Mobilisin

Package leaflet: Information for the user

MOBILISIN 40 g Cream

Flufenamic Acid + Ethylene glycol monosalicylate + Glycosaminoglycan polysulfate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What MOBILISIN is and what it is used for

MOBILISIN belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs),
used to relieve pain and inflammation.
MOBILISIN is used in adults to treat pain and inflammation of muscles, tendons, ligaments, and joints locally.
It is also indicated for the treatment of muscle tension, back pain, neck stiffness, neuralgia, and sciatica.

2. What you need to know before using MOBILISIN

Do not use MOBILISIN

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Consult your doctor or pharmacist before using MOBILISIN if you have renal insufficiency.
• Avoid exposing the treated areas to sunlight.
• DO NOT USE the cream on burns, infections, or other skin diseases.
• Chronic use may cause skin reactions. Immediately discontinue treatment and consult your doctor if an allergic reaction occurs after applying the cream.
• If this medicine is used over large skin areas and for prolonged periods, the possibility of systemic adverse effects (i.e., affecting various parts of the body) cannot be ruled out (see section 4 “Possible side effects”).

Children
There are no data available on efficacy and safety in this population. Therefore, do not use MOBILISIN in children.
Other medicines and MOBILISIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• methotrexate (a medicine used to treat certain types of cancer)
• sulfonylureas (e.g. glimepiride, gliclazide, medicines used to treat diabetes).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, you may use this medicine only if considered strictly necessary by your doctor, under their direct supervision, and only for a short treatment period.
Driving and using machines
No known effects.
MOBILISIN contains sorbic acid
Sorbic acid may cause local skin reactions (e.g. contact dermatitis).

3. How to use MOBILISIN

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is a 5–10 cm strip of cream, depending on the size of the area to be treated, applied several times a day.
If necessary, after consulting your doctor, MOBILISIN may also be used for prolonged periods.

Instructions for use:

• Gently massage to promote absorption.
• Wash your hands thoroughly after application, otherwise they will also be treated with the cream.
• Avoid contact with eyes or mucous membranes.
• Do not ingest.

If you use more MOBILISIN than you should
In case of accidental overdose or excessive application of MOBILISIN, thoroughly wash the treated area with running water and contact your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.
If the medicine is used on extensive skin areas and for a prolonged period, systemic side effects (which may affect various parts of the body) such as gastrointestinal disorders, nausea, headache, dizziness, and general malaise cannot be ruled out. If you experience any of these symptoms, stop treatment and consult your doctor.
Rare side effects (may affect up to 1 in 1,000 people):

• skin irritation or erythema
• itching
• skin rashes
• increased sensitivity of the skin to sunlight

These symptoms usually disappear upon discontinuation of treatment.

Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MOBILISIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What MOBILISIN contains

• The active substances are flufenamic acid, ethylene glycol monosalicylate, glycosaminoglycan polysulfate. 100 g of cream contain 3.0 g of flufenamic acid, 2.64 g of ethylene glycol monosalicylate and 0.20 g of glycosaminoglycan polysulfate.
• The other components are mono- and diglycerides of fatty acids, sodium salts of sulfonated fatty alcohols, triglycerides of vegetable fatty acids, myristyl alcohol, magnesium aluminium silicate, hydrochloric acid 25%, sorbic acid, isopropanol, rosemary oil, lemon balm oil, purified water.

Description of the appearance of MOBILISIN and pack contents
Topical cream for external use.
MOBILISIN is available in packs containing 40 g of cream in an aluminium tube.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Mobilat Produktions Gmbh, Luitpoldstrasse, 1 - 85276 - Pfaffenhofen (Germany)
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)