Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Mobilat (Mobilat-Salbe)
(0.2 g + 1.0 g + 2.0 g)/100 g, ointment
Mucopolysaccharide polysulphate + Suprarenal extract + Salicylic acid
Mobilat and Mobilat-Salbe are different trade names for the same medicinal product.
Please read carefully the information in this leaflet 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
the physician or pharmacist.

Keep this leaflet, so that you may read it again if necessary.
If advice or further information is needed, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What Mobilat is and what it is used for

Mobilat contains a suprarenal (adrenal) extract with anti-inflammatory and anti-exudative properties.
The action is enhanced by salicylic acid, which additionally exerts an analgesic effect and facilitates the penetration of biologically active components of Mobilat into tissues.
Mucopolysaccharide polysulphate acts anti-inflammatory, locally reduces blood coagulability, increases tissue perfusion, and accelerates tissue regeneration.

Indications for use
Treatment of traumatic and local inflammatory conditions, degenerative joint and periarticular tissue disorders.
Local supportive treatment of inflamed joints in rheumatic diseases.

2. Important information before using Mobilat

When not to use Mobilat
If the patient is allergic to the active substance or to any of the other components of this medicine
(listed in section 6).
Inform the doctor if the patient has: chickenpox, post-vaccination reactions,
fungal or bacterial skin infections, or other specific skin lesions in the area where the medicine is to be applied
(e.g. tuberculosis lesions, syphilis). The doctor will decide whether Mobilat can be used in the patient.
Use in children will be decided by the doctor after assessing the benefit-risk ratio. Do not use in children under 12 years of age without a doctor's prescription.
Patients with impaired kidney function: the doctor will decide on long-term use of Mobilat after assessing the benefit-risk ratio.

Warnings and precautions
Before starting to use Mobilat, discuss it with your doctor or pharmacist.
Mobilat ointment should only be applied to intact skin. Avoid contact of Mobilat ointment with open wounds, eyes, and mucous membranes.
After applying the ointment to diseased skin, hands should be washed unless the hands are the treated area.

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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Salicylic acid may increase the absorption of other topically applied medicines. Long-term use of Mobilat over large areas of skin may lead to increased toxic effects of methotrexate and hypoglycemic effects of sulfonylureas.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Mobilat should be used with caution in pregnant women. The doctor will decide whether to use Mobilat during pregnancy after considering whether the therapeutic benefits for the mother outweigh the risks to the fetus. Do not use Mobilat on large areas of skin.
Do not use Mobilat on the breast area in breastfeeding women.

Driving and operating machinery
Mobilat does not affect the ability to drive or operate machinery.

Mobilat ointment contains cetostearyl alcohol emulsifying (type A).
This 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 a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The duration of treatment with Mobilat is determined by the doctor and depends on the type and course of the disease.
Mobilat ointment is a topical medicine for use on the skin.
Recommended dose:
Unless otherwise advised by a doctor, apply once or three times daily a strip of ointment 5 to 15 cm long to the affected areas. If the patient uses an occlusive dressing, the dose may be appropriately increased. Mobilat ointment should only be applied to intact skin. After application to the affected area, gently massage the ointment into the skin.
Prolonged use of Mobilat over large areas of the body should be carried out under medical supervision.

Use of a higher than recommended dose of Mobilat
Due to the route of administration, overdose of Mobilat is unlikely. However, salicylate poisoning may occur if the medicine is accidentally swallowed. Symptoms of poisoning include vomiting, profuse sweating, tachycardia (rapid heartbeat, i.e. over 100 beats per minute), hyperventilation (excessively deep and rapid breathing), fever, tinnitus, disturbances of consciousness, respiratory alkalosis, and alkaline urine pH.
Treatment: gastric lavage, monitoring of serum salicylate concentrations, measurement of plasma pH and electrolytes. Forced diuresis may be necessary.
If symptoms of overdose occur, the doctor will administer appropriate symptomatic treatment.
If a higher than recommended dose of Mobilat has been used, contact a doctor immediately.

Missed 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 there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

Stopping treatment with Mobilat
Always follow the advice of the doctor or pharmacist regarding how long to use the medicine. The doctor will decide when treatment should be discontinued.
If in doubt or if there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following local adverse reactions 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Mobilat

Keep this 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 container. The expiry date refers to the last day of the stated month. After first opening, the medicine can be used for 6 months.
Medicines must 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 packaging and other information

What Mobilat contains
The active substances are: polysaccharide sulphate, adrenal cortex extract, and
salicylic acid.
Other ingredients include: disodium edetate, thymol, isopropyl alcohol, ethanolamine, myristyl alcohol, cetostearyl alcohol, emulsifying wax (type A), ointment base wax (corresponding to anhydrous eucerin and containing stearyl alcohol, white vaseline, wax base alcohols, cetyl alcohol), stearic acid, glycerol 85%, purified water.

What Mobilat looks like and contents of the pack
Aluminium tube with an internal protective layer, in a cardboard box, containing 40 g of ointment.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Austria, 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.
Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland

Austrian Marketing Authorisation number (country of export): 12.033
Parallel Import Authorisation number: 71/22