VOLTADOL UNIDIE 5CER MED 140MG

VOLTADOL UNIDIE 140 MG MEDICAL CERTO

active ingredients

Each medicated patch contains 140 mg of sodium diclofenac. Each medicated patch contains 2.90 mg of butylhydroxanisol (E 320). For the full list of excipients, see paragraph 6.1.

Excellent

Support layer: Polyester of nonwoven fabric. Adhesive layer: polyacrylate dispersion, tributyl citrate, butilidroxyanisol (E 320). Protective layer: single silicone paper.

Therapeutic indications

Short-term local treatment (maximum 7 days) of pain associated with muscle tears, distortions or contusions of arms and legs due to contusive trauma in adolescents from 16 years of age and adults.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs [FANS] - Patients who have had asthma, urticaria or acute rhinitis in the past after the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). - Patients with active peptic ulcer. - Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected injury, burns or wounds. - Third quarter of pregnancy. - Children and teenagers under the age of 16.

Population

Population Adults and teenagers from 16 years up Apply a medicated patch once a day on the sore part. The maximum daily dose is 1 medicated patch, although the areas to be treated are more than one. Therefore, only one painful area can be treated at a time. Duration of use Voltadol Unidie must be used for the minimum time necessary to control symptoms. The use of the plaster must not exceed 7 days. There has not yet been a therapeutic benefit for longer term administrations. Senior Patients The medicinal product must be used with caution in elderly patients as they are more prepared for the undesirable effects (see also paragraph 4.4). Patients with kidney or liver impairment For the treatment of patients with kidney or liver impairment see the paragraph 4.4. Pediatric population There is no sufficient information on the effectiveness and safety of Voltadol Unidie in children and adolescents under the age of 16 (see paragraph 4.3). It is recommended for the patient/parents of the teenager to consult a doctor if it is necessary to administer the medicine for more than 7 days to relieve pain or if symptoms worsen. Method of administration Skin use. The medicated plaster must be applied only on the intact and healthy skin and should not be applied when bathing or showering The medicated plaster should not be divided. If necessary, the medicated patch can be kept in place using a mesh elastic bandage. The medicated patch should not be used with an occlusive bandage.

Conservation

Store in the original packaging to protect the medicine from light and moisture.

Warnings

The medicated patch should not get in touch or be applied on eyes or mucosa. Undesirable effects can be reduced using the lowest effective dose for as short as possible (see paragraph 4.2). In patients suffering or suffering from bronchial asthma or allergies may occur bronchospasm. If after the application of the medicated plaster develops a rash, the treatment must be stopped immediately. After the removal of the medicated plaster, patients must be informed of the need to avoid exposure to sunlight or solar lamps, in order to reduce the risk of photosensitization. It is not possible to exclude the possibility of systemic adverse events arising from the application of medical plaster diclofenac, if the product is used on extended skin surfaces for a prolonged period of time. Although systemic effects may be of a minimum size, the medicated patch must be used with caution in patients with impairment of kidney, heart or liver function, or with peptic ulcer anamnesis, intestinal inflammation or hemorrhagic diathesis. Non-steroidal anti-inflammatory drugs must be used with caution in elderly patients, as such subjects are more exposed to the occurrence of unwanted effects. Do not simultaneously administer any other medicine containing diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs). Butylhydroxyanisol (E 320) can cause reactions to localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa.

Interactions

Since systemic absorption of diclofenac with the methods of use of medicated patches indicated on the label is very low, the risk of developing clinically significant interactions between drugs is negligible.

Effects

The side effects are shown on the basis of the following frequency categories:

Very common	≥1/10
Town	From ≥ 1/100 to
Not common	From ≥1/1.000 to
Rare	From ≥1/10.000 to
Very rare
Notable	Frequency cannot be defined on the basis of available data.

 

Infections and events
Very rare	Pustolose exantema
Immune system disorders
Very rare	Hypersensitivity (including hives), angiourotic edema, anaphylactoid reaction
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching
Rare	Bollous dermatitis (e.g. bollous erythema), dry skin
Very rare	Photosensitivity reactions
Systemic pathologies and conditions for administration
Town	Reactions in the administration

Diclofenac levels measured in systemic plasma according to the methods of use of medicated patches indicated on the label, are very low compared to those detected after oral diclofenac intake. The risk of developing systemic side effects (such as gastric, hepatic and kidney 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 appear. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system

Overdosing

No overdose cases were reported with diclofenac medicated patches. In the event of serious systemic side effects occurring as a result of incorrect use of the drug or accidental overdose (e.g. in children), the appropriate precautionary measures used for intoxication by non-steroidal anti-inflammatory drugs must be applied.

Pregnancy

The systemic concentration of diclofenac following topical administration is lower than that related to oral formulations. Referring to the experience deriving from the treatment with systemic NSAIDs, we recommend the following: the inhibition of the synthesis of prostaglandins can lead to negative effects during pregnancy and/or during embryo/fetal development. The data from epidemiological studies suggest an increased risk of miscarriage, heart and gastroschisis malformations, following the use of prostaglandin synthesis inhibitors in the early months of pregnancy. The absolute risk of cardiovascular malformations was increased from a value of less than 1% to a maximum of about 1.5%. The risk is believed to increase dose and duration of treatment. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. During the first and second trimester of pregnancy diclofenac should not be administered if not in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and anti-aggregating effect, which can also take place at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Food

Diclofenac, in small quantities, is secreted in breast milk. However, at therapeutic doses of medicated plaster diclofenac, there are no effects on the infant. Due to the lack of clinical studies controlled in nursing women, the medicinal product must be used during breastfeeding exclusively on the advice of the healthcare provider. In this case, Voltadol Unidie should not be applied on the breasts of nursing mothers, or elsewhere on extended skin surfaces or for a prolonged period of time.

Source: Farmadati