Dolifen 11.6 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Dolifen 11.6 mg/g gel
diclofenac, diethylamine
Read the entire patient information leaflet carefully before you start using this medicine, as it contains important information for you. Always follow the instructions for use of this medicine as described in this leaflet or as provided by your doctor or pharmacist.
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Contents of the leaflet:
- What Dolifen is and what it is used for.
- What you need to know before using Dolifen.
- How to use Dolifen.
- Possible side effects.
- Storage of Dolifen.
- Package contents and additional information.
1. What Dolifen is and what it is used for
Diclofenac diethylamine, the active ingredient in 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 of age for the local relief of mild and occasional pain and inflammation caused by:
- minor bruises, blows, sprains,
- torticollis or other muscle spasms,
- lumbago (occasional back pain),
- mild sprains resulting from twisting injuries
2. What you need to know before using Dolifen.
Do not use Dolifen:
- If you are allergic to diclofenac or to any other non-steroidal anti-inflammatory drug used in the treatment of pain, such as ibuprofen or acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6).
Symptoms related to an allergic reaction to these medicines may include: asthma, difficulty breathing, skin rash or itching, swelling of the face or tongue.
- If you are in the last three months of pregnancy.
- If you are under 14 years of age.
- Do not apply on wounds, eczematous lesions, burns, or mucous membranes.
Warnings and precautions
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Do not apply on areas of skin with cuts or open wounds, on mucous membranes, on eczema, or on areas of skin with a rash. Discontinue use if a skin rash occurs after application.
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Do not use on large areas of skin; use only on the affected area.
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Avoid contact of this medicine with the eyes. If contact occurs, rinse the eyes thoroughly with clean water. Consult your doctor or pharmacist if you experience any discomfort afterwards.
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Do not use occlusive dressings (e.g., plastic bandages).
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Do not use more medicine than indicated, or for longer than recommended, unless advised by your doctor.
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Do not apply this medicine simultaneously in the same area where another medicine has been applied.
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Do not ingest this medicine or use it in the mouth. This medicine is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
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Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet radiation lamps (UVA rays).
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Do not use during the first and second trimesters of pregnancy unless advised by a doctor.
Children and adolescents
Do not use in individuals under 14 years of age.
Other medicines and Dolifen
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery.
You should not use Dolifen gel during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is needed during this period, the lowest possible dose for the shortest possible time should be used.
Oral formulations (e.g., tablets) of diclofenac may cause adverse effects on the fetus. It is unknown whether the 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 specifically instructed by your doctor, as diclofenac passes into breast milk in small amounts.
Under no circumstances should this medicine be applied directly to the breast area in breastfeeding mothers, or to large areas of skin, or for prolonged periods.
Driving and using machines
No effects of the medicine on the ability to drive or use machinery have been reported.
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
Always follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
This medicine is for application to the skin (cutaneous use).
Recommended dose:
Adults and adolescents over 14 years of age:
Apply a small amount of gel to the inflamed or painful area 3 or 4 times a day.
The amount of gel will vary depending on the size of the affected area (normally, an amount similar in size to a cherry or a walnut will be sufficient).
Use the smallest amount necessary and for the shortest duration possible.
Instructions for use:
- For first use of the tube, unscrew the cap. Insert the back of the cap into the seal closing the tube. Turn the cap until the tube opens.
- Spread a thin layer of the gel over the painful and inflamed area of skin with gentle massage.
- Close the tube properly after each use.
After application:
- Clean your hands with a paper tissue and then wash them thoroughly, unless your hands are the treated area. Dispose of the used paper tissue in the waste bin.
- Wait until the medicine has dried on the skin before showering or bathing.
If 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 medicine, it is recommended to remove the excess by washing the affected area thoroughly with plenty of water.
If you accidentally swallow the gel or apply it over a large area of skin for a prolonged period, adverse reactions similar to those seen with oral diclofenac (e.g. tablets) may occur.
Main symptoms of overdose include: digestive or renal disorders and difficulty breathing.
In case of overdose or accidental ingestion, seek immediate medical advice from your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.
If you forget to use Dolifen
If you forget to apply this medicine at the scheduled time, apply the gel as soon as possible and continue treatment as normal.
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some rare and very rare adverse effects can be serious:
If you experience any serious adverse effect, stop treatment with this medicine and contact your doctor immediately.
Rare: May affect up to 1 in 1,000 patients
- Skin rash, with or without blisters; urticaria (reddish, raised patches, often accompanied by itching and burning sensation).
Very rare: May affect up to 1 in 10,000 patients
- Difficulty breathing or feeling of pressure in the chest (asthma); swelling of the face, lips, mouth, tongue, or throat.
Non-serious adverse effects
Other adverse effects may occur, but these are usually mild and transient. If you notice any of them, consult your doctor or pharmacist as soon as possible.
Frequent: May affect up to 1 in 10 patients
- Rash, itching, redness, or stinging of the skin after using the product.
Very rare: May affect up to 1 in 10,000 patients
- Skin may become more sensitive to sunlight (photosensitivity). Signs include: itchy sunburn, swelling, and blisters.
Frequency not known: Cannot be estimated from available data
- Burning sensation at the site of application; dry skin.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting adverse 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 expiry date stated on the container, after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dolifen
- The active substance is diethylamine diclofenac. Each gram of gel contains 11.6 mg of diethylamine diclofenac (equivalent to 10 mg of sodium diclofenac).
- The other components are: diethylamine, carbomer, macrogol cetyl stearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, lavender essence, propylene glycol (E-1520), and purified water.
Appearance of the product and contents of the pack
White, consistent, homogeneous gel with a characteristic lavender and isopropyl alcohol odour. It is supplied in an aluminium tube sealed with an aluminium membrane and a polypropylene screw cap.
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 most recent revision of this leaflet: 09/2024
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es./