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

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

• small bruises, bumps, strains
• torticollis or other contractures
• occasional back pain (as a result of sports activities or activities of daily living)

minor sprains produced as a result of a strain.

Do not use Voltadol Forte:

• 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 any of the other ingredients of this medicine (for the complete list see composition in section 6 ).

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

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

• If you are in the last 3 months of pregnancy

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

Take special care with Voltadol Forte:

• Do not apply to places on the skin where there are open cuts or wounds, or to mucous membranes, or to eczema or places on the skin where there is a skin rash. Stop using the medicine if a skin rash occurs after application.
• Do not use in large areas, use exclusively in the affected area
• Avoid getting Voltadol Forte in your eyes. If this happens, rinse your eyes with clean water. Consult your doctor or pharmacist in case you feel any further discomfort.
• Do not use occlusive bandages (eg plastic bandages).
• Do not use more of the medicine than indicated, or for a period of time longer than indicated, except on the advice of your doctor .
• Do not simultaneously apply Voltadol Forte in the same area where other medications have been applied.
• Do not ingest 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.
• The treated areas should not be exposed to the sun (even if it is cloudy) or to ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimesters of pregnancy except medical criteria

Use of other medications

Please inform your doctor or pharmacist if you are using or have recently taken any other medicines, especially pain relievers, even those obtained without a prescription.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, 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 taking any medicine.

During the first six months of pregnancy, Voltadol Forte should only be used after consulting your doctor. During the last three months of pregnancy, this medicine should not be used as it may harm the baby futuro , or cause problems in delivery.

Lactation

Consult your doctor or pharmacist before taking any medicine.

Do not use Voltadol Forte while breastfeeding, unless your doctor has told you to, as diclofenac passes into breast milk in small amounts.

And n should not apply any case mothers breastfeeding directly on the breast area or in other areas in large areas of the skin for prolonged periods of time.

Use in children

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

Driving and using machines

No effect on the ability to drive and use machinery has been reported when used externally on the skin.

Important information about some of the ingredients of Voltadol Forte

This medicine can cause skin irritation because it contains propylene glycol, it can also cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

Follow the following instructions exactly for administration of Voltadol Forte, unless your doctor has indicated different ones. Ask your doctor or pharmacist if you have any questions.

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

The normal dose is :

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

The amount of gel will vary depending on the size of the affected area (normally, it will be enough to apply an amount similar to the size of between a cherry and a walnut).

Use the least amount needed for the shortest time required.

How to use:

• For the first use of the tube, unscrew the cap. Insert the back of the cap into the part that closes the tube. Turn the cap until the tube opens.
• Spread a thin layer of the gel on the area of the skin where there is pain and inflammation, using a gentle massage.
• Close the tube tightly after use.
• Wash your hands after applying the gel unless they are the treatment area.

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

If you forget to use Voltadol Forte

If you forget to apply this medicine when it was due, apply the gel as soon as possible and continue the treatment as normal.

Do not take a double dose to make up for a forgotten dose.

If you use more Voltadol Forte than you should

If you accidentally swallow Voltadol Forte or if you have used it on a large area of the skin and over a long period of time, adverse reactions similar to those produced by diclofenac when taken by mouth (eg tablets) may occur.

The main symptoms of overdose are: digestive or kidney problems and shortness of breath.

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 a part.

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 further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Voltadol Forte 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 an allergy, stop using Voltadol Forte and consult a doctor or pharmacist immediately:

• Rare (seen in 1 to 10 out of 10,000 patients) : Skin rash with or without blisters; urticaria (raised, reddish bumps that are often itchy and burning).
• Very rare (seen in less than 1 in 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 side effects can occur, but these are usually mild and short-lived. If you notice any of them, check with your doctor or pharmacist as soon as possible.

• Common (seen in 1 to 10 in 100 patients): Rash, itching, redness, or stinging of the skin after using the product.
• Very rare (seen in less than 1 in 10,000 patients): The skin may be more sensitive to sunlight (photosensitivity). The signs are: itchy sunburn, swelling, and blisters.
•  

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

Communication of adverse effects

If you experience any kind of side effect, check with your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for medicines for human use, https: //www.notificaRAM.es. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the reach and sight of children.

Do not store above 30 ° C.

Do not use Voltadol Forte after the expiry date which is stated on the carton. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Voltadol Forte:

• The active substance is diclofenac diethylamine. Each gram of gel contains 23.2 mg of diclofenac diethylamine (corresponding to 20 mg of diclofenac sodium).
• The other ingredients (excipients) are: Butylhydroxytoluene (E 321), Carbomer, Ketomacrogol 1000, Cocoyl Caprylocaprate, Diethylamine, Isopropyl Alcohol, Propylene parafina , parafina Liquid, parafina Alcohol, Eucalyptus parafina , and Purified Water.

What the product looks like and contents of the pack

Voltadol Forte is a gel with a creamy appearance, and white in color,

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

Only some pack sizes may be marketed .

Marketing authorization holder

GLAXOSMITHKLINE CONSUMER HEALTHCARE SA

Madrid Technology Park, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid, Spain

Responsible for manufacturing

Novartis Consumer Health SA

Zielstattstrasse, 40

D-81379 (München), Germany

GSK Consumer Healthcare GmbH & Co. KG

Barthstrasse 4

80339 München

Germany

Date of the last revision of this leaflet: March 2019

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/