Voltadol Forte 23.2 mg/g gel

Diclofenac diethylamine

Read this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, you should consult a doctor.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The diclofenac diethylamine, active ingredient of this medication, belongs to the group of nonsteroidal anti-inflammatory drugs and acts topically as a local analgesic and anti-inflammatory.

Voltadol Forte is used 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
• occasional back pain (as a result of sports activities or daily activities)
• mild sprains caused by a twist.

Do not use Voltadol Forte:

• If you are allergic to diclofenac or any other nonsteroidal anti-inflammatory drug used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acidor to any of the other components of this medication (see complete list in section 6).

If you are unsure, consult your doctor or pharmacist.

The symptoms related to an allergic reaction to these medications may include: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and nasal discharge.

• If you are in the last three months of pregnancy

• Do not apply on wounds, eczematous lesions, mucous membranes, or burns.
• If you are under 14 years old.

Be especially careful with Voltadol Forte:

• Do not apply on areas of the skin where there are open cuts or wounds, mucous membranes, eczema, or skin eruptions.Stop using the medication if a skin eruption occurs after application.
• Do not use on extensive areas, use exclusively on the affected area
• Avoid contact of Voltadol Forte 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 (e.g., plastic dressings).
• Do not usemore than the indicated amount of the medication, nor for a longer period than indicated, unless advised by your doctor.
• Do not apply Voltadol Forte simultaneously on the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. Voltadol Forte 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).
• Do not use during the first and second trimester of pregnancy, except on medical advice

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, especially analgesics, even those obtained without a prescription.

Pregnancy, lactation, and fertility

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

During the last three months of pregnancy, this medication should not be used, as it may harm the fetus or cause complications during delivery. Do not use Voltadol Forte 23.2 mg/g gel during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is needed during this period, use the minimum dose possible for the shortest time possible. Oral formulations of diclofenac may cause adverse reactions to the fetus. It is unknown whether this risk applies to Voltadol Forte 23.2 mg/g gel when used on the skin.

Lactation

Consult your doctor or pharmacist before using any medication.

During lactation, do not use Voltadol Forte, except as advised by your doctor, as diclofenac passes into breast milk in small amounts.

Do not applyein any case on the breast area, nor on extensive areas of the skin for prolonged periods of time.

Use in children

Do not use in children under 14 years old, as there is insufficient data available on efficacy and safety.

Driving and operating machinery

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

Important information about some components of Voltadol Forte

This medication may cause skin irritation due to the presence of propylene glycol, and may also cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes due to the presence of butylhydroxytoluene.

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

This medication is for use only on the skin (cutaneous use).

Dosage::

Adults and adolescents over 14 years:Apply 2 times a day, every 12 hours, (preferably in the morning and at night) a small amount of gel on the affected 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 the minimum amount necessary for the shortest time required.

Method of use:

For aluminum tube with screw cap

• For the first use of the tube, unscrew the cap. Insert the back of the cap into the closing piece of the tube. Turn the cap until the tube opens.
• Apply a thin layer of gel to the skin area where there is pain and inflammation, using a gentle massage.
• Close the tube well after use.

For aluminum tube with pressure closure cap

1. Open the upper closure of the cap

Press the lower part of the closure with your fingers, the edge of your hand, or even the edge of a table, to easily open the closure. On each side of the closure, there are evidence of manipulation flaps that allow you to verify that the container is opened for the first time. Before the first use, check that these flaps are not broken.

1. Press to expel the gel and apply it

Press the tube gently to allow the gel to come out and apply it to the painful or inflamed area. Wipe your hands with a paper towel, and then wash them, unless they are the treatment area. The paper should be thrown away after use. Wait for Voltadol Forte to dry on the skin before showering or bathing.

1. Press the top of the cap to close it

After use, if necessary, remove the excess gel from the cap with a cloth or paper towel until it is visually clean and dry.

To close the pressure cap, press the upper closure with your fingers, the edge of your hand, or even the lower part of a table, until you hear "click". Keep the tube in a vertical position with the cap facing up, when opening or closing the container to avoid possible gel leaks from the tube.

For all formats

After application:

• Wipe your hands with a paper towel, and then wash them, unless they are the treatment area. The paper should be thrown away after use.

Wait for the gel to dry on the skin before showering or bathing.

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

If you forgot to use Voltadol Forte

If you forgot to apply this medication when it was 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 use more Voltadol Forte than you should

If you accidentally ingest the medication or if you have used it on a large area of the skin and for a long period of time, you may experience adverse reactions similar to those produced by diclofenac when taken orally (e.g., tablets).

The main symptoms of overdose are: digestive or renal disorders and difficulty breathing.

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 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 have any other doubts about the use of this medication, 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 the medication and consult a doctor or pharmacist immediately:

• Rare (may affect up to 1 in 1,000 patients): Skin rash, with or without blisters; urticaria (red, elevated patches, often with a sensation of itching and burning).
• Very rare (may affect up to 1 in 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.

• Common (may affect up to 1 in 10 patients): Rash, itching, redness, or stinging sensation in the skin after using the medication.
• Very rare (may affect up to 1 in 10,000 patients): The skin may be more sensitive to sunlight (photosensitivity). Symptoms are: sunburn with itching, swelling, and blisters.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above 86°F (30°C).

Do not usethis medicationafter the expiration date that appears on the packaging after CAD.. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Voltadol Forte:

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 23.2 mg of diclofenac diethylamine (which corresponds to 20 mg of diclofenac sodium).
• The other components (excipients) are: Butylhydroxytoluene (E 321), carbomer, cetomacrogol 1000, caprilocaprate of cocoil, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, oleic alcohol, eucalyptus essence, and purified water.

Appearance of Voltadol Forte and contents of the packaging

Creamy gel with a white appearance,

It is presented in an aluminum tube containing 50 grams or 100 grams of gel.

The tubes may be closed with screw caps of polypropylene, or pressure-closing caps, with easy opening, of polypropylene with a thin band of thermoplastic elastomer, with incorporated evidence of manipulation measures

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid, Spain

Responsible for manufacturing

Novartis Consumer Health S.A.

Zielstattstrasse, 40

D-81379 (Munich), Germany

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Last review date of this prospectus:August 2024

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