Aknichthol - Lotio

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AKNICHTHOL® - Lotion is an acne medication for topical application.

Application

What is Aknichthol® - Lotion and what is it used for?

AKNICHTHOL® - Lotion is an acne medication for topical application. It contains sulfonated shale oil (sodium bituminosulfonate (Ichthyol®-Sodium), light) and inhibits the increased production of sebum (‘oily skin’), has anti-inflammatory and mild antibacterial effects. Salicylic acid supports the absorption of Ichthyol light into the skin by lowering its pH value.

AKNICHTHOL® - Lotion is used to reduce the number of comedones in mild and moderate acne vulgaris.

October 2013/Austria Page 1Package leaflet for Aknichthol® - Lotion

How is it used?

What is Aknichthol® - Lotion and what is it used for?

AKNICHTHOL® - Lotion is an acne medication for topical application. It contains sulfonated shale oil (sodium bituminosulfonate (Ichthyol®-Sodium), light) and inhibits the increased production of sebum (‘oily skin’), has anti-inflammatory and mild antibacterial effects. Salicylic acid supports the absorption of Ichthyol light into the skin by lowering its pH value.

AKNICHTHOL® - Lotion is used to reduce the number of comedones in mild and moderate acne vulgaris.

October 2013/Austria Page 1Package leaflet for Aknichthol® - Lotion

What should you consider before taking it?

What should you consider before using Aknichthol® - Lotion?

AKNICHTHOL - Lotion must not be used,
if you are allergic to sulfonated shale oils such as ammonium bituminosulfonate and/or sodium bituminosulfonate, salicylic acid and salicylates or any of the other ingredients of this medicine listed in section 6.

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

Do not use in the area of the eyes or mucous membranes (mouth, nose), as this can cause irritation (burning).
Due to the salicylic acid content, long-term treatment of large areas should be avoided in patients with impaired renal function. In exceptional cases, AKNICHTHOL® - Lotion should be used for a maximum of 3 days on a skin area of up to 10 cm2.
If the symptoms persist or if the expected success is not achieved by the application, medical advice is required as soon as possible.

When using Aknichthol® - Lotion together with other medicinesInform your doctor or pharmacist if you are using, have recently used or intend to use other medicines.
The simultaneous additional use of other preparations to be applied to the skin, including cosmetics, can impair the effect of AKNICHTHOL® - Lotion. Sodium bituminosulfonate, light can increase the solubility of other active ingredients and thus enhance their absorption into the skin. Salicylic acid can increase the permeability of the skin for other locally administered medicines. The absorbed salicylic acid can interact with methotrexate (cytostatic/tumor growth inhibitor) and sulfonylureas (oral antidiabetics/blood sugar reducers).

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 data on the use of AKNICHTHOL® - Lotion in pregnancy and breast-feeding in humans. The available animal studies do not allow any conclusions to be drawn as to whether treatment with AKNICHTHOL® - Lotion has a harmful effect on pregnancy or the development of the offspring, and there are no studies on the passage into breast milk.
You must therefore not use AKNICHTHOL® - Lotion during pregnancy and breast-feeding.

Driving and using machines
AKNICHTHOL® - Lotion has no influence on the ability to drive and use machines.

How should the medicine be taken?

How to use AKNICHTHOL® - Lotion?

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.

October 2013/Austria Page 2Package leaflet for Aknichthol® - Lotion

Adults and adolescents aged 12 years and over:
Unless otherwise prescribed by a doctor, AKNICHTHOL - Lotion is used twice a day. Clean the affected skin areas twice a day, morning and evening, using a soap-free skin cleanser and dry carefully. Shake the bottle well, apply approx. 20 drops of the lotion to a swab and distribute evenly over the skin so that the affected skin areas are lightly covered. In the beard area, apply the lotion in the direction of beard growth. Eyelids and lips should not be treated. The duration of treatment depends on the type and extent of the disease. Unless otherwise prescribed by a doctor, the duration of treatment should not exceed 12 weeks.

Use in children
There are no data on use in children.

If you have used more AKNICHTHOL® - Lotion than you should
Skin irritation may occur during use. Consult a doctor for further action.

If you forget to use AKNICHTHOL® - Lotion
Simply continue treatment as usual.

If you stop treatment with AKNICHTHOL® - Lotion
Please discuss the further procedure 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.

What side effects are possible?

How to store Aknichthol® - Lotion?

Do not store above 25°C.

Keep this medicine out of the reach of children.

After opening, you can use the medicine until the expiry date.
Do not use this medicine after the expiry date which is stated on the label and carton after "use by". The expiry date refers to the last day of the month indicated.

Special storage instructions

5. How to store Aknichthol® - Lotion?

Do not store above 25°C.

Keep this medicine out of the reach of children.

After opening, you can use the medicine until the expiry date.
Do not use this medicine after the expiry date which is stated on the label and carton after,,use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You thereby contribute to the protection of the environment.

Special information on the content

Contents of the pack and further information

What AKNICHTHOL® - Lotion contains
The active ingredients are sodium bituminosulfonate (Ichthyol®-Sodium), light and salicylic acid in an aqueous alcoholic base.

100 g suspension contains: 1.0 g sodium bituminosulfonate (Ichthyol®-Sodium), light and
0.5 g salicylic acid.

The other ingredients are:
Highly dispersed silicon dioxide, Lauromacrogol 200, 2-propanol, lavender oil, corn starch, medium-chain triglycerides, titanium dioxide (E171), iron oxides and iron(III) hydroxide-oxide (E 172), purified water

What AKNICHTHOL® - Lotion looks like and contents of the pack
AKNICHTHOL® - Lotion is a skin-coloured liquid. AKNICHTHOL® - Lotion is available in bottles of 30 g (white plastic bottles with green plastic screw caps).