Diclomax mobilat

Package leaflet: Information for the patient

DicloMAX Mobilat, 20 mg/g, gel
Diclofenacum natricum
(in the form of Diclofenacum diethylammonium)
For use in adults and adolescents aged 14 years and older
Please read this 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 patient leaflet or as directed by a doctor 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 you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3–5 days, or if your condition worsens, consult your doctor.

Leaflet contents

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

DicloMAX Mobilat contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Adults and adolescents aged 14 years and older
For short-term, local, symptomatic treatment of mild to moderate pain associated with sprains, acute strains, or contusions following blunt trauma.

2. Important information before using DicloMAX Mobilat

When not to use DicloMAX Mobilat

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced breathing difficulties (asthma, bronchospasm), urticaria, rhinitis, or facial or tongue swelling after taking or using medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen),
• on open wounds, inflamed or infected skin areas, or on skin with rashes 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, consult your doctor.

• When DicloMAX Mobilat is applied over large skin areas or for prolonged periods, the possibility of systemic adverse reactions cannot be excluded. Therefore, the gel should be used with caution in patients with impaired kidney, heart, or liver function, and in patients with active gastric or duodenal ulcer disease.
• DicloMAX Mobilat should only be applied to intact, healthy, undamaged skin. Avoid contact of the gel with eyes and mucous membranes of the oral cavity. The gel must not be taken orally.
• After applying the gel to the skin, a breathable (non-occlusive) dressing may be used, but wait a few minutes until the gel has dried on the skin. Do not use airtight, non-breathable occlusive dressings.
• If symptoms worsen or there is no improvement within 3-5 days of treatment, consult a doctor.
• If the patient suffers from asthma, hay fever, nasal mucosal swelling (e.g. nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with symptoms typical of hay fever), or has hypersensitivity to other painkillers and various anti-rheumatic drugs, or is particularly prone to asthma attacks (so-called analgesic intolerance/analgesic-induced asthma), local skin or mucosal swelling (so-called Quincke's oedema), or urticaria, DicloMAX Mobilat should only be used with special precautions (be prepared for sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, manifesting as skin reactions, itching, or urticaria.
• If a skin rash occurs, treatment with DicloMAX Mobilat should be discontinued.
• There is a risk of skin reactions when exposed to direct sunlight or artificial UV radiation (solarium). During treatment with this medicine and for two weeks after stopping it, exposure to sunlight should be avoided and use of a solarium is not recommended.
• Measures should be taken to prevent children from touching skin areas to which the gel has been applied.

Children and adolescents
DicloMAX Mobilat must not be used in children and adolescents under 14 years of age.
DicloMAX Mobilat and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
No interactions have been observed so far when DicloMAX Mobilat is used as directed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
DicloMAX Mobilat must not be used during the last three months of pregnancy, as increased risk of complications for both mother and child cannot be excluded.
During the first six months of pregnancy, DicloMAX Mobilat should not be used unless necessary and specifically recommended by a doctor. If use is necessary, the lowest possible dose for the shortest possible duration should be administered.
Oral forms of diclofenac (e.g. tablets) may cause adverse effects in the unborn child. It is not known whether the same risk applies to DicloMAX Mobilat when applied topically.
Breastfeeding
Diclofenac passes into breast milk in small amounts. During breastfeeding, DicloMAX Mobilat may only be used on medical advice. The medicine should not be applied to the chest area, large skin areas, or for prolonged periods.
Driving and operating machinery
The use of DicloMAX Mobilat has no effect or only a negligible effect on the ability to drive vehicles or operate machinery.
DicloMAX Mobilat contains propylene glycol (E 1520), butylated hydroxytoluene (E 321), and
fragrance substances with allergens.
This medicine contains 50 mg of propylene glycol in each gram of gel.
Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
This medicine contains fragrance substances containing 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 patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and adolescents aged 14 years and older
DicloMAX Mobilat should be applied twice daily (preferably in the morning and evening).
Depending on the size of the treated area, 1 g to 4 g of gel is required, corresponding to the size from a cherry to a walnut.
The maximum daily dose is 8 g of gel.

Elderly patients
No special dose adjustment is necessary. Elderly individuals should pay particular attention to possible adverse 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 topical use on the skin.
Apply a thin layer of gel to the affected area and gently massage into the skin. Do not rub vigorously. After application, wipe hands with a paper towel and wash them, unless the hands themselves are the treated area. The paper towel should be disposed of in mixed waste.

If using a bandage (see section 2, "Warnings and precautions"), allow the gel to dry on the skin for several minutes. Similarly, wait until the gel has dried before taking a shower or bath.

Duration of treatment:
The duration of treatment depends on symptoms and underlying condition. DicloMAX Mobilat should not be used for longer than 7 days without consulting a doctor.
If there is no improvement or if symptoms worsen within 3–5 days of use, consult a doctor.

Use of more than the recommended dose of DicloMAX Mobilat
Overdose is unlikely due to the minimal systemic absorption following topical application. If the recommended dose is significantly exceeded, remove the gel from the skin (e.g., with a paper towel) and wash the area with water.
In case of accidental ingestion of DicloMAX Mobilat, contact a doctor immediately for appropriate management.

Missed dose of DicloMAX Mobilat
Do not use a double dose to make up for a missed dose.
If in doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may have serious consequences. You must stop using DicloMAX Mobilat and contact your doctor or pharmacist immediately.
Rare adverse effects (may occur in up to 1 in 1,000 people):

• Skin rash with blisters (bullous dermatitis)

Very rare adverse effects (may occur in up to 1 in 10,000 people):

• Wheezing, breathlessness, or feeling of tightness in the chest (asthma)
• Swelling of the face, lips, tongue, or throat (angioedema)

Other possible adverse effects:
Common adverse effects (may occur in up to 1 in 10 people):

• Skin rash
• Itching
• Redness of the skin
• Eruption
• Skin inflammation, including contact dermatitis

Uncommon adverse effects (may occur in up to 1 in 100 people):

• Skin peeling
• Skin dryness
• Swelling

Very rare adverse effects (may occur in up to 1 in 10,000 people):

• Papular rash
• Gastrointestinal disturbances
• Hypersensitivity reactions (including urticaria)
• Photosensitivity with skin reactions following exposure to sunlight

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

• Burning sensation at the application site
• Dry skin

When DicloMAX Mobilat is used over a large skin area or for prolonged periods, the possibility of systemic adverse effects (e.g. adverse effects on the liver, kidneys, or gastrointestinal system, systemic hypersensitivity reactions) cannot be excluded, which may occur after systemic administration of medicines containing diclofenac.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 .
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store DicloMAX Mobilat

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package and
tube after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not store in a refrigerator or freeze.
After first opening: Do not store above 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask a
pharmacist how to dispose of medicines no longer in use. This 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, equivalent to 20 mg of diclofenac sodium.
Other ingredients are: propylene glycol (E 1520), oleyl alcohol, isopropyl alcohol,
butylhydroxytoluene (E 321), diethanolamine, light liquid paraffin, cetostearyl macrogol ether,
carbomer 980, cococaprylocapronic glyceride, cream fragrance (containing eugenol and citral), purified water.

What DicloMAX Mobilat looks like and contents of the pack
A white gel.
The gel is packed in laminated aluminium tubes sealed with a top seal and closed with a polypropylene cap. The product is available in 30 g, 50 g, 60 g, 100 g, 120 g, 150 g and 180 g tubes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Poland
Tel. +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 medicinal product is authorised in the European Economic Area countries 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 gel
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