DICLODUO GEL

Package leaflet: Information for the user

DicloDuo gel
10 mg/g, gel
(Diclofenacum natricum)
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used according to the instructions in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or further information.
• If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.

Table of contents
1. What DicloDuo gel is and what it is 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 pack and other information

1. What DicloDuo gel is and what it is used for

DicloDuo gel is a topical gel. The active substance is sodium diclofenac at a concentration of 10 mg/g, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
The medicine has analgesic, anti-inflammatory and anti-edematous effects.
DicloDuo gel has a soothing and cooling effect on the skin.

Indications for use:

Adolescents over 14 years of age
Short-term treatment:
Local symptomatic treatment of pain due to acute strains, sprains or contusions caused by blunt trauma.

Adults
Local symptomatic treatment of pain and inflammation in:

• Injuries of tendons, ligaments, muscles and joints, e.g. due to sprains, strains and contusions
• Localized inflammatory conditions of soft tissues
• Mild forms of degenerative joint disease.

If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.

2. Important information before using DicloDuo gel

When not to use DicloDuo gel

• If the patient is allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6),
• If the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid,
• During the last three months of pregnancy,
• In children and adolescents under 14 years of age,
• In patients who experience asthma attacks, urticaria, or acute inflammation of the nasal mucosa after taking acetylsalicylic acid or other NSAIDs.

Warnings and precautions

• Do not apply to cuts, open wounds or skin rashes.
• Do not apply to eyes, nose or mouth. If the gel comes into contact with the eyes or mucous membranes, rinse thoroughly with water.
• Do not use for prolonged periods or over large areas of skin, as systemic adverse reactions may occur.
• Do not swallow DicloDuo gel.
• Do not cover treated areas with occlusive dressings (waterproof or air-tight) or plaster casts.
• Avoid sunbathing and using solariums during treatment with DicloDuo gel and for two weeks after treatment ends.

Patients with a history of or active peptic ulcer disease, and patients with bronchial asthma, should consult their doctor before using DicloDuo gel, as these conditions increase the risk of adverse effects. In isolated cases, patients with a history of active peptic ulcer disease may be at risk of gastrointestinal bleeding.

Consult your doctor before starting treatment with DicloDuo gel.

Other medicines and DicloDuo gel
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use DicloDuo gel during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. During the first six months of pregnancy, DicloDuo gel should not be used unless necessary and prescribed by a doctor. If use is necessary, the lowest dose for the shortest possible duration should be applied.
Oral formulations of diclofenac (e.g. tablets) may cause adverse effects in the unborn child. It is unknown whether the same risk applies to DicloDuo gel when applied to the skin.
Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
DicloDuo gel does not affect the ability to drive or operate machinery.

DicloDuo gel contains propylene glycol
This medicine contains 50 mg of propylene glycol, which may cause skin irritation.

DicloDuo gel contains fragrance
This medicine contains a fragrance composed of: amyl cinnamic aldehyde, coumarin, d-limonene and hexyl cinnamic aldehyde. Amyl cinnamic aldehyde, coumarin, d-limonene and hexyl cinnamic aldehyde may cause allergic reactions.

3. How to use DicloDuo gel

This medicine should always be used as described in the leaflet or as advised by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Use in adults and adolescents over 14 years of age:
Unless otherwise directed by a doctor, this medicine should be used as follows:
apply the gel 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, corresponding to a strip of gel
4 cm to 8 cm in length. This quantity is sufficient to cover approximately 400 to 800 cm² of skin surface.
The medicine should be applied 3 to 4 times daily.
In case of accidental ingestion, contact a doctor immediately.
After applying the medicine, wash your hands unless they are the area being treated.
Duration of treatment in adults:
The duration of treatment depends on the indication and the response to therapy. In the treatment of pain
associated with degenerative joint disease, the gel may 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 medicine without consulting a doctor, do not use it for longer than 14 days.
Medical evaluation after 7 days of using the gel is recommended if there is no improvement in symptoms or if
symptoms worsen.
Use in children and adolescents
Use in adolescents under 14 years of age:
There are insufficient data on the efficacy and safety of use in adolescents under 14 years of age.
Duration of treatment in adolescents over 14 years of age:
In adolescents aged 14 years and older, the medicine must not be used for longer than 7 days.
If treatment requires more than 7 days or if symptoms worsen, the patient or caregiver should contact a doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions occurring rarely or very rarely may be dangerous.
Adverse reactions which may be symptoms of allergy:

• very rare (may occur in not more than 1 in 10,000 people): skin rash with blisters, breathlessness or feeling of tightness in the chest (asthma), wheezing or swelling of the face, lips, tongue or throat.

If any of the above symptoms occur, stop using the medicine immediately and contact your doctor or go to the nearest hospital.
Other adverse reactions, usually mild, harmless and transient:

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

If any of the above symptoms occur, inform your doctor or pharmacist as soon as possible.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store DicloDuo gel

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

6. Contents of the pack and other information

What DicloDuo gel contains
The active substance is sodium diclofenac.
Other ingredients are: tromethamine, cocoyl caprylocapronate, cetostearyl macrogol ether, isopropyl alcohol, carbomer, propylene glycol, paraffin, purified water, fragrance composition containing amyl cinnamal aldehyde, coumarin, d-limonene and hexyl cinnamal aldehyde.

What DicloDuo gel looks like and contents of the pack
DicloDuo gel is a topical gel medicine, white in colour.
Pack: aluminium tube containing 50 g, 60 g or 100 g of gel.
Outer packaging: cardboard box.

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

Manufacturer:
EMO-FARM Sp. z o.o.
Łódzka 52
95-054 Ksawerów
Poland

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland - DicloDuo gel

November 2024