CINFADOL 11.6 mg/g GEL

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

Do not use Cinfadol

• if you are allergic to diclofenac or to any of the other components of this medication (included in section 6),
• if you have ever suffered an allergic reaction to diclofenac or to any other non-steroidal anti-inflammatory medication used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used to prevent blood clotting). If you are not sure, consult your doctor or pharmacist. The symptoms related to an allergic reaction to these medications can be: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and runny nose,
• if you are in the last 3 months of pregnancy,
• if you are under 14 years of age,
• do not apply to wounds, eczematous lesions, mucous membranes, or burns.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cinfadol.

• Do not apply to areas of the skin where there are cuts or open wounds, or to mucous membranes, or to areas with eczema or skin rash. Stop using the medication if a skin rash occurs after application.
• Do not use on large areas, use exclusively on the affected area.
• Avoid contact of Cinfadol 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.
• Do not use more medication than indicated, nor for a longer period than indicated, unless advised by your doctor.
• Do not apply Cinfadol simultaneously to the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. It is a medication 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 to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy unless medically justified.

Children and adolescents

This medication is not recommended for use in children and adolescents under 14 years of age, as there is not enough data available on safety and efficacy.

Use of Cinfadol with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, especially analgesics, including those purchased without a prescription.

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 medication.

Pregnancy

Do not use this medication if you are in the last 3 months of pregnancy. Do not use this medication 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 take the minimum possible dose for the shortest possible time.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use this medication, unless your doctor has indicated it, as diclofenac passes into breast milk in small amounts. It should not be applied in any case to breastfeeding mothers directly on the breast area or on other areas, in large areas of the skin during prolonged periods of time.

Driving and using machines

No effects on the ability to drive vehicles and use machinery have been described when used externally on the skin.

Cinfadol contains propylene glycol

This medication contains 50 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Cinfadol

Follow exactly the administration instructions of the medication contained in this prospectus or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

This medication is for application only 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 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 necessary for the shortest time required.

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 opened.
• Spread a thin layer of the gel over the area of the skin where there is pain and inflammation, through gentle massage.
• Close the tube well after use.
• Wash your hands after applying the gel, unless they are the area to be treated.

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

If you use more Cinfadol than you should

If you accidentally ingest Cinfadol 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.

If you have applied too much medication, it is recommended to eliminate it by washing the affected area with plenty of water, or by removing a part.

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

If you forget to use Cinfadol

If you forgot to apply this medication 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 forgotten doses.

If you interrupt treatment with Cinfadol

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Some rare and very rare adverse effects can be serious:

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

• Rare (may affect up to 1 in 1,000 patients): Skin rash with blisters; urticaria (red, raised, and often itchy and burning rashes).
• 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, tongue, or throat.

Non-serious adverse effects:

Other adverse effects may occur, but they 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 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 sunlight (photosensitivity). The signs are: sunburn with itching, swelling, and blisters.
• Frequency not known (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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cinfadol

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened, discard the tube with the remaining gel after 12 months.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the package and additional information

Composition of Cinfadol

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine, equivalent to 10 mg of diclofenac sodium.
• The other components are: propylene glycol, isopropanol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprylate/caprate, perfume cream 1876601, and purified water.

Appearance of the product and contents of the package

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

It is possible that only some package sizes are 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 last revision of this prospectus:September 2024

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