VOLTADOL FORTE 23.2 mg/g GEL

2. What you need to know before starting to use Voltadol Forte

Do not use Voltadol Forte:

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

If you are not sure, consult your doctor or pharmacist.

The symptoms related to an allergic reaction to these medications can be: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and runny nose.

• If you are in the last three months of pregnancy

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

Be careful with Voltadol Forte:

• Do not apply to areas of the skin where there are open cuts or wounds, or to mucous membranes, or over eczema or areas of the skin where there is a skin rash. Stop using the medication if a skin rash occurs after application.
• Do not use on large areas, use exclusively on the affected area
• Avoid contact of Voltadol Forte with the eyes. If this happens, rinse your eyes with clean water. Consult your doctor or pharmacist if you feel any discomfort afterwards.
• Do not use occlusive dressings (e.g., plastic bandages).
• Do not use more medication than indicated, nor for a longer period than indicated, unless advised by your doctor.
• Do not apply Voltadol Forte simultaneously to 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 to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy unless medically indicated

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, especially pain relievers, including those purchased without a prescription.

Pregnancy, breastfeeding, and fertility

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

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 unborn baby or cause problems during delivery. Do not use Voltadol Forte 23.2 mg/g gel during the first six months of pregnancy unless it is strictly necessary and recommended by your doctor. If you need treatment during this period, you should use 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 Voltadol Forte 23.2 mg/g gel when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use Voltadol Forte, unless your doctor has indicated it, as diclofenac passes into breast milk in small amounts.

Do not apply it to the breast area or to other areas of the skin in large areas for extended periods.

Use in children

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

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

Important information about some of the components of Voltadol Forte

This medication may cause skin irritation because it contains propylene glycol, and it may also cause local reactions on the skin (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

3. How to use Voltadol Forte

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

This medication is for external use only (cutaneous use).

The normal dose is:

Adults and adolescents over 14 years old:Apply 2 times a day, every 12 hours, (preferably in the morning and at night) a small amount of gel to the local inflamed or painful area.

The amount of gel will vary depending on the size of the affected area (normally, 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.

Mode 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 piece that closes the tube. Turn the cap until the tube is open.
• Spread a thin layer of the gel over the area of the skin where there is pain and inflammation, with a gentle massage.
• Close the tube well after use.

For aluminum tube with pressure cap

1. Open the top cap

Press the lower part of the cap with your fingers, the edge of your hand, or even the edge of a table, to open the cap easily. On each side of the cap, there are tamper-evident tabs that allow you to verify that the package is opened for the first time. Before the first use, check that these tabs are not broken.

1. Press to expel the gel and apply it

Gently press the tube to allow the gel to come out and apply it to the painful or inflamed area. Clean your hands with a paper towel, and then wash them, unless they are the area being treated. 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 any excess gel from the cap with a cloth or absorbent paper until it is visually clean and dry.

To close the pressure cap, press the top cap with your fingers, the edge of your hand, or even the bottom of a table, until you hear a “click”. Keep the tube in a vertical position with the cap facing up when opening or closing the package to avoid possible gel leaks from the tube-

For all formats

After application:

• Clean your hands with a paper towel, and then wash them, unless they are the area being treated. 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 the treatment normally.

Do not apply a double dose to make up for 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 skin and for a long period, adverse reactions similar to those produced by diclofenac when taken orally (e.g., tablets) may occur.

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

If you have applied too much medication, it is recommended to remove it by washing the affected area with plenty of water, or by removing some of it.

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 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.

Some rare and very rare side effects can be serious:

If you experience any of the following signs of an allergic reaction, 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, raised, and often itchy hives).
• Very rare (may affect up to 1 in 10,000 patients): Difficulty breathing or feeling of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

Non-serious side effects:

Other side effects may occur, but they are usually mild and temporary. If you notice any of them, consult your doctor or pharmacist as soon as possible.

• Frequent (may affect up to 1 in 10 patients): Rash, itching, redness, or burning sensation on 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). The signs are: sunburn with itching, swelling, and blisters.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 Pharmacovigilance System for human use medications, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Voltadol Forte

Keep out of the reach and sight of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the drains or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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, caprylic/capric triglyceride, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, oleic acid, eucalyptus essence, and purified water.

Appearance of Voltadol Forte and package contents

Creamy gel with a white color,

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

The tubes may be closed with screw caps made of polypropylene or pressure caps with easy opening, made of polypropylene with a thin band of thermoplastic elastomer, with tamper-evident measures incorporated

Only some package sizes may be marketed.

Marketing authorization holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 - Madrid - Spain

Manufacturer

Novartis Consumer Health S.A.

Zielstattstrasse, 40

D-81379 (Munich), Germany

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Date of the last revision of this leaflet:August 2024

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