Diclokern Spray 39.2 mg/ml solution for cutaneous spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diclokern Spray 39.2 mg/ml solution for cutaneous spray

Sodium diclofenac

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you:

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve within 3 days.

Leaflet contents:

1. What Diclokern Spray is and what it is used for.
2. What you need to know before using Diclokern Spray.
3. How to use Diclokern Spray.
4. Possible adverse effects.
5. How to store Diclokern Spray.
6. Contents of the package and other information.

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

Diclofenac sodium, the active ingredient in this medicine, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and acts as a local analgesic and anti-inflammatory agent.

This medicine is used in adults and adolescents over 14 years of age for the local symptomatic relief of mild to moderate pain and inflammation in small and medium joints and in the surrounding structures following an acute injury.

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

2. What you need to know before using Diclokern Spray

Do not use Diclokern Spray:

• If you are allergic (hypersensitive) to sodium diclofenac, peanut, soy, or any of the other components of this medicine (listed in section 6).
• If you have ever had an allergic reaction involving difficulty breathing, skin rash, or rhinorrhea (nasal discharge) 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 the patient is a child or adolescent under 14 years of age.
• On wounds, inflamed or infected skin, eczematous lesions, burns, or mucous membranes.
• During the last three 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 medicine.

• If you have or have had gastric ulcers, liver or kidney problems, a tendency to bleeding, or any inflammatory bowel disease.
• If you have suffered from bronchial asthma or allergies.
• Do not apply on areas of skin with cuts or open wounds, on mucous membranes, or on eczema or skin rashes.
• Stop using the medicine if a skin rash occurs after application.
• Avoid using it on large skin areas unless advised by a doctor. Use it only on the affected area.
• Avoid contact with the eyes. If this occurs, rinse the eyes thoroughly with clean water and consult your doctor or pharmacist if you experience any discomfort afterwards.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or adhesive plasters.
• Do not use more of the medicine than indicated or for longer than recommended, unless advised by your doctor.
• Do not apply simultaneously in the same area where other medicines have been applied.
• Do not swallow this medicine or use it in the mouth. This medicine is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet radiation lamps (UV lamps).

The possibility of systemic adverse effects related to the use of this medicine cannot be ruled out if it is used over large skin areas for prolonged periods.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Children and adolescents

Do not use this medicine in children and adolescents under 14 years of age.

Other medicines and Diclokern Spray

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Inform your doctor before using this medicine:

• If you are taking tablets, capsules, or using suppositories for pain, including any medicine containing sodium diclofenac, acetylsalicylic acid (aspirin), or any other anti-inflammatory medicine, for example ibuprofen.

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

Pregnancy and breastfeeding

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

Do not use Diclokern Spray during the last three months of pregnancy. You should not use Diclokern Spray during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is needed during this period, the lowest possible dose should be used for the shortest possible time.

Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions in 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 medicine.

During breastfeeding, do not use this medicine unless specifically instructed by your doctor.

Under no circumstances should it be applied directly to the chest area or to other large areas of skin or for prolonged periods.

Driving and use of machines

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

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

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

This medicine contains soybean lecithin. It must not be used if you are allergic to peanuts or soy.

Contains peppermint essence, which may cause allergic reactions.

3. How to use Diclokern Spray

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and adolescents over 14 years of age: Apply 4-5 sprays 3 times a day at regular intervals, either onto the hand or directly onto the painful or inflamed area, always with gentle massage to aid its penetration into the skin. The amount of this medicine will vary depending on the size of the affected area. A maximum dose of 5 sprays per application and 15 sprays per day on the affected area must never be exceeded.

Treatment may be discontinued when symptoms (pain and swelling) have subsided.

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

Consult your doctor if symptoms worsen or if there is no improvement after 3 days of treatment.

Use in children and adolescents:

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

Instructions for use:

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

Follow the instructions carefully:

• Remove the transparent protective cap from the pump.
• Before first use, press the pump four times to prime it, discarding the contents. Failure to properly prime the pump may result in an underdose upon first use.
• Apply the recommended dose of medicine with the dispenser held in an upright position, either onto the hand or directly onto the painful or inflamed area.
• Spread the solution on the skin over the painful and inflamed area with gentle massage. Afterwards, wash your hands unless they are the area being treated.

If you use more Diclokern Spray than you should

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

If you accidentally ingest this medicine, or if you have used it over a large area of skin and for a prolonged period of time, adverse reactions may occur similar to those produced by diclofenac when taken orally (e.g. tablets).

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 medicine and the amount ingested.

If you forget to use Diclokern Spray

If you forget to apply this medicine when scheduled, apply the solution as soon as possible and continue treatment as before. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Some rare and very rare adverse effects can be serious:

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

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

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.

• Common (may affect up to 1 in 10 people): Rash, itching, redness, or stinging of the skin after using the medicine.
• Very rare (may affect up to 1 in 10,000 people): Skin may become more sensitive to sunlight (photosensitivity). Signs include 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 topical diclofenac is applied over a very large area of skin and for a long period of time, systemic adverse effects may occur, such as stomach pain and gastric disturbances, heartburn, liver or kidney problems, and hypersensitivity reactions.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diclokern Spray

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

Store in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the container, following "EXP". The expiry date refers to the last day of the month indicated.

After first opening, discard the bottle with any remaining solution after 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Storage of the container and additional information

Composition of Diclokern Spray:

• The active substance is sodium diclofenac. Each ml of cutaneous spray solution (equivalent to 5 sprays) contains 39.2 mg of sodium diclofenac. Each spray (0.2 ml of solution) delivers 7.84 mg of sodium diclofenac.
• The other components (excipients) are: propylene glycol (E-1520), isopropyl alcohol, Phospholipon 90G (contains phosphatidylcholine derived from soybean lecithin, lysophosphatidylcholine, non-polar lipids and tocopherol), 96% ethanol, disodium phosphate, sodium dihydrogen 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:

Slightly yellowish, transparent solution with a mint odour that becomes gelatinous after application.

Amber glass bottle containing 30 ml of solution (25 g), equipped 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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain – Diclokern Spray 39.2 mg/ml cutaneous spray solution

Portugal – Diclokern Spray 39.2 mg/ml cutaneous spray solution

Date of the most recent review of this leaflet: July 2024

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