Voltadol Unidie 140 mg 5 medicated plasters

Voltadol Unidie 140 mg 5 medicated plasters is a topical pain reliever specifically formulated for the short-term local treatment of muscle and joint pain caused by muscle strains, sprains or bruises of the arms and legs due to trauma. Each plaster contains 140 mg of diclofenac sodium , an active ingredient belonging to the class of nonsteroidal anti-inflammatory drugs (NSAIDs) , known for its effectiveness in reducing inflammation and pain in a targeted way.

The pack contains 5 medicated plasters , each designed to adhere perfectly to the skin and ensure a constant release of the active ingredient directly to the affected area. Voltadol Unidie is indicated for adults and adolescents aged 16 and over and represents a practical and discreet solution for pain relief in the case of back pain, sports injuries, joint and muscle pain . The plaster should be applied only once a day to the painful area, offering a prolonged effect of up to 24 hours .

Thanks to its anti-inflammatory and analgesic action , Voltadol Unidie is ideal for those looking for an effective local treatment without having to resort to oral medications. The patch is easy to apply, non-greasy and can also be used under an elastic mesh bandage, ensuring comfort and practicality during daily activities. Choose Voltadol Unidie 140 mg for rapid and targeted relief from painful and inflammatory conditions of muscles, joints, tendons and ligaments .

ACTIVE INGREDIENTS

Active ingredients contained in Voltadol Unidie 140 mg 5 medicated plasters - What is the active ingredient in Voltadol Unidie 140 mg 5 medicated plasters?

Each medicated plaster contains 140 mg diclofenac sodium. Each medicated plaster contains 2.90 mg butylhydroxyanisole (E 320). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Voltadol Unidie 140 mg 5 medicated plasters - What does Voltadol Unidie 140 mg 5 medicated plasters contain?

Backing layer: Non-woven polyester. Adhesive layer: polyacrylate dispersion, tributyl citrate, butylhydroxyanisole (E 320). Protective layer: single-sided siliconized paper.

DIRECTIONS

Therapeutic indications Voltadol Unidie 140 mg 5 medicated plasters - Why is Voltadol Unidie 140 mg 5 medicated plasters used? What is it used for?

Short-term local treatment (maximum 7 days) of pain associated with muscle strains, sprains or bruises of the arms and legs due to blunt trauma in adolescents from 16 years of age and in adults.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Voltadol Unidie 140 mg 5 medicated plasters - When should Voltadol Unidie 140 mg 5 medicated plasters not be used?

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs [NSAIDs] - Patients who have had attacks of asthma, urticaria or acute rhinitis after the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past. - Patients with active peptic ulcer. - Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. - Third trimester of pregnancy. - Children and adolescents under 16 years of age.

DOSAGE

Quantity and method of taking Voltadol Unidie 140 mg 5 medicated patches - How to take Voltadol Unidie 140 mg 5 medicated patches?

Dosage Adults and adolescents aged 16 years and over Apply one medicated plaster once a day to the painful area. The maximum daily dose is 1 medicated plaster, even if more than one area is to be treated. Therefore, only one painful area can be treated at a time. Duration of use Voltadol Unidie should be used for the minimum time necessary to control the symptoms. The use of the plaster should not exceed 7 days. A therapeutic benefit for longer durations of administration has not yet been demonstrated. Elderly patients The medicinal product should be used with caution in elderly patients as they are more susceptible to undesirable effects (see also section 4.4). Patients with renal or hepatic impairment For the treatment of patients with renal or hepatic impairment, see section 4.4. Paediatric population There are insufficient data on the efficacy and safety of Voltadol Unidie in children and adolescents under 16 years of age (see section 4.3). The patient/parents of the adolescent are advised to consult a doctor if the medicinal product needs to be administered for more than 7 days to relieve pain or if symptoms worsen. Method of administration Cutaneous use. The medicated plaster should only be applied to intact, healthy skin and should not be applied when bathing or showering. The medicated plaster should not be divided. If necessary, the medicated plaster can be kept in place using an elastic mesh bandage. The medicated plaster should not be used with an occlusive dressing.

CONSERVATION

Storage Voltadol Unidie 140 mg 5 medicated plasters - How should Voltadol Unidie 140 mg 5 medicated plasters be stored?

Store in the original package in order to protect from light and moisture.

