Ichtho - Bath

Ichtho ®-Bath is a balneotherapeutic (medicinal bath additive) with an active ingredient from the group of sulphonated shale oils.

Application

1. WHAT IS ICHTHO® BATH AND WHAT IS IT USED FOR?

Ichtho® bath is a balneotherapeutic (medicinal bath additive) with an active ingredient from the group of sulphonated shale oils.
Ichtho® bath inhibits inflammation and itching, stimulates blood circulation and has a bacteriostatic and pain-relieving effect. The content of refatting agents in the base prevents excessive degreasing of normal skin.
Ichtho® bath is used for supportive treatment
- for diseases of the musculoskeletal system caused by wear and tear,
- for itchy and/or inflammatory skin diseases.
There are no sufficient clinical studies available on these areas of application.

If your complaints do not improve or even worsen, consult your doctor.

July 2013/Austria Page 1Information for use of Ichtho®-Bath

.

How is it applied?

What IS ICHTHO®-BATH AND WHAT IS IT USED FOR?

Ichtho®-Bath is a balneotherapeutic agent (medicinal bath additive) with an active substance from the group of sulphonated shale oils.
Ichtho® bath inhibits inflammation and itching, stimulates blood circulation and has a bacteriostatic and pain-relieving effect. The refatting agent content in the base prevents excessive degreasing of normal skin.
Ichtho® bath is used for the supportive treatment
- of diseases of the musculoskeletal system caused by wear and tear,
- of itchy and/or inflammatory skin diseases.
No adequate clinical studies are available for these areas of application.

If your complaints do not improve or even worsen, consult your doctor.

July 2013/Austria Page 1Information for use of Ichtho®-Bad

.

What should you pay attention to before taking it?

What SHOULD YOU CONSIDER BEFORE USING ICHTHO®-BATH ?
Ichtho®-Bath Must not be used.strong>must not be used
if you are hypersensitive (allergic) to sulphonated shale oils, such as ammonium bituminoside.ammonium bituminosulfonate and/or sodium bituminosulfonate or any of the other ingredients.

Ichtho® bath, like all baths, should not be used in febrile and infectious diseases, tuberculosis, severe cardiovascular diseases, high blood pressure, circulatory disorders of the arteries. In case of hypersensitivity to an ingredient.

Warnings and precautions:
Please talk to your doctor or pharmacist before using ICHTHO®-BAD.

In patients with circulatory sensitivity, the bath temperature should be below 37°C. Direct application of Ichtho® bath is not recommended for skin diseases. It is advisable to rest for half an hour after the bath.
Ichtho® bath should not be used on weeping and highly acute skin conditions.
A possible drying of the skin can be remedied by subsequent application of a grease cream.
Avoid eye contact.
Residues of Ichtho® bath in the bathtub can be removed with standard household cleaners. Textiles that have accidentally come into contact with Ichtho®-Bath in concentrated form can be cleaned again by normal washing.

If the symptoms persist or if the expected success from the application does not occur, medical advice is required as soon as possible.

Use of Ichtho® Bath with other medicines
Inform your doctor or pharmacist if you are using, have recently used or intend to use any other medicines.
The additional use of bath additives or soaps cancels out the effect of Ichtho® Bath.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
There are no sufficient data for the use of Ichtho® bath during pregnancy or breast-feeding.
A doctor will decide on its use during pregnancy or breast-feeding.

Driving and ability to operate machinery
ICHTHO®-BAD has no effect on the ability to drive and operate machinery.

ICHTHO®-BAD contains butylated hydroxytoluene
The perfume oil Chic contained in this medicinal product contains butylated hydroxytoluene for stabilisation. Butylhydroxytoluene may cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

July 2013/Austria Page 2Information for use of Ichtho®-Bad

How should the medicine be taken?

HOW TO USE ICHTHO®-BATH?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

How to use
For use on the skin.
Unless otherwise prescribed, Ichtho® bath is used as a full, sitting or partial bath as a course of treatment two to three times a week.

Shake before use.
Dosage
Dosage of Ichtho® bath is done with the help of tablespoons or teaspoons:

. .

1 ½ tablespoon	(approx. 20 g) - for a full bath
2 teaspoons	(approx. 10 g) - for a sitz bath
1 teaspoon	(approx. 5 g) - for a partial bath.

Children and young people:
No data available.

The duration of therapy (cure) depends on the type of disease and should be determined by a doctor.

The duration of a bath should be 20 to 30 minutes, and the water temperature should normally be body-warm (about 36° C). If itching is severe, a cooler bath (below 36° C) is recommended.

In the case of rheumatic diseases, Ichtho® bath undiluted can also be applied directly to the affected area and the bath taken only after a few minutes. Please ask a doctor whether this method of application is also possible for your condition. This procedure should not be used for skin diseases or in the mucous membrane area.

It is recommended to rest for half an hour after the bath.

If you take a large amount of Ichtho. ® Have used the bath more than you should.
If severe skin irritation occurs, discontinue the preparation. Consult a doctor about further action.

When you stop using Ichtho ® Have forgotten the bath.
After forgetting a single dose, do not apply double the amount of Ichtho® bath for the following treatment, but resume the treatment with the intended dose.

If you want to discontinue the use of Ichtho. ® Cancel bath
Please discuss the further course of action with a doctor, as the success of the treatment is at risk.

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

July 2013/Austria Page 3Information for use of Ichtho®-Bad

What are the possible side effects?

HOW TO STORE ICHTHO®-BATH?

Store away from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton or bottle label after "use by". The expiry date refers to the last day of the month stated.

After opening, the medicinal product can be used for 12 months, but not beyond the expiry date.

Do not dispose of medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You are thus helping to protect the environment.

July 2013/Austria Page 4Information for use of Ichtho® bath

Special instructions for storage

5. HOW TO STORE ICHTHO®-BAD?

Store away from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton or bottle label after "use by". The expiry date refers to the last day of the month stated.

The medicine can be used for 12 months after opening, but not beyond the expiry date.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You are thus helping to protect the environment.

July 2013/Austria Page 4Information for use of Ichtho® bath

Special notes on the content

FURTHER INFORMATION

.What Ichtho®-Bath contains
The active ingredient is: Ammonium Bituminosulfonate (Ichthyol®).
100 g liquid bath additive contain ammonium bituminosulfonate (Ichthyol®), spec. conc. 88 g.

The other ingredients are:
Coconut fatty acid monoethanolamide, Texapon CS (sodium cetylstearyl sulphate, sodium dodecyl sulphate, lauromacrogol 500), perfume oil, purified water

How Ichtho®is used.l Chic, purified water

How Ichtho® looks.strong>-Bath looks like and contents of the pack
Liquid dark brown concentrate for making an immersion bath, emulsion
Ichtho®-Bath is available in bottles (white plastic bottle with white plastic cap) of 130 g, 400 g and 1000 g.