Mobilat
Poland
Table of Contents
Package leaflet: Information for the patient
Mobilat (0.2 g + 1.0 g + 2.0 g)/100 g, gel
(Mucopolysaccharide polysulfate + Suprarenal extract + Salicylic acid)
Please read all of this leaflet carefully before using this medicine, because 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 can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If there is no improvement or if the patient feels worse, consult a physician.
Table of 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 an extract from adrenal cortex with anti-inflammatory and anti-exudative properties. Its effect is enhanced by salicylic acid, which additionally exerts analgesic action and facilitates penetration of biologically active components of Mobilat into tissues. Mucopolysaccharide polysulfate acts anti-inflammatory, locally reduces blood coagulability, increases tissue circulation, and accelerates tissue regeneration.
Indications
Treatment of post-traumatic inflammatory conditions of joints and hematomas.
Treatment of pain occurring during movement and in states of overuse of muscles and tendons.
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 ingredients 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.
The doctor decides on use in children after evaluating benefit versus risk. Do not use in children under 12 years of age without a doctor's prescription.
Patients with impaired kidney function: the decision on long-term use of Mobilat will be made by the doctor after evaluating benefit versus risk.
Warnings and precautions
Discuss with your doctor or pharmacist before starting to use Mobilat.
Mobilat gel should be applied only to intact skin. Avoid contact of Mobilat gel with open wounds, eyes, and mucous membranes.
After applying the gel 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 have a child, 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 in pregnant women after considering whether the therapeutic benefits to the mother outweigh the potential risk to the fetus. Do not use Mobilat over large skin areas.
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 gel contains 80 mg of propylene glycol per 1 g. Propylene glycol may cause skin irritation.
3. How to use Mobilat
This medicine should always be used exactly as described in the patient leaflet or according to the instructions given by your doctor or pharmacist. If in doubt, consult your 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 gel is a medicine intended for topical application to the skin.
Recommended dose:
Unless otherwise advised by a doctor, apply a strip of gel 5 to 15 cm long once or three times daily to the affected areas. If an occlusive dressing is used, the dose may be increased accordingly. After applying the gel to the affected area, gently massage it into the skin. Mobilat should be applied only to intact skin. Prolonged use of Mobilat over large areas should be carried out under medical supervision.
Use of a higher than recommended dose of Mobilat
Due to the method of administration, overdose of Mobilat is unlikely. However, salicylate poisoning may occur if the gel is accidentally swallowed. Symptoms of poisoning include vomiting, excessive sweating, tachycardia (rapid heartbeat, exceeding 100 beats per minute), hyperventilation (excessively deep and rapid breathing), fever, tinnitus (ringing in the ears), disturbances in consciousness, respiratory alkalosis, and alkaline urine pH.
Treatment: gastric lavage, monitoring of salicylate serum concentration, measurement of plasma pH and electrolytes. Forced diuresis may be required.
If symptoms of overdose occur, the doctor will initiate appropriate symptomatic treatment.
If a higher than recommended dose of Mobilat has been used, contact your doctor immediately.
Missed dose of Mobilat
Do not use a double dose to make up for a missed dose. Continue using the medicine as directed in the leaflet. If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Stopping treatment with Mobilat
Always follow the advice of your doctor or pharmacist regarding how long to use the medicine. Your doctor will decide when treatment should be discontinued.
If you have any further questions about the use of 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 side effects have been reported:
rare (may occur in no more than 1 in 1,000 people)
local skin irritation
very rare (may occur in no more than 1 in 10,000 people)
contact sensitization.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 helps to provide more information on the safety of this medicine.
5. How to store Mobilat
Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the label following “Expiry date” or “EXP”. 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 required. This will help protect the environment.
6. Contents of the packaging and other information
What Mobilat contains
The active substances in this medicinal product are: polysaccharide sulphate, adrenal cortex extract, and
salicylic acid.
Other components: disodium edetate, rosemary oil, ethanolamine, carbomer, propylene glycol, isopropyl alcohol, purified water.
What Mobilat looks like and contents of the pack
Aluminium tube internally coated with epoxyphenolic resin, with a PP cap, contained in a cardboard box, containing 25 g, 50 g or 100 g of gel.
Marketing Authorisation 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