DICLOFENAC STADA Pain gel forte 20 mg/g, 180 g

Instructions for use for DICLOFENAC STADA Pain gel forte 20 mg/g, 180 g

Instructions for use

Adolescents 14 years and older and adults

a sufficient amount (approx. 1-4 g)

twice daily

morning and evening

Areas of Use

Mode of Action

How does the active ingredient in the drug work?

The active ingredient has analgesic, antipyretic, and anti-inflammatory effects. The drug also has antirheumatic properties. It blocks the production of certain messenger substances in the body, so-called prostaglandins. These play a key role in the development of pain, fever, and inflammation.

Composition

Contraindications

What speaks against use?

- Hypersensitivity to the ingredients
- Open wounds, inflammations, or infections of the skin
- Eczema

Which age group should be considered?
- Children under 14 years of age: This medicine must not be used.

What about pregnancy and breastfeeding?
- Pregnancy: Consult your doctor. Various considerations play a role in whether and how the medicine can be used during pregnancy.
- Breastfeeding: Consult your doctor or pharmacist. They will assess your specific situation and advise you accordingly on whether and how you can continue breastfeeding.

If you have been prescribed the medicine despite a contraindication, consult your doctor or pharmacist. The therapeutic benefit may outweigh the risk associated with use with a contraindication.

Side effects

What adverse effects may occur?

- Hypersensitivity skin reactions, such as:
- Itching
- Reddening of the skin
- Rash
- Inflammatory skin reactions
- Contact dermatitis (allergic skin reactions that only occur with repeated use)
- Eczema
- Scaling of the skin
- Drying of the skin
- Water retention (edema)

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information provided here, we primarily consider side effects that occur in at least one in 1,000 treated patients.

Notes

What should you be aware of?
- Caution: Patients with nasal polyps, chronic respiratory infections, asthma, or a tendency to allergic reactions such as hay fever: This medicine may trigger an asthma attack or a severe allergic skin reaction. Therefore, consult your doctor before use.
- Caution if you are allergic to painkillers!
- Antioxidants (e.g., butylhydroxyanisole, butylhydroxytoluene) may cause skin irritation (e.g., contact dermatitis), eye irritation, and mucous membrane irritation.
- Solvents (e.g., propylene glycol, E 477) may cause skin irritation.

Detailed instructions for DICLOFENAC STADA Pain gel forte 20 mg/g, 180 g

Area of application

Diclofenac Stada Schmerzgel Forte 20 mg/g (Pack size: 180 g) For the short-term, local, symptomatic treatment of mild to moderate pain in acute strains, sprains, or bruises resulting from blunt trauma.

For acute injuries, muscle pain, and back pain.

Diclofenac STADA® forte relieves pain.
Diclofenac STADA® Schmerzgel forte has twice the concentration of the analgesic diclofenac and enables sustained release of the active ingredient into the tissue. Diclofenac STADA® also offers effective treatment for acute strains, sprains, or bruises. The pain gel targets the areas where the pain occurs.

HÄUFIGE FRAGEN & ANTWORTEN

Driving and using machines: Diclofenac STADA® forte has no or negligible influence on the ability to drive and use machines.

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

Pregnancy
During the first 6 months of pregnancy, Diclofenac STADA® forte should only be used after consulting a doctor.
You must not use Diclofenac STADA® forte during the last 3 months of pregnancy, as an increased risk of complications for mother and child cannot be ruled out.

Breast-feeding
Diclofenac passes into breast milk in small amounts. Diclofenac STADA® forte should only be used during breastfeeding after consulting a doctor. Do not use Diclofenac STADA® forte on the breast area or elsewhere on large areas of skin, or for an extended period of time.

Active ingredients / Ingredients

Diclofenac Stada Schmerzgel Forte 20 mg/g (Pack size: 180 g) contains:

The active ingredient is diclofenac.
1 g of gel contains 23.2 mg of diclofenac N-ethylethanamine, equivalent to 20 mg of diclofenac sodium.

The other ingredients are: Propylene glycol (E 1520), oleyl alcohol (Ph. Eur.), 2-propanol (Ph. Eur.), butylhydroxytoluene (Ph. Eur.) (E 321), N-ethylethanamine, liquid paraffin, macrogol cetostearyl ether (Ph. Eur.), carbomer 980, cocoyl caprylocaprate (Ph. Eur.), perfume cream (contains eugenol and citral), purified water.

Contraindications

Diclofenac Stada Schmerzgel Forte 20 mg/g (pack size: 180 g) should not be used if you are hypersensitive to any of the ingredients.

Dosage

Recommended use of Diclofenac Stada Schmerzgel Forte 20 mg/g (pack size: 180 g):

Always use this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you.
Consult your doctor or pharmacist if you are unsure.

