Voltaren Actigo Anti-Inflammatory Pain Relief Patch 10 x 14cm 5 patches

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated on: 06/11/2024

1. NAME OF THE MEDICINAL PRODUCT

VOLTARENACTIGO 140 mg, medicated plaster

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diclofenac sodium: 140 mg

Per medicated plaster.

Excipient with known effect: each medicated plaster contains 2.90 mg of butylated hydroxyanisole (E 320).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Medicated plaster.

White self-adhesive plaster measuring 10 x 14 cm, made of non-woven fabric on one side and paper on the other side. Once the protective film is removed, the adhesive film is translucent.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Short-term local treatment, maximum 7 days, of pain caused by minor painful injuries: strains, sprains, or bruises in adults and adolescents from 16 years of age.

4.2 Posology and method of administration

Dosage

Adults and adolescents from 16 years of age

The medicated plaster should be applied to the painful area once daily. The maximum daily dose is 1 plaster per day, even if there is more than one injury to treat.

Therefore, do not treat more than one painful area at a time.

Duration of use

Use of VOLTARENACTIGO 140 mg medicated plaster should be as short as possible to relieve symptoms.

The duration of use must not exceed 7 days. The therapeutic benefit of longer use has not been demonstrated.

Elderly population

This medicine should be used with caution in elderly patients, who are more prone to adverse effects. See section 4.4.

Patients with renal or hepatic impairment

For use of VOLTARENACTIGO 140 mg medicated plaster in patients with renal or hepatic impairment, see section 4.4.

Pediatric population

The safety and efficacy of VOLTARENACTIGO 140 mg medicated plaster in children and adolescents under 16 years of age have not been established. See section 4.3.

If use of the product for more than 7 days is needed to relieve pain, or if symptoms worsen, parents of adolescents/patients are advised to consult a doctor.

Method of application / administration

For cutaneous use only.

The product must be applied only to intact, healthy skin and must not be applied while bathing or showering.

Never cut the plaster.

If necessary, the medicated plaster may be held in place with an elastic net.

Do not use the plaster under an occlusive dressing.

4.3 Contraindications

Do not use in the following cases:

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

Hypersensitivity to any other analgesic medicine, including non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid;

History of asthma attack, urticaria, or acute rhinitis triggered by acetylsalicylic acid or another NSAID;

Active peptic ulcer;

Application to damaged skin, whatever the lesion: exudative dermatitis, open wounds, burns, skin infections, or eczema;

During the last trimester of pregnancy. See section 4.6;

In children and adolescents under 16 years of age.

4.4 Special warnings and precautions for use

VOLTARENACTIGO 140 mg medicated plaster must not come into contact with the eyes or mucous membranes, or be applied to the eyes or mucous membranes.

The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest treatment duration necessary to relieve symptoms. See section 4.2.

Bronchospasm may occur in patients who currently have or have previously had asthma or allergies.

If a skin rash appears after applying the plaster, treatment must be stopped immediately.

To reduce any risk of photosensitivity, patients should be advised to avoid exposing the treated area to sunlight or UV tanning booths after removing the plaster.

Systemic adverse effects following application of VOLTARENACTIGO 140 mg medicated plaster cannot be ruled out if it is used over a large area of skin and for a long period. Although systemic adverse effects are rare, VOLTARENACTIGO 140 mg medicated plaster should be used with caution in patients with impaired renal, cardiac, or hepatic function, or in patients with a history of gastrointestinal ulcer, inflammatory bowel disease, or gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more prone to adverse effects.

Do not administer any medicine containing diclofenac or other NSAIDs at the same time, whether systemic or topical.

Butylated hydroxyanisole (E 320) may cause local skin reactions, such as contact dermatitis, or irritation of the eyes and mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

Because systemic absorption is low during normal use of VOLTARENACTIGO 140 mg medicated plaster, drug interactions are unlikely.

4.6 Fertility, pregnancy, and breastfeeding

Pregnancy

Systemic diclofenac concentration is lower after topical application than after oral administration. There are no clinical data on the use of VoltarenActigo 140 mg medicated plaster during pregnancy. Even though systemic exposure is lower compared with oral administration, it is not known whether systemic exposure to VoltarenActigo 140 mg medicated plaster after topical administration may be harmful to an embryo/fetus. Based on experience with systemically absorbed NSAID treatments, the following recommendations apply:

Inhibition of prostaglandin synthesis may affect the course of pregnancy and/or embryo or fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations, and gastroschisis after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk appears to increase depending on the dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and increased embryo-fetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular malformations, has been reported in animals receiving a prostaglandin synthesis inhibitor during the organogenesis phase of gestation.

Unless absolutely necessary, diclofenac should therefore not be prescribed during the first and second trimesters. If diclofenac is administered to a woman trying to become pregnant or who is less than six months pregnant, the dose should be as low as possible and the treatment duration as short as possible.

During the third trimester of pregnancy, use of prostaglandin synthesis inhibitors exposes the fetus to the following risks:

Cardiopulmonary toxicity, including premature closure of the ductus arteriosus and pulmonary hypertension;

Renal function impairment, which may progress to renal failure with oligohydramnios.

At the end of pregnancy, the risks for the mother and newborn are as follows:

Risk of prolonged bleeding time due to an antiplatelet effect that may occur even at very low doses;

Inhibition of uterine contractions, resulting in delayed or prolonged labor.

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

Breastfeeding

Diclofenac is excreted in small amounts in breast milk. However, at therapeutic doses of VOLTARENACTIGO 140 mg medicated plaster, no effect on the infant is expected.

Due to a lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding after advice from a healthcare professional. In these circumstances, VOLTARENACTIGO 140 mg medicated plaster must not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period.

