DICLOKERN SPRAY 39.2 mg/ml CUTANEOUS SOLUTION FOR SPRAY

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

Do not use Diclokern Spray:

• If you are allergic (hypersensitive) to diclofenac sodium, peanut, 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 runny nose (rhinorrhea) to 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 the patient is a child or adolescent under 14 years of age.
• On wounds, inflamed or infected skin, eczematous lesions, or 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 breastfeeding women.

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 inflammatory bowel disease.
• If you have had bronchial asthma or allergies.
• Do not apply it to areas of the skin where there are cuts or open wounds, or to mucous membranes, or over eczema or areas of the skin with a rash.
• Stop using the medication if a skin rash appears after application.
• Avoid using it on large areas, unless advised by a doctor. Use it exclusively on the affected area.
• Avoid eye contact. If this occurs, rinse your eyes with clean water and consult your doctor or pharmacist if you experience any discomfort afterwards.
• Do not cover the treated area with occlusive dressings (impermeable to water or non-breathable) or band-aids.
• Do not use more of the medication than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply other medications simultaneously to the same area where Diclokern Spray has 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 to ultraviolet radiation lamps (UVA rays).

The possible appearance of systemic side effects related to the use of this medication cannot be excluded if it is used on extensive skin areas for a long period.

Side 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 of age.

Other Medications and Diclokern Spray

Inform your doctor or pharmacist if you are using, have recently used, 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 anti-inflammatory medication, such as ibuprofen.

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

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use this medication, unless your doctor has indicated it.

In no case should it be applied directly to the chest area or to other extensive areas of the skin or for a prolonged period.

Driving and Using Machines

The topical use of this medication has no effect on driving ability or the use of machinery.

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

This medication contains 147.00 mg of propylene glycol (E-1520) per ml. Propylene glycol may cause skin irritation.

This medication contains soy lecithin. It should not be used in case of peanut or soy allergy.

It contains peppermint oil, which may cause allergic reactions.

3. How to use Diclokern Spray

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 14 years of age:Apply 4-5 sprays of the spray 3 times a day at regular intervals, on the hand or directly on the painful or inflamed area, always with a gentle massage to facilitate 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.

Treatment can be interrupted when symptoms (pain and swelling) have subsided.

Treatment should not continue for more than 7 days without a medical review.

Consult your doctor if it worsens or does not improve after 3 days of treatment.

Use in Children and Adolescents:

Do not use in children or adolescents under 14 years of age.

Mode of Use:

This medication is a solution for cutaneous use (topical 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 four times to activate it, discarding the contents of the same. Failure to perform this priming process 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 on the hand or on the painful or inflamed area.
• Spread the solution on the skin over the area where there is pain and inflammation, through a gentle massage. Afterwards, wash your hands unless it 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 swab.

If you accidentally ingest this medication or if you have used it on an extensive area of skin and for a long period, side effects similar 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 Toxicology Information Service (91 562 04 20), indicating the medication and the amount ingested.

If you forget to use Diclokern Spray

If you forget to apply this medication when it was due, apply the solution as soon as possible and continue the treatment as you were doing. Do not use a double dose to make up for a forgotten dose.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Some rare and very rare side effects can be serious:

If you experience any of the following signs of allergy, interrupt the use of this medication and consult your doctor or pharmacist immediately.

• Rare (may affect up to 1 in 1,000 people): Skin rash with blisters; urticaria (red, elevated, and often itchy hives).
• Very rare (may affect up to 1 in 10,000 people): Difficulty breathing or feeling of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

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 (may affect up to 1 in 10 people): Rash, itching, redness, or burning sensation on the skin after using the medication.
• Very rare (may affect up to 1 in 10,000 people): The skin may be more sensitive to the sun (photosensitivity). The signs are: sunburn with itching, swelling, and blisters. Pustular rash.
• Frequency not known (cannot be estimated from available data): Burning sensation at the application site, dry skin.

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

Reporting Side Effects

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

5. Storage of Diclokern Spray

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 drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in 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. Package Contents and Additional Information

Composition of Diclokern Spray:

• The active ingredient is diclofenac sodium. Each ml of cutaneous spray solution (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 soybean lecithin-derived phosphatidylcholine, lysophosphatidylcholine, non-polar lipids, and tocopherol), 96% ethanol, disodium phosphate, sodium dihydrogen phosphate dihydrate, disodium edetate, ascorbyl palmitate, peppermint oil, diluted hydrochloric acid, 10% sodium hydroxide, and purified water.

Appearance of Diclokern Spray and Package Contents:

Light yellowish transparent solution with a peppermint smell that acquires a gel-like consistency after application.

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Manufacturer

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 medication is authorized in the Member States of the European Economic Area under the following names:

Spain – Diclokern Spray 39.2 mg/ml cutaneous spray solution

Portugal - Diclokern Spray 39.2 mg/ml solução para pulverização cutânea

Date of the last revision of this leaflet:July 2024

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