SOVENTOL

SOVENTOL Hydrocort 0.5% Cream

Important notes (mandatory information)

Soventol HydroCort 0.5% 5 mg/g cream. Active ingredient: Hydrocortisone. Areas of application: for the treatment of all skin diseases that respond to treatment with corticosteroids, such as inflammatory, allergic or itchy dermatoses (skin inflammations, eczema).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soventol HydroCort 0.5% 5 mg/g cream, for external treatment of inflammatory and allergic skin diseases, for adults and children from the age of 6 for short-term (max. 2 weeks) external use. For children under 6 years of age only on doctor's prescription.
Active ingredient: Hydrocortisone

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
• If you do not feel better or even worse, talk to your doctor.

This package leaflet contains

1. WHAT IS SOVENTOL HYDROCORT 0.5% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SOVENTOL HYDROCORT 0.5%?
3. HOW TO USE SOVENTOL HYDROCORT 0.5%?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SOVENTOL HYDROCORT 0.5%?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SOVENTOL HYDROCORT 0F5% AND WHAT IS IT USED FOR?

Soventol HydroCort 0.5% is a weakly effective corticosteroid (group I) for the treatment of skin diseases. Hydrocortisone is the physiologically most important corticoid from the group of glucocorticoids. When applied externally, hydrocortisone blocks inflammatory processes (antiphlogistic effect) regardless of their cause, and it also regulates the formation of connective tissue cells (fibroblasts) and collagen synthesis (antiproliferative effect). Soventol HydroCort 0.5% is used to treat all skin diseases that respond to treatment with corticosteroids, such as inflammatory, allergic or itchy dermatoses (skin inflammations, eczema).

2. WHAT SHOULD YOU CONSIDER BEFORE USING SOVENTOL HYDROCORT 0.5%?

Soventol HydroCort 0.5% must not be used:

• if you are allergic to hydrocortisone or any of the other ingredients of this medicine listed in section 6.
• in children under 6 years of age (children up to the age of 6 may only be treated with Soventol HydroCort 0.5% on doctor's prescription. Care must be taken to ensure that infants and toddlers are not treated under occlusive conditions [air occlusion by nappies]).
• in syphilitic or tuberculous skin diseases.
• in chickenpox and vaccination reactions.

In the case of a simultaneous skin infection with bacteria or fungi, this must be treated separately.

Warnings and precautions

Please talk to your doctor or pharmacist before using Soventol HydroCort 0.5%. Large-area application of the preparation and covering with a bandage (occlusive application) should only be done under medical supervision. Soventol HydroCort 0.5% should not be applied to an area of more than 1/10 of the body surface for more than one week. Do not use in the eye or on open wounds.

Use of Soventol HydroCort 0r5%

together with other medicines

No interactions with other medicines taken at the same time or applied externally are known to date. Please inform your doctor or pharmacist if you are taking or using, have recently taken/used or intend to take/use any other medicines.

Use of Soventol HydroCort 0.5%

together with food and drink

No interactions with food and drink are known to date.

Pregnancy and breast-feeding

During pregnancy, Soventol HydroCort 0.5% should only be used in urgent cases, not for long periods and not over a large area (on more than 30% of the body surface). Breastfeeding mothers must not apply Soventol HydroCort 0.5% to the breast area to avoid direct contact of the infant with the active ingredient.

Driving and using machines

No special precautions are required.

Soventol HydroCort 0f5%

contains sorbic acid, potassium sorbate and cetyl stearyl alcohol

These can cause localised skin irritation (e.g. contact dermatitis).

3. HOW TO USE SOVENTOL HYDROCORT 0.5%?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Children up to the age of 6 may only be treated with Soventol HydroCort 0.5% on doctor's prescription. The recommended dose is: Soventol HydroCort 0.5% is applied thinly to the affected skin areas 2-3 times a day and gently rubbed in. Once the condition has improved, once-daily application is often sufficient.

Method of administration

For application to the skin. Before first use, the thin aluminium foil must be pierced with the spike of the cap.

Duration of use

The duration of use depends on the success of the therapy and should not exceed 2 weeks without consulting a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Soventol HydroCort 0.5% is too strong or too weak.

If you have used a larger amount of Soventol HydroCort 0.5%

than you should

Hydrocortisone is a weakly effective corticoid that is contained in Soventol HydroCort 0.5% in a relatively low dosage. Therefore, no poisoning symptoms are to be expected even after an overdose. Please inform your doctor about the application error at your next visit.

If you forget to use Soventol HydroCort 0.5%

Forgetting to use it once does not lead to negative effects. Apply Soventol HydroCort 0.5% again at the next application time in the usual amount. Do not apply double the amount if you have forgotten the previous application.

If you stop using Soventol HydroCort 0r5%

No negative effects are known.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Significant side effects or signs to watch out for

Soventol HydroCort 0.5% is generally very well tolerated by the skin. In particularly sensitive patients, allergic skin reactions (hypersensitivity reactions) can occur in very rare cases.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SOVENTOL HYDROCORT 0.5%?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and tube after "Use by:". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Note on shelf life after opening: Soventol HydroCort 0.5% has a shelf life of 12 months after opening. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Soventol HydroCort 0.5%

contains

The active ingredient is: Hydrocortisone 5 mg/g cream. The other ingredients are: Liquid paraffin; Cetyl stearyl alcohol (Ph. Eur.); White petrolatum; Cetomacrogol 1000; Emulsifying wax; Propylene glycol; Phenoxyethanol (Ph. Eur.); Potassium sorbate (Ph. Eur.); Sorbic acid (Ph. Eur.); Sodium edetate (Ph. Eur.); Purified water.

What Soventol HydroCort 0.5%

looks like and contents of the pack

White cream. Soventol HydroCort 0.5% is available in original packs containing 15 g cream and 30 g cream.

Pharmaceutical entrepreneur and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
D-58638 Iserlohn
Telephone:+49 (0) 2371 937-0
Telefax: +49 (0) 2371 937-329
E-mail: info@medice.de
www.medice.de

This leaflet was last revised in July 2015.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Hydrocortisone. Areas of application: for the treatment of all skin diseases that respond to treatment with corticosteroids, such as inflammatory, allergic or itchy dermatoses (skin inflammations, eczema).