4.7 Effects on ability to drive and use machines

VOLTARENACTIGO 140 mg medicated plaster has no effect on the ability to drive vehicles or use machines.

4.8 Undesirable effects

The following frequency categories are used to report adverse 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
Frequency not known: cannot be estimated from the available data

Infections and infestations

Very rare: pustular rash

Immune system disorders

Very rare: hypersensitivity reaction, including urticaria, angioedema, anaphylactoid reaction.

Respiratory, thoracic, and mediastinal disorders

Very rare: asthma attack

Skin and subcutaneous tissue disorders

Common: local skin reactions such as skin redness, eczema, erythema, dermatitis, including contact and allergic dermatitis, itching.

Rare: bullous dermatitis, for example bullous erythema, dry skin.

Very rare: photosensitivity reactions.

General disorders and administration-site conditions

Common: application-site reactions.

Systemic absorption of diclofenac after topical application is very low, and plasma diclofenac levels are also very low compared with plasma levels of active substance observed after use of oral forms. The likelihood of systemic adverse effects, such as gastrointestinal, hepatic, and renal disorders or hypersensitivity reactions, during use of the plaster therefore appears to be low. However, when diclofenac is applied over a large skin surface and for a prolonged period, the possibility of systemic adverse effects cannot be excluded.

Reporting suspected adverse effects

Reporting suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse effect through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers – website: https://signalement.social-sante.gouv.fr/.

4.9 Overdose

No cases of overdose have been reported.

If serious systemic adverse effects occur after incorrect use or accidental overdose, for example in a child, refer to the usual measures used in cases of poisoning by non-steroidal anti-inflammatory drugs.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Non-steroidal anti-inflammatory drugs for topical use – ATC code: M02AA15

Diclofenac is a non-steroidal anti-inflammatory/analgesic drug that effectively inhibits prostaglandin synthesis in standard animal inflammation models. In humans, diclofenac reduces pain, edema, and fever associated with inflammation. Diclofenac also causes reversible inhibition of platelet aggregation induced by ADP and collagen.

5.2 Pharmacokinetic properties

Absorption

During cutaneous application, diclofenac is slowly and incompletely absorbed. At steady state, plasma diclofenac levels reflect continuous absorption of diclofenac from the plaster. When used topically, diclofenac may be stored in the dermis, from which it is slowly released into the central compartment.

Systemic absorption of topical products is between 2% and 10% of that obtained with the same dose administered orally.

Distribution

The observed therapeutic efficacy is mainly attributable to therapeutic tissue concentrations of the active substance beneath the application site. Penetration to the site of action depends on the extent and nature of the lesion as well as on the application and action sites.

Elimination

At peak plasma concentration, mean concentrations are approximately 1 ng/ml. Diclofenac has a high plasma protein binding rate of 99%. Metabolism and elimination are comparable after cutaneous application and oral administration. After rapid hepatic metabolism, involving hydroxylation and glucuronic acid conjugation, two-thirds of the active substance is eliminated renally and one-third via the bile.

5.3 Preclinical safety data

Non-clinical data from conventional safety pharmacology, genotoxicity, and carcinogenicity studies revealed no special risk for humans other than those already mentioned in other sections. In animal studies, chronic toxicity of diclofenac after systemic administration mainly manifested as gastrointestinal lesions and ulcers. A two-year toxicity study in rats showed a dose-dependent increase in the frequency of thrombotic occlusions of cardiac vessels during diclofenac treatment.

In animal studies on reproductive toxicity, systemic administration of diclofenac inhibited ovulation in rabbits and disrupted implantation and early embryonic development in rats. Diclofenac prolonged the duration of gestation and delivery. The embryotoxic potential of diclofenac was studied in three animal species: rat, mouse, and rabbit. Fetal deaths and growth retardation were observed at doses toxic to the mother. Based on current knowledge, diclofenac is considered non-teratogenic. Doses below those toxic to the mother had no influence on offspring development.

Standard local tolerance studies show no special risk for humans.

Environmental risk assessment (ERA)

Diclofenac presents a risk to the aquatic environment. See section 6.6.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Backing: non-woven polyester layer.

Adhesive layer: polyacrylate dispersion, tributyl citrate, butylated hydroxyanisole (E 320).

Protective film: mono-silicone-based paper.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

This medicine does not require any special temperature storage conditions. Store in the original outer packaging, protected from drying out and from light.

6.5 Nature and contents of outer packaging

Sealed and resealable sachets made of paper/PE/Al/EAA.

Boxes of 2, 5, 7, or 10 plasters.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and handling

After use, fold the plaster in half, with the adhesive side facing inward.

This medicine presents a risk to the environment. See section 5.3.

Any unused medicine or waste material should be disposed of in accordance with current regulations.

7. MARKETING AUTHORIZATION HOLDER

Haleon France
23 Rue François Jacob
92500 Rueil-Malmaison
France

8. MARKETING AUTHORIZATION NUMBER(S)

34009 302 873 0 9: Medicated plaster in sealed sachet, paper/PE/aluminum/ethylene and methacrylic acid copolymer. Box of 2.

34009 302 873 1 6: Medicated plaster in sealed sachet, paper/PE/aluminum/ethylene and methacrylic acid copolymer. Box of 5.

34009 302 873 2 3: Medicated plaster in sealed sachet, paper/PE/aluminum/ethylene and methacrylic acid copolymer. Box of 7.

34009 302 933 1 7: Medicated plaster in sealed sachet, paper/PE/aluminum/ethylene and methacrylic acid copolymer. Box of 10.

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

[to be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND SUPPLY CONDITIONS

Medicinal product not subject to medical prescription.