DICLOFENAC 10 mg /G Гель

Содержание инструкции

1. Diclofenac EG STADA GROUP 10 mg/g gel
   1. What is Diclofenac EG STADA GROUP and what is it used for
   2. What you need to know before using Diclofenac EG STADA GROUP
   3. How to use Diclofenac EG STADA GROUP
   4. Possible side effects
   5. How to store Diclofenac EG STADA GROUP
   6. Contents of the pack and other information

Diclofenac EG STADA GROUP 10 mg/g gel

For adults and adolescents aged 14 years and over

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet

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

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

Diclofenac EG STADA GROUP contains the active ingredient diclofenac, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

For adults
For the symptomatic local treatment of pain:

• associated with acute muscle strains, sprains or bruises resulting from impact trauma;
• 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 the tendon insertions in the elbow area, also known as tennis elbow or golfer's elbow);
• in acute muscle pain, for example in the back.

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

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 any of the other ingredients of this medicine (listed in section 6);
• if you have ever developed respiratory 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 (NSAIDs) (for example ibuprofen);
• on open wounds, inflammation or skin infections, on eczema or on mucous membranes;
• if you are in 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, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly
associated with symptoms similar to hay fever) or hypersensitivity to other painkillers and rheumatic medicines of any kind, you are more likely than other patients to experience asthma attacks (the
so-called analgesic intolerance or analgesic asthma), local skin or mucous membrane swelling (the
so-called Quincke's edema) and urticaria.
In these patients Diclofenac EG STADA GROUP can only be used with certain precautions
(preparation for emergencies) and under direct medical supervision. The same applies to patients who are
also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When Diclofenac EG STADA GROUP is applied to large areas of skin and for a prolonged period,
the possibility of systemic adverse effects associated with the application of Diclofenac
EG STADA GROUP cannot be excluded. Therefore, the gel should be used with caution by patients with reduced
kidney function, reduced heart function or reduced liver function, as well as by patients with active peptic ulcers
in the stomach or duodenum.
Apply Diclofenac EG STADA GROUP only to intact, healthy skin without wounds. Avoid contact
with the eyes and mucous membranes. The gel should not be taken orally.
Diclofenac EG STADA GROUP can be used with a permeable (non-occlusive) bandage, but not with an occlusive bandage that does not allow air to pass through.
Consult a doctor if the gel is used in acute conditions associated with severe redness,
swelling or overheating of the joints, in case of prolonged joint pain or severe back pain
that radiates to the legs and/or is 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 should be discontinued if you develop a skin rash.
If you are exposed to direct or artificial sunlight, there is a risk of skin reactions. Do not expose yourself to
direct or artificial sunlight during treatment and for two weeks after stopping
treatment.
Precautions must be taken to prevent children from touching the area to which the
gel has been applied.

Children and adolescents
This medicine should 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 are known to be associated with the intended cutaneous use of diclofenac.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

Do not useDiclofenac EG STADA GROUP if you are in the last 3 months of pregnancy as it
may harm the fetus or cause problems at the time of delivery. 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 necessary during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known
whether the same risk applies with Diclofenac EG STADA GROUP when used on the skin.
Breastfeeding
Diclofenac EG STADA GROUP during breastfeeding can only be used after 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 elsewhere on large areas of skin and for a prolonged period.

Driving and using machines
Diclofenac EG STADA GROUP does not alter or alters negligibly the ability to drive vehicles
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 following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults and adolescents aged 14 years and over
Apply Diclofenac EG STADA GROUP 3-4 times a day.
Depending on the size of the area to be treated, an amount of gel varying from the size of a cherry to a walnut, corresponding to 1-4 g of gel, is required.
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 undesirable effects and, if necessary, consult your doctor or pharmacist.

Impaired renal or hepatic function
No dose reductions are necessary.

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 using the medicine for the first time, open it as follows:

• 1) 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!
• 2) 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 external use.
Apply a thin layer of gel to the affected parts of the body and massage gently into the skin. Afterwards, your hands must be cleaned with a tissue and then washed, unless your hands are the area to be treated.
If too much gel is accidentally applied, the excess gel must be cleaned with a tissue.
The tissue should be disposed of in household waste to prevent unused medicine from reaching the aquatic environment.
Before applying a bandage, the gel should be allowed to dry on the skin for a few minutes.

Duration of treatment:
The duration of use depends on the symptoms and the underlying disease. Diclofenac EG STADA GROUP should not be used for more 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
It is unlikely that an overdose will occur if you use more Diclofenac EG STADA GROUP than you should, as absorption into the bloodstream is low when the medicine is applied to the skin.
If the recommended dose is significantly exceeded when applied to the skin, the gel should be removed (e.g. with a tissue) and washed off with water.
If you accidentally ingest Diclofenac EG STADA GROUP, seek medical advice, who will decide on the appropriate measures to take.

If you forget to use Diclofenac EG STADA GROUP
Do not use a double dose to make up for a missed application.
If you have any doubts about using 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.

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 tell your doctor or pharmacist immediately.

• Blistering skin rash; hives (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath or a feeling of 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 are also possible:

Common side effects(may affect up to 1 in 10 people):
Skin rash, itching, redness, eczema, dermatitis (skin inflammation), including
contact dermatitis.

Uncommon side effects(may affect up to 1 in 100 people):
Scaling, skin dehydration, swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)
Skin rash with pustules, gastrointestinal disorders, hypersensitivity reactions (including hives),
light sensitivity with the appearance of skin reactions after exposure to sunlight.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Burning sensation at the application site, dry skin.
When Diclofenac EG STADA GROUP is applied to a large area of skin and for a prolonged
period, it is not possible to completely exclude the possibility of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) – which
can occur after systemic administration of medicines containing diclofenac.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you 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 which is stated on the pack and the tube. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original tube to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac EG STADA GROUP contains

• The active ingredient is diclofenac.
• 1 g contains 11.6 mg of diclofenac diethylamine corresponding to 10 mg of diclofenac sodium.
• The other components are carbomer, caprylic/capric triglyceride, 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 from white to almost white, packaged in laminated aluminium tubes, sealed with a
PE seal and screw caps in PP and available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 120 g and
150 g tube.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area (EEA) with the
following denominations:
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 gels
LT: Diclofenac diethylamine STADA 11.6 mg/g gelis