Method of use
Diclofenac STADA® forte is for cutaneous use only.
Apply a thin layer of Diclofenac STADA® forte to the affected areas of the body and rub it gently into the skin. Do not rub it in with force. Afterwards, wipe your hands with a paper towel and then wash them, unless they are the area to be treated. Dispose of the paper towel in the general waste.
Diclofenac STADA® forte should be allowed to dry on the skin for a few minutes before applying a dressing. Also, wait until the gel has dried on the skin before showering or bathing.

Adults and adolescents 14 years and older
Diclofenac STADA® forte should be applied twice daily (preferably morning and evening).
Depending on the size of the affected area to be treated, a cherry- to walnut-sized amount, corresponding to 1 to 4 g of gel, is required.
The maximum total daily dose is 8 g of gel.


Elderly patients
No special dosage adjustment is required.
If you are elderly, you should pay particular attention to side effects and consult a doctor or pharmacist if necessary.

Impaired kidney or liver function
No dose reduction is necessary.

Use in children and adolescents (under 14 years of age)
Diclofenac STADA® forte should not be used in children and adolescents under 14 years of age.

Duration of use
The duration of use depends on the symptoms and the underlying condition. Diclofenac STADA® forte should not be used for longer than 7 days without medical advice. Consult a doctor if symptoms worsen or do not improve after 3–5 days.

How to take

• This medicine is intended for cutaneous application.
• Apply a thin layer of gel to the affected areas of the body and rub it gently into the skin. It should not be rubbed in with pressure. Afterwards, wipe your hands on a paper towel and then wash them, unless they are the area to be treated. The paper towel should be disposed of with general waste.
• Before applying a bandage, the product should be allowed to dry on the skin for a few minutes. Also, wait until the gel has dried on the skin before showering or bathing.

Patient Information

• Warnings and Precautions
  • Please consult your doctor or pharmacist before using this medicine.
    • If the gel is applied to large areas of the skin and used for a long period of time, the occurrence of systemic (affecting the entire body) side effects due to the use of the product cannot be ruled out. The gel should therefore be used with caution in patients with impaired renal, cardiac, or hepatic function, as well as in patients with active peptic ulcers in the stomach or duodenum.
    • The medicine should only be applied to intact, undisturbed, or unbroken skin. The medicine should not come into contact with the eyes or mucous membranes, and it should not be ingested.
    • After applying the gel to the skin, you can use a permeable (non-occlusive) dressing. However, the gel should be allowed to dry on the skin for a few minutes before applying a dressing. Do not use an airtight occlusive dressing.
    • Consult a doctor if symptoms worsen or do not improve after 3-5 days.
    • If you suffer from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps), chronic bronchoconstrictive (obstructive) respiratory diseases, chronic respiratory infections (especially those associated with hay fever-like symptoms), or hypersensitivity to other painkillers and antirheumatic drugs of any kind, you are more at risk than other patients of asthma attacks (so-called analgesic intolerance/analgesic asthma), local swelling of the skin or mucous membranes (so-called Quincke's edema), or urticaria. In these patients, the medication may only be used under certain precautions (emergency readiness) and under direct medical supervision. The same applies to patients who also experience allergic reactions to other substances, such as skin reactions, itching, or hives.
    • Discontinue treatment if a skin rash occurs during treatment with the medicine.
    • There is a risk of skin reactions if you are exposed to direct sunlight or artificial tanning. 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 rubbed skin.
  • Children and Adolescents
    • This medicine should not be used in children and adolescents under 14 years of age.

 

• Driving and Using Machines
  • This medicine has no or negligible influence on the ability to drive and use machines.

Pregnancy

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
• Pregnancy
  • During the first 6 months of pregnancy, this medicine should only be used after consulting a doctor.
  • Do not use this medicine during the last three months of pregnancy, as an increased risk of complications for mother and child cannot be ruled out.
• Breast-feeding
  • Diclofenac passes into breast milk in small amounts. This medicine should only be used during breastfeeding after consulting a doctor. Do not use this medicine in the breast area or on large areas of skin, or for extended periods.

Notes

Mandatory information for end users
Diclofenac STADA® Schmerzgel forte 20 mg/g Gel
For use in adults and adolescents aged 14 years and over.
Active ingredient: Diclofenac (as diclofenac-N-ethylethanamine).
For the short-term, local, symptomatic treatment of mild to moderate pain in acute strains, sprains, or bruises resulting from blunt trauma. Note: Contains propylene glycol, butylhydroxytoluene, and a fragrance containing eugenol and citral. The maximum total daily dose is 8 g of gel.
For risks and side effects, read the package insert and consult your doctor or pharmacist.
STADA Consumer Health Deutschland GmbH, Stadastraße 2-18, 61118 Bad Vilbel
As of: February 2023

Manufacturer:  STADA Consumer Health Deutschland, Stadastraße 2-18