Halciderm

Package leaflet: Information for the patient

Halciderm 0,1% cream

alcinonide
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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Halciderm is and what it is used for

Halciderm contains the active substance alclometasone, a compound belonging to a group of medicines known as corticosteroids. Corticosteroids have anti-inflammatory properties and are commonly used in the treatment of skin diseases.
Halciderm cream, when applied topically, is indicated for the treatment of numerous acute or chronic skin conditions (dermatoses) that are sensitive to corticosteroids, including:

• Atopic dermatitis, an inflammation of the skin with unknown causes;
• 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;
• Infantile eczema, a skin inflammation typical in infants.

Halciderm cream is used under occlusive dressing (see section “How to use Halciderm”) for the treatment of difficult-to-treat skin conditions such as:

• Psoriasis;
• Neurodermatitis, a psychosomatic skin disorder such as lichen simplex chronicus.

2. What you need to know before using Halciderm

Do NOT use Halciderm

• if you are allergic to alclometasone 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;
• for the eyes (it is not intended for ophthalmic use);
• in the external ear canal if you have suffered an injury resulting in perforation of the eardrum;
• during pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

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

• if an infection occurs, because your doctor will assess whether you need antibacterial or antifungal treatment to help heal the skin, or whether you should temporarily stop using Halciderm;
• if skin irritation or allergic reactions occur, especially with prolonged use. In this case, stop treatment with Halciderm;
• if you experience blurred vision or other visual disturbances.

Take particular care when using Halciderm:

• over large areas of skin and for prolonged periods, because, although rarely, it may increase absorption of the medicine into the body and its systemic effects. Increased systemic absorption may cause:
  o elevated blood sugar levels (hyperglycaemia);
  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;
• when using occlusive dressings:
  o treat one body area at a time when treating skin conditions affecting multiple areas, because occlusive dressings (see section “How to use Halciderm”) may enhance absorption of the medicine through the skin and increase the risk of systemic effects, especially when applied over large areas;
  o plastic films may easily catch fire;
  o in children, plastic films may cause suffocation;
  o if you develop a skin allergic reaction, it may be due to the material used for the dressing (plastic) or tape: in this case, replace them with alternative materials;
  o if your body temperature increases or you develop another infection different from the initial one (secondary infection): in this case, you must stop using the occlusive dressing and inform your doctor.

Children
In children, systemic absorption is more likely than in adults when Halciderm is used over large skin areas and for prolonged periods.
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;
• increased intracranial pressure (intracranial hypertension).

When using Halciderm cream in children, use a smaller amount than you would use for an adult and do not exceed the duration of treatment advised by your doctor. The doctor will closely monitor the child for signs and symptoms of systemic effects due to absorption of Halciderm.

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

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

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

Breastfeeding
It is not known whether this medicine passes into breast milk after skin application; therefore, Halciderm should be used with caution during breastfeeding.

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

Halciderm contains stearic acid propylene glycol ester, propylene glycol, and castor oil
Halciderm contains stearic acid propylene glycol ester and 225 mg of propylene glycol per maximum daily dose, equivalent to 150 mg/g. Stearic acid propylene glycol ester and propylene glycol may cause skin irritation.
Halciderm contains castor oil, which may cause local skin reactions.

3. How to use Halciderm

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Halciderm with gentle massage to the affected area 2–3 times a day.
A single daily application may be sufficient:

• for less severe skin conditions;
• for maintenance therapy of severe conditions such as psoriasis.

Your doctor will tell you how long you should use Halciderm on the affected area.
Your doctor may instruct you to use Halciderm with occlusive dressing.

How to use Halciderm with occlusive dressing:

1. massage a small amount of the medicine into the affected area until completely absorbed;
2. apply a second layer of cream, leaving a thin film;
3. cover the area with a plastic film, securing it with adhesive tape. Your doctor will tell you how long to keep the dressing in place. Generally, the dressing can be applied in the evening and removed in the morning (12-hour dressing). During the day, you should then apply Halciderm without occlusive dressing. You must apply the cream each time you change the dressing.

If you use more Halciderm than you should
If Halciderm is accidentally ingested or if an excessive dose is used, inform your doctor immediately or go to the nearest hospital.
The active substance in Halciderm may cause systemic effects due to absorption into the body: your doctor will treat your condition according to the symptoms.

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

If you stop using Halciderm
If you have any questions 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.
The use of Halciderm may cause 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);
• blurred vision, frequency not known.

When occlusive dressing is used, the following may also occur:

• various types of skin lesions (cutaneous atrophy, striae, skin maceration) and of the sweat glands (miliaria);
• a new infection different from the initial one (secondary infection).

Additional side effects in children
In children treated with Halciderm cream, the following have been observed:

• hormonal imbalances with growth delay;
• low plasma levels of cortisol;
• increased intracranial pressure with headache and vision problems (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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

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 contains

• The active substance is alclometasone dipropionate. 1 g of cream contains 1 mg of alclometasone dipropionate.
• The other ingredients are castor oil, white vaseline, polyethylene glycol fatty alcohol ether, propylene glycol stearate, silicone fluid, propylene glycol, purified water.

Description of the appearance of Halciderm 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

Patient information leaflet

Halciderm 0.1% + 2% Cutaneous Solution

alcinonide/salicylic acid
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 other people, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Halciderm is and what it is used for
2. What you need to know before using Halciderm
3. How to use Halciderm
4. Possible side effects
5. How to store Halciderm
6. Package contents and other information

1. What Halciderm is and what it is used for

Halciderm cutaneous solution contains the active substances alclometasone and salicylic acid.

