Voltadol Forte 23.2 mg/g gel

Package leaflet: Information for the user

Introduction

Voltadol Forte 23.2 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 severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Voltadol Forte is and what it is used for
2. Before you use Voltadol Forte
3. How to use Voltadol Forte
4. Possible side effects
5. How to store Voltadol Forte
6. Contents of the pack and other information

1. What Voltadol Forte is and what it is used for

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

Voltadol Forte is used 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 spasms
• occasional back pain (resulting from physical activity or daily activities)
• mild sprains resulting from twisting injuries.

2. What you need to know before using Voltadol Forte

Do not use Voltadol Forte:

• 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 (for a complete list, see the composition in section 6).

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.

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

• If you are under 14 years of age.

Take special care with Voltadol Forte:

• 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 if a skin rash occurs after application.
• Do not use on large areas; use only on the affected area.
• Avoid contact of Voltadol Forte with the eyes. If this occurs, rinse the eyes thoroughly with clean water. Consult your doctor or pharmacist if you experience any discomfort afterwards.
• Do not use occlusive dressings (e.g., plastic bandages).
• Do not use more of the medicine than indicated, or for longer than recommended, unless advised by your doctor.
• Do not apply Voltadol Forte simultaneously on the same area where other medicines have been applied.
• Do not swallow this medicine or use it in the mouth. Voltadol Forte is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet radiation lamps (UV rays).
• Do not use during the first or second trimester of pregnancy unless advised by a doctor.

Use with other medicines

Inform your doctor or pharmacist if you are 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 may 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 problems during delivery. Voltadol Forte 23.2 mg/g gel should not be used 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 Forte 23.2 mg/g gel when applied to the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Under no circumstances should it be applied directly on the breast area in breastfeeding mothers, or on other large areas of skin for prolonged periods.

Use in children

Do not use in children under 14 years of age, due to insufficient data on efficacy and safety.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported when this medicine is used externally on the skin.

Important information about some of the components of Voltadol Forte

This medicine may cause skin irritation because it contains propylene glycol. It may also cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxytoluene.

3. How to use Voltadol Forte

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

The usual dose is:

Adults and adolescents over 14 years of age: Apply a small amount of gel twice daily, every 12 hours (preferably in the morning and evening), to the affected area where inflammation or pain is present.

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

Use the smallest amount necessary for the shortest duration required.

Method of use:

For aluminum tube with screw cap

• For first use, unscrew the cap. Insert the back part of the cap into the seal at the tube opening. Turn the cap until the tube is punctured and opens.
• Spread a thin layer of gel over the painful or inflamed skin area using gentle massage.
• Close the tube tightly after use.

For aluminum tube with press-on 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 tamper-evident tabs that show whether the package has been opened previously. Before first use, check that these tabs are intact.

1. Press to dispense the gel and apply it

Gently squeeze the tube to dispense the gel and apply it to the painful or inflamed area. Wipe your hands with a paper tissue and then wash them, unless your hands are the area being treated. Dispose of the used paper tissue in the trash. Wait until Voltadol Forte has dried completely 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 tissue or absorbent paper until it is visibly clean and dry.

To close the press-on cap, press the upper closure with your fingers, the edge of your hand, or even the bottom of a table until you hear a "click". Always keep the tube in an upright position with the cap facing upwards when opening or closing the container to prevent accidental leakage of gel.

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 paper tissue in the trash.

Wait until the gel has dried completely on the skin before showering or bathing.

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

If you forget to use Voltadol Forte

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

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

If you use more Voltadol Forte than you should

If the medicine is accidentally ingested, or if it has been applied over a large area of skin and for a prolonged period, adverse reactions similar to those caused by oral diclofenac (e.g. tablets) may occur.

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

If too much of the medicine has been applied, it is recommended to remove the excess by washing the affected area thoroughly with water or by wiping off part of the gel.

In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare 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, this medicine can cause adverse effects, although not everyone will experience them.

Some rare and very rare adverse effects can be serious:

If you experience any of the following signs of allergy, stop using the medicine 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 rashes, often accompanied by itching and burning sensation).
• Very rare (may affect up to 1 in 10,000 patients): Difficulty breathing or a 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. 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 stinging of the skin after using the medicine.
• Very rare (may affect up to 1 in 10,000 patients): The skin may become more sensitive to sunlight (photosensitivity). Signs include: itchy sunburn, swelling, and blisters.

If you consider any of the adverse effects you experience to be serious, 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 may 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 Forte

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP.. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltadol Forte:

• The active substance is diethylamine diclofenac. Each gram of gel contains 23.2 mg of diethylamine diclofenac (equivalent to 20 mg of sodium diclofenac).
• The other components (excipients) are: Butylhydroxytoluene (E 321), carbomer, cetomacrogol 1000, coco-caprylocaprate, diethanolamine, isopropyl alcohol, propylene glycol, liquid paraffin, oleyl alcohol, eucalyptus essence, and purified water.

Appearance of Voltadol Forte and contents of the pack

Creamy-looking white gel.

Presented in an aluminum tube containing 50 grams or 100 grams of gel.

The tubes may be closed with polypropylene screw caps or easy-open polypropylene press-on caps with a thin band of thermoplastic elastomer, incorporating tamper-evident features.

Only certain pack sizes may be commercially available.

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

Haleon Italy Manufacturing S.R.L.,

Via Nettunense, 90, Aprilia (LT),

04011, Italy

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 for Medicines and Health Products (AEMPS): http://www.aemps.es/