Hydrocortisone ratiopharm 0.5%, 30 g cream

Hydrocortisone-ratiopharm 0.5% Cream. Indications: For inflammatory and allergic skin conditions with mild symptoms that respond to topical therapy with low-potency corticosteroids (max. 2 weeks).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrocortisone-ratiopharm 0.5% Cream for use in children aged 6 years and older and in adults.
Active ingredient: Hydrocortisone.

Read the entire package leaflet carefully, as it contains important information for you. This medicine is also available without a prescription. However, to achieve the best possible treatment success, Hydrocortisone-ratiopharm 0.5% Cream must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2 weeks, you must definitely see a doctor.
• If any of the listed side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What this leaflet contains:

1. WHAT IS HYDROCORTISONE-RATIOPHARM 0.5% CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HYDROCORTISONE-RATIOPHARM 0.5% CREAM?
3. HOW IS HYDROCORTISONE-RATIOPHARM 0.5% CREAM TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HYDROCORTISONE-RATIOPHARM 0.5% CREAM BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS HYDROCORTISONE-RATIOPHARM 0.5% CREAM AND WHAT IS IT USED FOR?

Hydrocortisone-ratiopharm 0.5% Cream is a cream for application to the skin in the treatment of inflammatory and allergic skin conditions. Hydrocortisone-ratiopharm 0.5% Cream is used for inflammatory and allergic skin conditions with mild symptoms that respond to topical therapy with low-potency corticosteroids (maximum 2 weeks).

2. WHAT SHOULD YOU KNOW BEFORE USING HYDROCORTISONE-RATIOPHARM 0.5% CREAM?

Hydrocortisone-ratiopharm 0.5% Cream must not be used:

• if you are allergic to hydrocortisone or any of the other ingredients of Hydrocortisone-ratiopharm 0.5% Cream listed in section 6.
• in cases of chickenpox and vaccination reactions.
• in cases of syphilitic or tuberculous skin diseases.
• In the case of a simultaneous skin infection caused by bacteria or fungi, this must be treated separately.
• in certain skin inflammations in the area of the mouth (perioral dermatitis) or face (rosacea) that are accompanied by redness and/or nodule formation.
• during the first third of pregnancy.

Furthermore, Hydrocortisone-ratiopharm 0.5% Cream must not be applied to or in the eye!

Warnings and precautions:
Please talk to your doctor or pharmacist before using Hydrocortisone-ratiopharm 0.5% Cream. If you experience blurred vision or other visual disturbances, contact your doctor.

Children:
Children up to the age of 6 should only be treated on the advice of a doctor.

Using Hydrocortisone-ratiopharm 0.5% Cream with other medicines:
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including medicines obtained without a prescription. No interactions are currently known.

Pregnancy:
Hydrocortisone-ratiopharm 0.5% Cream must not be used during the first trimester of pregnancy. In later stages of pregnancy, Hydrocortisone-ratiopharm 0.5% Cream should only be used after a careful benefit-risk assessment by the treating physician. In particular, large-scale or long-term use and occlusive dressings should be avoided during pregnancy.

Breastfeeding:
The active ingredient in Hydrocortisone-ratiopharm 0.5% Cream passes into breast milk. If the cream is used over a large area or for a prolonged period, you should stop breastfeeding. Contact of the infant with the treated skin areas should be avoided.

Driving and operating machinery:
No special precautions are necessary.

Hydrocortisone-ratiopharm 0.5% Cream contains propylene glycol:
Propylene glycol may cause skin irritation.

3. HOW TO USE HYDROCORTISONE-RATIOPHARM 0.5% CREAM?

Always use Hydrocortisone-ratiopharm 0.5% Cream exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the following dosage applies: Apply a thin layer of Hydrocortisone-ratiopharm 0.5% Cream to the affected areas two to three times a day and rub in gently. Once improvement has occurred, Hydrocortisone-ratiopharm 0.5% Cream usually only needs to be applied once a day or every two or three days. Even after the symptoms have subsided, Hydrocortisone-ratiopharm 0.5% Cream should be used for a few more days to prevent a relapse. When applying to the face, care should be taken to ensure that Hydrocortisone-ratiopharm 0.5% Cream does not get into the eyes. Hydrocortisone-ratiopharm 0.5% Cream is intended for short-term application to the skin (maximum 2 weeks) in adults and children aged 6 years and older. The duration of treatment depends on the therapeutic response. Treatment lasting longer than two weeks should only take place under medical supervision. Please talk to your doctor or pharmacist if you feel that the effect of Hydrocortisone-ratiopharm 0.5% Cream is too strong or too weak.

If you have used more Hydrocortisone-ratiopharm 0.5% Cream than you should:
No cases of poisoning from Hydrocortisone-ratiopharm 0.5% Cream have been reported to date. In case of overdose, side effects may be intensified. If you experience any side effects that significantly affect you or that are not listed in this leaflet, please contact your doctor immediately so that they can take the necessary measures without delay.

If you forget to use Hydrocortisone-ratiopharm 0.5% Cream:
If you have used too little Hydrocortisone-ratiopharm 0.5% Cream or have missed an application, you should continue the treatment as usual the next time and not apply the cream more frequently or thickly.

Effects of stopping treatment with Hydrocortisone-ratiopharm 0.5% Cream:
To achieve successful treatment with Hydrocortisone-ratiopharm 0.5% Cream, you should use it for a sufficient length of time. Therefore, talk to your doctor if you want to stop treatment prematurely.

4. POSSIBLE SIDE EFFECTS:

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

Very rarely:
Burning, itching, and a feeling of tightness may occur in cases of hypersensitivity to hydrocortisone or any of the other ingredients. If prescribed by a doctor for prolonged use (more than 2 weeks), watch for thinning of the skin (skin atrophy), tiny hemorrhages (telangiectasia), stretch marks (striae) caused by damage to the elastic fibers, or acne-like eruptions (steroid acne). In this case, inform your doctor.

Not known (frequency cannot be estimated from the available data):
Blurred vision.

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

5. HOW TO STORE HYDROCORTISONE-RATIOPHARM 0.5% CREAM?

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 container and the carton. Do not store above 30°C. Once opened, Hydrocortisone-ratiopharm 0.5% Cream can be used until the printed expiry date. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydrocortisone-ratiopharm 0.5% Cream contains:
The active ingredient is hydrocortisone. 1 g of cream contains 5 mg of hydrocortisone. The other ingredients are stearic acid, propylene glycol, sorbitan stearate, polysorbate, octyldodecanol, hard fat, and purified water.

What Hydrocortisone-ratiopharm 0.5% Cream looks like and contents of the pack:
Hydrocortisone-ratiopharm 0.5% Cream is a white cream and is available in packs of 15 g and 30 g.

Marketing Authorisation Holder:
ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm, Germany.

Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren, Germany.

(Apo) Usually ship out within 3-5 business days