• Alclometasone belongs to a group of medicines known as corticosteroids. Corticosteroids have anti-inflammatory activity and are often used in the treatment of skin diseases.
• Salicylic acid is able to inhibit bacterial growth (bacteriostatic), kill fungi (fungicidal), and remove dead cells from the surface of the skin (keratolytic). Topically applied Halciderm cutaneous solution is indicated for the treatment of numerous acute or chronic skin diseases (dermatoses) that are sensitive to corticosteroids, including:
• contact eczema, an inflammation of the skin caused by contact with certain substances;
• atopic dermatitis, an inflammation of the skin with unknown causes;
• seborrheic dermatitis, a skin inflammation characterized by mild redness, scales, and patches in various areas of the body;
• eczematous dermatitis, a skin inflammation characterized by redness, swelling, and small blisters;
• Halciderm may be used with partial or occlusive dressings, i.e. covering the affected area with a plastic film after applying the solution.
• neurodermatitis, a psychosomatic skin disorder such as lichen simplex chronicus;
• psoriasis.

2. What you need to know before using Halciderm

Do NOT use Halciderm

• if you are allergic to alclometasone, salicylic acid, or 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;
• if you have exudative dermatoses, i.e. skin inflammations characterized by the secretion of fluids;
• in or around the eyes (it is not for ophthalmic use);
• during pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

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

• if an infection occurs, as your doctor will assess whether you need antibacterial or antifungal treatment to help heal the skin, or whether to temporarily discontinue use of Halciderm;
• if skin irritation or allergic reactions occur, especially with prolonged use. In this case, stop treatment with Halciderm;
• if the patient is a child under 6 years of age;
• if blurred vision or other visual disturbances occur.

Take particular care when using Halciderm:

• over large areas of skin;
• near lesions in skin folds or joints;
• for long periods of time, because, although rarely, it may increase absorption of the medicine into the body and lead to systemic effects. Increased systemic absorption may cause:
  • elevated blood sugar levels (hyperglycaemia);
  • presence of sugar in urine (glucosuria);
  • 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;
  • a condition called salicylism, characterized by symptoms such as nausea, vomiting, dizziness, and ringing or buzzing in the ears;
• with occlusive dressings:
  • treat one body area at a time when treating skin conditions affecting multiple areas, because occlusive dressings may enhance absorption of the medicine through the skin and increase the risk of systemic effects, especially when applied over large areas;
  • because plastic films can easily catch fire;
  • because in children, plastic films may cause suffocation;
  • if you develop a skin allergic reaction, which may be due to the dressing (plastic) or adhesive material; in this case, replace them with another material;
  • if your body temperature increases or you develop another infection different from the initial one (secondary infection); in this case, discontinue use of the occlusive dressing and inform your doctor.

Keep Halciderm away from eyes and mucous membranes.

Do not dry your hair using open flames because the medicine is flammable.

Children and adolescents
In children, systemic absorption may occur more easily than in adults when Halciderm is used over large skin areas and for prolonged periods.

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;
• increased intracranial pressure (intracranial hypertension).

Inform your doctor before using Halciderm in children under 6 years of age.

In children aged between 6 and 12 years:

• use a smaller amount of topical solution than you would for an adult;
• use the topical solution only for the length of time prescribed by your doctor.

Be cautious when using Halciderm over large areas of the body in infants and young children, as in these patients the amount of medicine absorbed systemically may increase.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before using this medicine.

Pregnancy
This medicine should be used in pregnant women only if clearly needed and under the direct supervision of a doctor.
Do not use this medicine for prolonged periods or over large skin areas.

Breastfeeding
It is not known whether this medicine passes into breast milk after topical application; therefore, Halciderm should be used with caution during breastfeeding.

Driving and using machines
To date, no effects of Halciderm on the ability to drive vehicles or operate machinery have been reported.

3. How to use Halciderm

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Halciderm 2–3 times a day, drop by drop, to cover the entire affected area, and massage gently until fully absorbed.
Your doctor will tell you how long you should continue using Halciderm on the affected area.

Instructions for opening the bottle

• Unscrew the cap until the security seal is completely broken.
• Close the bottle carefully after each use.

If you use more Halciderm than you should
If Halciderm is accidentally ingested or if an excessive dose is used, inform your doctor immediately or go to the nearest hospital.
The active substance in Halciderm may cause effects due to systemic absorption. Your doctor will treat your condition according to your symptoms.

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

If you stop using Halciderm
If you have any questions 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 will experience them.
The use of Halciderm may cause 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);
• loss of skin pigmentation (hypopigmentation);
• inflammation of the skin around the mouth (perioral dermatitis);
• allergic skin inflammation due to contact with specific substances (allergic contact dermatitis);
• localized pain;
• symptoms of salicylism:
• loss of cells from the outer layer of the skin (desquamation);
• skin inflammation (dermatitis);
• local redness of the skin;
• itching;
• pain or nausea; or vomiting; or diarrhoea; or dizziness; or hearing loss; or ringing or buzzing in the ears (tinnitus); or drowsiness and lethargy (lethargy); or rapid and deep breathing (hyperpnea); or mental disturbances.
• blurred vision, with a frequency not known.

When occlusive dressings are used, the following may also occur:

• various types of skin damage (cutaneous atrophy, striae, skin maceration) and of sweat glands (miliaria);
• a new infection different from the initial one (secondary infection).

Additional side effects in children
In children treated with Halciderm cutaneous solution the following have been observed:

• hormonal imbalances with growth retardation;
• low plasma levels of cortisol;
• increased intracranial pressure with headache and vision problems (bilateral papilledema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the website 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

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 contains

• The active substances are alclometasone and salicylic acid. 100 g of cutaneous solution contain 0.1 g of alclometasone and 2 g of salicylic acid.
• The other components are alcohol and purified water.

Description of the appearance of Halciderm and contents of the pack
Each pack contains one 30 ml bottle of cutaneous solution.
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