SOVENTOL Hydrocort 0.5% Spray

Important notes (mandatory information)

Soventol HydroCort 0.5% Spray. Active ingredient: Hydrocortisone. Areas of application: for the relief of non-infected mild inflammatory, allergic or itchy skin conditions that respond to symptomatic treatment with low-potency glucocorticosteroids.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soventol HydroCort 0.5% Spray 5 mg/g solution for use in adults and children aged 6 years and over, for short-term (maximum 2 weeks) external use
Active ingredient: Hydrocortisone

Read the entire package leaflet carefully before you start using this medicine, as 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 need 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 HYDROCORT 0.5% SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SOVENTOL HYDROCORT 0.5% SPRAY?
3. HOW IS SOVENTOL HYDROCORT 0.5% SPRAY USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SOVENTOL HYDROCORT 0.5% SPRAY BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SOVENTOL HYDROCORT 0.5% SPRAY AND WHAT IS IT USED FOR?

Soventol HydroCort 0.5% Spray is a glucocorticoid (adrenal cortex hormone) for use on the skin. Area of application: for the relief of non-infected mild inflammatory, allergic or itchy skin conditions that respond to symptomatic treatment with low-potency glucocorticosteroids. Soventol HydroCort 0.5% Spray is preferably suitable for use on normal or oily skin.

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

Soventol HydroCort 0.5% Spray must not be used:

• if you are allergic to hydrocortisone or any of the other ingredients of Soventol HydroCort 0.5% Spray listed in section 6 or in the case of
• specific skin conditions (syphilis, tuberculosis),
• viral infections (e.g. chickenpox, herpes simplex, herpes zoster),
• vaccination reactions,
• fungal infections (mycoses),
• bacterial skin infections,
• acne vulgaris,
• steroid acne,
• skin inflammation around the mouth (perioral dermatitis),
• inflammatory redness of the face (rosacea),
• children under 6 years of age.

Do not use Soventol HydroCort 0.5% Spray on open wounds and for no longer than 2 weeks.

Warnings and precautions

Please talk to your doctor or pharmacist before using Soventol HydroCort 0.5% Spray.

Special care is required when using Soventol HydroCort 0.5% Spray:

• on the face (especially around the eyes), when applying to sore (intertriginous) areas, around skin ulcers and in the genital and anal area.
• in children and the elderly (ageing skin) due to reduced barrier function of the horny layer or a larger body surface area in relation to body weight.

Children

In children aged 6 years and over, external therapy with Soventol HydroCort 0.5% Spray should be used with restraint and for no longer than 2 weeks.

Use of Soventol HydroCort 0.5%

Spray 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.

If you accidentally ingest (orally) Soventol HydroCort 0.5% Spray or spray it on wounds, you must expect the following interactions:

• Cardiac glycosides: the glycoside effect can be increased by potassium deficiency.
• diuretics (saluretics): additional potassium excretion may occur.
• blood sugar-lowering medicines (antidiabetics): blood sugar reduction may be reduced.
• medicines to inhibit blood clotting (coumarin derivatives): the anticoagulant effect may be weakened.
• rifampicin, phenytoin, barbiturates: the corticoid effect may be reduced.
• non-steroidal painkillers (antiphlogistics)/antirheumatics: the risk of bleeding in the gastrointestinal tract is increased.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, 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.

Pregnancy

During pregnancy, the use of Soventol HydroCort 0.5% Spray should be avoided as far as possible and, if absolutely necessary, should be as brief and as small-area as possible. Since growth disorders and damage to the unborn child cannot be ruled out with long-term treatment with glucocorticoids during pregnancy, please inform your doctor if you want to become pregnant, are already pregnant or suspect you may be pregnant.

Breastfeeding

Glucocorticoids, including hydrocortisone, pass into breast milk. No harm to the infant has been reported to date. Nevertheless, you should only use Soventol HydroCort 0.5% Spray during breastfeeding after consulting your doctor. If your doctor considers it necessary to use Soventol HydroCort 0.5% Spray during breastfeeding, you must not use the spray in the breast area to avoid unwanted absorption by the infant. If your doctor considers higher doses necessary for medical reasons, you should stop breastfeeding.

Driving and using machines

No effects are known.

Soventol HydroCort 0.5%

Spray contains propylene glycol

Propylene glycol can cause skin irritation. The medicine is not suitable for people with dry skin or skin conditions associated with such.

3. HOW IS SOVENTOL HYDROCORT 0.5% SPRAY 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: At the start of treatment, you generally use the spray 2 - 3 times a day. Once the symptoms improve, a single application per day (or every 2 - 3 days) is usually sufficient.

Type and duration of use

Spray for use on the skin. Large-area application should be avoided or carried out as instructed by your doctor. Do not apply the spray to an area of more than 1/10 of the body surface for longer than one week. The duration of treatment must not exceed 2 weeks. If your symptoms worsen or do not improve after 2 weeks, you must consult a doctor in any case. This alcohol-based spray may limit the duration of use due to increasing dryness of the skin. In the case of significant dryness (e.g. scaling, tightness, itching), if the symptoms persist or if they worsen, you should consult a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Soventol HydroCort 0.5% Spray is too strong or too weak.

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

Spray than you should

Reduce the dose or - if possible - stop taking the medicine after high-dose and long-term use.

If you forget to use Soventol HydroCort 0.5%

Spray

Do not use double the amount to make up for the forgotten application.

If you stop using Soventol HydroCort 0.5%

Spray

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.

Possible side effects

Rare: allergic skin reactions With long-term use, the following side effects are known: skin atrophy, visible dilation of capillaries on the skin (telangiectasias), stretch marks on the skin (striae), steroid acne, skin inflammation around the mouth (perioral dermatitis), pathological increased body hair (hypertrichosis) and changes in skin pigmentation. Prolonged use can lead to local dryness of the skin (e.g. scaling, tightness, itching).

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, Pharmacovigilance Department, 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 HYDROCORT 0.5% SPRAY 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 store above 25°C. Note on shelf life after opening: Soventol HydroCort 0.5% Spray 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%

Spray contains

The active ingredient is hydrocortisone. 30 ml spray contains 0.15 g hydrocortisone. The other ingredients are: Ethanol 96%, propylene glycol, glycerol 85%, hypromellose, sodium edetate (Ph. Eur.), sodium hydroxide, citric acid monohydrate, purified water.

What Soventol HydroCort 0.5%

Spray looks like and contents of the pack

Clear colourless solution. Pack of 30 ml solution.

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 package leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Hydrocortisone. Areas of application: for the relief of non-infected mild inflammatory, allergic or itchy skin conditions that respond to symptomatic treatment with low-potency glucocorticosteroids.