Diclac Lipogel

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Diclac LipoGel (Diclofenac Sandoz 10 mg/g Gel)

10 mg/g, gel

Diclofenac sodium
Diclac LipoGel and Diclofenac Sandoz 10 mg/g Gel are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Diclac LipoGel and what is it used for
• 2. Important information before using Diclac LipoGel
• 3. How to use Diclac LipoGel
• 4. Possible side effects
• 5. How to store Diclac LipoGel
• 6. Contents of the packaging and other information

1. What is Diclac LipoGel and what is it used for

Diclac LipoGel is a gel for topical use. The active substance of the medicine, diclofenac, belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). Diclac LipoGel has a liposomal structure, which facilitates the absorption of the medicine through the skin. The water-alcohol base of the gel also provides a soothing and cooling effect.
The medicine has analgesic, anti-inflammatory, and anti-edematous effects.
It is used for local treatment of:

• in adults and adolescents over 14 years of age:
• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., resulting from sprains, strains, or bruises);
• back pain;
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.
• in adults (over 18 years of age)
• limited and mild forms of osteoarthritis.

2. Important information before using Diclac LipoGel

When not to use Diclac LipoGel

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• Symptoms of hypersensitivity to the medicine may include: wheezing or shortness of breath (asthma), skin rash with blistering or urticaria, swelling of the face or tongue, inflammation of the nasal mucosa (rhinitis);
• if you have ever had an allergic reaction (e.g., rash, difficulty breathing, or coughing fit) after using medicines containing acetylsalicylic acid, ibuprofen, or other medicines used to treat joint and muscle pain;
• in the last three months of pregnancy (see also "Pregnancy, breastfeeding, and fertility");
• in children and adolescents under 14 years of age.

Warnings and precautions

Before using Diclac LipoGel, you should discuss it with your doctor or pharmacist.
The gel can only be used on undamaged, healthy skin. It must not be applied to diseased skin, open wounds, or skin eruptions. You should stop using the medicine if a skin rash appears after application.
You should avoid using the medicine on large areas of skin and for a long time, unless advised by your doctor.
Diclac LipoGel is for external use only. It must not be used in the mouth. After use, you should wipe your hands with a paper towel (not a wet wipe) and then wash them, unless your hands are the area being treated. The used paper towel should be thrown away in a bin. You should avoid contact between the gel and your eyes. If the medicine gets into your eyes, you should rinse them with clean water and consult your doctor or pharmacist.
The area where Diclac LipoGel is applied can be covered with a bandage, but you should not use airtight bandages (so-called occlusive dressings).
You should be careful when sunbathing or using a sunbed, as your skin may be more sensitive to light during treatment with Diclac LipoGel.
Patients should be warned to be careful when smoking or near an open flame, due to the risk of severe burns. Diclac Lipogel contains paraffin, which is potentially flammable when it settles on fabrics (clothing, bedding, dressings, etc.).
Washing clothes and bedding may reduce the deposition of the product, but it may not completely remove it.

Use in children and adolescents

Children and adolescents under 14 years of age
Because there is insufficient data on the efficacy and safety of using Diclac LipoGel in children and adolescents under 14 years of age, the medicine must not be used in this age group.
Adolescents over 14 years of age
If it is necessary to use the medicine for pain for more than 7 days or if symptoms worsen, you should consult your doctor.

Diclac LipoGel and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Diclac LipoGel must not be used during the last three months of pregnancy, as it may harm the fetus or cause difficulties during delivery.
Diclac LipoGel should not be used during the first six months of pregnancy, unless it is necessary and advised by your doctor. If use is necessary, the smallest dose should be given for the shortest possible time.
After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Diclac LipoGel when used on the skin.
It is not recommended to use Diclac LipoGel during breastfeeding. However, if your doctor advises its use during this time, the medicine should not be applied to the breasts, used for a long time, or on large areas of skin.
If you have any further doubts about using Diclac LipoGel in pregnant or breastfeeding women, you should consult your doctor or pharmacist.

