Mobilat

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Mobilat Mobilat Ointment)
(0.2 g + 1.0 g + 2.0 g)/100 g, ointment
Mucopolysaccharide polysulfate + Suprarenal extract + Salicylic acid
Mobilat and Mobilat Ointment are different trade names for the same drug.

Read the 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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Mobilat and what is it used for

Mobilat contains an adrenal cortex extract with anti-inflammatory and anti-edematous properties. This action is supported by salicylic acid, which also has analgesic properties and facilitates the penetration of biologically active ingredients of Mobilat into tissues.
Mucopolysaccharide polysulfate has anti-inflammatory effects, reduces local blood coagulability, increases tissue perfusion, and accelerates tissue regeneration.
Indications for use:
Treatment of post-traumatic and local inflammatory conditions, degenerative joint and periarticular tissue diseases.
Local, supportive treatment of inflamed joints in rheumatic diseases.

2. Important information before using Mobilat

When not to use Mobilat

If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Tell your doctor if you have: chickenpox, post-vaccination reactions, fungal or bacterial skin infections, or other specific skin changes in the area of application (e.g., tuberculous, syphilitic). Your doctor will decide whether you can use Mobilat.
The use of Mobilat in children will be decided by a doctor after assessing the benefits and risks. Do not use in children under 12 years of age without a doctor's prescription.
Patients with impaired renal function: the long-term use of Mobilat will be decided by a doctor after assessing the benefits and risks.

Warnings and precautions

Before starting to use Mobilat, discuss it with your doctor or pharmacist.
Mobilat ointment should only be used on intact skin. Avoid contact with open wounds, eyes, and mucous membranes.
After applying the ointment to the affected area, wash your hands unless they are the area being treated.

Children and adolescents

Do not use in children under 12 years of age without a doctor's prescription.

Mobilat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Salicylic acid may increase the absorption of other locally applied medicines. Long-term use of Mobilat on large areas of skin may lead to increased toxic effects of methotrexate and hypoglycemic effects of sulfonylurea.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Mobilat should be used with caution in pregnant women. Your doctor will decide whether to use Mobilat during pregnancy after weighing the benefits and risks.
Do not use Mobilat on large areas of skin.
Do not use Mobilat on the breast area in breastfeeding women.

Driving and using machines

Mobilat does not affect the ability to drive and use machines.

Mobilat ointment contains cetylstearyl alcohol (type A).

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Mobilat

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The duration of use of Mobilat is determined by your doctor, depending on the type and course of the disease.
Mobilat ointment is for local use on the skin.
Recommended dose:
Unless otherwise prescribed by your doctor, apply a 5-15 cm long strip of ointment to the affected area once or three times a day. If you are using an occlusive dressing, the dose may be increased accordingly. Mobilat ointment should only be used on intact skin. After applying the ointment to the affected area, gently massage it into the skin.
Long-term use of Mobilat on large areas of skin should be done under medical supervision.

Using a higher dose of Mobilat than recommended

Overdose is unlikely due to the way Mobilat is administered.
Salicylate poisoning is possible in case of accidental ingestion of the medicine. Symptoms of poisoning are vomiting, excessive sweating, tachycardia (rapid heart rate, over 100 beats per minute), hyperventilation (too deep and intense breathing), fever, tinnitus, impaired consciousness, respiratory alkalosis, and alkaline urine reaction.
Treatment: gastric lavage, monitoring of salicylate levels in blood serum, measurement of blood pH and electrolytes. Forced diuresis may be necessary.
In case of overdose symptoms, your doctor will provide appropriate symptomatic treatment.
In case of using a higher dose of Mobilat than recommended, contact your doctor.

Missing a dose of Mobilat

Do not use a double dose to make up for a missed dose. Use the medicine as directed in the leaflet. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

Stopping the use of Mobilat

Always follow the advice of your doctor or pharmacist, who will tell you how long to use the medicine. Your doctor will decide when to stop the treatment.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following local side effects have been reported:
rare (may affect up to 1 in 1,000 people)
skin irritation
very rare (may affect up to 1 in 10,000 people)
contact allergies.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mobilat

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
After first opening, the medicine can be used for 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mobilat contains

The active substances are: mucopolysaccharide polysulfate, suprarenal extract, and salicylic acid.
The other ingredients are: disodium edetate, thymol, isopropyl alcohol, ethanolamine, myristyl alcohol, cetylstearyl alcohol, emulsifying (type A), ointment base (corresponding to anhydrous wool fat and containing stearyl alcohol, white petrolatum, wax alcohols, cetyl alcohol), stearyl acid, glycerol 85%, purified water.

What Mobilat looks like and contents of the pack

Aluminum tube with an inner protective layer, in a cardboard box, containing 40 g of ointment.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

STADA Arzneimittel GmbH
Muthgasse 36
AT-1190 Vienna, Austria

Manufacturer:

Mobilat Produktions GmbH
85276 Pfaffenhofen
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number: 12.033

Parallel import authorization number: 71/22 Date of leaflet approval: 03.02.2022

[Information about the trademark]