VOLTADOL 11.6 mg/g GEL

Introduction

Package Leaflet: Information for the User

Voltadol 11.6 mg/g Gel

Diclofenac diethylamine

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

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

• Keep this leaflet because 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 think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is Voltadol and what is it used for
2. What you need to know before using Voltadol
3. How to use Voltadol
4. Possible side effects
5. Storage of Voltadol
6. Additional information

1. What is Voltadol and what is it used for

Diclofenac diethylamine, the active ingredient of this medicine, belongs to the group of non-steroidal anti-inflammatory drugs and acts as a local analgesic and anti-inflammatory.

Voltadol is indicated in adults and adolescents over 14 years for the local relief of mild and occasional pain and inflammation caused by:

- minor bruises, blows, sprains

- torticollis or other contractures

- lumbalgia

- mild sprains caused as a consequence of a twist.

2. Before using Voltadol

Do not use Voltadol:

• If you are allergic to diclofenac or any other non-steroidal anti-inflammatory medicine used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid,or to any of the other components of this medicine (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 medicines can be: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and runny nose.

• If you are in the last 3 months of pregnancy.

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

Be careful with Voltadol:

• 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 medicine if a skin rash occurs after application.
• Do not use on large areas, use exclusively on the affected area.
• Avoid contact of Voltadol 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.
• Do not use more of the medicine than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply Voltadol simultaneously to the same area where other medicines have been applied.
• Do not ingest this medicine or use it in the mouth. Voltadol 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 if cloudy) or to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy unless medically indicated.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, 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 medicine.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

During the last three months of pregnancy, this medicine should not be used, as it may harm the unborn baby or cause problems during delivery. Do not use Voltadol 11.6 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 11.6 mg/g gel when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

It should not be applied in any case to breastfeeding mothers directly on the breast area or on other areas of the skin in large areas for prolonged periods.

Use in children

This medicine is not recommended for use in children and adolescents under 14 years old, as there is not enough data available on safety and efficacy.

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

This medicine may cause skin irritation because it contains propylene glycol.

3. How to use Voltadol

Follow exactly the following instructions for administering Voltadol, unless your doctor has indicated otherwise. Consult your doctor or pharmacist if you have doubts.

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

The normal dose is:

Adults and adolescents over 14 years:Apply 3 or 4 times a day a small amount of gel to the 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.

For aluminum tube with screw cap:

Mode of use:

• 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 opened.
• 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 applicator cap:

1. For the first use of the tube, remove the protective cap and unscrew the applicator. Insert the star of the applicator to eliminate the protective seal of the tube by turning until the tube is opened (see image 1). Screw the applicator back on before pressing the tube.

1. To open, pull on the white part of the applicator. Gently press the tube to allow the gel to come out onto the applicator. Use the applicator cap as if it were your fingers, spreading a thin layer of the gel over the area of the skin where there is pain and inflammation, with a gentle massage (see image 2).

1. After use, clean the applicator with a cotton swab or absorbent paper until it is clean and dry. Do not submerge or rinse with water. Do not use any detergent to clean the surface of the applicator. After cleaning, close the tube well. Do not reuse the applicator with another tube and put the protective cap back on.

For all formats:

After application:

• Wash your hands with a paper towel, and then wash them, unless the area being treated is your hands. The paper should be thrown away after use.
• Wait for Voltadol to dry on the skin before showering or bathing.

If the pain or swelling worsens or persists after 7 days of treatment, consult your doctor.

If you forgot to use Voltadol

If you forgot to apply this medicine 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 forgotten doses.

If you use more Voltadol than you should

If you accidentally ingest Voltadol 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 of the medicine, 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 medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, Voltadol can cause side effects, although not everyone gets them.

Some rare and very rare side effects can be serious:

If you experience any of the following signs of allergy, stop using Voltadol and consult a doctor or pharmacist immediately:

• Rare (observed in 1 to 10 out of 10,000 patients): Skin rash with or without blisters; urticaria (red, raised, and often itchy hives)
• Very rare (observed in less than 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 (observed in 1 to 10 out of 100 patients): Rash, itching, redness, or stinging on the skin after using the product.
• Very rare (observed in less than 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 think any of the side effects you are suffering from 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Voltadol

• Keep out of the reach and sight of children.
• Do not store above 30°C.
• Do not use Voltadol after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Additional information

Composition of Voltadol:

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine (which corresponds to 10 mg of diclofenac sodium).
• The other components (excipients) are: carbomer, cetomacrogol 1000, caprylocaproyl cocoate, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, perfume cream 45, and purified water.

Appearance of the product and packaging content

Voltadol is a gel with a creamy appearance and white color.

It is presented in an aluminum tube containing 60, 75, or 100 grams of gel. The 75g packaging includes an applicator cap. The packages with 60 or 100 grams of gel are presented with a screw cap.

Marketing authorization holder

Haleon Spain, S.A.

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

Manufacturer

Novartis Pharma Produktions GmbH,

öflinger Strasse 44,

79664 Wehr, Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 Munich, Germany

Haleon Germany GmbH

Barthstraße 4

80339 Munich, Germany

Date of the last revision of thisleafletAugust 2024

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