DERMOMYCIN 2% Cream

Зміст інструкції

1. Dermomycin 20 mg/g cream
   1. What Dermomycin is and what it is used for
   2. What you need to know before using Dermomycin
   3. How to use Dermomycin
   4. Possible side effects
   5. How to store Dermomycin
   6. Contents of the pack and other information
2. Dermomycin 250 mg hard capsules
   1. What Dermomycin is and what it is used for
   2. What you need to know before you take Dermomycin
   3. How to take Dermomycin
   4. Possible side effects
   5. How to store Dermomycin
   6. Contents of the pack and other information

Dermomycin 20 mg/g cream

sodium fusidate
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dermomycin is and what it is used for

Dermomycin contains the active ingredient sodium fusidate, an antibiotic that works by killing germs that cause infections. In particular, it is active against bacteria called Gram-positive cocci, staphylococci, pneumococci and streptococci.
Dermomycin is indicated for the treatment of skin inflammations caused by the staphylococcus bacterium, in particular:

• impetigo, a superficial skin infection with the presence of vesicles and pustules
• boils
• folliculitis, inflammation of the follicle, that is, the structure of the skin in which hair grows
• abscesses
• hidradenitis suppurativa, a painful inflammation of a type of sweat glands (apocrine glands) characterized by the presence of red-violet nodules similar to boils
• sycosis barbae, chronic inflammation of the follicle, that is, the structure of the skin in which hair grows
• infected wounds and abrasions of the skin

2. What you need to know before using Dermomycin

Do not use Dermomycin

• if you are allergic to sodium fusidate or any of the other ingredients of this medicine (listed in section 6)
• if you have a skin condition called rosacea.

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

• Even though the systemic absorption of fusidic acid applied locally to the skin is minimal, caution is necessary if you have severe liver problems.

During treatment with Dermomycin:

• Take particular care to avoid Dermomycin coming into contact with your eyes
• Inform your doctor if you notice the appearance of other infections, because during treatment with antibiotics other infections caused by bacteria or fungi may occur in addition to those already present. In these cases, your doctor will prescribe appropriate therapy to treat these infections.
• The use of topical products such as Dermomycin cream, especially when prolonged, can cause allergic reactions and irritation. If this occurs, stop treatment and contact your doctor who will prescribe suitable therapy.

Children
If the patient is very young, Dermomycin will be prescribed only in cases of actual
need and under the direct control of the doctor.

Other medicines and Dermomycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is no adequate information on the use of Dermomycin in pregnancy.
If you are pregnant, Dermomycin will be prescribed only in cases of actual need and under the direct
control of the doctor.
Breastfeeding
There are no data on the excretion of fusidic acid into breast milk. If you are breastfeeding, Dermomycin
will be prescribed only in cases of actual need. Do not apply DERMOMYCIN cream to the breast
during breastfeeding .
Fertility
There are no data on the effects of Dermomycin cream on fertility.

Driving and operating machinery
No effects on the ability to drive or operate machinery are known.

Dermomycin containsbutylhydroxyanisole and cetyl alcohol
Dermomycin contains butylhydroxyanisole, which may cause localized skin reactions (e.g.
contact dermatitis) or irritation to the eyes and mucous membranes.
Dermomycin contains cetyl alcohol, which may cause localized skin reactions (e.g.
contact dermatitis).

3. How to use Dermomycin

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Apply Dermomycin 2-3 times a day to the affected area.

If you use more Dermomycin than you should
In case of accidental ingestion or use of an excessive dose of Dermomycin, immediately inform
your doctor or go to the nearest hospital.
To date, there are no known cases of accidental ingestion or use of an excessive dose of sodium fusidate.

If you forget to use Dermomycin
Do not use a double dose of cream to make up for a missed dose.

If you stop using Dermomycin
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.

Side effects reported after use of Dermomycin cream

Uncommon(in more than 1 in 1,000, but less than 1 in 100 patients);

• Allergic reaction that can cause serious illnesses (Hypersensitivity)

Rare(in more than 1 in 10,000, but less than 1 in 1,000 patients);

• Hair loss (Alopecia)
• Burning sensation
• Redness of the skin (erythema)
• Itching
• Abnormal change in skin color and skin texture that becomes covered with red spots or bumps (rash)
• Pain
• Skin irritation.

Not known(frequency cannot be estimated based on available data )

• Allergic rashes on the skin

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dermomycin

Do not store at a temperature above 25°C.
Keep this medicine out of 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.
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 Dermomycin contains

• The active ingredient is sodium fusidate. 100 grams of cream contain 2 g of sodium fusidate.
• The other ingredients are light liquid paraffin, soft white paraffin, cetyl alcohol, butylated hydroxyanisole (E320), polysorbate 60, purified water, glycerol, potassium sorbate.

Description of the appearance of Dermomycin and contents of the pack
Each pack contains a tube of 20 g or 30 g of 2% cream.

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

Manufacturer
Alfasigma S.p.A.Via Pontina Km 30,400
00071 Pomezia (Roma)

Dermomycin 250 mg hard capsules

sodium fusidate

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dermomycin is and what it is used for

Dermomycin contains the active ingredient sodium fusidate, an antibiotic that works by killing the
germs that cause infections. In particular, it is active against bacteria called gram-positive cocci,
staphylococci, pneumococci and streptococci.
Dermomycin is indicated for the treatment of acute and chronic infections caused by gram-positive
bacteria and in particular those caused by the staphylococcus bacterium such as:

• abscesses
• skin inflammations characterized by clusters of boils (furunculosis)
• infected wounds
• lung infections (bronchopneumonia)
• intestinal inflammations (enteritis)
• bone and marrow inflammations (osteomyelitis)
• inflammation of the peritoneum, the membrane that lines the wall of the abdomen and the abdominal organs (peritonitis).

