MOBILAT gel 50 g, Stada

MOBILAT EMULGEL 2.32% gel 50 g STADA Leaflet: user information Mobilat Emulgel 2.32% gel / Mobilat Emulgel 2.32% gel diclofenac diethylamine
For adults and adolescents over 14 years old
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 3-5 days or your condition worsens, you should seek medical attention.

What is in this leaflet 1. What Mobilat Emulgel 2,32% gel is and what it is used for 2. What you need to know before you use Mobilat Emulgel 2,32% gel 3. How to use Mobilat Emulgel 2,32% gel 4. Possible side effects 5. How to store Mobilat Emulgel 2,32% gel 6. Contents of the pack and other information
1. What Mobilat Emulgel 2,32% gel is and what it is used for Mobilat Emulgel 2,32% gel contains the active ingredient diclofenac, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
For adults and adolescents aged 14 years and over For short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.
2. What you need to know before you use Mobilat Emulgel 2,32% gel
Do not use Mobilat Emulgel 2,32% gel

if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of the product listed in section 6;
if you have ever had breathing problems (asthma, bronchospasm), urticaria (skin rash), runny nose or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen);
on open wounds, inflammations or infections of the skin, or on eczema and mucous membranes;
if you are in the last 3 months of pregnancy;
in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Mobilat Emulgel 2,32% gel.

If Mobilat Emulgel 2,32% gel is applied to a large area of skin and for a prolonged period of time, the possibility of systemic adverse reactions resulting from its application cannot be excluded. Therefore, the gel should be used with caution in patients with reduced renal function, reduced cardiac function or reduced hepatic function, as well as in patients with active peptic ulcer of the stomach or duodenum,
Mobilat Emulgel 2,32% gel is applied only to healthy skin without damage and without open wounds. Avoid contact with eyes or mucous membranes of the mouth - The gel should not be taken orally.
After applying the gel to the skin, you may use an elastic (non-occlusive) bandage, but the gel should be allowed to dry on the skin for a few minutes before applying it. It should not be used with an impermeable occlusive bandage.
If you do not feel better after 3-5 days or your condition worsens, you should seek medical attention.
If you suffer from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps), chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with hay fever symptoms) or are hypersensitive to other types of painkillers and antirheumatic drugs of any kind, you are more likely than other patients to experience an asthma attack (so-called analgesic intolerance/analgesic asthma), local swelling of the skin or mucous membrane (so-called Quincke's edema) or hives. In such patients Mobilat
Emulgel 2,32% gel can only be used after taking precautions (emergency preparedness) and under direct medical supervision. This also applies to patients who are allergic to other substances, for example with skin reactions, itching or hives.
Discontinue treatment if a skin rash appears after applying the product.
If you are exposed to direct sunlight or a solarium, there is a risk of skin reactions. You should avoid sunlight or a solarium during treatment and for two weeks after stopping treatment.
Precautions should be taken to ensure that children do not touch the areas of skin to which the gel has been applied.

