Patient Information Leaflet

ALTERGEN 0.2% + 1% cream, 2 mg + 40 mg medicated gauze pads

sodium hyaluronate / silver sulfadiazine
Please 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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What ALTERGEN is and what it is used for

ALTERGEN is a medicine containing two active substances: hyaluronic acid and silver sulfadiazine.
Hyaluronic acid is a very important component of the human body: it is naturally present, for example, in the skin, the eye, and cartilage, and accelerates the wound healing process.
Silver sulfadiazine is an antibiotic belonging to the sulfonamide class of drugs, which kill certain types of germs, providing protection against infections caused by them.
ALTERGEN is used to treat skin lesions such as pressure sores, wounds due to circulatory disorders (venous ulcers), or burns.
Consult your doctor if you do not notice improvement or if you observe a worsening of symptoms after a short period of treatment.

2. What you should know before using ALTERGEN

Do not use ALTERGEN:

if you are allergic to silver sulfadiazine or to any of the other ingredients of this medicine (listed in section 6);
during pregnancy and breastfeeding, unless otherwise directed by a physician;
in premature infants and newborns during the first months of life.

Warnings and precautions
Consult your doctor or pharmacist before using ALTERGEN if:

you have previously experienced allergic reactions after taking antibiotics belonging to the sulfonamide class;
you have kidney problems (renal insufficiency) or liver problems (hepatic insufficiency).

If you use ALTERGEN for a prolonged period and/or over large areas of the body, your doctor may recommend blood tests to monitor your white blood cell count.
Other medicines and ALTERGEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use ALTERGEN concurrently with other topical medicines (e.g. creams or lotions) containing proteolytic enzymes (which degrade proteins), used, for example, to treat burns.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, use this medicine only if your doctor considers it strictly necessary.
Driving and using machines
ALTERGEN does not affect the ability to drive vehicles or operate machinery.

3. How to use ALTERGEN

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.
ALTERGEN is a medicine for application on the skin (topical use).
ALTERGEN cream
Apply an even layer of cream 2-3 mm thick over the entire affected area, 1 or 2 times daily.
ALTERGEN medicated gauzes
Apply 1 or more gauzes, depending on the extent of the lesions, 2 or more times daily.
If you use more ALTERGEN than you should
Cases of overdose have not been reported. However, if you use ALTERGEN on large areas of skin and/or for a very long period of time, the side effects listed in section 4 may occur.
If you forget to use Altergen
Do not use a double dose to make up for the missed dose.
If you stop using Altergen
Use ALTERGEN continuously, without interruption, until the lesion is completely healed (fully healed).
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
everyone will experience them.
The following side effects have been reported with oral sulfonamides and
affect the whole body (systemic effects):

more or less sudden appearance of skin lesions, for example discolouration in spots or widespread (skin rashes);
kidney problems (renal failure);
inflammation of the liver (toxic hepatitis);
blood disorders such as reduction in certain types of white blood cells (agranulocytosis, leucopenia) or platelets (thrombocytopenia).

It is unlikely that such side effects will occur with the use of ALTERGEN, since
ALTERGEN is applied directly to the affected area. However, if you use ALTERGEN on
large areas of skin and/or for a very long period of time, these effects may still occur.
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 the website
“www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects, you can
help provide more information on the safety of this medicine.

5. How to store ALTERGEN

Keep this medicine out of the sight and reach of children.
ALTERGEN cream
Store the medicine at a temperature not exceeding 25°C. After opening the tube,
use the cream within 3 months.
ALTERGEN medicated gauzes
Store the medicine at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 ALTERGEN contains
The active substances are: sodium hyaluronate and silver sulfadiazine.
ALTERGEN 0.2% + 1% cream
100 g of cream contain: 0.2 g of sodium hyaluronate and 1 g of silver sulfadiazine.
The other components are: polyethylene glycol 400 monostearate, oleic acid decyl ester, emulsifying wax, glycerol, sorbitol 70% solution, purified water.
ALTERGEN 2 mg + 40 mg impregnated gauzes
Each gauze is impregnated with 4 g of cream having the following percentage composition: 0.05% sodium hyaluronate and 1% silver sulfadiazine.
The other components are: polyethylene glycol 4000, glycerol, purified water.

Description of the appearance of ALTERGEN and contents of the pack
ALTERGEN 0.2% + 1% cream is available in 25 g aluminium tubes.
ALTERGEN 2 mg + 40 mg impregnated gauzes are available in packs of 15 gauzes. Each impregnated gauze is individually packaged in a sealed pouch.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia, 2, 26900 Lodi

Manufacturer
Laboratoires Genévrier SA - 280, rue de Goa - Z.I. Les Trois Moulins - 06600 Antibes - France