Package leaflet: Information for the patient

Oviderm, 250 mg/g, cream
Propylenglycolum
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after a few days, contact your doctor.

Table of contents of the leaflet

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

1. What Oviderm is and what it is used for

Oviderm is a skin-softening cream which contains a substance called propylene glycol (25%).
Propylene glycol has water-binding properties and also exhibits mild antimicrobial activity, acting against certain bacteria and fungi.
Oviderm is used for the treatment of dry skin.

2. Important information before using Oviderm

When not to use Oviderm:

if the patient is allergic to propylene glycol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not use Oviderm:

on burned skin,
in the ear canal, as propylene glycol may cause ear damage.

Pregnancy and breastfeeding
The risk of use during pregnancy is unknown.
To avoid unintentional ingestion of propylene glycol by the infant, do not apply Oviderm to the breasts or the area around them during breastfeeding.
Oviderm contains cetostearyl alcohol.
It may cause local skin reactions (e.g. contact dermatitis).

3. How to use Oviderm

This medicine should always be used exactly as described in the patient leaflet, or as directed by a doctor, pharmacist or nurse. If in doubt, consult a doctor, pharmacist or nurse.
Adults, children and adolescents
The cream can be applied as needed, several times a day, and should always be applied after the skin has been in contact with water. Apply an amount of cream that the skin can absorb without leaving a sticky feeling.
Pump activation
At first use, press the pump several times quickly. Continue pressing the pump until the cream appears.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Common: may affect up to 1 in 10 people

Transient worsening of symptoms, itching, burning sensation, and redness of the skin.
Allergic reactions, including skin reactions such as rash.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet,
please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Oviderm medicine
Keep the medicine out of sight and reach of children.
No special storage instructions apply for this medicinal product.
Do not use this medicine after the expiry date stated on the tube and carton or container after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Oviderm contains

The active substance in Oviderm is propylene glycol. 1 gram of cream contains 250 mg of propylene glycol.
The other ingredients are: purified coconut oil, cetostearyl alcohol, stearic acid Type 50, macrogol stearate Type I, glycerol monostearate 44-55 Type II, sodium citrate (for pH adjustment), anhydrous citric acid (for pH adjustment), purified water.

What Oviderm looks like and contents of the pack
Oviderm is a white, odourless cream. It is available in a plastic tube (100 g) closed with a flip-top cap, packed in a cardboard box, or in a plastic container with a pump (500 g), or in a dual pack of 600 g containing a plastic container with a pump holding 500 g of cream and a plastic tube containing 100 g of cream, closed with a white flip-top cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
Ostródzka Street 74N
03-289 Warsaw
Poland
e-mail: [email protected]

Manufacturer
Bioglan AB
Borrgatan 31
211 24 Malmö
Sweden

Galenica AB
P A Hanssons väg 41
205 12 Malmö
Sweden