Patient Information Leaflet: Information for the User

Oilatum
634 mg/g, emulsion for bathing
(Paraffinum perliquidum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.
Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet:

What Oilatum is and what it is used for
Important information before using Oilatum
How to use Oilatum
Possible side effects
How to store Oilatum
Contents of the pack and other information

1. What Oilatum is and what it is used for

Oilatum bath emulsion contains light liquid paraffin as the active substance, which forms an oily film on the stratum corneum of the skin, preventing excessive evaporation of water from the skin surface and thereby providing adequate hydration and emollient action.
Oilatum is indicated for the topical treatment of irritated, dry, itchy, and flaky skin.
The product is also suitable for bathing infants.

2. Important information before using Oilatum

When not to use Oilatum

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

Warnings and precautions
When using this medicine, care should be taken to avoid slipping in the bath.
If redness or skin irritation occurs, treatment should be discontinued.
Oilatum and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used,
including herbal medicines, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning a pregnancy,
consult a doctor or pharmacist before using this medicine.
If the doctor decides that Oilatum can be used during breastfeeding, any residue of the medicine should be thoroughly removed from the breasts before each feeding to avoid accidental ingestion by the infant.
Driving and operating machinery
The use of Oilatum should not affect the ability to drive or operate machinery.

3. How to use Oilatum

This medicine should always be used as described in the patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Oilatum is intended for external use on the skin only.
The medicine is usually used as an additive to bath water, but may also be applied directly to damp skin.
Oilatum is an effective skin cleansing agent and may be used instead of soap. This product may be used as often as necessary.
Unless otherwise advised by a doctor, the medicine is usually used as described below.

Bathing for adults, adolescents and children
Add 1–3 caps of bath emulsion to a bathtub filled with water to a depth of 20 cm. Mix thoroughly.
Remain in the bath for 10–20 minutes, then gently pat the skin dry with a towel.
In cases of extensive dry skin areas, ensure that the entire affected skin surface is immersed in the bath.

Bathing for infants
Add ½–2 caps of bath emulsion to a filled baby bath. Gently wash the entire body of the infant with the water. Pat the skin dry with a clean towel.

Local skin cleansing
Rub a small amount of bath emulsion into previously moistened skin, then rinse off with water and pat dry with a towel.
If the effect of the medicine seems too strong or too weak, consult a doctor or pharmacist.

In case of accidental ingestion of Oilatum
Accidental ingestion of the medicine may cause gastrointestinal irritation, including nausea, vomiting and diarrhoea. In such a case, contact a doctor immediately.

4. Possible adverse reactions

Like any medicinal product, Oilatum may cause adverse reactions, although not everyone will
experience them.
Data from post-marketing experience
Adverse reactions occurring rarely (no more frequently than in 1 out of 1000 patients using the
medicinal product):

reactions at the application site, including skin irritation, rash, erythema, pruritus
hypersensitivity at the application site, including dermatitis

If redness or skin irritation occurs, treatment should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Oilatum

Store below 25°C.
Keep 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Oilatum contains

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

What Oilatum looks like and contents of the pack
A bottle with a screw cap containing 150 ml, 250 ml or 500 ml of bath emulsion, packed in a cardboard box.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20