Prospect: information for the patient

Diclokern Spray 39.2 mg/ml skin spray solution

Sodium diclofenac

Read this prospect carefully before starting to use this medication, as it contains important information for you:

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

-Keep this prospect, as you may need to read 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 prospect. See section 4.

-You should consult a doctor if you worsen or do not improve after 3 days.

1.What is Diclokern Spray and what it is used for.

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

3.How to use Diclokern Spray.

4.Possible adverse effects.

5.Storage of Diclokern Spray.

6.Contents of the package and additional information

Diclofenac sodium, the active ingredient of this medication, belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) and acts as a local analgesic and anti-inflammatory.

This medication is used in adults and adolescents over 14 years old,for the symptomatic relief of mild to moderate pain and inflammation of small and medium-sized joints and surrounding structures after an acute trauma.

You should consult a doctor if it worsens or does not improve after 3 days.

Do not use Diclokern Spray:

• If you are allergic (hypersensitive) to diclofenac sodium, peanuts, soy or any of the other components of this medication (listed in section 6).
• If you have ever had an allergic reaction associated with difficulty breathing, skin rash and nasal discharge (runny nose) to any other medication used in the treatment of pain, fever or inflammation such as ibuprofen oracetylsalicylic acid(also used to prevent blood clotting). If you are unsure, consult your doctor or pharmacist.
• If the patient is a child or adolescent under 14 years old.
• On wounds, inflamed or infected skin, eczematous lesions or on burns or mucous membranes.
• If you are in the last 3 months of pregnancy.– see the section on pregnancy and breastfeeding.
• On the chest area in women who are breastfeeding.

Warnings and precautions

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

• If you have or have had stomach ulcers, liver or kidney problems, bleeding tendency or any inflammatory bowel disease.
• If you have had bronchial asthma or allergies.
• Do not apply it on areas of the skin where there are cuts or open wounds, or on mucous membranes, or on eczema or areas of the skin where there is a skin rash.
• Stop using the medication if a skin rash occurs after application.
• Avoid using it on large areas, unless advised by a doctor. Use it exclusively on the affected area
• Avoid contact with the eyes. If this happens, rinse the eyes with clean water and consult your doctor or pharmacist if you experience any subsequent discomfort.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or 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 it simultaneously on the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. This medication 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).

The possible occurrence of systemic adverse effects related to the use of this medication cannot be ruled out if it is used on extensive skin areas for a long period of time.

The adverse effects can be reduced by using the minimum effective dose for the shortest possible time.

Children and adolescents

Do not use this medication in children and adolescents under 14 years old.

Other medications andDiclokern Spray

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

Inform your doctor before using this medication:

- If you are taking tablets, capsules or using suppositories for pain, including any medication that contains diclofenac sodium, acetylsalicylic acid (aspirin) or any other nonsteroidal anti-inflammatory drug (NSAID), for example ibuprofen.

The use of another NSAID (e.g. acetylsalicylic acid or ibuprofen) with this medication may increase the risk of adverse effects.

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 Spray if you are in the last 3 months of pregnancy. Do not use Diclokern Spray 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 of diclofenac (e.g. tablets) may cause adverse reactions to the fetus. It is unknown whether this same risk applies to Diclokern Spray when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use this medication during breastfeeding, except if advised by your doctor.

Do not apply it directly on the chest area or on other extensive areas of the skin or for a prolonged period.

Driving and operating machinery

The cutaneous use of this medication has no effect on the ability to drive or operate machinery.

Diclokern Spray contains propylene glycol (E-1520), soy lecithin and peppermint essence:

This medicationcontains 147.00 mg of propylene glycol (E-1520) in each ml. Propylene glycol may cause skin irritation.

This medication contains soy lecithin. Do not use it if you are allergic to peanuts or soy.

It contains peppermint essence that may cause allergic reactions.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 14 years old:Apply 4-5 sprays of the pump 3 times a day at regular intervals, over the hand or directly over the painful or inflamed area, always through a gentle massage to facilitate its penetration into the skin.The amount of this medication will vary depending on the size of the affected area. Never exceed a maximum dose of 5 sprays at a time or 15 sprays per day on the affected area.

