Patient Information Leaflet

Halciderm Combi 0.1% + 0.37% cream

alclometasone dipropionate/neomycin sulfate
Please read this leaflet carefully before using this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Halciderm Combi is and what it is used for

Halciderm Combi contains the active substances alclometasone and neomycin sulfate.

Alclometasone is a substance belonging to a group of medicines known as corticosteroids. Corticosteroids have anti-inflammatory activity.
Neomycin sulfate belongs to a group of medicines known as aminoglycosides and has antibacterial action. These substances are often used together in the treatment of skin diseases associated with bacterial infections.

Halciderm Combi is indicated for the treatment of skin disorders such as:

Atopic dermatitis, an inflammation of the skin of unknown cause;
Contact dermatitis, an inflammation of the skin caused by contact with certain substances;
Eczematous dermatitis, an inflammation of the skin characterized by redness, swelling, and small blisters;
Stasis dermatoses, a skin disease caused by poor blood circulation;
Nummular dermatitis, an inflammation of the skin characterized by coin-shaped patches;
Seborrheic dermatitis, an inflammation of the skin characterized by mild redness, scales, and patches in various areas of the body;
Neurodermatitis, skin diseases of psychosomatic origin (such as lichen simplex chronicus, infantile eczema, and psoriasis), worsened by bacterial infections.

2. What you need to know before using Halciderm Combi

Do NOT use Halciderm Combi

if you are allergic to alclometasone, sulfate neomycin, or to any of the other ingredients of this medicine (listed in section 6);
if you have tuberculosis of the skin or fungal or viral skin diseases, such as herpes simplex, vaccinia, or varicella;
in the eyes (it is not for ophthalmic use);
in the external ear canal if you have sustained an injury resulting in perforation of the eardrum.

Warnings and precautions
Talk to your doctor or pharmacist before using Halciderm Combi.
Inform your doctor:

if an infection occurs that is not sensitive to Halciderm Combi, because your doctor will assess whether to prescribe an antibacterial or antifungal treatment to help heal the skin, or whether to temporarily discontinue Halciderm Combi;
if skin irritation or allergic reactions occur, especially with prolonged use. In this case, stop treatment with Halciderm Combi;
if you experience blurred vision or other visual disturbances.

Take particular care when using Halciderm Combi:

on large areas of skin (such as burns or other skin injuries), because increased systemic absorption may raise the risk of kidney or ear toxicity, especially with long-term use. Although rarely, this may increase the absorption of the medicine and its systemic effects, causing:
o elevated blood sugar levels (hyperglycemia);
o presence of sugar in the urine (glycosuria);
o a syndrome whose symptoms may include, for example, accumulation of fat especially in the neck, abdomen, and face, fluid retention, and increased blood pressure, etc. (Cushing's syndrome);
o hormonal disturbances;
with occlusive dressings:
o discontinue the use of occlusive dressings and inform your doctor if you develop an increase in body temperature or a new infection (secondary infection);
o replace the dressing material (plastic) or tape if you develop a skin allergic reaction;
o treat one body area at a time when managing skin conditions affecting multiple areas, because occlusive dressing (see section “How to use Halciderm Combi”) may increase the absorption of the medicine and its systemic effects;
o use plastic films cautiously, as they may easily catch fire and could cause suffocation in children.

Children and adolescents
In children, increased systemic absorption of the medicine may more likely cause:

a syndrome whose symptoms may include, for example, accumulation of fat especially in the neck, abdomen, and face, fluid retention, and increased blood pressure, etc. (Cushing's syndrome);
hormonal disturbances.

Prolonged, long-term use of Halciderm Combi may interfere with growth and development in children.
When using Halciderm Combi in children, use a smaller amount of cream than you would for an adult, and do not exceed the duration of treatment advised by your doctor.

Other medicines and Halciderm Combi
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No adverse interactions with other medicines are currently known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.

Pregnancy
This medicine should be used during pregnancy only if clearly needed and under direct medical supervision.
Do not use this medicine for prolonged periods or on large areas of skin.

Breastfeeding
Do not apply this medicine to the nipples.
It is not known whether this medicine passes into breast milk following skin application; therefore, Halciderm Combi should be used with caution during breastfeeding, especially when applied to large skin areas or for prolonged periods.

Driving and using machines
Currently, no effects of Halciderm Combi on the ability to drive or operate machinery are known.

Halciderm Combi contains propylene glycol
Halciderm Combi contains 225 mg of propylene glycol per maximum daily dose, equivalent to 150 mg/g. Propylene glycol may cause skin irritation.

3. How to use Halciderm Combi

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Halciderm Combi with gentle massage to the affected area 2–3 times daily.
Your doctor will tell you how long you should use Halciderm Combi on the affected area.
Your doctor may instruct you to use Halciderm Combi with occlusive dressing.

How to use Halciderm Combi with occlusive dressing:

massage a small amount of the medicine into the affected area until fully absorbed;
apply a second layer of cream, leaving a thin film;
cover the area with a plastic film and secure it with adhesive tape;
if increased moisture is needed, before applying the plastic, cover the lesion with a clean, damp cotton cloth, or immerse the affected area in water for a short time.
Your doctor will tell you how long to keep the dressing in place. You must reapply the cream each time you change the dressing.

If you use more Halciderm Combi than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
The active substances in Halciderm Combi may cause systemic effects due to absorption into the body. Your doctor will treat your condition according to the symptoms presented.

If you forget to use Halciderm Combi
Do not use a double dose to make up for the missed dose.

If you stop using Halciderm Combi
If you have any doubts about using 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.

Use of Halciderm Combi may lead to the following side effects:

burning sensation, itching, dry skin;
irritation;
inflammation of the hair follicle, i.e. the skin structure where hair grows (folliculitis);
increased growth and number of hairs (hypertrichosis);
acne-like skin lesions (acneiform eruptions);
decreased skin pigmentation (hypopigmentation);
inflammation of the skin around the mouth (perioral dermatitis);
allergic skin inflammation due to contact with specific substances (allergic contact dermatitis);
various types of skin lesions and lesions of the sweat glands (which produce sweat);
a new infection different from the initial one (secondary infection);
thinning of the skin, which may appear dry and wrinkled (cutaneous atrophy);
purplish skin streaks (striae);
blockage of the small ducts carrying sweat to the skin surface, causing inflammation and resulting in irritation, itching, and a skin rash consisting of small swellings or tiny blisters (miliaria);
delayed-type hypersensitivity reactions to neomycin;
sensitization phenomena after prolonged use;
blurred vision, frequency not known (may affect up to 1 in 100 people).

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 Halciderm Combi

Do not store above 25°C.
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 "Exp.". 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 Halciderm Combi contains

The active substances are alclometasone and neomycin sulfate. Each gram of cream contains 1 mg of alclometasone and 2,500 IU of neomycin sulfate.
The other components are propylene glycol, sodium citrate, citric acid, titanium dioxide (E171), dimethylpolysiloxane, white soft paraffin, polyoxyethylene fatty alcohol, sorbitol solution, silicone oil, purified water.

Description of the appearance of Halciderm Combi and contents of the pack
Each pack contains one 30 g tube of cream.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia