Diclokern Forte 23.2 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Diclokern Forte 23.2 mg/g gel
diclofenac diethylamine
Read the entire leaflet carefully as it contains important information for you.
This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond 7 days, you should consult a doctor.
- If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
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What Diclokern Forte is and what it is used for
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What you need to know before using Diclokern Forte
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How to use Diclokern Forte
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Possible side effects
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How to store Diclokern Forte
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Contents of the pack and other information
1. What Diclokern Forte is and what it is used for
Diclofenac diethylamine, the active substance in this medicine, belongs to the group of non-steroidal anti-inflammatory drugs and, when applied topically, acts as a local analgesic and anti-inflammatory agent.
Diclokern Forte 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
- occasional back pain (as a result of physical activities or daily routine tasks)
- mild sprains resulting from twisting injuries.
2. What you need to know before using Diclokern Forte
Do not use Diclokern Forte:
- If you are allergic to diclofenac or to any other non-steroidal anti-inflammatory drug used in the treatment of pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid, or to any of the other components of this medicine (for a complete list, see the composition in section 6).
Symptoms related to 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.
- Do not apply on wounds, eczematous lesions, mucous membranes, or burns.
- If under 14 years of age.
Take special care with Diclokern Forte:
- 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 on large areas. Use only on the affected area.
- Avoid contact of Diclokern Forte 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 (e.g., plastic bandages).
- Do not use more of the medicine than indicated, or for longer than recommended, unless advised by your doctor.
- Do not apply Diclokern Forte simultaneously on the same area where other medicines have been applied.
- Do not swallow this medicine or use it in the mouth. Diclokern Forte is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
- Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet radiation lamps (UV rays).
- Do not use during the first and second trimesters of pregnancy unless advised by a physician.
Use with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, especially painkillers, including those obtained without a prescription.
Pregnancy, breastfeeding, and fertility
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
Diclokern Forte must not be used during the last three months of pregnancy. It should not be used 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 the same risk applies to Diclokern Forte when used on the skin.
Breastfeeding
Consult your doctor or pharmacist before using any medicine.
During breastfeeding, do not use Diclokern Forte unless specifically instructed by your doctor.
Under no circumstances should it be applied directly to the chest area.
Use in children
Do not use in children under 14 years of age due to insufficient data on efficacy and safety.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported with external application to the skin.
Important information about some components of Diclokern Forte
This medicine may cause skin irritation as it contains propylene glycol.
This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes as it contains butylhydroxytoluene.
This medicine may be mildly irritating to the skin, eyes, and mucous membranes as it contains hexyl benzoate.
3. How to use Diclokern Forte
Follow exactly the instructions below for using Diclokern Forte, unless your doctor has prescribed otherwise. Consult your doctor or pharmacist if you have any doubts.
This medicine is for external use on the skin only (cutaneous use).
Normal dosage:
Adults and adolescents over 14 years of age: Apply twice daily, every 12 hours (preferably in the morning and at night), 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, an amount the size of a cherry to a walnut will be sufficient).
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. Twist the cap to pierce and open the tube.
- Spread a thin layer of the 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 for more than 7 days of treatment, consult your doctor.
If you forget to use Diclokern Forte
If you forget to apply the 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 use more Diclokern Forte than you should
If Diclokern Forte is accidentally swallowed, or if it has been applied over a large area of skin for a prolonged period, adverse reactions similar to those of orally administered diclofenac (e.g. tablets) may occur.
Main symptoms of overdose include: gastrointestinal or renal disorders and difficulty breathing.
If too much medicine has been applied, it is recommended to remove it by washing the affected area thoroughly with water or by wiping off excess gel.
In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare center or call the Toxicology Information Service (91 562 04 20), indicating the name of the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Diclokern Forte can 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 Diclokern Forte and consult a doctor or pharmacist immediately:
- Rare (observed in 1 to 10 out of 10,000 patients): Skin rash accompanied by blisters; urticaria (reddish, raised rashes, often with itching and burning sensation).
- Very rare (observed in fewer than 1 in 10,000 patients): Difficulty breathing or sensation of chest tightness (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 (observed in 1 to 10 out of 100 patients): Rash, itching, redness, or stinging of the skin after using the product.
- Very rare (observed in fewer than 1 in 10,000 patients): Skin may become more sensitive to sunlight (photosensitivity). Symptoms include: itchy sunburn, swelling, and blisters.
- Frequency not known (cannot be estimated from available data): Burning sensation at the application site, dry skin.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Diclokern Forte
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use Diclokern Forte after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
After first 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 the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diclokern Forte:
- The active substance is diethylamine diclofenac. Each gram of gel contains 23.2 mg of diethylamine diclofenac (equivalent to 20 mg of sodium diclofenac).
- The other components (excipients) are: propylene glycol (E-1520), oleyl alcohol, isopropyl alcohol, butylhydroxytoluene, diethanolamine, liquid paraffin, macrogol cetyl ether stearyl ether, carbomer, cocoyl caprylocaprate, cream perfume 1876601 (contains hexyl benzoate) and purified water.
Appearance of the product and contents of the pack
Diclokern Forte is a white, viscous gel. It is packaged in a laminated aluminium tube composed of several layers: low-density polyethylene, aluminium, and high-density polyethylene (inner layer), bonded to a high-density polyethylene piece, which is sealed, and fitted with a polypropylene cap.
The medicine is available in tubes containing 50, 100 or 150 grams of gel.
Only certain pack 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 most recent revision of this leaflet: June 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.