Driving and using machines

Diclac LipoGel does not affect the ability to drive or use machines.

3. How to use Diclac LipoGel

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Diclac LipoGel should be used topically on the skin, on the affected areas of the body, three or four times a day, gently rubbing in.
The amount of gel should be adjusted to the size of the affected area: 2 g to 4 g of gel (an amount equivalent to the size of a cherry to a walnut) is sufficient to treat a skin area of about 400 cm to 800 cm. After applying the medicine, you should wipe your hands with a paper towel and then wash them, unless your hands are the area being treated. If you accidentally apply too much gel, the excess should be wiped off with a paper towel. The used paper towel should be thrown away in a household waste bin to prevent the unused medicine from entering the water environment.
Before taking a shower or bath, you should wait until Diclac Lipogel has dried.
Use only on undamaged skin.
You should avoid contact between the gel and your eyes or mucous membranes.
The area where Diclac LipoGel is applied can be covered with a bandage, but you should not use airtight bandages (so-called occlusive dressings). Before applying a bandage, the gel should be left to dry on the skin for a few minutes.

Do not use the medicine for longer than:

• in adults and adolescents over 14 years of age: 14 days for muscle and joint injuries (sprains, strains, or bruises) and tendonitis;
• in adults (over 18 years of age): 21 days for pain associated with osteoarthritis, unless otherwise advised by your doctor.

If pain and swelling do not improve within 7 days or worsen, you should consult your doctor.

Using more than the recommended dose of Diclac LipoGel

If you use more Diclac LipoGel than recommended or accidentally swallow the gel, you should contact your doctor immediately.

Missing a dose of Diclac LipoGel

If you miss a dose of Diclac LipoGel, you should not use a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diclac LipoGel can cause side effects, although not everybody gets them.
Some side effects that occur rarely or very rarely can be serious.

If you experience any of the following symptoms, which may be signs of an allergic reaction, you should stop using the medicine immediately and consult your doctor or go to the nearest hospital:

Rare (may affect up to 1 in 1000 people using the medicine):
skin rash with blisters, urticaria (blistering skin rash).
Very rare (may affect up to 1 in 10,000 people using the medicine):
swelling of the face, lips, tongue, or throat, sudden difficulty breathing, and a feeling of tightness in the chest with wheezing or coughing (asthma).

Other side effects

Other side effects that may occur when using Diclac LipoGel are usually mild, harmless, and temporary. If you experience any of these symptoms, you should inform your doctor or pharmacist as soon as possible.
Common (may affect up to 1 in 10 people using the medicine):
skin rash, itching, redness of the skin.
Very rare (may affect up to 1 in 10,000 people using the medicine):
hypersensitivity reactions, including urticaria-like rash, rash with pus-filled blisters, increased sensitivity of the skin to sunlight. Symptoms of hypersensitivity include sunburn with itching, swelling, and blistering.
If a rash occurs, you should stop using the medicine.
Frequency not known (frequency cannot be estimated from the available data):
burning sensation at the application site, dry skin.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Diclac LipoGel

The medicine should be kept out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diclac LipoGel contains

The active substance of the medicine is diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium.
The other ingredients are: RRR-α-tocopherol, carbomer 980 NF, decyl oleate, 2-octyldodecanol, lecithin, ammonium hydroxide 10%, disodium edetate, fragrance, isopropyl alcohol, purified water.

What Diclac LipoGel looks like and what the packaging contains

Diclac LipoGel is available in an aluminum tube with a screw cap in a cardboard box.
The packaging contains 100 g of gel.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Sandoz Farmacêutica, Lda
Avenida Professor Doutor Cavaco Silva, n 10E
Taguspark, 2740-255 Porto Salvo
Portugal

Manufacturer:

Salutas Pharma GmbH
Lange Göhren 3 Osterweddingen
39171 Osterweddingen
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Portuguese marketing authorization number: 5519087
Parallel import authorization number:147/20

Date of leaflet approval: 18.06.2025

[Information about the trademark]