Cinfadol 11.6 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinfadol 11.6 mg/g gel

Diclofenac diethylamine

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Cinfadol is and what it is used for

2. What you need to know before using Cinfadol

3. How to use Cinfadol

4. Possible adverse effects

5. How to store Cinfadol

6. Contents of the pack and other information

1. What Cinfadol 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 agent.

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 contractures,

• lumbago (back pain),

• mild sprains resulting from twisting injuries.

2. What you need to know before using Cinfadol

Do not use Cinfadol

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6),
• if you have ever had an allergic reaction to diclofenac or to any other non-steroidal anti-inflammatory drug used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used to prevent blood clotting). If you are unsure, consult your doctor or pharmacist. Symptoms of an allergic reaction to these medicines may include asthma, difficulty breathing, skin rash or itching, swelling of the face or tongue, and runny nose,
• 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, mucous membranes, or on burns.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cinfadol.

• Do not apply on areas of skin with cuts or open wounds, on mucous membranes, over eczema, or on areas of skin with a rash. Discontinue use if a skin rash occurs after application.
• Do not use over large areas; use only on the affected area.
• Avoid contact of Cinfadol with the eyes. If contact occurs, rinse eyes thoroughly with clean water. Consult your doctor or pharmacist if you experience any subsequent discomfort.
• Do not use occlusive dressings.
• Do not use more medicine than indicated, or for longer than recommended, unless advised by your doctor.
• Do not apply Cinfadol simultaneously on the same area where other medicines have been applied.
• Do not swallow this medicine or use it in the mouth. This is a topical medicine for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet radiation lamps (UV rays).
• Do not use during the first and second trimesters of pregnancy unless advised by a doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 14 years of age due to insufficient data on safety and efficacy.

Use of Cinfadol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially analgesics, including those obtained without a prescription.

Pregnancy and breastfeeding

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

Pregnancy

Do not use this medicine during the last three months of pregnancy. You should not use this medicine during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

Oral formulations (e.g., tablets) of diclofenac may cause adverse effects on the fetus. It is unknown whether this same risk applies when diclofenac is used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not use this medicine during breastfeeding unless specifically instructed by your doctor, as diclofenac passes into breast milk in small amounts. Under no circumstances should it be applied directly on the breast area or on large skin areas for prolonged periods in breastfeeding mothers.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported with external use on the skin.

Cinfadol contains propylene glycol

This medicine contains 50 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Cinfadol

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.

This medicine is for application on the skin only (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 for the shortest time required.

Instructions for use:

• For first use of the tube, unscrew the cap. Insert the back end of the cap into the seal closing the tube. Turn the cap until the tube opens.
• Spread a thin layer of gel over the painful and inflamed area of skin, using gentle massage.
• Close the tube properly after use.
• Wash your hands after applying the gel, unless the hands are the area being treated.

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

If you use more Cinfadol than you should

If Cinfadol is accidentally ingested or applied over a large area of skin for a prolonged period, adverse reactions similar to those caused by oral diclofenac (e.g. tablets) may occur.

Main symptoms of overdose: gastrointestinal or renal disorders and difficulty breathing.

If you have applied too much medicine, it is recommended to remove it by washing the affected area thoroughly with water or by wiping off a portion of the gel.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Cinfadol

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 missed doses.

If you stop using Cinfadol

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 may cause adverse effects, although not everyone experiences them.

Some rare and very rare adverse effects can be serious:

If you experience any of the following signs of allergy, stop using this medicine and consult your doctor or pharmacist immediately.

• Rare (may affect up to 1 in 1,000 patients): Skin rash accompanied by blisters; urticaria (reddish, raised rashes, often with 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, tongue, or throat.

Non-serious adverse effects:

Other adverse effects may occur, but these are usually mild and temporary. 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 application site, 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinfadol

Keep this medicine out of the sight and reach of children.

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 indicated.

Do not store above 30°C.

After opening, discard the tube with any remaining gel after 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the container and additional information

Composition of Cinfadol

• 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: propylene glycol, isopropyl alcohol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprate/caprylate, cream perfume 1876601, and purified water.

Appearance of the product and contents of the container

Cinfadol is packaged in an aluminum tube with a screw cap. The medicine is available in tubes containing 60 g and 100 g of gel.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Kern Pharma, S.L.

Polígono Ind.

Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: September 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.