Beben
Italy
Table of Contents
Package leaflet: Information for the patient
Beben 0.025% Cream
betamethasone
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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Beben is and what it is used for
- What you need to know before using Beben
- How to use Beben
- Possible side effects
- How to store Beben
- Contents of the pack and other information
1. What Beben is and what it is used for
Beben contains the active substance betamethasone, a substance belonging to a group of medicines known as corticosteroids. Betamethasone applied to the skin has anti-inflammatory, antiallergic, vasoconstrictive properties and also helps reduce swelling caused by fluid accumulation in the tissues (anti-edematous activity).
Beben is indicated for all inflammatory and allergic skin diseases (dermatoses) that may benefit from local treatment with corticosteroids.
Specifically for:
- skin inflammation characterized by redness, swelling and small blisters (eczematous dermatitis). These may, for example, be constitutional, contact or seborrheic types, etc.;
- skin inflammations (dermatitis) caused by physical agents (light, heat, X-rays);
- a skin condition characterized by red, inflamed skin covered with multiple layers of whitish scales (psoriasis);
- an inflammatory disease affecting the skin and/or mucous membranes (lichen ruber planus);
- localized lesions in skin folds (intertrigo).
2. What you should know before using Beben
Do NOT use Beben
- if you are allergic to betamethasone or to any closely related substances from a chemical standpoint, or to any of the other ingredients of this medicine (listed in section 6);
- if you have tuberculosis of the skin or skin diseases caused by fungi or viruses (especially chickenpox, vaccine-induced pustules, or herpes simplex);
- if you are pregnant (see section "Pregnancy and breastfeeding").
Warnings and precautions
Talk to your doctor or pharmacist before using Beben.
- Exercise particular caution when Beben is applied over large areas of skin, especially when using occlusive dressings (i.e., when the affected area is covered with a plastic film after applying the cream), as this may lead to increased systemic absorption of the active ingredient;
- if you have a skin infection, your doctor will prescribe an appropriate antibacterial or antifungal treatment;
- the use, especially if prolonged, of topical medicines may cause allergic reactions;
- Beben must not be used in the eyes (it is not intended for ophthalmic use).
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
In very young infants, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Beben
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
To date, no interactions or incompatibilities with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
If you are pregnant, this medicine will be prescribed only when strictly necessary and under direct medical supervision.
Driving and using machines
To date, no adverse effects on the ability to drive or operate machinery are known.
Beben cream contains cetyl alcohol and propylene glycol
Cetyl alcohol may 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 may cause skin irritation.
3. How to use Beben
Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Apply Beben 2-3 times a day. If possible and tolerated, you may gently massage the treated area and, if necessary, protect it with a bandage. If your doctor considers it appropriate, the treated area may be covered for 8 hours or more with gauze, followed by an impermeable plastic material secured at the edges with adhesive tape (occlusive dressing).
Once a clear improvement has been achieved, gradually reduce the frequency of applications until treatment is discontinued.
If you use more Beben than you should
In case of accidental ingestion or excessive dose of Beben, contact your doctor immediately or go to the nearest hospital.
If you stop using Beben
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 gets them.
Treatment with topical corticosteroids may cause:
- burning sensation, itching, irritation, dryness of the skin;
- 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);
- reduction in skin pigmentation (hypopigmentation);
- blurred vision, occurring with uncommon frequency (may affect up to 1 in 100 people).
In particular, when occlusive dressings are used, the following may occur:
• softening and breakdown of the skin due to accumulation of excessive amounts of fluid on the skin (skin maceration);
• thinning of the skin and appearance of stretch marks (skin atrophy and atrophic striae).
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 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 Beben
Do not store above 30 °C.
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 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 Beben contains
Beben 0.025% cream
- The active substance is betamethasone 17-benzoate. 100 g of Beben 0.025% cream contains 0.025 g of betamethasone 17-benzoate.
- The other components are cetyl alcohol, glyceryl monostearate, liquid paraffin, propylene glycol, disodium monooleamide sulfosuccinate, citric acid monohydrate, purified water.
Description of the appearance of Beben and contents of the pack
Each pack contains one 30 g tube of 0.025% cream.
Marketing Authorization Holder
Teofarma S.r.l.
F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia
Package leaflet: information for the patient
Beben 0.1% Cream, 0.1% Cutaneous Emulsion
betamethasone
Please 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be dangerous.
