Cinfadol 11,6 mg/g gel

Prospect: information for the user

Cinfadol 11.6 mg/g gel

Diclofenaco dietilamina

Read this prospect carefully before starting to use this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, 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 not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

6. Contents of the package and additional information

The diclofenac dietilamine, 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,

• lower back pain,
• mild sprains resulting from a twist.

Do not use Cinfadol

• if you are allergic to diclofenac or any of the other components of this medication (listed in section 6),
• if you have ever had an allergic reaction to diclofenac or any other nonsteroidal 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.
  The symptoms related to an allergic reaction to these medications may include: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and nasal discharge,
• if you are in the last 3 months of pregnancy,
• if you are under 14 years old,
• do not apply on wounds, lesions, eczema, mucous membranes, or burns.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cinfadol.

• Do not apply on skin areas where there are open cuts or wounds, mucous membranes, eczema, or skin areas with 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 Cinfadol with the eyes. If this occurs, rinse the eyes with clean water. Consult your doctor or pharmacist if you experience any subsequent discomfort.
• Do not use occlusive dressings.
• Do not use more of the medication than indicated, nor for a longer period than indicated, unless advised by your doctor.
• Do not apply Cinfadol simultaneously on the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. This is an external use medication 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

This medication is not recommended for use in children and adolescents under 14 years old, due to insufficient data on safety and efficacy.

Use of Cinfadol with other medications

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 strictly necessary and recommended by your doctor. If you need treatment during this period, you should take the minimum dose possible for the shortest time possible.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use this medication during breastfeeding, except as advised by your doctor, as diclofenac passes into breast milk in small amounts. Do not apply this medication directly to the breast area or on other skin areas, in extensive areas of the skin for prolonged periods of time.

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described when using Cinfadol externally on the skin.

Cinfadol contains propylene glycol

This medication contains 50 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

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

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

The recommended dose is:

Adultsand 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 (usually, 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.

Method of use:

-To use the tube for the first time, unscrew the cap. Insert the back of the cap into the piece that closes the tube. Turn the cap until the tube opens.

-Apply a thin layer of gel to the skin area where there is pain and inflammation, using a gentle massage.

-Close the tube well after use.

-Wash your hands after applying the gel, unless they are the area being treated.

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

If you use moreCinfadolthan you should

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

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

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

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

If you forgot to useCinfadol

If you forgot to apply this medication when 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 interrupt the treatment withCinfadol

If you have any other doubts 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 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 accompanied by 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, tongue, or throat.

Mild Adverse Effects:

Other adverse effects may occur, but these are usually mild and of short duration. 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 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 sunlight (photosensitivity). Symptoms are: 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 through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cinfadol

• The active principle 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, polyoxethylene alkyl ether, carbomer 934P NF, coco-caprilate/caprate, fragrance cream 1876601, and purified water.

Appearance of the product and content of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind.

Colón II C/ Venus 72

08228 Terrassa (Barcelona)

Spain

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Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:September 2024

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.es/.