WARNINGS

Warnings Voltadol Unidie 140 mg 5 medicated plasters - About Voltadol Unidie 140 mg 5 medicated plasters it is important to know that:

The medicated plaster should 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 time (see section 4.2). Bronchospasm may occur in patients who suffer or have suffered in the past from bronchial asthma or allergies. If a skin rash develops after applying the medicated plaster, treatment should be stopped immediately. After removal of the medicated plaster, patients should be advised to avoid exposure to sunlight or sun lamps in order to reduce the risk of photosensitization. The possibility of systemic adverse events resulting from the application of diclofenac medicated plaster cannot be excluded if the product is used on large skin surfaces for a prolonged period of time. Although systemic effects may be minimal, the medicated plaster should be used with caution in patients with impaired renal, cardiac or hepatic function, or with a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis. Nonsteroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more susceptible to adverse effects. Do not administer simultaneously, topically or systemically, any other medicinal product containing diclofenac or other nonsteroidal anti-inflammatory drugs (NSAIDs). Butylhydroxyanisole (E 320) may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

INTERACTIONS

Interactions Voltadol Unidie 140 mg 5 medicated plasters - Which medicines or foods can modify the effect of Voltadol Unidie 140 mg 5 medicated plasters?

Since the systemic absorption of diclofenac with the labeled use of medicated plasters is very low, the risk of developing clinically significant drug interactions is negligible.

SIDE EFFECTS

Like all medicines, Voltadol Unidie 140 mg 5 medicated plasters can cause side effects - What are the side effects of Voltadol Unidie 140 mg 5 medicated plasters?

Undesirable effects are reported according to the following frequency categories:

Very common	≥1/10
Common	From ≥ 1/100 to <1/10
Uncommon	From ≥1/1,000 to <1/100
Rare	From ≥1/10,000 to <1/1,000
Very rare	<1/10,000
Not known	Frequency cannot be estimated from available data.

Infections and manifestations
Very rare	Pustular rash
Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic edema, anaphylactoid reaction
Respiratory, thoracic and mediastinal pathologies
Very rare	Asthma
Skin and subcutaneous tissue disorders
Common	Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus
Rare	Bullous dermatitis (e.g. bullous erythema), dry skin
Very rare	Photosensitivity reactions
Systemic disorders and conditions related to the administration site
Common	Reactions at the administration site

The levels of diclofenac measured in systemic plasma according to the instructions for use of medicated patches indicated on the label, are very low when compared with those detected after oral intake of diclofenac. The risk of developing systemic side effects (such as gastric, hepatic and renal disorders, systemic hypersensitivity reactions), therefore, appears low with the use of the patch. However, if diclofenac is used on large skin surfaces and for long periods of time, systemic side effects may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system

OVERDOSE

Overdose Voltadol Unidie 140 mg 5 medicated plasters - What are the risks of Voltadol Unidie 140 mg 5 medicated plasters in case of overdose?

No cases of overdose with diclofenac medicated plasters have been reported. In case of serious systemic side effects following incorrect use of the drug or accidental overdose (e.g. in children), appropriate precautionary measures employed for intoxication with nonsteroidal anti-inflammatory drugs should be applied.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Voltadol Unidie 140 mg 5 medicated plasters.

Pregnancy The systemic concentration of diclofenac following topical administration is lower than that related to oral formulations. Based on experience with treatment with systemic NSAIDs, the following is recommended: inhibition of prostaglandin synthesis may lead to adverse effects during pregnancy and/or during embryonic/foetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations was found to increase from a value less than 1% up to a maximum of approximately 1.5%. The risk is believed to increase with increasing dose and duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors 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 fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamnios; the mother and neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect, which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding Diclofenac, in small quantities, is secreted in breast milk. However, at therapeutic doses of diclofenac medicated plaster, no effects on the infant are expected. Given the lack of controlled clinical studies in breastfeeding women, the medicinal product should be used during breastfeeding only on the advice of a healthcare professional. In this case, Voltadol Unidie should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

DRIVING AND USE OF MACHINERY

Taking Voltadol Unidie 140 mg 5 medicated patches before driving or using machines - Does Voltadol Unidie 140 mg 5 medicated patches affect driving or using machines?

Voltadol Unidie does not alter the ability to drive vehicles or use machines.