Diclomax Mobilat

Package Leaflet: Information for the Patient

DicloMAX Mobilat, 20 mg/g, Gel

Diclofenac sodium
(in the form of Diclofenac diethylammonium)
For use by adults and adolescents aged 14 years and older

Read this leaflet carefully before using this medicine, as it contains important information for you.

This medicine should always be used exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is DicloMAX Mobilat and what is it used for

DicloMAX Mobilat contains the active substance diclofenac, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

Adults and adolescents aged 14 years and older

For short-term, local, symptomatic treatment of mild to moderate pain in sprains, acute strains or bruises after blunt trauma.

2. Important information before using DicloMAX Mobilat

When not to use DicloMAX Mobilat

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had breathing difficulties (asthma, bronchospasm), hay fever, or an itchy rash (pruritus) or swelling of the face or throat after taking or using medicines containing acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., ibuprofen),
• on open wounds, inflammatory or infected skin lesions, as well as on skin with eczema and mucous membranes,
• during the last three months of pregnancy,
• in children and adolescents under 14 years of age.

Warnings and precautions

Before starting to use DicloMAX Mobilat, you should discuss it with your doctor.

• In case DicloMAX Mobilat is used on large areas of skin or for a long time, it cannot be excluded that systemic side effects may occur. Therefore, the gel should be used with caution in patients with impaired renal, cardiac, or hepatic function, as well as in patients with active peptic ulcer disease of the stomach or duodenum.
• DicloMAX Mobilat should only be used on intact, non-diseased, undamaged skin surface. You should avoid contact of the gel with eyes and mucous membranes of the mouth. The gel must not be taken orally.
• After applying the gel to the skin, you can apply a breathable (non-occlusive) bandage, but you should wait a few minutes until the gel dries on the skin. Similarly, before showering or bathing, you should wait until the gel dries on the skin.
  Do not useocclusive dressings.
• In case of worsening symptoms or lack of improvement within 3-5 days of use, you should consult a doctor.
• If you have asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease, or if you are more likely to have asthma attacks (so-called analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's edema), or urticaria, DicloMAX Mobilat may only be used with certain precautions (you should be prepared for the occurrence of sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, e.g., skin reactions, itching, or urticaria.
• In case of skin rash, treatment with DicloMAX Mobilat should be discontinued.
• In case of exposure to direct sunlight or artificial radiation (solarium), there is a risk of skin reactions. During the use of this medicine and for two weeks after its completion, you should avoid exposure to sunlight and not use a solarium.
• You should take measures to prevent children from touching the skin where the gel has been applied.

Children and adolescents

DicloMAX Mobilat should not be used in children and adolescents under 14 years of age.

DicloMAX Mobilat and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In case of using DicloMAX Mobilat as recommended, no interactions have been found so far.

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.
Pregnancy
Do not useDicloMAX Mobilat during the last three months of pregnancy, as it cannot be excluded that there is an increased risk of complications for the mother and child.
In the first six months of pregnancy, DicloMAX Mobilat should not be used unless it is necessary and recommended by a doctor. If necessary, the smallest dose should be administered for the shortest possible time.
After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to DicloMAX Mobilat when used on the skin.
Breastfeeding
Diclofenac passes into breast milk in small amounts. During breastfeeding, DicloMAX Mobilat may only be used on the advice of a doctor. The medicine should not be applied to the breast or large areas of skin or for a long time.

Driving and using machines

Using DicloMAX Mobilat does not affect or slightly affects the ability to drive and use machines.

DicloMAX Mobilat contains propylene glycol (E 1520), butylhydroxytoluene (E 321), and a fragrance with allergens.

This medicine contains 50 mg of propylene glycol in each gram of gel.
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
This medicine contains a fragrance with eugenol and citral, which may cause allergic reactions.

3. How to use DicloMAX Mobilat

This medicine should always be used exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults and adolescents aged 14 years and older

DicloMAX Mobilat should be used 2 times a day (preferably in the morning and evening).
Depending on the surface area of the treated site, 1 g to 4 g of gel is required, i.e., an amount corresponding to the size of a cherry to a walnut.
The maximum daily dose is 8 g of gel.

Elderly patients

No special dose adjustment is necessary. Elderly patients should pay particular attention to side effects and, if necessary, consult a doctor or pharmacist.

Renal or hepatic impairment

Dose reduction is not required.

