Voltadol 11.6 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voltadol 11.6 mg/g Gel

Diclofenac diethylamine

Read the entire leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If symptoms worsen or persist beyond 7 days, you should consult a doctor.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

1. What Voltadol is and what it is used for

Diclofenac diethylamine, the active ingredient in 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 of age for the local relief of mild and occasional pain and inflammation caused by:

• minor bruises, blows, sprains
• torticollis or other muscle contractures
• lumbago
• mild sprains resulting from twisting injuries.

2. Before using Voltadol

Do not use Voltadol:

• If you are allergic to diclofenac or to any other non-steroidal 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 medicine (to see the full list, refer to section 6, Composition). If you are unsure, consult your doctor or pharmacist.

Symptoms related to an allergic reaction to these medicines may include: asthma, difficulty breathing, skin rash or itching, swelling of the face or tongue, and runny nose.

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

• If you are under 14 years of age.

• Do not apply on wounds, eczematous lesions, mucous membranes, or burns.

Take special care with Voltadol:

• Do not apply on areas of skin with cuts or open wounds, on mucous membranes, on eczema, or on areas of skin with a rash. Discontinue use of the medicine if a skin rash occurs after application.
• Do not use over large areas; use only on the affected area.
• Avoid contact of Voltadol with the eyes. If contact occurs, rinse eyes thoroughly 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 medicine than indicated, or for longer than recommended, unless advised by your doctor.
• Do not apply Voltadol simultaneously on the same area where other medicines have been applied.
• Do not swallow this medicine or use it in the mouth. Voltadol is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimesters of pregnancy unless advised by a doctor.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, especially painkillers, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 must not be used, as it may harm the unborn baby or cause complications during delivery. You should not use Voltadol 11.6 mg/g gel during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used. Oral formulations (e.g., tablets) of diclofenac may cause adverse effects on the fetus. It is unknown whether the same risk applies to Voltadol 11.6 mg/g gel when applied to the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not use Voltadol during breastfeeding unless specifically instructed by your doctor, as diclofenac passes into breast milk in small amounts.

Under no circumstances should Voltadol be applied directly on the breast area in breastfeeding mothers, or on other areas over extensive skin surfaces for prolonged periods.

Use in children

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

Driving and using machines

No effects on the ability to drive or operate machinery have been reported with external application to the skin.

Important information about some of the components of Voltadol

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

3. How to use Voltadol

Follow exactly the instructions below for using Voltadol, unless your doctor has given you different advice. If in doubt, consult your doctor or pharmacist.

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

The usual dose is:

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

The amount of gel will vary depending on the size of the affected area (normally, an amount the size of a cherry to a walnut will be sufficient).

Use the smallest amount necessary for the shortest time required.

For aluminum tube with screw cap:

Instructions for use:

• For first use, unscrew the cap. Insert the back end of the cap into the seal closing the tube. Turn the cap until the tube opens.
• Spread a thin layer of the gel over the painful or inflamed area of skin with a gentle massage.
• Close the tube properly after use.

For aluminum tube with applicator cap:

1. For first use, remove the protective cap and unscrew the applicator. Insert the star-shaped end of the applicator into the tube seal and turn to break the seal and open the tube (see image 1). Rescrew the applicator before squeezing the tube.

2. To open, pull the white part of the applicator. Gently squeeze the tube to allow the gel to come out onto the applicator. Use the applicator tip as if it were your finger, spreading a thin layer of gel over the painful or inflamed area of skin with a gentle massage (see image 2).

3. After use, clean the applicator with a cotton pad or absorbent paper until it is clean and dry. Do not immerse or rinse with water. Do not use any detergent to clean the applicator surface. After cleaning, close the tube tightly. Do not reuse the applicator with another tube, and replace the protective cap.

For all pack types:

After application:

• Wipe your hands with a paper tissue and then wash them, unless your hands are the treated area. Dispose of the used tissue in the trash.
• Wait until Voltadol forte has dried on the skin before showering or bathing.

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

If you forget to use Voltadol

If you forget to apply the medicine at the scheduled time, apply the gel as soon as you remember and continue treatment as normal.

Do not apply a double dose to make up for a missed dose.

If you use more Voltadol than you should

If Voltadol is accidentally swallowed, or if it has been applied over a large area of skin and for a prolonged period, adverse reactions similar to those seen with oral diclofenac (e.g. tablets) may occur.

Main symptoms of overdose include: digestive or renal disorders and difficulty breathing.

If you have applied too much medicine, it is recommended to remove it by washing the affected area thoroughly with water, or by wiping off the excess.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (91 562 04 20), stating the name of the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, Voltadol may cause adverse effects, although not everyone experiences 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 (reddish, raised rashes, often with itching and burning sensation)
• Very rare (observed in less than 1 out of 10,000 patients): Difficulty breathing or feeling of pressure in the chest (asthma); swelling of the face, lips, tongue, or throat.

Non-serious adverse effects:

Other adverse effects may occur, but these are usually mild and transient in duration. 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 out of 10,000 patients): The skin may become more sensitive to sunlight (photosensitivity). Signs include sunburn with itching, swelling, and blisters.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products, https://www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container. The expiry date refers to 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 medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Voltadol:

• The active substance is diethylamine diclofenac. Each gram of gel contains 11.6 mg of diethylamine diclofenac (equivalent to 10 mg of sodium diclofenac).
• The other components (excipients) are: carbomer, cetomacrogol 1000, coco-caprylate caprate, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, cream 45 fragrance, and purified water.

Appearance of the product and contents of the pack

Voltadol is a creamy-looking white gel.

It is supplied in an aluminium tube containing 60, 75 or 100 grams of gel. The 75 g pack includes an applicator cap. The 60 g and 100 g packs are supplied with a screw closure 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 most recent review of this package leaflet: August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/