Leaflet: information for the user

Dolifen11,6 mg/g gel

diclofenaco, dietilamina

1.What is Dolifen and what it is used for.

2.What you need to know before starting to use Dolifen.

3.How to use Dolifen.

4.Possible side effects

5.Storage of Dolifen.

6.Contents of the pack and additional information

Diclofenac diethylamine, the active ingredient of this medication, belongs to the group of nonsteroidal anti-inflammatory drugs and acts as a local analgesic and anti-inflammatory.

This medication is indicated in adults and adolescents over 14 years old for local relief of mild and occasional pain and inflammation caused by:

• small bruises, blows, strains,
• stiff neck or other contractures,
• occasional back pain
• mild sprains resulting from a twist

Do not use Dolifen:

• If you are allergic to diclofenac or any other nonsteroidal anti-inflammatory drug used in the treatment of pain such as ibuprofen or acetylsalicylic acid, or to any of the other components of this medication(listed in section 6).

The symptoms related to an allergic reaction to these medications may be: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue

• If you are in the last 3 months of pregnancy.
• If you are under 14 years old.
• Do not apply on wounds, eczematous lesions, or on burns or mucous membranes.

Warnings and precautions

• Do not apply in areas of the skin where there are cuts or open wounds, or on mucous membranes, or on eczemas or areas of the skin where there is a skin rash. Stop using the medication if a skin rash occurs after application.
• Do not use on extensive areas, use exclusively on the affected area.
• Avoid contact of this medication with the eyes. If this occurs, rinse the eyes with clean water. Consult your doctor or pharmacist if you feel any discomfort afterwards.
• Do not use occlusive dressings (e.g. plastic dressings).
• Do not use more of the medication than indicated, or for a longer period than indicated, except on the advice of your doctor.
• Do not apply this medication simultaneously on the area where you have applied other medications.
• Do not ingest this medication or use it in the mouth. This medication is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet radiation lamps (UVA rays)

-Do not use during the first and second trimester of pregnancy, except on medical advice.

Children and adolescents

Do not use in children under 14 years old.

Other medications and Dolifen

Inform your doctor or pharmacist if you are using, or have used recently, or may have to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Do not use Dolifen gel if you are in the last 3 months of pregnancy, as it may harm the future baby or cause problems during delivery.

You should not use Dolifen gel during the first 6 months of pregnancy, except on strict medical advice. If you need treatment during this period, you must use the minimum dose possible for the shortest time possible.

Oral formulations (e.g. tablets) of diclofenac may cause adverse reactions to the fetus. It is unknown if this same risk applies to Dolifen gel when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not usethis medication, except on the advice of your doctor, as diclofenac passes into breast milk in small amounts.

Do not apply it in any case directly on the breast area, or on extensive areas of the skin or for prolonged periods of time.

Driving and operating machinery

No effects of the medication on the ability to drive vehicles and use machinery have been described.

Dolifen contains propylene glycol(E 1520)

This medication contains 200mg of propylene glycol (E 1520) in 4 g of gel, equivalent to 50mg/g. Propylene glycol may cause skin irritation.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for application on the skin (cutaneous use).

The recommended dose is:

Adults and adolescents over 14 years:

Apply 3 or 4 times a day a small amount of gel on the inflamed or painful area.

The amount of gel will vary depending on the size of the affected area (usually, it will be enough to apply an amount similar to the size of a cherry or a walnut).

Use the smallest amount for the shortest time necessary.

Method of use:

• For the first use of the tube, unscrew the cap. Insert the back of the cap into the piece that closes the tube. Turn the cap until the tube opens.

• Extend a thin layer of gel on the skin area where there is pain and inflammation, using a gentle massage.

• Close the tube well after each use.

After application:

If the pain or swelling worsen or persist after 7 days of treatment, consult your doctor.

If you use more Dolifen than you should

If you have applied too much of the medication, it is recommended to remove it by washing the affected area with plenty of water.

If you accidentally ingest the gel or if you have used it on a large area of the skin and for a long period of time, similar adverse reactions to those produced by diclofenac when taken orally (e.g. tablets) may occur.

The main symptoms of overdose are: digestive or renal disorders and difficulty breathing.

In case of overdose or accidental ingestion, go immediately to your doctor, pharmacist or call the Toxicological Information Service, Tel.: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you forgot to use Dolifen

If you forgot to apply this medication when it was due, apply the gel as soon as possible and continue with the normal treatment.

Do not apply a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Some rare and very rare adverse effects may be severe:

If you experience a severe adverse effect,interrupt treatment with this medication and inform your doctor immediately.

Rare:May affect up to 1 in 1,000 patients

• Skin rash, with or without blisters; urticaria (red, elevated patches, often with a sensation of itching and burning).

Very rare:May affect up to 1 in 10,000 patients

• Difficulty breathing or sensation of pressure in the chest (asthma); swelling in the face, lips, mouth, tongue, or throat.

Mild adverse effects

Other adverse effects may occur, but these are usually mild and ofshort duration. If you notice any of them, consult your doctor or pharmacist as soon as possible.

Common:May affect up to 1 in 10 patients.

• Rash, itching, redness, or stinging sensation in the skin after using the product.

Very rare:May affect up to 1 in 10,000 patients

• The skin may be more sensitive to the sun (photosensitivity). Signs include sunburn with itching, swelling, and blisters.

Unknown frequency:Cannot be estimated from available data

• Burning sensation at the application site; dry skin.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaRAM.es).By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not use this medicine after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dolifen

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine (which corresponds to 10 mg of diclofenac sodium).
• The other components are: diethylamine, carbomer, cetoestearic ether of macrogol, caprilocaprate of cocoilic acid, isopropyl alcohol, liquid paraffin, lavender essence, propylene glycol (E-1520) and purified water.

Appearance of the product and content of the packaging

White, consistent, homogeneous gel with a characteristic lavender and isopropyl alcohol odor. It is presented in a sealed aluminum tube with an aluminum membrane and a polypropylene screw cap.

Each tube contains 60 grams of gel.

Holder of the marketing authorization:

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing:

Faes Farma Portugal, S.A.

Rua Elias García, 28

2700-327 Amadora

Portugal

Date of the last review of this leaflet:09/2024

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es./