Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for Voltarol ONE A DAY Medicated Plaster is a medicine that relieves pain. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Voltarol ONE A DAY Medicated Plaster is used for the local symptomatic short-term treatment (max. 7 days) of pain associated with acute strains, sprains or bruises on the arms and legs as a result of blunt injuries in adolescents from 16 years of age and adults.
e Voltarol ONE A DAY Medicated Plaster Do not use Voltarol ONE A DAY Medicated Plaster
Side effects can be reduced by using the lowest effective dose for the shortest possible period of time. Important precautions
Voltarol ONE A DAY 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 once daily. Attach one medicated plaster to the painful area. The maximum total daily dose is 1 medicated plaster a day, even if there is more than one injured area to be treated. Treat only one painful area at once. Method of administration For application on the skin (cutaneous use). Instructions for use: 1. Cut the sachet along the dotted line 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 non-diseased skin. Do not use the medicated plaster together with an air-tight (occlusive) bandage. Do not wear it when bathing or showering. You should not divide the medicated plaster. Duration of use Do not use Voltarol ONE A DAY Medicated Plaster for longer than 7 days. If this medicine is required for more than 7 days for pain relief or if the symptoms worsen you are advised to consult a doctor. If you use more Voltarol ONE A DAY Medicated Plaster than you should Please tell your doctor if significant side effects occur after incorrect use of this medicine or accidental overdose (e.g. in children). He will be able to advise you of any action that may need to be taken. If you forget to use Voltarol ONE A DAY Medicated Plaster Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 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). In patients externally using medicines from the same active substance group as diclofenac, there have been isolated reports of generalised skin rash, hypersensitivity reactions such as swelling of the skin and mucous membranes and
anaphylactic-type reactions with acute circulatory regulation disorders and light sensitivity reactions. Absorption of diclofenac into the body by the skin is very low compared to the concentration of active substance in the blood following oral use of diclofenac. Therefore, the likelihood of side effects occurring in the body as a whole (such as gastrointestinal or kidney disturbances 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.
Voltarol ONE A DAY Medicated Plaster Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the sachet after "EXP". The expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. Do not use Voltarol ONE A DAY 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.
What Voltarol ONE A DAY Medicated Plaster contains
33001755/B
The active substance in Voltarol ONE A DAY 140 mg Medicated plaster is diclofenac sodium.
Medicines with the same active substance, strength and form include: Voltarol 140mg Medicated Plaster. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Voltarol ONE A DAY 140 mg 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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Local symptomatic short-term treatment (max. 7 days) of pain in acute strains, sprains or bruises of the extremities following blunt trauma in adolescents from 16 years of age and adults.
Posology
Adults and adolescents from 16 years of age
One medicated plaster should be applied to the painful area once daily. The maximum daily dose is 1 medicated plaster a day, 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 ONE A DAY Muscle Pain Relief 140 mg Medicated Plaster is to be used for the shortest duration necessary to control symptoms.
The duration of use should not exceed 7 days. The therapeutic benefit of longer use has not been established.
Elderly patients
This medicinal product should be used with caution in elderly patients who are more prone to adverse events (see also section 4.4).
Patients with renal or hepatic impairment
In treatment of patients with renal or hepatic impairment see section 4.4.
Paediatric population
The safety and efficacy of Voltarol ONE A DAY Muscle Pain Relief 140 mg Medicated Plaster in children and adolescents under 16 years of age has not been established (see also section 4.3).
If this medicinal 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.
The medicated plaster must 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.
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
- hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs];
- patients who have previously experienced an asthma attack, urticaria or acute rhinitis when taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAIDs);
- patients with active peptic ulcer;
- on damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound;
- third trimester of pregnancy;
- children and adolescents aged less than 16 years.
The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes.
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.
Although the systemic effects are expected to be minimal, the medicated plasters 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.
Butylated hydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
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.
Pregnancy
There is no clinical data from the use of diclofenac during pregnancy.
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic diclofenac exposure reached after topical administration can be harmful to an embryo/fetus. With reference to experience from treatment with NSAIDs 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 (see section 4.3).
Breast-feeding
Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plaster no effects on the breast-fed child are anticipated.
Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Voltarol Once-a-day 140 mg Plaster should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time.
Voltarol Once-a-day 140 mg Plaster has no influence on the ability to drive and use machines.
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 disorders
Very rare
Hypersensitivity (including urticaria), angioneurotic oedema, anaphylactic type reaction
Respiratory, thoracic and mediastinal disorders
Very rare
Asthma
Skin and subcutaneous tissue disorders
Common
Rash, eczema, erythema, dermatitis (including allergic and contact dermatitis), 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 medicated plasters are very low compared to those obtained after oral intake of diclofenac. The risk of developing systemically induced undesirable effects (like gastric, hepatic and renal disorders, systemic hypersensitivity reactions) 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 undesirable 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is no experience with overdose of diclofenac medicated plaster.
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 anything about Voltarol ONE A DAY 140 mg 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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