SOVENTOL

SOVENTOL hydrocortisone acetate 0.25% cream

Important notes (mandatory information)

Soventol Hydrocortisone Acetate 0.25% 2.5 mg/g Cream. Active ingredient: Hydrocortisone-21-Acetate. Areas of application: for the treatment of inflammatory and allergic dermatoses (skin inflammations and eczema) with low to medium severity of symptoms that respond to external treatment with low-potency corticosteroids.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soventol Hydrocortisone Acetate 0.25% 2.5 mg/g Cream for use in adults and children aged 6 years and over
Active ingredient: Hydrocortisone-21-Acetate

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 package 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.
• If you do not feel better or if you feel worse, talk to your doctor.

This package leaflet contains

1. WHAT IS SOVENTOL HYDROCORTISONE ACETATE 0.25% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SOVENTOL HYDROCORTISONE ACETATE 0.25%?
3. HOW IS SOVENTOL HYDROCORTISONE ACETATE 0.25% USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SOVENTOL HYDROCORTISONE ACETATE 0.25% BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SOVENTOL HYDROCORTISONE ACETATE 0.25% AND WHAT IS IT USED FOR?

Soventol Hydrocortisone Acetate 0.25% is a low-potency 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 (anti-inflammatory effect) regardless of their cause, and it also regulates the formation of connective tissue cells (fibroblasts) and collagen synthesis (antiproliferative effect). Soventol Hydrocortisone Acetate 0.25% is used for the treatment of inflammatory and allergic dermatoses (skin inflammations and eczema) with low to medium severity of symptoms that respond to external treatment with low-potency corticosteroids.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SOVENTOL HYDROCORTISONE ACETATE 0.25%?

Soventol Hydrocortisone Acetate 0.25% must not be used:

• if you are allergic to hydrocortisone-21-acetate or any of the other ingredients of Soventol Hydrocortisone Acetate 0.25% listed in section 6.
• in case of syphilitic or tuberculous skin diseases.
• in case of chickenpox and vaccination reactions.

It is important to ensure that the product is not used on infants and toddlers under occlusive conditions (lack of air circulation due to diapers). In case of a simultaneous skin infection caused by bacteria or fungi, this must be treated separately.

Warnings and precautions

Please talk to your doctor or pharmacist before using Soventol Hydrocortisone Acetate 0.25%. Soventol Hydrocortisone Acetate 0.25% must not be used in or around the eyes.

Using Soventol Hydrocortisone Acetate 0.25%

together with other medicines

Please tell your doctor or pharmacist if you are taking or using, have recently taken or used, or plan to take or use any other medicines. No interactions with other medicines are known to date.

Using Soventol Hydrocortisone Acetate 0.25%

together with food and drink

No interactions with food and drink are known to date.

Pregnancy and breast-feeding

Soventol Hydrocortisone Acetate 0.25% should not be used over large areas during pregnancy, especially during the first 3 months. Breast-feeding mothers should not apply Soventol Hydrocortisone Acetate 0.25% to the breast area. If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No special precautions are necessary.

3. HOW IS SOVENTOL HYDROCORTISONE ACETATE 0.25% USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Soventol Hydrocortisone Acetate 0.25% should be applied to the affected areas of skin in a thin layer 2 - 3 times a day. If your condition permits, the product can also be gently massaged in. Slight burning may occur immediately after applying Soventol Hydrocortisone Acetate 0.25%, but this will quickly disappear.

Method of administration

For application to the skin.

Duration of use

The duration of use depends on the success of the therapy and should not exceed 4 weeks without consulting a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Soventol Hydrocortisone Acetate 0.25% is too strong or too weak.

If you have used more Soventol Hydrocortisone Acetate 0.25%

than you should

Overdose symptoms are not to be expected for 0.25% hydrocortisone formulations when used as directed.

If you forget to use Soventol Hydrocortisone Acetate 0.25%

Forgetting to use the product once will not have any negative effects. Apply Soventol Hydrocortisone Acetate 0.25% again as soon as possible. Do not use double the amount to make up for the forgotten application.

If you stop using Soventol Hydrocortisone Acetate 0.25%

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 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

If you are affected by any of the following side effects, stop using Soventol Hydrocortisone Acetate 0.25% and see your doctor as soon as possible. Soventol Hydrocortisone Acetate 0.25% is generally very well tolerated by the skin. In very rare cases, allergic skin reactions (hypersensitivity reactions) may occur in particularly sensitive patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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 SHOULD SOVENTOL HYDROCORTISONE ACETATE 0.25% BE STORED?

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. Storage conditions: Do not freeze! Do not store above 25°C. Note on shelf life after opening: Soventol Hydrocortisone Acetate 0.25% 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 Hydrocortisone Acetate 0.25%

contains

The active ingredient is: Hydrocortisone-21-acetate 2.5 mg/g cream. The other ingredients are: Ammonia; Carbopol 1382 polymer; Sodium edetate (Ph. Eur.); Decyl oleate; Purified water; Isopropyl myristate (Ph. Eur.); Macrogol 400; Liquid paraffin; Perfume oil; Propan-2-ol.

What Soventol Hydrocortisone Acetate 0.25%

looks like and contents of the pack

White cream gel. Soventol Hydrocortisone Acetate 0.25% is available in packs of 20 g cream and 50 g cream.

Pharmaceutical entrepreneur and manufacturer

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

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Hydrocortisone-21-Acetate. Areas of application: for the treatment of inflammatory and allergic dermatoses (skin inflammations and eczema) with low to medium severity of symptoms that respond to external treatment with low-potency corticosteroids.