DOLIFEN 11.6 mg/g GEL

Introduction

Leaflet: information for the user

Dolifen11.6 mg/g gel

diclofenac, diethylamine

Contents of the leaflet:

1. What is Dolifen and what is it 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. Package contents and additional information

1. What is Dolifen and what is it used for

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

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

• small bruises, blows, strains,
• torticollis or other contractures,
• low back pain (occasional back pain)
• mild sprains caused by a twist

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

Do not use Dolifen:

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

The symptoms related to an allergic reaction to these medicines can 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 to wounds, eczematous lesions, or burns, or to mucous membranes.

Warnings and precautions

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

• Do not use during the first and second trimester of pregnancy unless medically justified.

Children and adolescents

Do not use in children under 14 years old.

Other medicines and Dolifen

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

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

Do not use Dolifen gel during the first 6 months of pregnancy, unless it is strictly necessary and recommended by your doctor. If you need treatment during this period, you should use the minimum possible dose for the shortest possible time.

The oral formulations (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is not known if this same risk applies to Dolifen gel when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

During breastfeeding, do not use this medicine, unless your doctor has indicated it, as diclofenac passes into breast milk in small amounts.

Do not apply it in any case to breastfeeding mothers directly on the breast area, or on other areas in large areas of the skin or for prolonged periods of time.

Driving and using machines

No effects of the medicine on the ability to drive vehicles or use machinery have been described.

Dolifen contains propylene glycol(E 1520)

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

3. How to use Dolifen

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults and adolescents over 14 years old:

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

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

Use the minimum amount for the minimum time necessary.

Mode 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 is open.
• Spread a thin layer of the gel over the area of the skin where there is pain and inflammation, using a gentle massage.
• Close the tube well after each use.

After application:

• Wash your hands with a paper towel, and then wash them, unless they are the treatment area. The paper should be thrown away after use.
• Wait for the medicine to dry on the skin before showering or bathing.

If the pain or swelling worsens or persists after 7 days of treatment, consult your doctor.

If you use more Dolifen than you should

If you have applied too much of the medicine, 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, adverse reactions similar to those produced by diclofenac when taken orally (e.g., tablets) may occur.

The main symptoms of overdose are: gastrointestinal or kidney disorders and difficulty breathing.

In case of overdose or accidental ingestion, go immediately to your doctor, pharmacist, or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to use Dolifen

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

Do not apply a double dose to make up for the forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some rare and very rare side effects can be serious:

If you suffer from any serious side effect, stop the treatment with this medicine and inform your doctor immediately.

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

• Skin rash with or without blisters; urticaria (red, raised, and often itchy patches).

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

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

Non-serious side effects

Other side effects may occur, but they are usually mild and temporary. 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 burning sensation on 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). The signs 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.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolifen

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

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, cetostearyl ether of macrogol, capric/caprylic triglyceride, isopropyl alcohol, liquid paraffin, lavender essence, propylene glycol (E-1520), and purified water.

Appearance of the product and package contents

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

Each tube contains 60 grams of gel.

Marketing authorization holder:

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer:

Faes Farma Portugal, S.A.

Rua Elias García, 28

2700-327 Amadora

Portugal

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

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es./