Package Leaflet: Information for the User

Voltadol 140 mg Adhesive Medicament

Diclofenac Sodium

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

-For advice on any aspect of your dose, including has side effects, contact your pharmacist.

-Report any side effects you may get to your doctor or pharmacist. This includes very rare side effects. See section 4.

-You must see a doctor if your symptoms worsen or do not improve after 7 days.

1.What is Voltadol 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.Storage of Voltadol

6.Contents of the pack and additional information

Voltadol is a medication that relieves pain. It belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication is used for the symptomatic treatment and short-term (up to 7 days) relief of pain associated with acute strains, sprains, or contusions in the arms and legs resulting from traumatic injuries in adolescents aged 16 years and older and in adults.

Do not use VOLTADOL

-if you areallergictodiclofenacor to any of theother componentsof this medication (listed in section6);

-if you areallergicto anyother nonsteroidal anti-inflammatory drug (NSAID)(e.g., acetylsalicylic acid or ibuprofen);

-if you have ever hadasthma attacks, urticariaorswelling and irritation inside the noseafter taking acetylsalicylic acid or any other NSAID;

-if you currently have anactive stomach or duodenal ulcer;

• if you have skin lesions(e.g., skin abrasions, cuts, burns),infected skin or skin affected by inflammation (exudative dermatitis) or eczema.

-if you are in the last three months of pregnancy;

-if you are a child or adolescent under 16years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication

•if you have or have hadbronchial asthma or allergies; you may experience a bronchospasm, which makes breathing difficult.

•ifyou notice a rash on your skinthat appears after applying the medicated adhesive patch. If this happens, remove the patch immediately and discontinue treatment.

•if you havekidney, heartorliver problems, or have had astomach or intestinal ulcerorinflammatory bowel diseaseor atendency to bleed.

The adverse effects can be reduced by using the lowest effective dose for the shortest possible period.

Important precautions

•The medicated adhesive patch should not come into contact with the eyes or mucous membranes or be applied to them.

•Patients over 65 years old should use this medication with caution, as they are more likely to experience side effects.

After removing the medicated adhesive patch, avoid exposing the treated area to direct sunlight or tanning beds to reduce the risk of photosensitivity.

Do not use this medication at the same time as any other medication that contains diclofenac or other NSAIDs, regardless of whether they are used externally or taken orally.

Children and adolescents

Diclofenac is contraindicated for use in children and adolescents under 16years old. There is insufficient data on the efficacy and safety of diclofenac in children and adolescents under 16years old (see section “Do not use VOLTADOL).

Other medications and VOLTADOL

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

As long as this medication is used correctly, the body only absorbs a small amount of diclofenac, making it unlikely to cause the interactions described for medications that contain diclofenac and are taken orally.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use VOLTADOL in the last trimester of pregnancy, as it cannot be ruled out that there may be a higher risk of complications for the mother and child (see “Do not use VOLTADOL).

In the first and second trimesters of pregnancy or if you wish to become pregnant, this medication should only be used after consulting your doctor. If you need treatment during this period, you should take the minimum dose possible for the shortest time possible.

Oral formulations of diclofenac (e.g., tablets) can cause

adverse reactions to the fetus. It is unknown whether this same risk applies to Voltadol

when used on the skin.

Breastfeeding

Small amounts of diclofenac are excreted in breast milk.

Consult your doctor before starting to use this medication during breastfeeding. In any case, if you are breastfeeding, VOLTADOL should not be applied directly to the breast area.

Driving and operating machinery

This medication has no influence on the ability to drive and operate machinery.

VOLTADOL contains butylhydroxyanisole (E320)

Butylhydroxyanisole may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is one medicated adhesive patch per day.

Apply a medicated adhesive patch to the painful area. The maximum total daily dose is 1 medicated adhesive patch per day, even if there are multiple injured areas to treat. Treat only one painful area at a time.

Administration Form

For use on the skin (cutaneous use).

Usage Instructions:

1. Cut the package along the dotted line and remove the medicated adhesive patch.

To apply the patch:

2. Remove one of the protective films.

3. Apply the patch to the affected area and remove the remaining protective film.

4. Apply gentle pressure with the palm of your hand until complete adhesion to the skin is achieved.

To remove the patch:

5. Moisten the patch with water, peel off one edge of the patch, and gently separate it from the skin.

6. To remove any remaining product residue, wash the affected area with water, gently rubbing the area with your fingers in a circular motion.

If necessary, the medicated adhesive patch can be secured in place using an elastic bandage.

Use the medicated adhesive patch only on intact, healthy skin.

Do not use the medicated adhesive patch with a waterproof dressing (occlusive).

Do not use when bathing or showering.

The medicated adhesive patch must be used in its entirety. (Do not divide the patch)

Duration of Use

Do not use Voltadol for more than 7 days.

If you need to use this medication for more than 7 days to relieve pain or if symptoms worsen, consult your doctor.

Using more Voltadol than you should

Inform your doctor if you experience significant side effects after using this medication incorrectly or accidentally taking too much (e.g., in children). Your doctor will inform you of any necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Voltadol

Do not take a double dose to make up for the missed dose.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor immediately and stop using the dressing if you notice any of the following adverse effects:

Urticaria with sudden itching; swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; decreased blood pressure or weakness.

You may experience the following adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people):

Local skin reactions, such as skin redness, burning sensation, itching, inflamed skin redness, skin rash, sometimes with pustules or rashes.

Rare adverse effects (may affect up to 1 in 10,000 people):

Contact dermatitis or local allergic reactions (skin hypersensitivity reactions).

In patients who use externally medications from the same active ingredient group as diclofenac, there have been isolated reports of generalized skin rash, hypersensitivity reactions such as skin swelling and mucous membrane swelling, and anaphylactic reactions with acute circulatory regulation disorders and light sensitivity reactions.

The absorption of diclofenac into the body through the skin is very low compared to the concentration of active principle in the blood after oral use of diclofenac. Therefore, the probability of adverse effects occurring in the body as a whole (such as gastrointestinal or renal disorders or respiratory difficulties) is very low.

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:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light and moisture.

Do not usethis medicationif you observe that it is damaged.

The adhesive dressings used should be folded in half with the adhesive side facing inward.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Voltadol

-The active ingredient is diclofenac sodium.

Each medicated adhesive plaster contains diclofenac in the form of 140mg of diclofenac sodium.

-The other components are:

Outer layer:

Non-woven polyester material

Adhesive layer:

Acrylic dispersion

Tributyl citrate

Butilhydroxyanisole

Protective coating:

Monolayer-coated silicon paper

Appearance of the product and contents of the package

Voltadol is a medicated adhesive plaster, white, 10×14cm in size, made from non-woven material on one side and paper on the other side. Once the protective film is removed, the adhesive film is a bright translucent.

Voltadol is available in packages of 2, 5, 7, and 10medicated adhesive plasters, each in an individual package.

Only some package sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

C/ Severo Ochoa, nº 2,

28760, Tres Cantos, Madrid

Spain

Responsible for manufacturing

Fidia Farmaceutici S.p.A.

Via Ampère, 29

20037 Paderno Dugnano (MI)

Italy

Or

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaVoltadol 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster

BelgiumVoltaren Patch Once Daily, 140 mg pleister emplâtre médicamenteux / Wirkstoffhaltiges Pflaster.

Bulgaria:???????? 140 mg ??????? ???????.

Czech Republic:Voltaren 1x denne.

Estonia:Voltinex.

France:Voltarenactigo 140 mg, emplâtre médicamenteux.

Germany:Voltaren 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster.

Greece:VOLTADOL24-HOURS

Hungary:Voltaren 140 mg gyógyszeres tapasz

Italy:Voltadol Unidie 140 mg cerotto medicato.

Latvia:Voltinex 140 mg arstnieciskais plaksteris.

LithuaniaVoltinex 140 mg vaistinis pleistras.

Luxembourg:Voltaren Patch Once Daily, 140 mg emplâtre médicamenteux / Wirkstoffhaltiges Pflaster.

NetherlandsVoltaren Pleister 140 mg.

Poland:Voltaren Forte.

Portugal:Voltaren 24h, 140 mg, emplastro medicamentoso.

Romania:Voltaren 140 mg emplastru medicamentos.

Spain:Voltadol 140 mg medicated adhesive plaster.

Slovak Republic:Voltaren 1x denne140 mg liecivá náplast.

Last review date of this leaflet:September 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)