO MARCO VITI, 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 gets them.
Frequency not known (frequency cannot be estimated from the available data):

decrease in blood glucose levels (hypoglycaemia);
skin irritation and inflammation (dermatitis, erythema, burning, itching, skin peeling), facial scarring.

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

5. How to store ACIDO SALICILICO MARCO VITI

Keep this medicine out of the sight and reach of children.
Keep the tube tightly closed to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored under proper conditions.
After first opening the container, the medicine should be used within 12 months. After this period, any remaining medicine should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACIDO SALICILICO MARCO VITI 20 mg/g ointment contains

The active substance is acetylsalicylic acid. 1 g of ointment contains 20 mg of salicylic acid.
The other component is white soft paraffin.

What ACIDO SALICILICO MARCO VITI 50 mg/g ointment contains

The active substance is acetylsalicylic acid. 1 g of ointment contains 50 mg of salicylic acid.
The other component is white soft paraffin.

What ACIDO SALICILICO MARCO VITI 100 mg/g ointment contains

The active substance is acetylsalicylic acid. 1 g of ointment contains 100 mg of salicylic acid.
The other component is white soft paraffin.

Description of the appearance of ACIDO SALICILICO MARCO VITI and package contents
ACIDO SALICILICO MARCO VITI is an ointment presented in a 30 g tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 (VI) - Italy.
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy.