Pharmacy Guide

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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Voltarol 140mg Medicated Plaster

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Diclofenac sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Diclofenac sodium

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for 2. What you need to know before you use Voltarol 140 mg Medicated Plaster 3. How to use Voltarol 140 mg Medicated Plaster 4. Possible side effects 5. How to store Voltarol 140 mg Medicated Plaster 6. Contents of the pack and other information

1. WHAT VOLTAROL 140 MG MEDICATED PLASTER IS AND WHAT IT IS USED FOR Voltarol 140 mg Medicated Plaster is a medicine that relieves pain. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Voltarol 140 mg Medicated Plaster is used for the local symptomatic and short term treatment of pain associated with acute strains, sprains or bruises on the arms and legs as a result of injuries, e.g. sports injuries in adolescents from 16 years of age and adults.

What you need to know before you take it

E VOLTAROL 140 MG MEDICATED PLASTER Do not use Voltarol 140 mg Medicated Plaster

  • if you are allergic to diclofenac or any of the other ingredients in this medicine (listed in section 6);
  • if you are allergic to any other non-steroidal antiinflammatory drug (NSAID, e.g. acetylsalicylic acid or ibuprofen);
  • if you have ever developed asthma, hives or swelling and irritation inside the nose after taking acetylsalicylic acid or any other NSAID;
  • if you are suffering from an active stomach or duodenal ulcer;
  • if you are in the last three months of pregnancy.
  • if you are a child or an adolescent younger than 16 years of age. Do not use Voltarol 140 mg Medicated Plaster on injured skin (e.g. skin abrasions, cuts, burns), infected skin or skin affected by exudative dermatitis or eczema; Warnings and precautions Talk to your doctor or pharmacist before using Voltarol 140 mg Medicated Plaster
  • if you suffer or have previously suffered from bronchial asthma or allergies; you may experience a bronchial muscle cramp (bronchospasm), which makes breathing difficult
  • if you notice a skin rash, blistering, burning sensation, tightness of breath or wheezing that develops after applying the medicated plaster. If this happens, immediately remove the medicated plaster and stop treatment.
  • if you suffer from disorders of the kidneys, heart or liver
  • if you have previously suffered from a stomach or intestinal ulcer, intestinal inflammation or a tendency to bleed.

PHARMA CODE REF. IS: XX

PHARMA CODE REF. IS: XX

PACKAGE LEAFLET: INFORMATION FOR THE USER

Side effects can be reduced by using the lowest effective dose for the shortest possible period of time. IMPORTANT precautions

  • The medicated plaster must not come into contact with or be applied to the eyes, lips, mouth or throat.
  • Elderly patients should use Voltarol 140 mg Medicated Plaster with caution because they are more likely to experience side effects. After taking off the medicated plaster, avoid exposing the treated area to direct sunlight or tanning lamps in order to reduce the risk of sensitivity to light. Children and adolescents Voltarol 140 mg Medicated Plaster should not be used in children and adolescents under 16 years of age because no adequate experience is available for this age group. Other medicines and Voltarol 140 mg Medicated Plaster Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Voltarol 140 mg Medicated Plaster may interact with blood pressure lowering drugs and may possibly enhance the effects of blood thinning drugs, although the chance of either of these occurring with a topically administered preparation is extremely low. Provided that Voltarol 140 mg Medicated Plaster is used correctly, only a small amount of diclofenac is absorbed into the body so that the interactions described for diclofenac-containing medicines taken orally are unlikely to happen. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy In the last 3 months of pregnancy, Voltarol 140 mg Medicated Plaster must not be used because an increased risk of complications for the mother and the child cannot be ruled out (see "Do not use Voltarol 140 mg Medicated Plaster"). In the first 6 months of pregnancy or if you want to become pregnant, Voltarol 140 mg Medicated Plaster should be used only after talking to your doctor. Breast-feeding Small quantities of diclofenac pass into the breast milk. Talk to your doctor before using Voltarol 140 mg Medicated Plaster during breast-feeding. In any case, if you are breast-feeding Voltarol 140 mg Medicated Plaster should not be applied directly onto the breast area. Driving and using machines Voltarol 140 mg Medicated Plaster has no influence on your ability to drive and use machines.

How to take it

VOLTAROL 140 MG MEDICATED PLASTER Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one medicated plaster twice daily. Attach one medicated plaster to the painful area twice daily, in the morning and in the evening. The maximum total daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Treat only one painful area at a time. Use in children and adolescents Voltarol 140 mg Medicated Plaster is contraindicated for use in children and adolescents under 16 years of age.

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There are insufficient data of efficacy and safety available for children and adolescents below 16 years (see section 2). In adolescents aged 16 years and over, if this medicine is required for more than 7 days for pain relief or if the symptoms worsen, please consult a doctor. Method of administration Use this medicine only on the skin. Instructions for use: 1. Tear open the envelope containing the medicated plaster on the notch and remove the medicated plaster. To apply the plaster: 2. Remove one of the two protective films.

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

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

To remove the plaster: 5. Moisten the plaster with water and peel away an edge of the plaster and pull smoothly away from the skin. 6. To remove any product residues, wash the affected area with water gently rubbing the area with your fingers using a circular movement. If necessary, the medicated plaster can be held in place using a net bandage. Use the medicated plaster only on intact, healthy skin. The medicated plaster should not be applied to the face, eyes, lips, mouth or throat. Do not use the medicated plaster together with an air-tight (occlusive) bandage. Do not wear it when bathing or showering. Do not divide the medicated plaster, by cutting with scissors, for example. Duration of use Do not use Voltarol 140 mg Medicated Plaster for longer than 7 days. If symptoms worsen or persist for longer than 7 days, you should consult a doctor. If you have the impression that the effect of Voltarol 140 mg Medicated Plaster is too strong or too weak, please talk to your doctor or pharmacist. If you apply more Voltarol 140 mg Medicated Plaster than you should Please tell your doctor if you experience side effects after incorrect use of this medicine, if you apply more patches than you should or if a patch is accidently applied to a child. They will be able to advise you of any action that may need to be taken. If you forget to use Voltarol 140 mg Medicated Plaster You should apply a new patch to the affected area when you remember. Do not apply more than one patch to make up for the missed patch. Do not use in children and adolescents under 16 years of age. Do not use more than 2 plasters within 24 hours. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 plaster if you notice any of the following: sudden itchy rash (hives); swelling of the hands, feet, ankles, face, lips, mouth or throat; difficulty breathing; drop in blood pressure (feeling lightheaded) 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 skin redness, burning sensation, itching, inflamed skin redness, skin rash, sometimes with pustules or wheals. Very rare side effects (may affect up to 1 in 10,000 people): Hypersensitivity reactions or local allergic reactions (contact dermatitis). Photosensitivity (sensitivity to sunlight). In patients externally using drugs from the same drug group as diclofenac, there have been isolated reports of generalised skin rash, hypersensitivity reactions such as swelling of the skin, lips, eyes or throat and anaphylactictype (severe allergic) reactions. Including problems with blood circulation and light sensitivity reactions. Absorption of diclofenac into the body by the skin is very low compared to the drug concentration in the blood following diclofenac taken by mouth. Therefore, the likelihood of side effects occurring in the body as a whole (such as stomach or kidney problems or difficulty breathing) is very low. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

VOLTAROL 140 MG MEDICATED PLASTER Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after "EXP". The expiry date refers to the last day of that month. Store below 30 °C. Store in the original package in order to protect from desiccation and light. Keep the sachet tightly closed in order to protect from desiccation and light. Do not use Voltarol 140 mg Medicated Plaster if you notice that it is damaged. Used plasters should be folded in half with the sticky side inwards. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Voltarol 140 mg Medicated Plaster contains The active substance is diclofenac sodium. Each medicated plaster contains 140 mg diclofenac sodium. The other ingredients are: Supporting layer: Polyester non-woven fabric Adhesive layer: Basic butylated methacrylate copolymer Copolymer acrylate vinyl acetate PEG 12 stearate Sorbitan oleate Liner: Mono silicone coated paper What Voltarol 140 mg Medicated Plaster looks like and contents of the pack Voltarol 140 mg Medicated Plaster are white 10×14 cm sized self-adhesive plasters made of non-woven fabric on one and paper on other side. Voltarol 140 mg Medicated Plaster is available in packs of 2, 5 and 10 plasters, each in a single sachet. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, County Waterford, Ireland. Manufacturer: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. Ibsa Farmaceutici Italia S.r.l. Strada Statale n. 11 Padana Superiore, km 160 20060 Cassina de' Pecchi (MI), Itália. This leaflet was last revised in July 2022. NPA005167

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Frequently asked questions about Voltarol 140mg Medicated Plaster

What is the active substance in Voltarol 140mg Medicated Plaster?

The active substance in Voltarol 140mg Medicated Plaster is diclofenac sodium.

Are there equivalent medicines to Voltarol 140mg Medicated Plaster?

Medicines with the same active substance, strength and form include: Voltarol ONE A DAY 140 mg Medicated plaster. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Voltarol 140mg Medicated Plaster, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Voltarol 140mg Medicated Plaster without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Diclofenac sodium (22 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Short term treatment (max. 7 days)

Local symptomatic and short term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries in adolescents from 16 years of age and adults.

4.2. Posology and method of administration

Adults and adolescents from 16 years of age

One medicated plaster should be applied to the painful area twice daily, in the morning and in the evening. The maximum daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Therefore, only one painful area can be treated at a time.

