DICLO-ADGC pain gel forte 20 mg/g, Diclofenac gel, What is diclofenac?
DICLO-ADGC ® pain gel forte 20 mg/g gel
active ingredient: diclofenac (as diclofenac-N-ethylethanamine).
What is diclofenac?
Diclofenac is a medicine that reduces swelling (inflammation) and pain.
It's used to treat aches and pains, as well as problems with joints, muscles and bones. These include:
rheumatoid arthritis and osteoarthritis
sprains and strains in muscles and ligaments
back pain
toothache
migraine
gout
ankylosing spondylitis – this causes inflammation of the spine and other parts of the body
Areas of Diclofenac gel, pain gel application:
For adults and young people aged 14 and over. For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or bruises resulting from blunt trauma. Warning: contains butylated hydroxytoluene and a fragrance with benzyl alcohol (0.15 mg/ml), citronellol, geraniol, linalool, DLimonene, citral, farnesol, coumarin, eugenol.
For Diclofenac gel, pain gel information about risks and side effects, read the package leaflet and ask your doctor or pharmacist.
Zentiva Pharma GmbH, 65927 Frankfurt am Main. As of: May 2022
Active Diclofenac gel, pain gel ingredients
- 23.2 mg diclofenac diethylamine
Diclofenac gel, pain gel ingredients
- 0.15 mg benzyl alcohol
- Isopropanol
- D-Limonene
- Eugenol
- Farnesol
- Linalool
- Citral
- Diethylamine
- 1 mg perfume oil
- Paraffin, thick
- Coumarin
- Ceteareth-22
- Citronellol
- Cocoyl caprylocaprate
- Carbomer 974 P
- Geraniol
- Water, purified
- 0.2 mg butylhydroxytoluene
- Oleic acid
- 54 mg propylene glycol
Indication :
- The medicine contains the active ingredient diclofenac, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
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For adults and young people aged 14 and over
- For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or bruises resulting from blunt trauma.
Dosage :
- Always use this medicine exactly as described or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.
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Adults and young people aged 14 and over
- The preparation should be used twice a day (preferably in the morning and evening).
- Depending on the size of the affected area to be treated, an amount the size of a cherry to a walnut, corresponding to 1 - 4 g of gel, is required.
- The maximum total daily dose is 8 g of gel.
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Elderly patients
- No special dose adjustment is required. If you are older, you should pay particular attention to side effects and, if necessary, consult a doctor or pharmacist.
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Impaired kidney or liver function
- No dose reduction is required.
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Use in children and adolescents (under 14 years of age)
- This medicine must not be used in children and adolescents under 14 years of age.
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Duration of treatment:
- The duration of use depends on the symptoms and the underlying disease. The medicine should not be used for longer than 1 week without medical advice.
- Seek medical attention if symptoms worsen or do not improve after 3-5 days.
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If you have used more than you should
- An overdose is unlikely if you use more than you should, as absorption into the bloodstream is low when applied to the skin. If the recommended dose is significantly exceeded when applied to the skin, the gel should be removed and washed off with water.
- If accidentally swallowed, contact your doctor who will decide on appropriate measures.
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If you forget to use it
- Do not use a double dose if you have forgotten the previous application.
- If you have any further questions about using this medicine, talk to your doctor or pharmacist.
Way :
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Before the first use, open the tube as follows:
- 1. Unscrew the cap from the tube. To open the security seal, turn the cap over and place it on the tube opening. You must not use scissors or other sharp objects!
- 2. Remove the plastic seal from the tube by twisting. Apply the gel as described. If the seal is broken, do not use the medicine.
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Applying the gel:
- The gel is intended for use on the skin.
- Apply the gel thinly to the affected areas of the body and rub it lightly into the skin. After rubbing in the gel, wash your hands unless they are the area to be treated.
Side effects :
- Like all medicines, this medicine can cause side effects, although not everyone gets them.
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Some rare and very rare side effects can be serious.
If you notice any of the following signs of allergy, stop using the medicine and contact a doctor or pharmacist immediately:- rash with blistering; Hives (may affect up to 1 in 1,000 people).
- Wheezing, shortness of breath or chest tightness (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).
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Other possible side effects include:
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Common side effects (may affect up to 1 in 10 people):
- Rash, itching, redness, eczema, dermatitis (inflammation of the skin) including contact dermatitis.
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Uncommon side effects (may affect up to 1 in 100 people):
- Flaking, drying of the skin, swelling (edema).
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Very rare side effects (may affect up to 1 in 10,000 people):
- Pustular skin rash, gastrointestinal complaints, hypersensitivity reactions (including hives), photosensitivity with appearance of skin symptoms after exposure to light (photosensitization).
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Frequency of side effects not known (frequency cannot be estimated from the available data):
- Burning at the application site, dry skin.
- If the preparation is applied to a large area of the skin and used for a long period of time, the occurrence of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions), as may occur after systemic use of medicinal products containing diclofenac cannot be completely ruled out.
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Common side effects (may affect up to 1 in 10 people):
- If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not specified.
Interactions :
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Use together with other medicines
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- No interactions have been reported to date when the product is used as intended on the skin.
Contraindications :
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The medicine must not be used
- if you are allergic to diclofenac or any of the other ingredients of this medicine;
- if you have had a history of breathing problems (asthma, bronchospasm), hives, runny nose or swelling of the face or tongue after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen);
- on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes;
- in the last trimester of pregnancy.
- in children and young people under 14 years of age.
Pregnancy and breastfeeding :
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
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pregnancy
- Do not use this medicine in the last trimester of pregnancy as it may harm the unborn baby or cause problems during birth. If you intend to become pregnant, as well as in the first and second trimesters of pregnancy, the product should only be used after consulting your doctor.
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lactation
- Since diclofenac passes into breast milk in small quantities, the medicine should only be used under medical supervision during breastfeeding. If you are breastfeeding, do not use this product on the breast area or other large areas of skin or for a long period of time.
Patient information :
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Warnings and Precautions
- Please talk to your doctor or pharmacist before using the medicine.
- If you suffer from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps) or chronic bronchi-constricting (obstructive) respiratory diseases, chronic respiratory infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and rheumatism medications of all kinds, you are at risk of asthma attacks (so-called Analgesic intolerance/analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's edema) or urticaria are more at risk than other patients.
- In these patients, this medicine may only be used under certain precautionary measures (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances, such as: B. with skin reactions, itching or hives.
- If the gel is applied to a large area of the skin and used over a longer period of time, the occurrence of systemic (affecting the entire body) side effects due to the use of the preparation cannot be ruled out. The gel should therefore be used with caution in patients with impaired renal, cardiac or liver function as well as in patients with active peptic ulcers in the stomach or duodenum.
- The medicine may only be applied to intact, not diseased or injured skin. Eyes and mucous membranes must not come into contact with the medicine and it must not be taken.
- After applying the gel to the skin, you can use a permeable (non-occlusive) dressing. However, the gel should dry on the skin for a few minutes before applying a bandage. You must not use an airtight occlusive dressing.
- Seek medical attention if symptoms worsen or do not improve after 3-5 days.
- Discontinue treatment if a skin rash occurs during treatment with the product.
- If you are exposed to direct sunlight or artificial tanning, there is a risk of skin reactions. You should avoid sunlight or artificial tanning during and for two weeks after treatment.
- Care should be taken to ensure that children do not come into contact with areas of skin that have been rubbed.
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Children and young people
- This medicine must not be used in children and adolescents under 14 years of age.
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Ability to drive and use machines
- The preparation has no or negligible influence on the ability to drive and use machines.