Soventol hydrocortisone acetate 0.25% cream 20 g

Soventol hydrocortisone acetate is a medicine with a low concentration of a weakly effective corticosteroid that is used for the short-term (maximum 2 weeks) external treatment of moderate inflammatory and allergic skin diseases.

The active ingredient in the cream is the weakly effective corticosteroid hydrocortisone acetate. It has a mild anti-inflammatory effect.

Soventol hydrocortisone acetate is used:

• for the treatment of moderately red, inflamed or allergic skin conditions in adults and children over 6 years of age for whom weakly effective corticosteroids in low concentrations are indicated.

Contraindications

Soventol hydrocortisone acetate must not be used

• if you are allergic to hydrocortisone acetate or any of the other ingredients of this medicine listed in section 6 (see “Further information”).
• without a doctor's prescription in children under 6 years of age.
• for certain skin diseases (syphilis, tuberculosis of the skin).
• for viral infections such as chickenpox, herpes or shingles.
• for skin reactions after vaccinations.
• for acne vulgaris or acne that occurred after cortisone treatment (steroid acne).
• for skin inflammation in the mouth area (perioral dermatitis).
• for inflammatory redness of the face (rosacea).
• around the eyes.
• on open wounds.

Interactions

Using Soventol Hydrocortisone Acetate with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

There are no known interactions with other medicines.

Paraffin is another component of Soventol Hydrocortisone Acetate Cream and can impair the tear resistance and protective effect of latex-containing products such as condoms or diaphragms.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
There is currently no experience with the use of Soventol hydrocortisone acetate in pregnant women. No increased risk of malformations or other birth defects was observed in 363 children whose mothers were treated with topical glucocorticoids (applied to the skin) during pregnancy. A number of epidemiological studies suggest that there may be an increased risk of cleft lip and palate in newborns of women treated with systemic (e.g. oral) glucocorticoids during the first three months of pregnancy.

Given the low exposure after application to the skin, Soventol Hydrocortisone Acetate can be used during pregnancy after careful benefit-risk assessment, but use on large areas or for long periods of time and airtight dressings should be avoided.
In general, topical use of corticoid-containing preparations should be avoided in the first trimester of pregnancy.

Breastfeeding
If you are breastfeeding, you must not apply Soventol hydrocortisone acetate to the breast area to avoid direct contact between the baby and the active ingredient.

Before using any medicine during pregnancy or breastfeeding, ask your doctor or pharmacist for advice.

Application

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

Children under 6 years of age
You may only treat your child with Soventol Hydrocortisone Acetate if the doctor has prescribed Soventol Hydrocortisone Acetate for the child.

The recommended dose is:
adults and children over 6 years old

Apply a thin layer of Soventol hydrocortisone acetate to the affected skin areas up to 3 times a day. Immediately after applying the cream, a slight burning sensation may occur, but this usually subsides quickly. Once the condition has improved, once daily use is often sufficient.

Method of application
Soventol hydrocortisone acetate is applied in a thin layer to the skin and rubbed in gently.
The tube is sealed with a thin aluminum foil. Before first use, pierce the seal with the spike on the top of the tube cap.

Duration of treatment
The duration of use depends on how well you respond to the treatment. However, Soventol Hydrocortisone Acetate must not be used for longer than 2 weeks without consulting your doctor and the duration should be kept to a minimum in children.

Please talk to your doctor or pharmacist if you have the impression that the effect of Soventol hydrocortisone acetate is too strong or too weak.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
What side effects are possible?

Common (may affect up to 1 in 10 people)

• Immediately after applying Soventol Hydrocortisone Acetate, a slight burning sensation often occurs, but this usually subsides quickly.

Uncommon (may affect up to 1 in 100 people)

• Blurred vision

Very rare (may affect up to 1 in 10,000 people)

• Allergic skin reactions (hypersensitivity symptoms) can occur, especially in sensitive patients.

If you notice any signs of a hypersensitivity reaction, stop using Soventol hydrocortisone acetate. Also, contact your doctor so they can give you further advice.

Not known (frequency cannot be estimated from available data)

• Thinning of the skin (skin atrophy)
• Dryness and redness at the application site (erythema)
• Stretch marks (skin striae)
• Inflamed hair follicles (application site folliculitis)
• Excessive hair growth (hypertrichosis)
• Spider veins (telangiectasia)
• Red rash around the mouth (perioral dermatitis)
• Skin discoloration
• Acne
• and/or allergic reactions to any of the components of the formulation

If semi-solid preparations containing corticoids are applied to the skin, the active ingredient can be absorbed through the skin into the body and cause side effects.

Side effects on the body from low-strength corticosteroids such as hydrocortisone include adrenal suppression (the body produces insufficient amounts of certain hormones), especially with prolonged use on the skin (see Warnings and Precautions).

composition

The active ingredient is: hydrocortisone acetate

The other ingredients are: Purified water, isopropyl alcohol, decyl oleate, macrogol 400, isopropyl myristate, thick paraffin, Carbopol 1382 polymer, perfume oil, concentrated. Ammonia solution (25%) to adjust the pH value, disodium edetate

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