DICLOKERN FORTE 23.2 mg/g GEL

2. What you need to know before starting to use Diclokern Forte

Do not use Diclokern 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 acidor to any of the other components of this medication (to consult the complete list see composition in section 6).

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.
• Do not apply to wounds, eczematous lesions, mucous membranes, or burns.
• If you are under 14 years old.

Be careful with Diclokern Forte:

• Do not apply to areas of the skin where there are cuts or open wounds, or to mucous membranes, or over eczema or areas of the skin where there is a 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 Diclokern Forte 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 medication than indicated, nor for a longer period than indicated, unless advised by your doctor.
• Do not apply Diclokern Forte simultaneously to the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. Diclokern Forte 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 on cloudy days) or to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy unless medically indicated.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, 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

Diclokern Forte should not be used if you are in the last 3 months of pregnancy. Diclokern Forte should not be used 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 unknown if this same risk applies to Diclokern Forte when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use Diclokern Forte, unless your doctor has indicated it.

Under no circumstances should it be applied directly to the breast area.

Use in children

Do not use in children under 14 years old, as there is not enough data available on efficacy and safety.

Driving and using machines

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

Important information about some of the components of Diclokern Forte

This medication may cause skin irritation because it contains propylene glycol.

This medication may cause local reactions on the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

This medication may be slightly irritating to the skin, eyes, and mucous membranes because it contains hexyl benzoate.

3. How to use Diclokern Forte

Follow exactly the following instructions for administering Diclokern Forte, unless your doctor has indicated otherwise. Consult your doctor or pharmacist if you have doubts.

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

The normal dose is:

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 on 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).

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 treatment area.

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

If you forgot to use Diclokern Forte

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 use more Diclokern Forte than you should

If you accidentally ingest Diclokern Forte 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 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, go immediately to a medical center or call the Toxicological Information Service (91 562 04 20), indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Diclokern Forte 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 allergy, stop using Diclokern Forte and consult a doctor or pharmacist immediately:

• Rare (observed in 1 to 10 out of 10,000 patients): Skin rash with blisters; urticaria (red, raised, and often itchy and burning rashes).
• Very rare (observed in less than 1 out of 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 (observed in 1 to 10 out of 100 patients): Rash, itching, redness, or burning sensation on the skin after using the product.
• Very rare (observed in less than 1 out of 10,000 patients): The skin may be more sensitive to the sun (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.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

5. Storage of Diclokern Forte

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

No special storage conditions are required.

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

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. If in 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 Diclokern Forte:

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 23.2 mg of diclofenac diethylamine (which corresponds to 20 mg of diclofenac sodium).
• The other components (excipients) are: propylene glycol (E-1520), oleic alcohol, isopropyl alcohol, butylhydroxytoluene, diethylamine, liquid paraffin, macrogol cetostearyl ether, carbomer, coco-caprylate/caprate, perfume cream 1876601 (contains hexyl benzoate), and purified water.

Appearance of the product and contents of the package

Diclokern Forte is a viscous and white gel. It is packaged in an aluminum laminate tube consisting of several layers of low-density polyethylene, aluminum, and high-density polyethylene (inner layer), attached to a piece of high-density polyethylene, which is sealed, and equipped with a polypropylene cap.

The medication is presented in a tube with 50, 100, 150 grams of gel.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: June 2021

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

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