CALMINEMED 7CER MEDIC 140MG

CALMINEMED 140 MG MEDICAL CERTO

active ingredients

Each medicated patch (10 cm x 14 cm) contains: Active ingredient: Diclofenac epolamina 180 mg (corresponding to 140 mg of sodium diclofenac). Excipients with known effects: propylene glycol, methyl-parahydroxybenzoate (E218), propyl-parahydroxybenzoate (E216). Perfume Dalin PH containing amile cinnamal, amylcinnamilic alcohol, benzil benzoato, benzil salicylate, cinnammale, cinnamilic alcohol, citronellol, d-Limonene, eugenol, foliage, geranium, aldehyde exil cinnamica, hydroxycitronellal, iso,eugenol. For the full list of excipients, see paragraph 6.1.

Excellent

Glycol, polyethylene.

Therapeutic indications

Local symptomatic treatment of acute painful states that affect joints, muscles, tendons and ligaments. Calminemed is indicated in adults and adolescents aged 16.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Hypersensitivity to other analgesics or other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients in which acetylicylic acid or other NSAIDs accelerated the occurrence of asthma, angioedema, urticaria or rhinitis attacks. Cute does not integrate, regardless of the type of injury: exudative dermatitis, eczema, infected injury, burn or injury. During the third trimester pregnancy (see paragraph 4.6). Patients with peptic ulcer in active phase.

Population

Skin use exclusively for the skin integrates Population The medicated patch must be used for the shortest period of time possible, according to the instructions for use. Adults and teenagers aged 16 Apply 1 patch per day (one application every 24 hours) for a maximum of 7 days. If you do not get an improvement during the recommended treatment period or notice a worsening of symptoms, you should consult a doctor. See paragraph 4.4. Pediatric population The use of this medicated patch should be avoided in children and adolescents under 16 years of age, as there is no sufficient information on the effectiveness and safety of this medicine. Senior Patients This medicine should be used with caution in elderly patients as they are more likely to have side effects. Use in patients with liver or kidney failure This patch must be used with caution in patients with liver impairment or kidney damage, see paragraph 4.4. Method of administration Cut the envelope containing the patch. Extract the medicated plaster, remove the plastic film to protect the adhesive surface and apply the plaster on the sore area. If necessary, it is possible to fix the plaster with a bandage, provided it is not a dressing that does not let the air pass, or using the elastic net contained in the box. Carefully close the foldable envelope as indicated for packs of 2, 5 and 10 medicated patches. Only the pack of 7 patches contains 7 sealed envelopes that cannot be closed with 1 medicated patch each. The plaster must be used whole. You can only use 1 patch at a time.

Conservation

Store at a temperature below 30 °C. Store the medicated patch in the original packaging in order to preserve its integrity.

Warnings

In order to minimize the appearance of unwanted effects, it is recommended to use the lowest effective dose for as little time as possible to control symptoms. The medicated patch must be applied exclusively on the skin integral and healthy, and not on wounds or skin lesions. Do not use with occlusive bandages. The medicated plaster should not be used when bathing or showering. The medicated patch should not get in touch with the mucosa or with the eyes. Avoid the contemporary use of other topical or systemic medicines containing diclofenac or other NSAIDs. The use of this product, especially if prolonged as well as other NSAIDs for skin use, can cause local awareness. Immediately interrupt the treatment if an exantema of the skin appears following the application of the medicated patch. It is not possible to exclude the possibility of systemic adverse events arising from the application of topical diclofenac if the product is used for a prolonged period of time. Senior Patients Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more likely to report adverse events. Kidney damage and liver impairment Although systemic effects should be reduced, the patch should be used with caution in patients with kidney damage, heart disease or liver impairment and in patients with clinical history of peptic ulcer, intestinal inflammatory disease or hemorrhagic diathesis. This medicine contains: - 420 mg of propylene glycol, which could cause skin irritation - methyl-parahydroxybenzoate (E218), propyl-parahydroxybenzoate (E216) and Dalin PH perfume containing amile cinnamon, amylcynnamilic alcohol, benzil benzoato, benzil salicylate, cinnamathrogen. Patients must be warned to avoid exposure to direct sunlight or a solarium, in order to reduce the risk of photo-sensitivity. Broncospasms or other manifestations of allergic diseases can be enhanced in patients with asthma, allergic rhinitis, hives or angioedema.

Interactions

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

Effects

The most frequent adverse reactions are those related to disorders regarding the area of application of the patch, which are mainly mild and usually do not require the interruption of treatment. Table 1 lists adverse reactions observed during clinical studies and after marketing. The side effects (listed in Table 1) are shown on the basis of the frequency, the most frequent at the beginning, using the following convention: very common (≥1/10); common (≥1/100, Table 1

Infections and events
Very rare	Pustolose exantema
Immune system disorders
Very rare	Hypersensitivity reactions (including hives), angioedema, anaphylactic type reaction
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Skin rash, eczema, erythema* (including allergic dermatitis and contact dermatitis), itching*
Rare	Bold dermatitis (p.e., bollous erythema), dry skin
Very rare	Photosensitivity
Systemic pathologies and conditions for administration
Town	Local reaction at administration*

*Reactions observed, with an incidence >1%, in 881 patients who participated in controlled clinical studies, of which 445 were treated with Calminemed 180 mg medicated patch and 436 were treated with a placebo patch. The systemic absorption of topical diclofenac is very low when compared to plasma levels detected following the administration of oral forms of diclofenac and therefore the probability that systemic side reactions occur (such as gastric, hepatic and kidney disorders) following the administration of topical diclofenac is very low compared to the frequency of unwanted effects associated with oral diclofenac. However, when Calminemed is applied for a prolonged period, the possibility of systemic side effects cannot be excluded. 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 via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is no systemic absorption of diclofenac as a result of topical application, even in case of overdose. No case of overdose was reported with Calminemed. If systemic side effects occur due to incorrect use or accidental overdose of this product (p.e., in children), it is necessary to resort to the recommended general measures in case of intoxication from non-steroidal anti-inflammatory drugs.

Pregnancy

The systemic concentration of diclofenac following topical administration is lower than that related to oral formulations. Referring to the experience resulting from the treatment with systemic FANS, we recommend the following: The inhibition of prostaglandin synthesis 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. Animal studies have shown reproductive toxicity (see paragraph 5.3). In the period during which a pregnancy is planned and during the first and second trimester of pregnancy, diclofenac must be administered only if strictly necessary. In case of use of diclofenac, the dose and duration of treatment must be the lowest and the shortest possible. During the third trimester of pregnancy, all prostaglandin inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can evolve to kidney failure with oligoidramnios; Also, at the end of pregnancy can expose the mother and the newborn to: - possible extension of bleeding time, an anti-aggregating effect that can also occur at very low doses. - inhibition of uterine contractions, resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Food

Like other NSAIDs, diclofenac, in small quantities, passes into breast milk. However, at the therapeutic doses of Calminemed, there are no effects on the infant. Due to the lack of clinical studies controlled in nursing women, the product must be used during breastfeeding exclusively on the advice of medical staff. In this case, Calminemed should not be applied to the breasts of nursing mothers, or elsewhere on relatively extended skin surfaces or for a prolonged period of time (see paragraph 4.4).

Fertility

As with other NSAIDs, the use of diclofenac can compromise female fertility and should be avoided in women who are planning a pregnancy. In women who have difficulty in conceiving or who are undergoing infertility investigations, the use of diclofenac must be avoided.

Source: Farmadati