Package Insert: Information for the User

Diclokern 11.6 mg/g gel

Diclofenac diethylamine

Read this entire package insert carefully before starting to use this medication because it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

The active ingredient diclofenac diethylamine, 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 old for local relief of mild and occasional pain and inflammation caused by:

-small bruises, blows, strains,

-stiff neck or other contractures,

-backaches,

-mild sprains resulting from a twist.

Consult a doctor if it worsens or does not improve after 7 days.

No use Diclokern

• 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 medication 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 3 months of pregnancy,
• If you are under 14 years old,
• Do not apply to wounds, lesions, eczematous areas, mucous membranes, or burns.

If you think you may be allergic, consult your doctor.

Warnings and precautions

• Do not apply to areas of the skin where there are open cuts or wounds, mucous membranes, or eczema, or areas of the skin where there is a skin eruption.
• Avoid contact of Diclokern 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 on extensive areas. Use exclusively on the affected area.
• Do not apply Diclokern simultaneously in the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. Diclokern 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 ultraviolet radiation lamps (UVA rays).

Consult your doctor or pharmacist before starting to use Diclokern.

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 Diclokern with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use Diclokern if you are in the last 3 months of pregnancy. Do not use Diclokern 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.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use Diclokern during breastfeeding, except as directed by your doctor.

Do not apply directly to the breast area.

Driving and operating machinery

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

Diclokern contains propylene glycol (E-1520)

This medication contains 50 mg of propylene glycol in each gram of gel.

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 application on the skin (cutaneous use).

Recommended dose is:

Adults and adolescents over 14 years:Apply 3 or 4 times a day a small amount of gel on 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 in childrenand adolescents

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

Method 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 opens.
• Apply a thin layer of gel on 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.

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

If you use more Diclokern than you should

If you accidentally ingest Diclokern or if you have used it on a large area of the skin and for a long period of time, similar adverse reactions to those produced by diclofenac when taken orally (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 medication, it is recommended to remove it by washing the affected area with plenty of water, or by removing a part.

In case of accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to use Diclokern

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 with Diclokern

If you have any other doubt about the use of this product, 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 can be severe:

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 of every 10,000 patients): Skin rash accompanied by blisters; urticaria (red, elevated patches, often with a sensation of itching and burning).
• Very rare (may affect fewer than 1 of every 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 between 1 and 10 of every 100 patients): Rash, itching, redness, or stinging sensation on the skin after using the product.
• Very rare (may affect fewer than 1 of every 10,000 patients): The skin may be more sensitive to the sun (photosensitivity). Symptoms are: sunburn with itching, swelling, and blisters.
• Unknown frequency (cannot be estimated from available data): Sensation of burning 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 theSpanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above30°C.

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.

Once opened, discard the tube with the remaining gel after 12 months.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Diclokern

• The active principle is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine (which corresponds to 10 mg of diclofenac sodium).
• The other components (excipients) are: propylene glycol (E-1520), isopranol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprylate/caprate, cream fragrance 1876601, purified water.

Appearance of the product and contents of the packaging

Diclokern is a viscous and white gel. It is packaged in an aluminum tube with a screw cap.

The medicine is presented in a tube with 60 and 100 grams of gel.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: September 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.