Oilatum

Leaflet attached to the packaging: information for the user

Oilatum

634 mg/g, bath emulsion
(Paraffinum perliquidum)

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Oilatum and what is it used for
• 2. Important information before using Oilatum
• 3. How to use Oilatum
• 4. Possible side effects
• 5. How to store Oilatum
• 6. Package contents and other information

1. What is Oilatum and what is it used for

The Oilatum bath emulsion contains light liquid paraffin as an active substance, which forms an oily layer on the stratum corneum of the skin, preventing excessive evaporation of water from the skin surface and thus providing it with proper moisture and lubrication.
Oilatum is indicated for local treatment of irritated, dry, itchy, and flaky skin.
The medicine is also indicated for bathing infants.

2. Important information before using Oilatum

When not to use Oilatum

• if the patient is allergic to the active substance - light liquid paraffin, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

When using this medicine, care should be taken not to slip during bathing.
If redness or skin irritation occurs, treatment should be discontinued.

Oilatum and other medicines

The doctor or pharmacist should be informed about all medicines currently being used or recently used, including herbal medicines, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, the doctor or pharmacist should be consulted before using this medicine.
If the doctor decides that Oilatum can be used during breastfeeding, the medicine should be thoroughly removed from the breast before starting breastfeeding to avoid accidental ingestion by the infant.

Driving and operating machinery

Using Oilatum should not affect the ability to drive and operate machinery.

3. How to use Oilatum

This medicine should always be used as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Oilatum is intended for use on the skin only.
The medicine is usually used as an additive to bath water, but it can also be applied directly to damp skin.
Oilatum is an effective skin cleanser and can be used instead of soap. This product can be used as often as necessary.
If the doctor does not recommend otherwise, the medicine is usually used as described below.
Baths for adults, adolescents, and children
Add 1-3 caps of bath emulsion to a bath filled with water to a height of 20 cm. Mix thoroughly.
Stay in the bath for 10-20 minutes, then gently dry the skin with a towel.
In the case of large areas of dry skin, make sure that the entire skin surface affected by the changes is submerged in the bath.
Baths for infants
Add ½ to 2 caps of bath emulsion to a filled bath. Gently wash the entire body of the child with water. Dry the skin with a clean towel.
Local skin cleansing
Rub a small amount of bath emulsion into the previously dampened skin, then rinse with water and dry with a towel.
If it feels like the effect of the medicine is too strong or too weak, the doctor or pharmacist should be consulted.

In case of accidental ingestion of Oilatum

Accidental ingestion of the medicine may cause irritation of the gastrointestinal tract, including nausea, vomiting, and diarrhea. In such a case, a doctor should be contacted immediately.

4. Possible side effects

Like all medicines, Oilatum can cause side effects, although not everybody gets them.
Data after the medicine was placed on the market

Uncommon side effects (occurring in less than 1 in 100 patients using the medicine):

• reactions at the application site, including skin irritation, rash, redness, itching
• hypersensitivity at the application site, including skin inflammation

If redness or skin irritation occurs, treatment should be discontinued.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Oilatum

Store at a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Oilatum contains

• -The active substance of the medicine is light liquid paraffin 634 mg;
• -The other ingredients of the medicine are: acetylated lanolin alcohols, isopropyl palmitate, ethylene glycol dilaurate 400 (PEG 400 DL), Arlatone T (Polyoxyethylene 40 sorbitan oleate), "Floral Spice" fragrance.

What Oilatum looks like and what the package contains

A bottle with a cap, containing 150 ml, 250 ml, or 500 ml of bath emulsion, placed in a cardboard box.

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer:

Stiefel Laboratories (Ireland) Ltd
Finisklin Business Park, Sligo
Ireland
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Date of last update of the leaflet: