Patient Information Leaflet

Altażel Oceanic, 10 mg/g, gel
Aluminii acetotartras
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by a
physician or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a physician or pharmacist. See section 4.
If there is no improvement after 3 to 5 days, or if the patient feels worse, consult a physician.

Table of Contents

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

1. What is Altażel Oceanic and what it is used for

Altażel Oceanic gel is intended for external application on the skin.
The active substance is aluminium acetotartrate, which has astringent and anti-edematous properties, thereby reducing swelling and pain following application at the site of injury. Additionally, the formulation contains menthol (one of the excipients), which provides a local cooling effect.
Indications
The medicine is used topically on the skin for contusions, and for joint and traumatic edema.

2. Important information before using Altażel Oceanic

When not to use Altażel Oceanic

if the patient is allergic to aluminium acetowinate or any of the other ingredients of this medicine (listed in section 6),
on open, extensive wounds,
on infected skin,
on diseased or damaged skin,
on large areas of skin,
in children under 3 years of age. Altażel Oceanic must not be taken orally or used long-term.

Warnings and precautions
Before starting to use Altażel Oceanic, discuss it with your doctor or pharmacist.
If irritation symptoms or skin changes occur, discontinue use of Altażel Oceanic. If symptoms persist, consult a doctor.
Avoid contact of the medicine with eyes and mucous membranes. If the medicine gets into the eyes or onto mucous membranes, remove it by thoroughly rinsing with water.

Children and adolescents
Altażel Oceanic must not be used in children under 3 years of age.

Altażel Oceanic and other medicines
There are no known interactions between Altażel Oceanic and other medicines, but you should inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Altażel Oceanic has no influence on the ability to drive or operate machinery.

Altażel Oceanic contains ethanol
This medicine contains 20 mg of alcohol (ethanol) per gram of gel. The medicine may cause a burning sensation on damaged skin.

Altażel Oceanic contains ethyl parahydroxybenzoate (E 214) and propyl parahydroxybenzoate (E 216)
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Altażel Oceanic

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Dosage
The gel should be applied to clean, dry skin, 3 to 4 times daily, every few hours, preferably as drying dressings that allow air access to the skin.

Method of administration
Altażel Oceanic is intended for topical use only.
Do not use the medicine under occlusive dressings or plastic film, as these do not allow air to reach the area where the gel is applied.
After applying the medicine, wash your hands unless the hands are the treated area.

If there is no improvement or if symptoms worsen after 3 to 5 days, consult a doctor.

Use in children and adolescents
Altażel Oceanic must not be used in children under 3 years of age.

Use of a higher than recommended dose of Altażel Oceanic
There have been no reported cases of overdose with Altażel Oceanic when used according to the recommended dosage and indications.

Missed dose of Altażel Oceanic
Do not use a double dose to make up for a missed dose.

Discontinuation of Altażel Oceanic
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Accidental ingestion of Altażel Oceanic
If Altażel Oceanic is accidentally swallowed, seek medical advice immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Local skin reactions (redness, itching, burning) may occur, which should resolve after discontinuing the use of the medicine.
With prolonged or too frequent use of Altażel Oceanic, skin maceration may occur, and in some individuals, erythematous, papular or granular reactions may appear.
With prolonged use in severe renal insufficiency, there is a risk of developing symptoms of hyperaluminemia (increased aluminium ion concentration in blood) and hypophosphatemia (decreased phosphate ion concentration in blood).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Altażel Oceanic

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 1 year.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 Altażel Oceanic contains

The active substance is aluminium dihydroxyacetate. 1 g of gel contains 10 mg of aluminium dihydroxyacetate.
The other ingredients are: ethyl parahydroxybenzoate (E 214), propyl parahydroxybenzoate (E 216), levomenthol, anhydrous ethanol, carbomer, sodium hydroxide, purified water.

What Altażel Oceanic looks like and contents of the pack
Altażel Oceanic is a gel for topical application to the skin.
The available pack is a tube containing 75 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OCEANIC Spółka Akcyjna
Łokietka 58
81-736 Sopot
Manufacturer:
OCEANIC Spółka Akcyjna
Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
OCEANIC Spółka Akcyjna, Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie, Tel.: + 48 58 692 10