Dermomycin is also used in patients who have been treated without results with other antibiotics and
in patients allergic to other antibiotics.

2. What you need to know before you take Dermomycin

Do not take Dermomycin

• if you are allergic to sodium fusidate or any of the other ingredients of this medicine (listed in section 6)
• if you have a skin condition called rosacea
• if you are using statins (medicines used to reduce cholesterol in the blood).
• if you are using medicines for the treatment of HIV (HIV-1 protease inhibitors, such as lopinavir, ritonavir and saquinavir).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dermomycin.
Tell your doctor before taking Dermomycin:

• if you have severe liver problems because Dermomycin should be taken with caution. if you are using medicines for the treatment of HIV (HIV-1 protease inhibitors, such as lopinavir, ritonavir and saquinavir) because it may cause liver toxicity (see section “Do not take Dermomycin” and “Other medicines and Dermomycin”).
• if you are using an antibiotic (flucloxacillin) because your white blood cell count may decrease.
• if you are using an antibiotic (rifampicin) because you may develop resistance.

During treatment with Dermomycin:

• Tell your doctor if you notice the appearance of other infections, because during treatment with antibiotics, other infections caused by bacteria or fungi may occur in addition to those already present. In these cases, your doctor will prescribe appropriate therapy to treat these infections.
• Your doctor will perform tests to assess liver function, especially if you take Dermomycin at high doses or for a long time.

Children
If the patient is very young, Dermomycin will be prescribed only in cases of actual
need and under the direct control of the doctor.

Other medicines and Dermomycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
You must not take Dermomycin together with HMG–CoA reductase inhibitors (e.g. statins,
medicines used to reduce cholesterol in the blood). The simultaneous administration of
Dermomycin and HMG–CoA reductase inhibitors may cause muscle weakness, pain and
a serious muscle disease called rhabdomyolysis.
You must not take Dermomycin together with medicines used for the treatment of HIV (HIV-1 protease inhibitors, such as lopinavir, ritonavir and saquinavir) as it may cause liver toxicity (see section “Do not take Dermomycin” and “Other medicines and Dermomycin”).
Use with caution together with flucloxacillin (antibiotic) as your white blood cell count may decrease.
Use with caution together with rifampicin as you may develop resistance.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Fusidic acid has been found in the blood of the fetus after systemic treatment.
If you are pregnant, Dermomycin will be prescribed only in cases of actual need and under the direct
control of the doctor.
Breastfeeding
Fusidic acid passes into breast milk and the risk to the breastfed infant cannot be excluded.
Dermomycin will be prescribed only in cases of actual need and under the direct control
of the doctor.
Fertility
There are no data on the effects of Dermomycin on fertility.

Driving and operating machinery
No effects on the ability to drive or operate machinery are known.

3. How to take Dermomycin

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Use in adults
The recommended dose is 2 capsules (each containing 250 mg), 3 times a day.
If the infection is particularly resistant to treatment, your doctor may tell you to increase the
dose up to 4 capsules (each containing 250 mg), 3 times a day.

Use in children
The recommended dose is half the dose prescribed for adults.

If you take more Dermomycin than you should
In case of accidental ingestion of an excessive dose of Dermomycin, immediately inform your
doctor or go to the nearest hospital.
To date, there are no known cases of ingestion of an excessive dose of sodium fusidate.

If you forget to take Dermomycin
Do not take a double dose to make up for a missed dose.

If you stop taking Dermomycin
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.

Side effects reported after use of Dermomycin capsules

Uncommon(in more than 1 in 1,000, but in less than 1 in 100 patients);
Feeling of dizziness,
Headache (Cephalgia),
Drowsiness,
Upper abdominal pain,
Diarrhoea,
Flatulence,
Gastrointestinal disorders,
Difficult digestion which can be avoided by taking the capsules with a full stomach,
Nausea,
Vomiting,

Rare(in more than 1 in 10,000, but in less than 1 in 1,000 patients);
Infections,
Decrease in the number of red blood cells (Anemia),
Decrease in a type of white blood cells (Neutropenia),
Allergic reaction that can cause serious illnesses (Hypersensitivity)
Localized discomfort in the abdomen,
Constipation,
Dry mouth,
Reduced appetite
Skin problems (Skin pathology),
Urticaria,
Redness of the skin (Erythema),
Itching,
Skin rash (Rash),
General disorders and conditions relating to administration,

Very rare(in less than 1 in 10,000 patients).
Problems affecting the nervous system
Alteration of the sense of taste (Dysgeusia),
Tingling (Paresthesia),
Flushing,
Alterations in liver function,
Appearance of moderate urticaria, spots or red papules that become purplish in color (Henoch-Schonlein purpura),
Sweating (Hyperhidrosis),
Feeling of fatigue,
Perception of change in body temperature,
Pain,
Swelling,

Frequency not known (the frequency cannot be estimated from available data)
Yellowing of the skin, mucous membranes and eyes (jaundice), which resolved after
discontinuation of treatment or dose reduction.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dermomycin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Scad. The
expiry date refers to the last day of that month.
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 Dermomycin contains

• The active ingredient is sodium fusidate. Each capsule contains 250 mg of sodium fusidate.
• The other ingredients are magnesium stearate.
• The capsule is composed of animal gelatin, yellow iron oxide, titanium dioxide.

Description of the appearance of Dermomycin and contents of the pack
Each pack contains 8 capsules of 250 mg in blisters.

Marketing Authorisation Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A.
Via Pontina Km 30,400
00071 Pomezia (Roma)