Altazhel Oceanic

Package Leaflet: Information for the Patient

Altażel Oceanic, 10 mg/g, Gel

Aluminum Acetotartrate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Altażel Oceanic and what is it used for
• 2. Important information before using Altażel Oceanic
• 3. How to use Altażel Oceanic
• 4. Possible side effects
• 5. How to store Altażel Oceanic
• 6. Contents of the pack and other information

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

Altażel Oceanic gel is intended for external use on the skin.
The active substance is aluminum acetotartrate with astringent and anti-edematous action, which reduces swelling and pain after application to the injury site. Additionally, the medication contains menthol (one of the excipients), which has a local cooling effect.

Indications for Use

The medication is used locally on the skin for bruises and joint and post-traumatic swelling.

2. Important Information Before Using Altażel Oceanic

When Not to Use Altażel Oceanic

• if the patient is allergic to aluminum acetotartrate or any of the other ingredients of this medication (listed in section 6),
• on open, extensive wounds,
• on infected skin,
• on skin altered by disease or damaged skin,
• on large skin surfaces,
• in children under 3 years of age. Altażel Oceanic should not be used orally or for a long time.

Warnings and Precautions

Before starting to use Altażel Oceanic, the patient should discuss it with their doctor or pharmacist.
If signs of irritation or skin changes occur, the use of Altażel Oceanic should be discontinued. If the symptoms do not disappear, the patient should consult a doctor.
Contact with the eyes and mucous membranes should be avoided. If the medication gets into the eyes or onto mucous membranes, it should be removed by rinsing with plenty of water.

Children and Adolescents

Altażel Oceanic should not be used in children under 3 years of age.

Altażel Oceanic and Other Medications

No interactions between Altażel Oceanic and other medications are known, but the patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to use.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.

Driving and Operating Machinery

Altażel Oceanic does not affect the ability to drive or operate machinery.

Altażel Oceanic Contains Ethanol

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

Altażel Oceanic Contains Ethyl Parahydroxybenzoate (E 214) and Propyl Parahydroxybenzoate (E 216)

The medication may cause allergic reactions (possible late reactions).

3. How to Use Altażel Oceanic

This medication should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Dosage
The gel should be applied to clean, dry skin, 3 to 4 times a day, every few hours, preferably in the form of drying dressings that allow air to reach the skin.
Method of Administration
Altażel Oceanic is intended for use on the skin.
The medication should not be used under occlusive dressings or under foil that does not allow air to reach the application site.
After using the medication, the patient should wash their hands, unless they are being treated.
If after 3 to 5 days there is no improvement or the patient feels worse, they should consult their doctor.

Use in Children and Adolescents

Altażel Oceanic should not be used in children under 3 years of age.

Using More Than the Recommended Dose of Altażel Oceanic

No cases of overdose with Altażel Oceanic have been reported when the medication was used according to the indications and dosage instructions.

Missing a Dose of Altażel Oceanic

A double dose should not be used to make up for a missed dose.

Stopping the Use of Altażel Oceanic

In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

Accidental Ingestion of Altażel Oceanic

In case of accidental ingestion of Altażel Oceanic, the patient should immediately contact their doctor.

4. Possible Side Effects

Like all medications, Altażel Oceanic can cause side effects, although not everybody gets them.
Local skin reactions (redness, itching, burning) may occur, which should disappear after discontinuing the medication.
Prolonged or too frequent use of Altażel Oceanic may lead to skin maceration, and some individuals may experience redness, papular, or granulomatous reactions.
With prolonged use in severe renal failure, there is a risk of developing symptoms of hyperaluminemia (increased aluminum ion concentration in the blood) and hypophosphatemia (decreased phosphate ion concentration in the blood).

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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, Tel.: +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 to gather more information on the safety of this medication.

5. How to Store Altażel Oceanic

The medication should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 1 year.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Altażel Oceanic Contains

• The active substance of the medication is aluminum acetotartrate. 1 g of gel contains 10 mg of aluminum acetotartrate.
• 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 What the Pack Contains

Altażel Oceanic is a gel for application to the skin.
The available packaging is a tube containing 75 g of gel, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

OCEANIC Spółka Akcyjna
ul. Łokietka 58
81-736 Sopot

Manufacturer:

OCEANIC Spółka Akcyjna
ul. Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie
To obtain more detailed information about this medication, the patient should contact the local representative of the marketing authorization holder:
OCEANIC Spółka Akcyjna, ul. Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie, Tel.: +48 58 692 10 00

Date of the Last Update of the Leaflet: