Diclokern 11.6 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Diclokern 11.6 mg/g gel
Diclofenac diethylamine
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet:
- What Diclokern is and what it is used for
- What you need to know before using Diclokern
- How to use Diclokern
- Possible side effects
- How to store Diclokern
- Contents of the pack and other information
1. What Diclokern is and what it is used for
Diclofenac diethylamine, the active substance of this medicine, belongs to the group of non-steroidal anti-inflammatory drugs and acts as a local analgesic and anti-inflammatory.
Diclokern 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 spasms,
- lumbago (back pain),
- mild sprains resulting from twisting injuries.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before using Diclokern
Do not use Diclokern
- if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6),
- if you have ever had an allergic reaction to diclofenac or to any other medicine 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,
- if you are in the last three months of pregnancy,
- if you are under 14 years of age,
- do not apply on wounds, eczematous lesions, mucous membranes, or on burns.
If you think you may be allergic, consult your doctor.
Warnings and precautions
- Do not apply on areas of skin with cuts or open wounds, on mucous membranes, eczema, or areas with skin eruptions.
- Avoid contact of Diclokern with the eyes. If this occurs, rinse the eyes thoroughly with clean water. Consult your doctor or pharmacist if you experience any subsequent discomfort.
- Do not use occlusive dressings.
- Do not use over large areas. Use exclusively on the affected area only.
- Do not apply Diclokern simultaneously on the same area where other medicinal products have been applied.
- Do not swallow this medicine or use it in the mouth. Diclokern 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 (UVA rays).
Consult your doctor or pharmacist before starting to use Diclokern.
Children and adolescents
This medicine is not recommended for use in children and adolescents under 14 years of age due to insufficient data on safety and efficacy.
Use of Diclokern with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 medicine.
Pregnancy
Diclokern must not be used during the last three months of pregnancy. Diclokern 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 when used on the skin.
Breastfeeding
Consult your doctor or pharmacist before using any medicine.
Do not use Diclokern during breastfeeding unless specifically instructed by your doctor.
Under no circumstances should it be applied directly to the chest area.
Driving and use of machines
No effects on the ability to drive or operate machinery have been reported with external use on the skin.
Diclokern contains propylene glycol (E-1520)
This medicine contains 50 mg of propylene glycol in each gram of gel.
3. How to use Diclokern
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is for application to the skin (cutaneous use).
The recommended dose is:
Adults and adolescents over 14 years of age: Apply a small amount of gel to the inflamed or painful area 3 or 4 times a day.
The amount of gel will vary depending on the size of the affected area (normally, applying an amount equivalent in size to between a cherry and a walnut will be sufficient).
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 14 years of age due to insufficient data on safety and efficacy.
Method of use:
- For first use of the tube, unscrew the cap. Insert the back end of the cap into the seal closing the tube. Turn the cap until the tube opens.
- 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.
If pain or swelling worsens or persists after 7 days of treatment, consult your doctor.
If you use more Diclokern than you should
If Diclokern is accidentally ingested or applied over a large area of skin for a prolonged period, adverse reactions similar to those caused by oral diclofenac (e.g. tablets) may occur.
The main symptoms of overdose are: gastrointestinal or renal disorders and difficulty breathing; nausea, vomiting, abdominal pain, and decreased level of consciousness may occur.
If you have applied too much of the medicine, it is recommended to remove the excess by washing the affected area thoroughly with water or by wiping off part of the gel.
In case of accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service at: 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to use Diclokern
If you forget to apply this 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 stop using Diclokern
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may 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 and consult your doctor or pharmacist immediately:
- Rare (may affect between 1 and 10 in 10,000 patients): Skin rash accompanied by blisters; urticaria (red, raised patches, often itchy and burning).
- Very rare (may affect less than 1 in 10,000 patients): Difficulty breathing or feeling of pressure in the chest (asthma); swelling of the face, lips, tongue, or throat.
Non-serious adverse effects:
Other adverse effects may occur, but these are usually mild and transient. If you notice any of them, consult your doctor or pharmacist as soon as possible.
- Frequent (may affect between 1 and 10 in 100 patients): Rash, itching, redness, or stinging of the skin after using the product.
- Very rare (may affect less than 1 in 10,000 patients): Skin may become more sensitive to sunlight (photosensitivity). Symptoms include sunburn with itching, swelling, and blisters.
- Frequency not known (cannot be estimated from available data): Burning sensation at the application site, dry skin.
Reporting of 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 leaflet. You can 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
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Diclokern
- The active substance is diethylamine diclofenac. Each gram of gel contains 11.6 mg of diethylamine diclofenac (equivalent to 10 mg of sodium diclofenac).
- The other components (excipients) are: propylene glycol (E-1520), isopropanol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprylate/caprate, perfume cream 1876601, purified water.
Appearance of the product and contents of the container
Diclokern is a white, viscous gel. It is packaged in an aluminum tube with a screw cap.
The medicine is available in tubes containing 60 and 100 grams of gel.
Only certain package sizes may be commercially available.
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: September 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.