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Diclofenac sodium transdermal medicated plaster


Medicated plaster formulation of diclofenac sodium.

Drugs List

  • diclofenac sodium 140mg medicated plaster
  • FLECTOR TISSUGEL 140mg medicated plaster
  • VOLTAROL 140mg medicated plaster
  • Therapeutic Indications




    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.

    The duration of use should not exceed 7 days.


    1 medicated plaster to be applied to the painful area twice daily in the morning and in the evening.

    1 medicated plaster to be applied to the painful area once or twice a day, refer to brand information for appropriate dose.

    1 medicated plaster to be applied to the painful area twice daily in the morning and in the evening.


    Children aged 16 years and older
    1 medicated plaster to be applied to the painful area twice daily in the morning and in the evening.

    1 medicated plaster to be applied to the painful area once or twice a day, refer to brand information for appropriate dose.

    1 medicated plaster to be applied to the painful area twice daily in the morning and in the evening.


    Children under 16 years
    Open wounds
    Exudative dermatosis
    Peptic ulcer
    Skin infection
    Third trimester of pregnancy

    Precautions and Warnings

    Allergic disposition
    Haemorrhagic diathesis
    Cardiac impairment
    First trimester of pregnancy
    Hepatic impairment
    History of peptic ulcer
    Inflammatory bowel disease
    Renal impairment
    Second trimester of pregnancy

    Not all available brands are licensed for all indications
    Some formulations contain hydroxybenzoate
    Some formulations contain propylene glycol
    Avoid broken or inflamed skin
    Avoid contact with eyes, lips or mouth
    Avoid occlusive dressings
    Discontinue treatment if rash occurs
    Maintain treatment at the lowest effective dose
    Advise patient that photosensitivity possible
    Advise patient to see doctor if symptoms persist for 7 days with treatment
    Avoid direct exposure to sunlight

    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.

    Pregnancy and Lactation


    Diclofenac is contraindicated in the third trimester of pregnancy.

    Use of any NSAID is considered contraindicated during the third trimester of pregnancy.

    First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low.

    When an NSAID is considered essential, a more established drug such as ibuprofen may be considered. Diclofenac should be used with caution in the first and second trimesters. Schaefer (2015) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.

    Diclofenac is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use diclofenac sodium with caution in breastfeeding.

    No other published information on topical diclofenac has been found although secretion in maternal milk following oral administration is minimal and probably too low to affect the infant (Schaefer 2015).

    In limited studies so far available, oral NSAIDs can appear in breast milk in very low concentrations.

    When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible.

    Not to be applied to the breasts of nursing mothers or on larges areas of skin or for prolonged periods of time in breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Allergic dermatitis
    Anaphylactic reaction
    Angioneurotic oedema
    Application site reaction
    Bullous dermatoses
    Contact dermatitis
    Dry skin
    Feeling hot
    Hypersensitivity reactions
    Pustular rash


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: September 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Flector Tissugel 140mg medicated plaster. Disposable medical equipment Ltd. Revised February 2014.

    Summary of Product Characteristics: Voltarol medicated plaster. Novartis Consumer Health. Revised March 2016.

    NICE - Evidence Services
    Available at:
    Last accessed: 06 September 2018

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Diclofenac Last revised: 09 August 2018
    Last accessed: 06 September 2018

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