BEBEN 0.025% Krem

Treść ulotki

1. Beben 0.025 % Cream
   1. What is Beben and what is it used for
   2. What you need to know before using Beben
   3. How to use Beben
   4. Possible side effects
   5. How to store Beben
   6. Contents of the pack and other information
2. Beben 0.1 % Cream, 0.1 % Cutaneous Emulsion
   1. What is Beben and what is it used for
   2. What you need to know before using Beben
   3. How to use Beben
   4. Possible side effects
   5. How to store Beben
   6. Contents of the pack and other information

Beben 0.025 % Cream

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

1. What is Beben and what is it used for

Beben contains the active ingredient betamethasone, a substance that belongs to a group of
medicines known as corticosteroids. Betamethasone used on the skin has anti-inflammatory,
anti-allergic, vasoconstrictive activity and also helps to counteract the formation of
swelling caused by the accumulation of fluids in the tissue (anti-edema activity).
Beben is indicated in all skin diseases (dermatoses) of an inflammatory and allergic nature that
may benefit from local treatment with corticosteroids.
In particular for:

• skin inflammation characterized by the presence of redness, swelling and small blisters (eczematous dermatitis). These can be for example constitutional, contact, seborrheic etc;
• skin inflammations (dermatitis) due to physical agents (light, heat, X-rays);
• skin disease characterized by the presence of reddened skin covered with multiple layers of whitish scales (psoriasis);
• inflammatory disease affecting the skin and/or mucous membranes (lichen ruber planus);
• lesions located in the skin folds (intertrigo).

2. What you need to know before using Beben

DO NOT use Beben

• if you are allergic to betamethasone or to chemically similar substances or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from skin tuberculosis or skin diseases caused by fungi and viruses (in particular chickenpox, pustules caused by vaccinations and herpes simplex);
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Beben.

• Pay particular attention when Beben is applied to very large areas of the skin and especially when using occlusive dressings (i.e. when the affected area is covered with a plastic film after applying the cream), because increased absorption of the active ingredient into the body may occur;
• in case of skin infection, your doctor will prescribe appropriate therapy against bacteria (antibacterial) or against fungi (antifungal);
• the use, especially if prolonged, of medicines for local use can cause allergic reactions.
• Beben should not be used for the eyes (it is not for ophthalmic use).

Contact your doctor if you experience blurred vision or other visual disturbances.

Children
In early infancy, the medicine should only be used in cases of actual necessity and under direct
medical supervision.

Other medicines and Beben
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
To date, no interactions and incompatibilities with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine.
If you are pregnant, the medicine will only be prescribed to you in cases of actual necessity and
under direct medical supervision.

Driving and operating machinery
To date, no adverse effects on the ability to drive and operate machinery are known.

Beben cream contains cetyl alcohol and propylene glycol
Cetyl alcohol can cause local skin reactions (e.g. contact dermatitis).
This medicine contains 375 mg of propylene glycol per maximum daily dose,
equivalent to 250 mg/g. Propylene glycol can cause skin irritation.

3. How to use Beben

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Apply Beben 2-3 times a day. If possible and tolerated, you can gently massage the treated area and possibly protect it with a bandage. If your doctor deems it appropriate, the treated area may be covered for 8 hours or more first with gauze and then with waterproof plastic material fixed to the edges with an adhesive bandage (occlusive dressing).
Once a noticeable improvement is achieved, the applications will be gradually reduced until the treatment is discontinued.

If you use more Beben than you should
In case of accidental ingestion or use of an excessive dose of Beben, immediately inform your doctor or go to the nearest hospital.

If you stop using Beben
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.
Treatment with local corticosteroids can cause:

• a burning sensation, itching, irritation, dryness of the skin;
• inflammation of the follicle, i.e. the structure of the skin where hair grows (folliculitis);
• increased hair growth and number of hairs (hypertrichosis);
• skin lesions similar to acne (acneiform eruptions);
• decreased skin pigmentation (hypopigmentation);
• blurred vision with uncommon frequency (which may affect up to 1 in 100 people).

In particular, when an occlusive dressing is used, the following may occur:
or softening and degradation of the skin due to high amounts of fluid accumulated on the
skin (skin maceration);
or thinning of the skin and appearance of stretch marks (skin atrophy and atrophic striae).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult 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 Beben

Do not store at a temperature above 30 °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 Beben contains
Beben 0.025% cream

• The active ingredient is betamethasone 17-benzoate. 100 g of Beben 0.025% cream contains 0.025 g of betamethasone 17-benzoate.
• The other ingredients are cetyl alcohol, glyceryl monostearate, liquid paraffin, propylene glycol, disodium monooleoamido sulfosuccinate, citric acid monohydrate, purified water.

Description of the appearance of Beben and contents of the pack
Each pack contains a 30 g tube of 0.025% cream.

