Label: Information for the User

Voltadol 11.6 mg/g Gel

Diclofenac diethylamine

1. What Voltadol is and for what it is used

2.What you need to know before using Voltadol

3.How to use Voltadol

4.Possible adverse effects

5.Storage of Voltadol

6.Additional information

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

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

-small bruises, blows, strains

-torticollis or other contractures

-lower back pain

-mild sprains resulting from a twist.

Do not use Voltadol:

• 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 acid,or to any of the other components of this medication (see the 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.

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

Be especially careful with Voltadol:

• Do not apply on areas of the skin where there are open cuts or wounds, mucous membranes, eczemas, 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 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.
• Do not use more of the medication than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply Voltadol simultaneously on the same area where other medications have been applied.
• Do not ingest this medication 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 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, 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 fetus or cause problems during delivery. Voltadol 11.6 mg/g gel should not be used during the first six months of pregnancy, except in cases where it is strictly necessary and recommended by your doctor. If treatment is needed during this period, the minimum dose should be used for the shortest possible time. Oral formulations of diclofenac may cause adverse reactions in the fetus. It is unknown whether this risk applies to Voltadol 11.6 mg/g gel when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Do not apply Voltadol directly to the breast area or on extensive areas of the skin for prolonged periods of time.

Use in children

This medication is not recommended for use in children and adolescents under 14 years old, due to insufficient data on safety and efficacy.

Driving and operating machinery

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

Important information about some of the components of Voltadol

This medication may cause skin irritation due to the presence of propylene glycol.

Follow these exact administration instructions for Voltadol, unless your doctor has told you otherwise. Consult your doctor or pharmacist if you have any doubts.

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

The usual dose is:

Adults and adolescents over 14 years:Apply 3 or 4 times a day a small amount of gel to 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 smallest amount necessary for the shortest time required.

For aluminum tube with screw cap packaging:

Method of use:

• 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 applicator cap packaging:

1. For the first use of the tube, remove the protective cap and unscrew the applicator. Insert the applicator star to remove the protective seal from the tube by turning until the tube opens (see image 1). Tighten the applicator again before pressing the tube.

2. To open, pull 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 to apply a thin layer of gel to the skin area where there is pain and inflammation, using a gentle massage (see image 2).

3. 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 replace the protective cap.

For all formats:

After application:

•Wash 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.

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

If you forgot to use Voltadol

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 make up for the missed 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 the skin and for a long period of time, you may experience adverse reactions similar to those caused 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 of it.

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, Voltadol can 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 Voltadol and consult a doctor or pharmacist immediately:

• Rare (observed between 1 and 10 of every 10,000 patients) : Skin rash accompanied, or not, by blisters; urticaria (red, elevated patches often with a sensation of itching and burning)
• Very rare (observed in fewer than 1 of every 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.

• Frequent (observed between 1 and 10 of every 100 patients): Skin rash, itching, redness, or stinging after using the product.
• Very rare (observed in fewer than 1 of every 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 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 through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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, caprilocaprate of cocoil, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, cream fragrance 45, and purified water.

Appearance of the product and contents of the package

Voltadol is a creamy gel with a white appearance.

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

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 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

Last review date of thisleafletAugust 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/