Patient Information Leaflet

Diclofenac EG STADA GROUP 10 mg/g gel

For adults and adolescents aged 14 years and older
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always 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, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

What Diclofenac EG STADA GROUP is and what it is used for
What you need to know before using Diclofenac EG STADA GROUP
How to use Diclofenac EG STADA GROUP
Possible side effects
How to store Diclofenac EG STADA GROUP
Contents of the pack and other information

1. What Diclofenac EG STADA GROUP is and what it is used for

Diclofenac EG STADA GROUP contains the active substance diclofenac, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
For adults
For local symptomatic treatment of pain:

associated with acute muscle strains, sprains or bruises resulting from impact injuries;
of soft tissues adjacent to the joint (e.g. bursae, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints;
in epicondylitis (inflammation of tendon insertions in the elbow area, also known as tennis elbow or golfer's elbow);
in acute muscular pain, for example in the back.

For adolescents aged 14 years and older
For short-term treatment.
For local symptomatic treatment of pain associated with acute muscle strains, sprains or
bruises resulting from impact injuries.

2. What you need to know before using Diclofenac EG STADA GROUP

Do not use Diclofenac EG STADA GROUP

if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
if you have ever developed breathing problems (asthma, bronchospasm), skin reactions (urticaria), runny nose, or swelling of the face or tongue after taking or using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen);
on open wounds, inflamed or infected skin, on eczema, or on mucous membranes;
during the last 3 months of pregnancy “see Pregnancy”;
in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac EG STADA GROUP.
If you suffer from asthma, hay fever, nasal mucosa swelling (nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms), or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind, you may be more likely than other patients to experience asthma attacks (so-called analgesic intolerance or analgesic-induced asthma), local skin or mucous membrane swelling (so-called Quincke's edema), or urticaria.
In such patients, Diclofenac EG STADA GROUP should only be used with specific precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances and who may experience, for example, skin reactions, itching, or urticaria.
When Diclofenac EG STADA GROUP is applied over large areas of skin and for prolonged periods, the possibility of systemic adverse effects associated with the application of Diclofenac EG STADA GROUP cannot be ruled out. Therefore, the gel should be used with caution in patients with impaired renal function, impaired cardiac function, or impaired hepatic function, as well as in patients with active peptic ulcers of the stomach or duodenum.
Apply Diclofenac EG STADA GROUP only to intact, healthy, and non-wounded skin. Avoid contact with eyes and mucous membranes. The gel must not be taken orally.
Diclofenac EG STADA GROUP may be used with a permeable (non-occlusive) dressing, but not with an occlusive dressing that does not allow air passage.
Consult your doctor if the gel is used under acute conditions associated with severe redness, swelling, or overheating of the joints, in case of prolonged joint pain, or severe back pain radiating to the legs and/or associated with neurological deficits (e.g., numbness, tingling).
If symptoms worsen or do not improve after 3–5 days of treatment, consult your doctor.
The use of Diclofenac EG STADA GROUP must be discontinued if you develop a skin rash.
Exposure to direct sunlight or artificial light may cause skin reactions. Avoid exposure to direct sunlight or artificial light during treatment and for two weeks after stopping treatment.
Precautions must be taken to ensure that children do not touch the area where the gel has been applied.

Children and adolescents
This medicine must not be used in children and adolescents under 14 years of age.

Other medicines and Diclofenac EG STADA GROUP
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions have been reported with the intended topical use of diclofenac.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Diclofenac EG STADA GROUP during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. Do not use Diclofenac EG STADA GROUP during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with Diclofenac EG STADA GROUP when applied to the skin.

Breastfeeding
Diclofenac EG STADA GROUP may be used during breastfeeding only on medical advice, as diclofenac passes into breast milk in small amounts. If you are breastfeeding, do not apply Diclofenac EG STADA GROUP to the breast or to other large skin areas and avoid prolonged use.

Driving and using machines
Diclofenac EG STADA GROUP does not affect or affects negligibly the ability to drive and use machines.

Diclofenac EG STADA GROUP contains propylene glycol (E1520)
This medicine contains 50 mg of propylene glycol in 1 gram of gel.

Diclofenac EG STADA GROUP contains fragrances
This medicine contains a fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalool, which may cause allergic reactions.
In addition, benzyl alcohol may cause mild local irritation.

