Voltadol 140 mg medicated patch

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voltadol 140 mg medicated adhesive patch

diclofenac sodium

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

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. Contents of the pack and other information

1. What Voltadol is and what it is 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 local and short-term symptomatic treatment (up to 7 days maximum) of pain associated with sprains, strains or contusions in the arms and legs resulting from blunt injuries in adolescents aged 16 years and older and in adults.

2. What you need to know before using VOLTADOL

Do not use VOLTADOL

• if you are allergic to diclofenac or to 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 experienced asthma attacks, urticaria, 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

Talk to your doctor or pharmacist before using this medicine

• if you suffer from or have previously suffered from bronchial asthma or allergies; you may experience bronchial muscle spasm (bronchospasm), which makes breathing difficult.
• if you develop a skin rash after applying the medicated adhesive patch. If this occurs, remove the medicated adhesive patch immediately and discontinue treatment.
• if you have kidney, heart, or liver disorders, or have previously had a stomach or intestinal ulcer, intestinal inflammation, or a tendency to bleeding.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Important precautions

• The medicated adhesive patch must not come into contact with the eyes, mucous membranes, or be applied to them.
• Elderly patients should use this medicine 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 medicine simultaneously with any other medicine containing diclofenac or other analgesic and non-steroidal anti-inflammatory drugs, regardless of whether they are used externally or taken orally.

Children and adolescents

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

Other medicines and VOLTADOL

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

When this medicine is used correctly, only a small amount of diclofenac is absorbed into the body, making it unlikely that interactions described for orally taken diclofenac-containing medicines will occur.

Pregnancy and breastfeeding

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

VOLTADOL must not be used during the last trimester of pregnancy because an increased risk of complications for both mother and child cannot be ruled out (see "Do not use VOLTADOL").

During the first and second trimesters of pregnancy or if you are planning to become pregnant, this medicine should only be used after consulting your doctor. If treatment is needed 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 when used on the skin.

Breastfeeding

Small amounts of diclofenac are excreted in breast milk.

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

Driving and using machines

This medicine has no influence on the ability to drive or operate machinery.

VOLTADOL contains butylated hydroxyanisole (E320)

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

3. How to use Voltadol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is one medicated adhesive patch once daily.

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

Method of administration

For application on the skin (cutaneous use).

Instructions for use:

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

To apply the patch:

1. Remove one of the two protective liners.

2. Apply the patch to the area to be treated and remove the remaining protective liner.

3. Press gently with the palm of your hand to ensure complete adhesion to the skin.

To remove the patch:

1. Moisten the patch with water, lift one edge of the patch, and gently peel it off the skin.

2. To remove any residual product, wash the affected area with water, gently rubbing the area in circular motions with your fingers.

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

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

Do not use the medicated adhesive patch together with an occlusive dressing.

Do not use while bathing or showering.

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

Duration of use

Do not use Voltadol for longer than 7 days.

If use of this medicine beyond 7 days is required to relieve pain, or if symptoms worsen, you are advised to consult a doctor.

If you use more Voltadol than you should

Inform your doctor if significant adverse effects occur following incorrect use of this medicine or accidental overdose (e.g., in children). The doctor can advise you on any necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 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 missed doses.

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 may produce adverse effects, although not everyone will experience them.

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

Sudden skin rash (urticaria) with 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 redness of the skin, burning sensation, itching, redness of inflamed skin, rash, sometimes with pustules or bumps.

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

Hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using topical medicines from the same active substance group as diclofenac, there have been isolated reports of generalized skin rash, hypersensitivity reactions such as swelling of the skin and mucous membranes, and anaphylactic-type reactions with acute disturbances in circulatory regulation and photosensitivity reactions.

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

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 on the sachet 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 packaging to protect it from light and moisture.

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

Used adhesive patches should be folded in half with the adhesive side facing inwards.

Medicines must not be disposed of via wastewater or household waste. Take used containers and any medicines you no longer need to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you do not need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltadol

• The active substance is sodium diclofenac.

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

• The other components are:

Outer layer:

Non-woven polyester material

Adhesive layer:

Polyacrylate dispersion

Tributyl citrate

Butylated hydroxyanisole

Protective liner:

Silicone-coated single-sided paper

Nature of the product and contents of the pack

Voltadol is a white medicated self-adhesive patch measuring 10 × 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 adhesive patches, each individually packed in a sachet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 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 medicinal product is authorized in the European Economic Area member states 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

Slovakia: Voltaren 1x denne 140 mg liecivá náplast

Date of latest review of this leaflet: September 2024

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