Use in children and adolescents under 14 years of age

DicloMAX Mobilat is contraindicated in children and adolescents under 14 years of age (see section 2 "When not to use DicloMAX Mobilat").

How to use the medicine:

DicloMAX Mobilat is intended for use on the skin.
A thin layer of gel should be applied to the affected area of the body and gently massaged into the skin. Do not rub vigorously. Then, wash your hands with soap and water, unless they are the area being treated. Dry your hands with a paper towel and dispose of it in the household waste.
In case of using a bandage (see section 2 "Warnings and precautions"), the gel should be left on the skin to dry for a few minutes. Similarly, before showering or bathing, you should wait until the gel dries on the skin.
Treatment duration:
The duration of treatment depends on the symptoms and underlying disease. DicloMAX Mobilat should not be used for more than 7 days without consulting a doctor.
In case of lack of improvement or worsening of symptoms within 3-5 days of use, you should consult a doctor.

Using more than the recommended dose of DicloMAX Mobilat

Overdose of DicloMAX Mobilat is unlikely due to its low absorption into the bloodstream when used locally. If the recommended dose is significantly exceeded, the gel should be removed from the skin (e.g., with a paper towel) and the skin should be rinsed with water.
In case of accidental ingestion of DicloMAX Mobilat, you should immediately contact a doctor, who will recommend the appropriate course of action.

Missing a dose of DicloMAX Mobilat

You should not use a double dose to make up for a missed dose.
In case of doubts about the use of this medicine, you should consult a 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 may have serious consequences. You should stop usingDicloMAX Mobilat and immediately contactyour doctor or pharmacist.
Rare side effects(may affect up to 1 in 1,000 people)

• skin rash with blisters (bullous dermatitis)

Very rare side effects(may affect up to 1 in 10,000 people)

• wheezing, shortness of breath, or feeling of tightness in the chest (asthma)
• swelling of the face, lips, tongue, or throat (angioedema)

Other possible side effects:
Common side effects(may affect up to 1 in 10 people):

• skin rash
• itching
• redness of the skin
• eruption
• dermatitis, including contact dermatitis

Uncommon side effects(may affect up to 1 in 100 people):

• peeling of the skin
• dryness of the skin
• swelling

Very rare side effects(may affect up to 1 in 10,000 people)

• papular rash
• gastrointestinal disorders
• allergic reactions (including urticaria)
• photosensitivity with skin reactions after exposure to sunlight

Frequency not known(frequency cannot be estimated from the available data)

• burning sensation at the application site
• dryness of the skin

In case of using DicloMAX Mobilat on a large area of skin or for a long time, it cannot be excluded that systemic side effects may occur (e.g., adverse effects on the liver, kidneys, or gastrointestinal tract, systemic allergic reactions), which may occur after systemic use of medicines containing diclofenac.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DicloMAX Mobilat

This medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not store in the refrigerator or freeze.
After first opening: Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What DicloMAX Mobilat contains

The active substance is diclofenac.
1 g contains 23.2 mg of diclofenac diethylammonium, which corresponds to 20 mg of diclofenac sodium.
The other ingredients are: propylene glycol (E 1520), oleyl alcohol, isopropyl alcohol, butylhydroxytoluene (E 321), diethylamine, light liquid paraffin, macrogol cetostearyl ether, carbomer 980, cocoyl caproyl caprate, fragrance (containing eugenol and citral), purified water

What DicloMAX Mobilat looks like and contents of the pack

White gel
The gel is packed in aluminum, laminated tubes sealed with a polypropylene cap. The product is available in tubes of 30 g, 50 g, 60 g, 100 g, 120 g, 150 g, and 180 g.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Clonmel Healthcare Limited
Waterford Road, Clonmel. Tipperary
E91 D768
Ireland
Kern Pharma S.L.
Calle Venus 72,
Poligono Industrial Colom II
08228 Terrassa, Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Diclofenac EG Forte 20 mg/g gel
Bulgaria:
Mobilat Emulgel 2.32% gel
Estonia:
Ditel
Germany:
Diclofenac AL Schmerzgel forte 20 mg/g Gel
Ireland:
Diclomel Max Strength 2% w/w gel
Italy:
Diclofenac EG STADA Italia
Latvia:
Ditel 23.2 mg/g gels
Lithuania:
Ditel 23.2 mg/g gelis
Luxembourg:
Diclofenac EG Forte 20 mg/g gel
Malta:
Diclomel Max Strength 2% w/w gel
Poland:
DicloMAX Mobilat
Date of last revision of the leaflet:10/2024