Diclac Lipogel

Package Leaflet: Information for the Patient

Diclac LipoGel, 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 exactly as described in this package leaflet for the patient or as advised 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 further information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 pack and other information

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

Diclac LipoGel is a gel for rubbing into the skin. 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 acts as a pain reliever, anti-inflammatory, and anti-swelling agent.
It is used for local treatment:

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

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 blisters or hives, 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 eczema. 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 it is your hands that are being treated. The used paper towel should be thrown away in the trash. 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 contact 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 pain treatment is necessary for longer than 7 days or if symptoms worsen, you should contact 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 baby, you should ask your doctor or pharmacist for advice 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.
In the first six months of pregnancy, Diclac LipoGel should not be used unless it is necessary and advised by your doctor. If use is necessary, the lowest possible 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 whether the same risk applies to Diclac LipoGel when used on the skin.
Diclac LipoGel is not recommended during breastfeeding. If your doctor advises you to use it during this time, you should not apply the medicine to your breasts, use it for a long time, or on large areas of skin.
If you have any further questions on the use of Diclac LipoGel in pregnant or breastfeeding women, you should ask your doctor or pharmacist.

Driving and using machines

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

Diclac Lipogel contains a fragrant substance (including benzyl alcohol and benzyl benzoate)

Diclac Lipogel contains a fragrant substance containing allergens:
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amylcinnamaldehyde, hexylcinnamaldehyde, benzyl alcohol, pentylcinnamyl alcohol, benzyl benzoate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, iso-eugenol, coumarin, d-limonene, and linalool. These may cause allergic reactions.
This medicine contains benzyl alcohol. The medicine may cause mild local irritation.
This medicine contains benzyl benzoate. Benzyl benzoate may cause mild local irritation.

3. How to use Diclac LipoGel

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by your doctor or pharmacist. If you are unsure, you should speak to your doctor or pharmacist.
Diclac LipoGel should be used locally on the skin, on the affected areas of the body, three or four times a day, gently rubbing in.
The amount of gel to be used should be adjusted to the size of the affected area: 2 g to 4 g of gel (an amount corresponding 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 it is your hands that are 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 the household trash to prevent the unused medicine from getting into 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 and 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 notuse 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 degenerative joint disease, unless your doctor advises otherwise.
If pain and swelling do not improve within 7 days or worsen, you should contact your doctor.

Using more Diclac LipoGel than recommended

If you use more Diclac LipoGel than you should 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 questions about using this medicine, you should speak to 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 are rare or very rare, but they 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 contact your doctor or go to the nearest hospital:

Rare (may affect up to 1 in 1,000 people using the medicine):
skin rash with blisters, hives (bullous dermatitis).
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 hives-like rash, rash with pus-filled blisters, increased sensitivity of the skin to sunlight. Symptoms of hypersensitivity include sunburn with itching, swelling, and blisters.
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 site of application, dry skin.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 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 after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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, fragrant oil "Vert de Creme-lilialfree" (contains 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amylcinnamaldehyde, hexylcinnamaldehyde, benzyl alcohol, pentylcinnamyl alcohol, benzyl benzoate, benzyl salicylate, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, iso-eugenol, coumarin, d-limonene, linalool), isopropyl alcohol, purified water.

What Diclac LipoGel looks like and contents of the pack

Diclac LipoGel is available in an aluminum tube with a screw cap, in a cardboard box.
The pack contains 50 g or 100 g of gel.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Salutas Pharma GmbH
Lange Göhren 3
39171 Osterweddingen, Germany
To obtain more detailed information, you should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

Date of last revision of the leaflet:

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