Children and adolescents
Mobilat Emulgel 2,32% gel is contraindicated in children and adolescents under 14 years of age.
Other medicines and Mobilat Emulgel 232% gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If used as recommended, no reactions with other medications have been observed so far.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
During the first six months of pregnancy, Mobilat Emulgel 2,32% gel should only be used after consulting your doctor.
Mobilat Emulgel 2,32% gel should not be used during the last 3 months of pregnancy, as an increased risk of complications for the mother and child cannot be excluded.
Breastfeeding
Mobilat Emulgel 2,32% gel should only be used on medical advice during breast-feeding, as diclofenac passes into breast milk in small amounts. However, Mobilat Emulgel 2,32% gel should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin for a prolonged period of time.
Driving and using machines
Mobilat Emulgel 2,32% gel has no or negligible influence on the ability to drive and use machines.
Mobilat Emulgel 2,32% gel contains propylene glycol (E1520), butylhydroxytoluene (E321) and fragrance 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 or mucous membranes.
This medicine contains eugenol and citral fragrance, which may cause allergic reactions.
3. How to use Mobilat Emulgel 2,32% gel
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and adolescents aged 14 years and over
Apply Mobilat Emulgel 2,32% gel 2 times a day (preferably morning and evening).
Depending on the size of the painful area to be treated, a cherry-sized to walnut-sized amount is required, corresponding to 1-4 g of gel.
The maximum daily dose is 8 g of gel.
Elderly patients
No dose adjustment is necessary. If you are elderly, you should be especially alert for side effects and consult a doctor or pharmacist if necessary.
Patients with impaired renal or hepatic function
No dose reduction is necessary.
Use in children and adolescents (under 14 years)
Mobilat Emulgel 2,32% gel is contraindicated in children and adolescents under 14 years of age (see section 2 „Do not use Mobilat Emulgel 2,32% gel“).
Method of administration
Mobilat Emulgel 2,32% gel is for external use on the skin only. Apply Mobilat Emulgel 2,32% gel to the affected areas of the body in a thin layer and gently rub into the skin. It should not be rubbed with pressure. Hands should then be wiped with a paper towel and washed, unless they are the treated area. Used paper towels should be disposed of in the residual waste.
If you are applying a bandage (see section 2 „Warnings and precautions“) the gel should be allowed to dry for a few minutes on the skin. Similarly, before taking a shower, wait until the gel has dried on the skin.
Duration of treatment
The duration of use depends on the symptoms and the underlying disease. Mobilat Emulgel 2,32% gel should not be used for more than 7 days without medical advice.
If symptoms do not improve or worsen after 3-5 days, you should consult a doctor.
If you use more Mobilat Emulgel 2,32% gel than you should
Due to the low absorption of diclofenac throughout the body with limited application to the skin, overdose is unlikely.
If the recommended dose is significantly exceeded when used on the skin, the gel should be removed (e.g. with a paper towel) and the treated area washed with water. If you or a child accidentally swallows the gel, contact your doctor immediately and he will decide what appropriate measures should be taken.
If you forget to use Mobilat Emulgel 2,32% gel Do not apply a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask 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 may have serious consequences. Stop using Mobilat Emulgel 2,32% gel and contact your doctor or pharmacist immediately.
Rare side effects (may affect up to 1 in 1,000 users) Skin rash with blistering of the skin (bullous dermatitis);
Very rare side effects (may affect up to 1 in 10,000 users)

Wheezing, shortness of breath or chest tightness (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 (erythema);
Eczema;
Dermatitis (skin inflammation), including contact dermatitis.

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

Peeling;
Drying of the skin;
Swelling (edema).

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

Pustular rash;
Gastrointestinal complaints;
Hypersensitivity reactions (including hives);
Sensitivity to light with skin reactions occurring after exposure to sunlight.

Not known (frequency cannot be estimated from the available data)

Burning sensation at the site of application;
Dry skin.

When Mobilat Emulgel 2,32% gel is applied to large areas of skin and for a prolonged period, the possibility of systemic adverse reactions (renal, hepatic, gastrointestinal, systemic hypersensitivity reactions) cannot be completely excluded - as they are likely to occur after systemic administration of drugs containing diclofenac.
Reporting of side effectsIf you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, tel: +359 28903417, website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
How to store Mobilat Emulgel 2,32% gel Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze. Shelf life after first opening the tube: Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Mobilat Emulgel 2,32% gel contains

The active substance is diclofenac. 1 g contains diclofenac as 23.2 mg diclofenac diethylamine, corresponding to 20 mg diclofenac sodium.
The other ingredients (excipients) are: propylene glycol (E1520), oleyl alcohol, isopropyl alcohol, butylhydroxytoluene (E321), diethylamine, light liquid paraffin, macrogol cetostearyl ether, carbomer 980, cocoyl caprylocaprate, perfume cream (contains eugenol and citral), purified water.

What Mobilat Emulgel 2,32% gel looks like and contents of the pack
White gel.
The gel is packaged in aluminum laminate tubes, sealed with a gasket and closed with a polypropylene screw 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 types of packaging can be placed on the market.
Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: STADA Arzneimittel AG, Germany