The treatment may be interrupted when the symptoms (pain and swelling) have subsided.

The treatment should not continue for more than 7 days without a review by the doctor.

Consult your doctor if it worsens or if no improvement is seen after 3 days of treatment.

Use in children and adolescents:

Do not use in children or adolescents under 14 years old.

Mode of use:

This medication is a solution for use on the skin (cutaneous use). It should not be administered by any other route under any circumstances.

Follow the instructions carefully:

• Remove the transparent protective cap from the pump
• Before the first use, it is necessary to press the pump 4 times for its activation, discarding its contents. A failure in this process of priming may result in the application of a lower dose when used for the first time.
• Administer the recommended dose of medication with the dispenser container in a vertical position over the hand or over the painful or inflamed area.
• Extend the solution on the skin over the area where there is pain and inflammation, through a gentle massage.Then, wash your hands unless this is the area being treated.

If you use more Diclokern Spray than you should

If you apply more medication than indicated, remove the excess with a dressing.

If you accidentally ingest this medication 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.

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 forgot to use Diclokern Spray

If you forgot to apply this medication when due, apply the solution as soon as possible and continue the treatment as you were doing it. Do not use a double dose to compensate for a missed dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop treatment with this medicine if a skin rash appears. After topical application (skin application) of preparations containing diclofenac, skin reactions at the application site have been observed frequently, such as skin eruption, itching, redness, burning sensation, or skin peeling.

Some rare and very rare side effects may be serious:

If you experience any of the following allergy signs,stop using this medicineand consult your doctor or pharmacist immediately.

• Rare (may affect up to 1 in 1,000 people): Skin eruption accompanied by blisters; urticaria (red, elevated patches, often with a sensation of itching and burning).
• Very rare (may affect up to 1 in 10,000 people): Difficulty breathing or sensation of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

Other side 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.

• Common (may affect up to 1 in 10 people): Skin eruption, itching, redness, or stinging sensation in the skin after using the medicine.
• Very rare (may affect up to 1 in 10,000 people): The skin may be more sensitive to the sun (photosensitivity). Signs are: sunburn with itching, swelling, and blisters. Pustular eruption.
• Unknown frequency (cannot be estimated from available data): Burning sensation at the application site, dry skin.

If diclofenac is applied topically to a large area of skin and for a long period of time, systemic side effects may occur, such as stomach pain and gastrointestinal disorders, acid reflux, liver or kidney problems, and hypersensitivity reactions.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from light.

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 bottle with the remaining solution after 6 months.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthecontainers and themedications that you no longerneed. By doing so, you will help protect the environment.

Composition ofDiclokern Spray:

• The active principle is diclofenac sodium. Each ml of skin solution for spraying (equivalent to 5 sprays) contains 39.2 mg of diclofenac sodium. Each spray (0.2 ml of solution) releases 7.84 mg of diclofenac sodium.
• The other components (excipients) are: propylene glycol (E-1520), isopropyl alcohol, Phospholipon 90G (contains soy lecithin-derived phosphatidylcholine, lysophosphatidylcholine, non-polar lipids, and tocopherol), 96% ethanol, disodium phosphate, dihydrogen sodium phosphate dihydrate, disodium edetate, ascorbyl palmitate, peppermint essence, diluted hydrochloric acid, 10% sodium hydroxide, and purified water.

Appearance of Diclokern Spray and contents of the container:

Transparent, slightly yellowish solution with a minty odor that becomes gelatinous after application.

Amber glass bottle with 30 ml of solution (25 g) provided with a pump and a polyethylene immersion tube.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Responsible for manufacturing

FARMALIDER, S.A.

Aragoneses, 2

28108 Madrid

Spain

or

MEDINFAR MANUFACTURING S.A.

Parque Industrial Armando Martins Tavares,

Rua Outeiro Da Armada No 5,

Condeixa-a-Nova, 3150-194, Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain – Diclokern Spray 39.2 mg/ml skin solution for spraying

Portugal - Diclokern Spray 39.2 mg/ml skin solution for spraying

Last review date of this leaflet:July 2024

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