3. How to use Diclofenac EG STADA GROUP

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 14 years and older
Apply Diclofenac EG STADA GROUP 3-4 times a day.
Depending on the size of the area to be treated, apply a thin layer of gel corresponding to the size of a cherry to a walnut, which corresponds to 1-4 g of gel.
The maximum daily dose is 16 g of gel.
Elderly patients
No dose adjustment is necessary. If you are elderly, you should pay particular attention to possible side effects and, if necessary, consult your doctor or pharmacist.
Impaired renal or hepatic function
Dose reduction is not required.
Use in children and adolescents (under 14 years of age)
Do not use this medicine in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac EG STADA GROUP”).
Before first use, open the tube as follows:

Unscrew the cap from the tube. To open the safety seal of the tube, turn the cap and insert it into the nozzle. Do not use scissors or other sharp objects!
Rotate and remove the plastic seal from the tube. Use the gel as described in this leaflet.
Do not use the medicine if the seal is broken.
How to apply:
Diclofenac EG STADA GROUP is for topical use only.
Apply a thin layer of gel to the affected areas of the body and gently massage into the skin. Afterwards, clean your hands with a paper tissue and then wash them, unless the hands are the area being treated.
If too much gel is accidentally applied, wipe off the excess gel with a paper tissue.
The paper tissue should be disposed of in household waste to prevent unused medicine from entering the aquatic environment.
Allow the gel to dry on the skin for a few minutes before applying a dressing.
Duration of treatment:
The duration of use depends on the symptoms and underlying condition. Diclofenac EG STADA GROUP should not be used for longer than 1 week without consulting a doctor.
If symptoms worsen or do not improve after 3-5 days of treatment, consult your doctor.
If you use more Diclofenac EG STADA GROUP than you should
Overdose is unlikely if you use more Diclofenac EG STADA GROUP than recommended, as absorption into the bloodstream is low when the medicine is applied to the skin.
If the recommended dose is significantly exceeded during topical application, remove the gel (e.g. with a paper tissue) and wash the area with water.
If Diclofenac EG STADA GROUP is accidentally ingested, contact your doctor, who will decide on appropriate measures.
If you forget to use Diclofenac EG STADA GROUP
Do not use a double dose to make up for the missed application.
If you have any 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 everyone gets them.
Some rare and very rare side effects can be serious.
If you experience any of the following signs of allergy, stop using Diclofenac EG STADA GROUP and inform your doctor or pharmacist immediately.

Skin rash with blisters; hives (may affect up to 1 in 1,000 people).
Wheezing, shortness of breath, or tightness in the chest (asthma) (may affect up to 1 in 10,000 people).
Swelling of the face, lips, tongue, or throat (may affect up to 1 in 10,000 people).

Other side effects may also occur:
Common side effects (may affect up to 1 in 10 people):
Skin rash, itching, redness, eczema, dermatitis (inflammation of the skin), including contact dermatitis.
Uncommon side effects (may affect up to 1 in 100 people):
Peeling, dryness of the skin, swelling (oedema).
Very rare side effects (may affect up to 1 in 10,000 people):
Skin rash with pustules, gastrointestinal disturbances, hypersensitivity reactions (including hives), photosensitivity with skin reactions after exposure to sunlight.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Burning sensation at the application site, dry skin.

When Diclofenac EG STADA GROUP is applied over a large skin area and for prolonged periods, the possibility of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) cannot be completely ruled out – these may occur following systemic administration of medicines containing diclofenac.

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 reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Diclofenac EG STADA GROUP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original tube to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diclofenac EG STADA GROUP contains

The active substance is diclofenac.
1 g contains 11.6 mg of diclofenac diethylamine, equivalent to 10 mg of sodium diclofenac.
The other components are carbomer, cocoile caprilocaprate, macrogol cetostearyl ether, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Description of the appearance of Diclofenac EG STADA GROUP and contents of the pack
Homogeneous gel, white to almost white, packed in laminated aluminium tubes, closed with a PE seal and screw caps in PP, available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 120 g and 150 g tubes.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
Merckle GmbH, Graf-Arco-Str.3 89079 Ulm - Germany
STADA Arzneimittel AG, Stadastrasse 2-18 61118 Bad Vilbel - Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
DE: Diclofenac STADA Schmerzgel 10 mg/g Gel
BE: Diclofenac Eurogenerics 10 mg/g gel
EE: Diclofenac STADA
IT: Diclofenac EG STADA GROUP
LV: Diclofenac diethylamine STADA 11,6 mg/g gel
LT: Diclofenac diethylamine STADA 11,6 mg/g gel