ratioDolor Diclofenac Pain Gel 2%

ratioDolor Diclofenac Pain Relief Gel contains the active substance diclofenac, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

ratioDolor Diclofenac Pain Relief Gel is used in adults and adolescents aged 14 and over.

For adults and adolescents from the age of 14
For the local, symptomatic treatment of pain in acute strains, sprains or bruises as a result of blunt trauma.

The drug is intended for short-term treatment in adolescents aged 14 and over.

Contraindications

ratioDolor Diclofenac Pain Relief Gel must not be used

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you have ever experienced breathing problems (asthma, bronchospasm), hives, runny nose or swelling of the face or tongue after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (e.g. ibuprofen);
• in patients with bronchial asthma or other respiratory diseases associated with marked hypersensitivity of the airways. Inhaling ratioDolor Diclofenac Pain Relief Gel can cause shortness of breath or trigger an asthma attack.
• on open injuries, inflammation or infections of the skin as well as on eczema or mucous membranes;
• in the last trimester of pregnancy (see “Pregnancy”);
• in children and adolescents under 14 years of age.

interactions

Other medicines and ratioDolor Diclofenac Pain Relief Gel Tell
your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use other medicines.

If ratioDolor Diclofenac Pain Gel is used as intended on the skin, no interactions have been reported to date.

Pregnancy and breast-feeding
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.

Pregnancy
You must not use ratioDolor Diclofenac Pain Relief Gel during the last trimester of pregnancy, as it can harm the unborn child or cause problems during birth. In the first and second trimester of pregnancy, ratioDolor Diclofenac Pain Gel may only be used after consulting a doctor.

Breast- feeding
Since small amounts of diclofenac pass into breast milk, ratioDolor Diclofenac Pain Relief Gel may only be used during breast-feeding after consulting a doctor. If you are breastfeeding, you must not apply ratioDolor Diclofenac Pain Relief Gel to the chest area, to large areas of skin or over a longer period of time.

application

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents from the age of 14 years
ratioDolor Diclofenac Pain Gel 2% Gel should be used twice a day (preferably in the morning and in the 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.

Elderly
No specific dose adjustment is required. However, elderly patients should pay particular attention to side effects and, if necessary, consult their doctor or pharmacist.

Impaired kidney or liver function
No dose reduction is required.

Use in children and adolescents (under 14 years of age)
ratioDolor Diclofenac Pain Relief Gel must not be used in children under 14 years of age (see section 2 "Do not use ratioDolor Diclofenac Pain Relief Gel").

Before 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 over the opening of the tube. You must not use scissors or other sharp objects!
2. Remove the plastic seal from the tube by twisting. Use the gel as described in this leaflet. If the seal is broken, you must not use the product.

Applying the gel:
ratioDolor Diclofenac Pain Gel is intended for use on the skin.
Apply the gel thinly to the affected parts of the body and rub it gently into the skin. Wash your hands after rubbing the gel in, unless this is the area to be treated.

Duration of treatment:
The duration of use depends on the symptoms and the underlying disease.
ratioDolor Diclofenac Pain Relief Gel should not be used for longer than 1 week without medical advice.

If the symptoms have not improved after 3-5 days or have even worsened, contact your doctor.

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 notice any of the following signs of allergy, stop using ratioDolor Diclofenac Pain Relief Gel and contact a doctor or pharmacist immediately:

• blistering skin rash; 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 possible side effects include:
Common side effects (may affect up to 1 in 10 people):
rash, itching, redness, eczema, dermatitis (inflammation of the skin) including contact dermatitis.

Uncommon side effects (may affect up to 1 in 100 people):
flaking, dry skin, swelling (oedema).

Very rare side effects (may affect up to 1 in 10,000 people):
pustular rash, gastrointestinal discomfort, hypersensitivity reactions (including hives), photosensitivity with the occurrence of skin reactions after exposure to the sun.

Frequency of side effects not known (cannot be estimated from the available data):
burning sensation at the application site, dry skin.

If ratioDolor Diclofenac Pain Relief Gel is applied to large areas of the skin and used over a longer period of time, the occurrence of systemic side effects (e.g. on the part of the kidneys, liver, gastrointestinal tract, general hypersensitivity reactions) as they may occur after systemic use of diclofenac-containing medicines cannot be completely ruled out.

composition

The active substance is diclofenac.
1 g contains 23.2 mg diclofenac diethylamine, equivalent to 20 mg diclofenac sodium.

The other ingredients are: isopropyl alcohol, propylene glycol (E1520), cocoyl caprylocaprate, liquid paraffin, carbomer, macrogolcetylstearyl ether, diethylethanamine, oleic acid (E570), butylated hydroxytoluene, fragrance (contains camphor, eucalyptol, ambroxide, citronellol, geraniol, benzyl alcohol, linalool, limonene , Citral, Farnesol, Coumarin, Eugenol), (contains Citronellol, Geraniol, Benzyl Alcohol, Linalool, Limonene, Citral, Farnesol, Coumarin, Eugenol), Purified Water.

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