Duration of use

Voltarol 140 mg Medicated Plaster is for short-term treatment.

The duration of use should not exceed 7 days. The therapeutic benefit of longer use has not been established.

If there is no improvement, during the recommended duration of treatment or a worsening of symptoms, a doctor should be consulted.

Voltarol 140 mg Medicated Plaster is to be used for the shortest duration necessary to control symptoms depending on the indication.

Elderly patients and patients with renal or hepatic impairment

This medication should be used with caution in elderly patients who are more prone to adverse events (see also section 4.4).

In treatment of elderly and patients with renal or hepatic impairment see section 4.4.

Paediatric population

There are insufficient data on efficacy and safety available for children and adolescents below 16 years of age (see also section 4.3).

In adolescents aged 16 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescent is/are advised to consult a doctor.

Method of administration

Cutaneous use only.

The medicated plaster should be applied only to intact non-diseased skin and should not be worn when bathing or showering.

The medicated plaster should not be divided.

If necessary, the medicated plaster can be held in place using a net bandage.

The medicated plaster must not be used together with an occlusive dressing.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1;

• In patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs];

• In patients who have previously experienced asthma, angioedema, urticaria or acute rhinitis when taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAIDs);

• In patients with active peptic ulcer;

• On damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound;

• During the last trimester of pregnancy.

Children and adolescents:

The use in children and adolescents aged less than 16 years is contraindicated.

4.4. Special warnings and precautions for use

The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes. It should be applied only to intact non-diseased skin, and not to skin wounds or open injuries.

Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Undesirable effects can be reduced by using the lowest effective dose for the shortest possible period of time (see section 4.2).

Bronchospasm can occur in patients who suffer or have previously suffered from bronchial asthma or allergies

Treatment must be stopped immediately if a skin rash develops after applying the medicated plaster.

Patients should be warned against exposure to sunlight or solarium radiation after removal of the medicated plaster in order to reduce the risk of photosensitisation.

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).

Although the systemic effects are expected to be minimal, the medicated plaster should be used with caution in patients with impaired renal, cardiac or hepatic function, or a history of peptic ulcer, inflammatory bowel disease or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients as they are more likely to experience undesirable effects.

No other medicinal products containing diclofenac or any other non-steroidal anti-inflammatory drugs (NSAIDs) should be used concomitantly, neither topically nor systemically.

The label contains the following statement: “Do not use with any other Voltarol products or any other NSAIDs.”

Paediatric population

Voltarol 140 mg Medicated Plaster is not recommended for use in children and adolescents under 16 years of age.

4.5. Interaction with other medicinal products and other forms of interaction

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

Since systemic absorption of diclofenac during labelled use of the medicated plasters is very low, the risk of developing clinically relevant drug-drug interactions is negligible.

4.6. Fertility, pregnancy and lactation

Fertility

There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans. The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. As for other NSAIDs, the oral use of diclofenac may impair female fertility and is not recommended in women attempting to conceive.

Pregnancy

The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with pharmaceutical forms with systemic uptake, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Breastfeeding

Like other NSAIDs, diclofenac is excreted into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plaster no effects on the suckling child are anticipated.

Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, Voltarol 140 mg Medicated Plaster should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

4.7. Effects on ability to drive and use machines

Voltarol 140 mg Medicated Plaster has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The following frequency categories are used for reporting undesirable effects:

Very common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1,000 to <1/100

Rare

≥1/10,000 to <1/1,000

Very rare

<1/10,000

Not known

cannot be estimated from the available data

Infections and infestations

Very rare

Rash pustular

Immune system disorder

Very rare

Angioneurotic oedema, hypersensitivity (including urticaria), anaphylactic type reaction

Respiratory, thoracic and mediastinal disorders

Very rare

Asthma

Skin and subcutaneous tissue disorders

Common

Dermatitis (including allergic and contact dermatitis), rash, erythema, eczema, pruritus

Rare

Dermatitis bullous (e.g. erythema bullosum), dry skin

Very rare

Photosensitivity reaction

General disorders and administration site conditions

Common

Application site reactions

Systemic plasma diclofenac levels measured during labelled use of the cutaneous patches are very low compared to those obtained after oral intake of diclofenac. The risk of developing systemically induced side effects (like gastric, hepatic and renal disorders) during use of the plaster therefore appears to be low. However, in particular when the medicated plaster is used on a large area of skin and over a prolonged period of time, systemic side effects may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

The low systemic absorption of topical diclofenac renders overdose unlikely. Should significant systemic undesirable effects occur following incorrect use or accidental overdose (e.g. in children), the precautions appropriate for poisoning with non-steroidal anti-inflammatory drugs should be taken.

💬 Ask about this leaflet

Ask anything about Voltarol 140mg Medicated Plaster. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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