CINFADOL FORTE 23.2 mg/g GEL

Introduction

Package Leaflet: Information for the User

Cinfadol Forte 23.2 mg/g Gel

Diclofenac Diethylamine

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3-5 days.

Contents of the Package Leaflet

1. What Cinfadol Forte is and what it is used for
2. What you need to know before using Cinfadol Forte
3. How to use Cinfadol Forte
4. Possible side effects
5. Storage of Cinfadol Forte
6. Package Contents and Additional Information

1. What Cinfadol Forte is and what it is used for

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

This medication 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, strains,
• torticollis or other contractures,
• occasional back pain (as a result of practicing sports or during daily activities),
• mild sprains caused by a twist.

2. What you need to know before using Cinfadol Forte

Do not use Cinfadol Forte

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

• The symptoms related to an allergic reaction to these medications may 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.
• Do not apply to wounds, eczematous lesions, mucous membranes, or burns.
• If you are under 14 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

• Do not apply to areas of the skin where there are open cuts or wounds, or to mucous membranes, or over eczema or areas of the skin with a 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 this medication 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 medication than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply this medication simultaneously to the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. It is 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 if cloudy) or to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy unless medically indicated.

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 its efficacy and safety.

Other Medications and Cinfadol Forte

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

Pregnancy, Breastfeeding, and Fertility

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 dose possible for the shortest time possible.

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

Breastfeeding

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

Do not apply it to the breast area or to other extensive areas of the skin during prolonged periods.

Driving and Using Machines

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

Cinfadol Forte contains Propylene Glycol (E-1520)

This medication contains 54 mg of propylene glycol per 1 gram of gel.

Propylene glycol may cause skin irritation.

Cinfadol Forte contains Butylhydroxytoluene (E-321)

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

Cinfadol Forte contains Fragrances

This medication contains fragrances with benzyl alcohol (E-1519) (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalol, which may cause allergic reactions.

3. How to use Cinfadol Forte

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is for external use only (cutaneous use).

Adults and Adolescents over 14 years old

Apply 2 times a day, every 12 hours (preferably in the morning and at night), a small amount of gel to the local 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 of the tube. To open the security seal of the tube, invert the cap and hook it with the nozzle. Do not use scissors or other sharp objects.
• Turn and remove the plastic seal from the tube. Use the gel as described in this package leaflet. Do not use if the seal is broken.

How to apply:

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

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 this medication 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 Cinfadol Forte than you should

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

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

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

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 Forte

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some rare and very rare side effects can be serious:

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

• Rare (may affect up to 1 in 1,000 patients): Skin rash with or without blisters; urticaria (red, raised, and often itchy hives).
• 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 side effects:

Other side 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 medication.
• 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 Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cinfadol Forte

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

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

This medication does not require any special storage temperature.

Keep it in the original tube to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Cinfadol Forte Composition

• The active ingredient is diclofenac diethylamine.
• 1 gram contains 23.2 mg of diclofenac diethylamine, equivalent to 20 mg of diclofenac sodium.
• The other ingredients are isopropyl alcohol, propylene glycol (E-1520), coco-caprylate, liquid paraffin, carbomer, macrogol stearyl ether, diethylamine, oleic acid (E-570), butylhydroxytoluene (E-321), fragrance (containing citronellol, geraniol, benzyl alcohol (E-1519), linalool, limonene, citral, farnesol, coumarin, eugenol), and purified water.

Product Appearance and Package Contents

White or almost white gel, homogeneous, packaged in laminated aluminum tubes with a molded plastic seal (PE) and screw caps made of polypropylene in package sizes of 30 grams, 50 grams, 60 grams, and 100 grams of gel per tube.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Merckle GmbH,

Graf-Arco-Str. 3, 89079 Ulm,

Germany

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this package leaflet: September 2024

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