SOFARGEN 1% Крем

Содержание инструкции

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

Sofargen 1% cream

Micronized silver sulfadiazine

Read this leaflet carefully before 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is Sofargen and what is it used for

Sofargen contains the active ingredient silver sulfadiazine and belongs to a group of medicines called
sulfonamides. Silver sulfadiazine is a sulfonamide antibiotic capable of blocking bacterial replication mechanisms thanks to the action of the sulfadiazine radical and exerts a broad-spectrum bactericidal action due to the presence of the silver ion.
Sofargen is a topical antibiotic indicated:

• in the prevention and treatment of bacterial infections that develop on burns that have affected more or less deep layers of skin (second and third degree burns);
• in the treatment of bacterial infections developed on lesions that usually form near the ankle due to circulatory disorders of the blood (varicose ulcers) and on wounds that are difficult to heal that may occur following prolonged immobility (pressure ulcers);
• in the treatment of skin diseases that present a bacterial infection or that may be at risk of further infections.

2. What you need to know before using Sofargen

Do not use Sofargen if:
you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in
section 6);
you are in the last months of pregnancy.
Do not use Sofargen on your premature baby or in the first months of life (see section “Children and
adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before using Sofargen if:

• you have liver problems (hepatic insufficiency);
• you have kidney problems (renal insufficiency);
• you have a deficiency of an enzyme called glucose-6 phosphate dehydrogenase.

Stop treatment with Sofargen and consult your doctor if you experience:

• hypersensitivity reactions (allergic reactions) that develop after prolonged use of the cream;
• secondary infections (superinfections) caused by microorganisms resistant to treatment with Sofargen.

If you need to apply Sofargen to large areas of skin (for example in the case of large burns), your
doctor will prescribe tests to check the concentration of sulfadiazine in your blood, the function of your
kidneys and liver, and the presence of any sulfamide crystals in your urine. Your doctor will advise you to
stop treatment with Sofargen if they find kidney or liver failure.

Children and adolescents
Sofargen should not be used in premature babies and newborns in the first months of life, as
sulfonamides increase the risk, for your baby, of developing a yellowing of the skin
associated with an increase in the level of bilirubin in the blood (neonatal jaundice).

Other medicines and Sofargen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pay particular attention when using Sofargen together with proteolytic enzymes for topical use, as
their anti-inflammatory action may be inactivated by the silver ions present in the cream.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Sofargen should only be used during pregnancy or breastfeeding if absolutely necessary and under the
direct supervision of your doctor. Do not use Sofargen in the last months of pregnancy as it may
increase the risk of neonatal jaundice.

Driving and using machines
Sofargen does not impair the ability to drive vehicles or use machines.

Sofargen contains:
Stearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis);

Propylene glycolwhich may cause skin irritation;

Methyl p-hydroxybenzoatewhich may cause allergic reactions (including delayed reactions).

3. How to use Sofargen

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.
Consult your doctor if symptoms persist after a short period of treatment or if they worsen at any time.

Treatment of burns
Clean the skin area to be treated before applying Sofargen. Apply a uniform layer of cream 2 or 3 mm thick to the burned surface, one or two times a day. You can apply the cream directly
to the lesion, possibly with the help of a clean glove, or you can spread it on a sterile gauze.
Clean the wound thoroughly with water or saline solution with each dressing change,
using showers or sponges. Be careful to repeat the application of the cream promptly
if it has been inadvertently removed.
The application of the cream should continue without interruption as long as there is a risk of infection and
until complete healing of the lesion.

Treatment of varicose ulcers, pressure sores, wounds and skin diseases that may be at risk

of infection
Clean, if necessary, the skin area to be treated and apply a uniform layer of cream 2 or 3 mm thick, one or two times a day. You can apply the cream directly to the lesions, possibly with
the help of a clean glove, or you can spread it on a sterile gauze. Be careful to keep the lesion
always completely covered with cream.
If you need a stocking-type dressing, unfold portions of 20-30 cm of a bandage of
adequate length and spread a generous layer of cream on it. Rewrap the portion of bandage impregnated with
cream, unfold another 20-30 cm and repeat the operation until the entire length of the bandage has been
completely impregnated with cream. Use the bandage thus medicated to perform the bandage.

If you use more Sofargen than you should
In case of ingestion/accidental intake of an excessive dose of Sofargen, immediately notify your
doctor or go to the nearest hospital.
No cases of overdose due to the use of an excessive amount of Sofargen are known.

If you forget to use Sofargen
If you forgot to apply the cream, do so as soon as you remember. Then continue the application
according to the usual schedule.

If you stop using Sofargen
Do not interrupt the treatment as long as there is a risk of infection and until complete
healing of the lesion.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sofargen can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)
temporary reduction in the number of white blood cells in the blood (transient leukopenia);
local reactions, such as pain and burning, and hypersensitivity reactions (allergic reactions) at the site of
administration
Following the application of Sofargen to extensive areas of the skin, you may experience side effects
that are usually observed with the intake of sulfamide-based medicines orally or
by injection (systemic routes).

Reporting of side effects
If you get any side effects, even 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: 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 Sofargen

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 “Scad”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging, correctly stored.
The cream must be used within 6 months of first opening the tube.
Store at a temperature below 30°C.
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 Sofargen contains
The active ingredient is micronized silver sulfadiazine.
100 g of cream contain 1 g of micronized silver sulfadiazine.
The other ingredients are: stearyl alcohol, isopropyl myristate, propylene glycol,
polyethylene glycol monostearate, polysorbate 20, methylparaben, distilled water.

Description of the appearance of Sofargen and contents of the pack
Sofargen is a pearly white cream, dispensed in an aluminum tube of 30 g, 50 g, 120 g, 180
g or in a jar of 600 g. The 180 g and 600 g packs are intended for exclusive use in hospital
settings.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturers
SOFAR S.p.A.
via Firenze 40
20060 Trezzano Rosa (MI)
VAMFARMA S.r.l.
Via Kennedy 5
26833 Comazzo (LO)