- If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Beben is and what it is used for
- What you need to know before using Beben
- How to use Beben
- Possible side effects
- How to store Beben
- Package contents and other information
1. What Beben is and what it is used for
Beben contains the active substance betamethasone, a substance belonging to a group of medicines known as corticosteroids. Betamethasone applied to the skin has anti-inflammatory, antiallergic, vasoconstrictive properties, and also helps reduce swelling caused by fluid accumulation in the tissues (anti-edematous activity).
Beben is indicated for all inflammatory and allergic skin diseases (dermatoses) that may benefit from local treatment with corticosteroids.
Specifically for:
- skin inflammation characterized by redness, swelling, and small blisters (eczematous dermatitis), such as constitutional, contact, or seborrheic types, etc.;
- skin inflammations (dermatitis) caused by physical agents (light, heat, X-rays);
- a skin condition characterized by red skin covered with multiple layers of whitish scales (psoriasis);
- an inflammatory disease affecting the skin and/or mucous membranes (lichen ruber planus);
- localized lesions in 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 closely related substances, 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 (particularly chickenpox, vaccine-induced pustules, or herpes simplex);
- if you have rosacea (an inflammatory condition characterized by redness, fluid-filled blisters, spots, and skin thickening), or non-healing skin lesions (cutaneous ulcers);
- if you are pregnant (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using Beben.
- Exercise particular caution when Beben is applied over large skin areas, especially when using occlusive dressings (i.e., when the affected area is covered with a plastic film after cream application), as this may lead to increased systemic absorption of the active substance;
- if you have a skin infection, your doctor will prescribe appropriate antibacterial or antifungal treatment;
- the use, especially if prolonged, of topical medicines may cause allergic reactions;
- Beben must not be used in the eyes (it is not for ophthalmic use).
Contact your doctor if you experience blurred vision or any other visual disturbances.
Children
In early infancy, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Beben
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Currently, no interactions or incompatibilities with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
If you are pregnant, this medicine will be prescribed only when strictly necessary and under direct medical supervision.
Driving and operating machinery
No negative effects on the ability to drive or 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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Apply once daily a sufficient amount of Beben to cover the affected area.
Beben is available as a cream and as a cutaneous emulsion; your doctor will determine which of these formulations
is most suitable for your condition.
Beben 0.1% cream is indicated for:
- exudative dermatitis, i.e. skin diseases with fluid discharge;
- subacute-chronic dry dermatitis, i.e. slowly healing skin inflammations of moderate intensity.
Beben 0.1% cutaneous emulsion is indicated for dermatoses of hairy areas.
If possible and tolerated by the patient, a gentle massage of the treated area may be performed,
which may then be protected with a dressing or, if necessary, with an occlusive bandage.
If you use more Beben than you should
In case of accidental ingestion or excessive dose of Beben, inform your
doctor immediately or go to the nearest hospital.
If you stop treatment with Beben
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 gets them.
Treatment with topical corticosteroids may cause:
- burning sensation, itching, irritation, dry skin;
- 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);
- reduction in skin pigmentation (hypopigmentation);
- capillary fragility;
- purple or red-brown patches on the skin (purpura);
- blurred vision (uncommon frequency, may affect up to 1 in 100 people).
In particular, when occlusive dressings are used, the following may occur:
• softening and breakdown of the skin due to excessive accumulation of fluid on the skin (skin maceration);
• thinning of the skin and appearance of stretch marks (skin atrophy and atrophic striae).
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 Beben
This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product 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 medicinal product in wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Beben contains
Beben 0.1% cream
- The active substance is betamethasone 17-benzoate. 100 g of Beben 0.1% cream contains 0.1 g of betamethasone 17-benzoate.
- The other components are cetyl alcohol, glyceryl monostearate, liquid paraffin, propylene glycol, disodium monooleyl amido sulfosuccinate, citric acid monohydrate, purified water.
Beben 0.1% cutaneous emulsion
- The active substance is betamethasone 17-benzoate. 100 ml of Beben 0.1% cutaneous emulsion contains 0.1 g of betamethasone 17-benzoate.
- The other components are white soft paraffin, 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 one 30 g tube of 0.1% cream.
Beben 0.1% cutaneous emulsion
Each pack contains one 30 ml bottle of 0.1% emulsion.
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