Marketing Authorisation Holder
Teofarma S.r.l.
F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia

Beben 0.1 % Cream, 0.1 % Cutaneous Emulsion

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

1. What is Beben and what is it used for

Beben contains the active ingredient betamethasone, a substance that belongs to a group of
medicines known as corticosteroids. Betamethasone used on the skin has anti-inflammatory,
anti-allergic, vasoconstrictive activity and also helps to counteract the formation of
swelling caused by the accumulation of fluids in the tissue (anti-edema activity).
Beben is indicated in all skin diseases (dermatoses) of an inflammatory and allergic nature that
may benefit from local treatment with corticosteroids.
In particular for:

• skin inflammation characterized by the presence of redness, swelling and small blisters (eczematous dermatitis). These can be, for example, constitutional, contact, seborrheic etc;
• skin inflammations (dermatitis) due to physical agents (light, heat, X-rays);
• skin disease characterized by the presence of reddened skin covered with multiple layers of whitish scales (psoriasis);
• inflammatory disease that affects the skin and/or mucous membranes (lichen ruber planus);
• lesions located in the skin folds (intertrigo).

2. What you need to know before using Beben

DO NOT use Beben

• if you are allergic to betamethasone or to chemically related substances or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from skin tuberculosis or skin diseases caused by fungi and viruses (in particular chickenpox, pustules caused by vaccinations and herpes simplex);
• if you have rosacea, an inflammatory disease characterized by redness, blisters filled with liquid, spots and thickening of the skin (if you have rosacea) or skin lesions that do not heal (skin ulcers);
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Beben.

• Pay particular attention when Beben is applied to very large areas of the skin and especially when using occlusive dressing (i.e. when the affected area is covered with a plastic film after applying the cream), because increased absorption of the active ingredient into the body may occur;
• in case of skin infection, your doctor will prescribe appropriate therapy against bacteria (antibacterial) or against fungi (antifungal);
• the use, especially if prolonged, of medicines for local use can cause allergic reactions;
• Beben should not be used for the eyes (it is not for ophthalmic use).

Contact your doctor if you experience blurred vision or other visual disturbances.

Children
In early infancy, the medicine should only be used in cases of actual need and under the direct
supervision of a doctor.

Other medicines and Beben
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
To date, no interactions and incompatibilities with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine.
If you are pregnant, the medicine will only be prescribed to you in cases of actual need and
under the direct supervision of a doctor.

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

Beben cutaneous emulsion contains cetyl alcohol, sorbic acid, propylene glycol and sodium
lauryl sulfate
Cetyl alcohol and sorbic acid may cause local skin reactions (e.g. contact dermatitis)
Propylene glycol may cause skin irritation.
This medicine contains 2.5 mg of sodium lauryl sulfate per maximum daily dose,
equivalent to 5 mg/ml.
Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or
intensify skin reactions caused by other medicines when applied to the same area.

Beben cream contains cetyl alcohol and propylene glycol
Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis)
This medicine contains 125 mg of propylene glycol per maximum daily dose,
equivalent to 250 mg/g.
Propylene glycol may cause skin irritation.

3. How to use Beben

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Apply once a day a sufficient amount of Beben to cover the affected area.
Beben is available in cream and cutaneous emulsion, your doctor will assess which of these preparations
is most suitable for your condition.
Beben 0.1% cream is indicated in:

• weeping dermatitises, that is, skin diseases with fluid production;
• subacute-chronic dry dermatitises, i.e., slowly healing and moderate intensity skin inflammations.

Beben 0.1% cutaneous emulsion is indicated for dermatoses of areas covered with hair.
If possible and if tolerated by the patient, a gentle massage of the treated area can be performed,
which can then be protected with a bandage or possibly with an occlusive dressing.

If you use more Beben than you should
In case of accidental ingestion or use of an excessive dose of Beben, immediately inform your
doctor or go to the nearest hospital.

If you stop using Beben
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.
Treatment with local corticosteroids can cause:

• burning sensation, itching, irritation, dryness of the skin;
• inflammation of the follicle, i.e. the structure of the skin where hair grows (folliculitis);
• increased hair growth and number of hairs (hypertrichosis);
• skin lesions similar to acne (acneiform eruptions);
• decrease in skin pigmentation (hypopigmentation);
• fragility of capillaries;
• purple or reddish-brown spots on the skin (purpura);
• blurred vision (uncommon frequency (which may affect up to 1 in 100 people).

In particular, when an occlusive dressing is used, the following may occur:
or softening and degradation of the skin due to high amounts of liquid accumulated
on the skin (skin maceration);
or thinning of the skin and appearance of stretch marks (skin atrophy and atrophic striae).

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
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 Beben

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported 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 that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Beben contains
Beben 0.1% cream

• The active ingredient is betamethasone 17-benzoate. 100 g of Beben 0.1% cream contains 0.1 g of betamethasone 17-benzoate.
• The other ingredients are cetyl alcohol, glyceryl monostearate, liquid paraffin, propylene glycol, disodium monooleoamido sulfosuccinate, citric acid monohydrate, purified water.

Beben 0.1% cutaneous emulsion

• The active ingredient is betamethasone 17-benzoate. 100 ml of Beben 0.1% cutaneous emulsion contains 0.1 g of betamethasone 17-benzoate.
• The other ingredients are white petrolatum, cetyl alcohol, propylene glycol, sodium lauryl sulfate, sorbic acid, citric acid, triethanolamine, purified water.

Description of the appearance of Beben and contents of the pack
Beben 0.1% cream
Each pack contains a tube of 30 g of 0.1% cream.
Beben 0.1% cutaneous emulsion
Each pack contains a bottle of 30 ml of 0.1% emulsion.

Marketing Authorisation 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