DICLODUO 10 mg /G Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. DicloDuo Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
   3. What is DicloDuo Gel and What is it Used For
3. Important Information Before Using DicloDuo Gel
4. How to Use DicloDuo Gel
5. Possible Side Effects
6. How to Store DicloDuo Gel
7. Contents of the Package and Other Information
8. What is DicloDuo Gel and What is it Used For
   1. Indications:
   2. Adolescents Over 14 Years of Age, Short-Term Treatment:
   3. Adults
9. Important Information Before Using DicloDuo Gel
   1. When Not to Use DicloDuo Gel
   2. Warnings and Precautions
   3. Other Medicinal Products and DicloDuo Gel
   4. Pregnancy and Breastfeeding
   5. Driving and Using Machines
   6. DicloDuo Gel Contains Propylene Glycol
   7. DicloDuo Gel Contains a Fragrance
10. How to Use DicloDuo Gel
    1. Use in Children and Adolescents Use in Adolescents Under 14 Years of Age:
11. Possible Side Effects
    1. If You Experience Any of the Above Symptoms, Stop Using the Medicinal Product Immediately, Consult a Doctor, or Go to the Nearest Hospital.
    2. Reporting Side Effects
12. How to Store DicloDuo Gel
13. Contents of the Package and Other Information
    1. What DicloDuo Gel Contains
    2. What DicloDuo Gel Looks Like and What the Package Contains
    3. Marketing Authorization Holder:
    4. Manufacturer:
    5. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:
    6. Poland
    7. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

DicloDuo Gel

10 mg/g, gel
(Diclofenac Sodium)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or further information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet

1.

What is DicloDuo Gel and What is it Used For

2. Important Information Before Using DicloDuo Gel

3. How to Use DicloDuo Gel

4. Possible Side Effects

5. How to Store DicloDuo Gel

6. Contents of the Package and Other Information

1. What is DicloDuo Gel and What is it Used For

DicloDuo Gel is a medicinal product in the form of a gel for topical use. The active substance of the medicinal product is diclofenac sodium in a concentration of 10 mg/g, which belongs to nonsteroidal anti-inflammatory drugs (NSAIDs).
The medicinal product has analgesic, anti-inflammatory, and anti-edematous effects.
The medicinal product has a soothing and cooling effect on the skin.

Indications:

Adolescents Over 14 Years of Age, Short-Term Treatment:

Local, symptomatic treatment of pain in acute sprains, strains, or bruises caused by blunt injuries.

Adults

Local, symptomatic treatment of pain and inflammation in:

• injuries to tendons, ligaments, muscles, and joints, e.g., due to sprains, strains, and bruises
• limited forms of soft tissue inflammation
• mild forms of degenerative joint disease.

If after 7 days there is no improvement or the patient feels worse, consult a doctor.

2. Important Information Before Using DicloDuo Gel

When Not to Use DicloDuo Gel

• if the patient is hypersensitive to diclofenac sodium or any of the other ingredients of this medicinal product (listed in section 6),
• if the patient is hypersensitive to other nonsteroidal anti-inflammatory drugs and acetylsalicylic acid,
• in the last three months of pregnancy,
• in children and adolescents under 14 years of age,
• in patients in whom asthma attacks, urticaria, or acute rhinitis are triggered by the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Warnings and Precautions

• Do not apply to open wounds, cuts, or skin eruptions,
• Do not apply to the eyes, nose, or mouth; in case the gel comes into contact with the eyes or mucous membranes, rinse thoroughly with water,
• Do not use the medicinal product for a long time or on large areas of skin, as there is a risk of systemic side effects,
• Do not swallow DicloDuo Gel,
• Do not cover the treated areas with occlusive dressings (waterproof or airtight) or plaster,
• Do not sunbathe or visit a solarium during treatment with DicloDuo Gel and for two weeks after the end of treatment. Patients with a history of or active peptic ulcer disease and patients with asthma should consult their doctor before using DicloDuo Gel, as these conditions pose a high risk of side effects. In individual cases, in patients who have had active peptic ulcer disease in the past, there is a likelihood of gastrointestinal bleeding.

Before starting treatment with DicloDuo Gel, consult a doctor.

Other Medicinal Products and DicloDuo Gel

Tell your doctor or pharmacist about all medicinal products you are currently using or have recently used, as well as any medicinal products you plan to use.

Pregnancy and Breastfeeding

In pregnancy and breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medicinal product.
Do not use DicloDuo Gel in the last three months of pregnancy due to the risk of fetal harm or difficulties during delivery. In the first six months of pregnancy, do not use DicloDuo Gel unless it is necessary and recommended by a doctor. If use is necessary, use the smallest possible dose for the shortest possible time.
After oral administration of diclofenac-containing medicinal products (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to DicloDuo Gel when used on the skin.
Use of the medicinal product during breastfeeding is not recommended.

