Mobilat

Package Leaflet: Information for the Patient

Mobilat(0.2 g + 1.0 g + 2.0 g)/100 g, ointment
(Mucopolysaccharide polysulfate + Suprarenal extract + Salicylic acid)

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package 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 extract from the suprarenal gland with anti-inflammatory and anti-edematous properties. This action is supported by salicylic acid, which also has analgesic effects 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 disease, and periarticular tissues.
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 any of the other ingredients of this medicine (listed in section 6).
The doctor should be informed if the patient has: chickenpox, post-vaccination reactions, fungal or bacterial skin infections, or other specific skin changes in the area of application (e.g., tuberculous or syphilitic changes). The doctor will decide whether the patient can use Mobilat.
The use of Mobilat in children will be decided by a doctor after assessing the benefits and risks. Mobilat should not be used 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, the patient should discuss it with their doctor or pharmacist.
Mobilat ointment should only be used on intact skin. Contact between Mobilat ointment and open wounds, eyes, and mucous membranes should be avoided.
After applying the ointment to the affected area, the hands should be washed, unless the hands are the area being treated.

Children and adolescents

Mobilat should not be used in children under 12 years of age without a doctor's prescription.

Mobilat and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to use.
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 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 medicine.
Mobilat should be used with caution in pregnant women. The doctor will decide whether to use Mobilat in pregnant women after weighing the benefits and risks. Mobilat should not be used on large areas of skin.
Mobilat should not be used on the breast area in breastfeeding women.

Driving and using machines

Mobilat does not affect the ability to drive or operate 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 package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The duration of use of Mobilat is determined by the doctor, depending on the type and course of the disease.
Mobilat ointment is for local use on the skin.
Recommended dose:
Unless otherwise directed by the doctor, a strip of ointment 5 to 15 cm long should be applied once or three times a day to the affected area. If the patient uses 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, it should be gently massaged into the skin.
Long-term use of Mobilat on large areas of skin should be done under medical supervision.

Using more than the recommended dose of Mobilat

Due to the way Mobilat is administered, overdose is unlikely.
Salicylan poisoning is possible in case of accidental ingestion of the medicine. Symptoms of poisoning are vomiting, excessive sweating, tachycardia (tachycardia, i.e., heart rate above 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, the doctor will provide appropriate symptomatic treatment.
In case of using more than the recommended dose of Mobilat, the patient should contact their doctor.

Missing a dose of Mobilat

A double dose should not be used to make up for a missed dose. The medicine should be used as directed in the package leaflet. If there are any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

Stopping use of Mobilat

The patient should always follow the doctor's or pharmacist's instructions on how long to use the medicine. The doctor will decide when to stop treatment.
If there are any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mobilat can cause side effects, although not everybody gets them.
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 the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Mobilat

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the label after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
After first opening, the medicine can be used for 12 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 of Mobilat are: mucopolysaccharide polysulfate, suprarenal gland extract, and salicylic acid.
Other ingredients are: disodium edetate, thymol, isopropyl alcohol, ethanolamine, myristyl alcohol, cetylstearyl alcohol emulsifying (type A), ointment base, stearic acid, glycerol 85%, purified water.

What Mobilat looks like and contents of the pack

Aluminum tube internally coated with epoxyphenolic resin with a PP cap in a cardboard box containing 50 g or 100 g of ointment.

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

Mobilat Produktions GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Date of last revision of the package leaflet: