VOLTADOL 140 MG MEDICINAL ADHESIVE PATCH

Introduction

Package Leaflet: Information for the User

Voltadol 140 mg medicated adhesive patch

diclofenac sodium

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Voltadol and what is it used for
2. What you need to know before you start using Voltadol
3. How to use Voltadol
4. Possible side effects
5. Storage of Voltadol
6. Contents of the pack and further information

1. What is Voltadol and what is it used for

Voltadol is a medicine that relieves pain. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic local and short-term (up to 7 days) treatment of pain associated with sprains, strains, or bruises in the arms and legs as a result of blunt injuries in adolescents from 16 years of age and adults.

2. What you need to know before you start using VOLTADOL

Do not use VOLTADOL

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID; e.g., acetylsalicylic acid or ibuprofen);
• if you have ever had asthma attacks, hives, or swelling and irritation inside the nose after taking acetylsalicylic acid or any other NSAID;
• if you currently have an active 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 16 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you have or have had asthma or allergies; you may experience a muscle spasm in the airways (bronchospasm), which makes breathing difficult.
• if you notice a rash on the skin that appears after applying the medicated patch. If this happens, remove the medicated patch immediately and discontinue treatment.
• if you have kidney, heart, or liver disorders, or have previously had a stomach or intestinal ulcer or intestinal inflammation or a tendency to bleeding.

The side effects can be reduced by using the lowest effective dose for the shortest possible time.

Important precautions

• The medicated patch should not come into contact with the eyes or mucous membranes or be applied to them.
• Elderly patients should use this medicine with caution because they are more likely to experience side effects.

After removing the medicated patch, avoid exposing the treated area to direct sunlight or radiation in a solarium to reduce the risk of sensitivity to light.

Do not use this medicine at the same time as any other medicine that contains diclofenac or other non-steroidal anti-inflammatory drugs, whether used externally or taken orally.

Children and adolescents

Diclofenac is contraindicated for use in children and adolescents under 16 years of age. There is not enough data on the efficacy and safety in the case of children and adolescents under 16 years of age (see section "Do not use VOLTADOL").

Other medicines and VOLTADOL

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

As long as this medicine is used correctly, the body only absorbs a small amount of diclofenac, so it is unlikely that the interactions described for medicines that contain diclofenac and are taken orally will occur.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

In the last trimester of pregnancy, VOLTADOL should not be used because it cannot be ruled out that there is a higher risk of complications for the mother and child (see "Do not use VOLTADOL").

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

Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions in the fetus. It is not known if 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 medicine during breastfeeding. In any case, if you are breastfeeding, VOLTADOL should not be applied directly to the breast area.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is nil.

VOLTADOLcontains butylhydroxyanisole (E 320)

Butylhydroxyanisole may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to use Voltadol

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is one medicated patch once a day.

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

Method of administration

For application to the skin (cutaneous use).

Instructions for use:

1. Cut the pouch along the dotted line and remove the medicated patch.

To apply the patch:

1. Remove one of the two protective films.

1. Apply the patch to the area to be treated and remove the remaining protective film.

1. Apply gentle pressure with the palm of your hand until the patch is completely adhered to the skin.

To remove the patch:

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

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

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

Use the medicated patch only on intact, healthy skin.

Do not use the medicated patch with an airtight (occlusive) dressing.

Do not use it when bathing or showering.

The medicated patch should be used whole. (Do not divide the patch)

Duration of use

Do not use Voltadol for more than 7 days.

If you need to use this medicine for more than 7 days to relieve pain or if the symptoms worsen, you are advised to consult a doctor.

If you use more VOLTADOL than you should

Tell your doctor if you experience significant side effects after incorrect use of this medicine or accidental overdose (e.g., in children). Your doctor may inform you of any measures that need to be taken.

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 medicine and the amount ingested.

If you forget to use VOLTADOL

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop using the patch if you notice any of the following side effects:

Sudden itchy rash (hives); swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure or weakness.

You may experience the following side effects:

Common side effects (may affect up to 1 in 10 people):

local skin reactions, such as redness of the skin, burning sensation, itching, inflamed skin redness, rash, sometimes with blisters or hives.

Very rare side effects (may affect up to 1 in 10,000 people):

hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using external medicines of the same active substance group as diclofenac, there have been isolated reports of generalized skin rash, hypersensitivity reactions such as skin swelling and mucous membrane irritation, and anaphylactic-type reactions with acute disorders of circulation and light sensitivity reactions.

The absorption of diclofenac into the body through the skin is very low compared to the concentration of the active substance in the blood after oral use of diclofenac. Therefore, the likelihood of systemic side effects (such as gastrointestinal or renal disorders or respiratory difficulties) is very low.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website (http://www.aemps.gob.es).

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Voltadol

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

Do not use this medicine after the expiry date stated on the carton and pouch after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original package to protect from light and moisture.

Do not use this medicine if you notice it is damaged.

Used medicated patches should be folded in half with the adhesive side inward.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Voltadol

• The active substance is diclofenac sodium.

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

• The other ingredients are:

Outer layer:

Non-woven polyester material

Adhesive layer:

Acrylic dispersion

Tributyl citrate

Butylhydroxyanisole

Protective coating:

Silicone-coated paper

Appearance and packaging of the product

Voltadol is a white medicated adhesive patch, 10 x 14 cm, made of non-woven material on one side and paper on the other. Once the protective film is removed, the adhesive film is translucent and shiny.

Voltadol is available in packs of 2, 5, 7, and 10 medicated patches, each in an individual pouch.

Not all pack sizes may be marketed.

Marketing authorisation holder

Haleon Spain, S.A.

C/ Severo Ochoa, nº 2,

28760, Tres Cantos, Madrid

Spain

Manufacturer

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 authorised in the Member States of the European Economic Area under the following names:

Austria Voltadol 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster

Belgium Voltaren 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: VOLTADOL 24-HOURS

Hungary: Voltaren 140 mg gyógyszeres tapasz

Italy: Voltadol Unidie 140 mg cerotto medicato.

Latvia: Voltinex 140 mg arstnieciskais plaksteris.

Lithuania Voltinex 140 mg vaistinis pleistras.

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

Netherlands Voltaren Pleister 140 mg.

Poland: Voltaren Forte.

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

Romania: Voltaren 140 mg emplastru medicamentos.

Spain: Voltadol 140 mg apósito adhesivo medicamentoso.

Slovak Republic: Voltaren 1x denne 140 mg liecivá náplast.

Date of last revision of this leaflet:September 2024

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