Driving and Using Machines

Use of the medicinal product does not affect the ability to drive or operate machinery.

DicloDuo Gel Contains Propylene Glycol

The medicinal product contains 50 mg of propylene glycol. It may cause skin irritation.

DicloDuo Gel Contains a Fragrance

This medicinal product contains a fragrance with the following composition: amylcinnamaldehyde, coumarin, d-limonene, and hexylcinnamaldehyde. Amylcinnamaldehyde, coumarin, d-limonene, and hexylcinnamaldehyde may cause allergic reactions.

3. How to Use DicloDuo Gel

This medicinal product should always be used in accordance with the description in the package leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use in Adults and Adolescents Over 14 Years of Age:
If the doctor does not recommend otherwise, use the medicinal product as follows:
apply the medicinal product to the skin, spread it over the painful area, and gently massage until completely absorbed.
The amount of gel depends on the size of the painful area, usually 2 g to 4 g, which corresponds to a strip of gel 4 cm to 8 cm long. This is enough to cover an area of about 400 to 800 cm² of skin.
Use the medicinal product 3 to 4 times a day.
In case of accidental ingestion, consult a doctor.
After using the medicinal product, wash your hands unless they are being treated.
Duration of Use in Adults:
The duration of use depends on the indications and response to treatment. In the treatment of pain associated with degenerative joint disease, the gel can be used for up to 7 days (allowing for regeneration of damaged joint tissue). The gel may be used for up to 14 days only under the supervision of a pharmacist.
If using the medicinal product without consulting a doctor, do not use it for more than 14 days.
Medical supervision is recommended after 7 days of using the gel if there is no improvement or if symptoms worsen.

Use in Children and Adolescents Use in Adolescents Under 14 Years of Age:

There are no sufficient data on the efficacy and safety of use in adolescents under 14 years of age.
Duration of Use in Adolescents Over 14 Years of Age:
In adolescents over 14 years of age, the medicinal product should not be used for more than 7 days.
If use of the medicinal product requires a longer period than 7 days or if symptoms worsen, the patient or caregivers should consult a doctor.
If you have any further doubts about using this medicinal product, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, DicloDuo Gel can cause side effects, although not everybody gets them.
Some side effects that occur rarely or very rarely can be serious.
Side effects that may be symptoms of an allergic reaction:

• very rare (may occur in less than 1 in 10,000 people): skin rash with blisters, shortness of breath or feeling of tightness in the chest (asthma), wheezing or swelling of the face, lips, tongue, or throat.

If You Experience Any of the Above Symptoms, Stop Using the Medicinal Product Immediately, Consult a Doctor, or Go to the Nearest Hospital.

Other side effects, usually mild, harmless, and transient:

• common (may occur in less than 1 in 10 people): skin rash, local irritation, itching, redness, or burning of the skin;
• rare (may occur in less than 1 in 1,000 people): urticaria;
• very rare (may occur in less than 1 in 10,000 people): increased sensitivity to sunlight, symptoms of which are sunburn with itching, swelling, and blisters;
• frequency not known (cannot be estimated from the available data): burning sensation at the application site, dry skin.

If you experience any of the above symptoms, inform your doctor or pharmacist as soon as possible.

Reporting Side Effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store DicloDuo Gel

Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicinal product after the expiry date stated on the tube and carton, after "EXP".
The expiry date refers to the last day of that month.
Do not use this medicinal product if you notice a change in its appearance or smell.
Use the medicinal product within 6 months of first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What DicloDuo Gel Contains

The active substance is diclofenac sodium.
The other ingredients are: trometamol, cocoyl caprylocaprate, macrogol cetostearyl ether, isopropyl alcohol, carbomer, propylene glycol, paraffin, purified water, fragrance composition containing amylcinnamaldehyde, coumarin, d-limonene, and hexylcinnamaldehyde.

What DicloDuo Gel Looks Like and What the Package Contains

DicloDuo Gel is a medicinal product in the form of a gel for topical use, white in color.
Packaging: aluminum tube containing 50 g, 60 g, or 100 g of the medicinal product.
Outer packaging: cardboard box.

Marketing Authorization Holder:

BAUSCH HEALTH IRELAND LIMITED
3013 Lake Drive, Citywest Business Campus,
Dublin 24, D24 PPT3
Ireland

Manufacturer:

EMO-FARM Sp. z o.o.
ul. Łódzka 52
95-054 Ksawerów

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Poland

• -DicloDuo Gel

Date of Last Revision of the Leaflet:

November 2024