OTHER MEDICINAL PRODUCTS

DICLOFENAC MYLAN PHARMA 180 MG MEDICAL PRODUCT

active ingredients

Each medicated patch of the size of 10 cm x 14 cm contains a total of 180 mg of epolamine diclofenac equivalent to 140 mg of sodium diclofenac. Excipients with known effects: parahydroxybenzoate (E218): 14 mg propile parahydroxybenzoate (E216): 7 mg propylene glycol: 420 mg reported to the quantity for patch. For the full list of excipients, see paragraph 6.1.

Excellent

Support layer: polyester support of nonwoven fabric. Adhesive layer (gel active): gelatin, povidone (K90), liquid sorbitol (non crystallized), heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propile parahydroxybenzoate (E216), disodium edetate, tartaric acid, aluminum glycinate, carmellosa sodium, polyacrylate sodium, 1,3-butilate. Protective layer: polypropylene film.

Therapeutic indications

Local symptomatic treatment of pains and inflammations of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

This medicine is contraindicated in the following cases: - Hypersensitivity to diclofenac, acetylsalicylic acid or other analgesics or other non-steroidal anti-inflammatory drugs (FANS) or any of the excipients of the medicinal product listed in the paragraph 6.1. - Patients who have had asthmatic attacks, hives or acute rhinitis triggered by acetylsalicylic acid or other nonsteroidal inflammatory drugs (ANS). - Cute lesa, regardless of the type of injury: exudatory dermatitis, eczema, infected lesion, burns or wounds. - From the beginning of the sixth month of pregnancy (see 4.6 Pregnancy and nursing). - Patients with active peptic ulcer. - Children and teenagers under the age of 16.

Population

Only for skin use. Population One (1) plaster in the most painful area once or twice a day. Duration of administration Diclofenac Mylan Pharma must be used as soon as possible. The maximum duration of treatment is 14 consecutive days. Seniors This medicinal product must be used with caution in elderly patients as they are more prepared for unwanted effects (see paragraph 4.4). Children and teenagers under 16 years old There is no sufficient information on the safety and effectiveness of the medicinal product in children and adolescents under the age of 16 (see also contraindications in paragraph 4.3). In adolescents aged 16 or older In teenagers aged 16 or older, if the product is necessary for a treatment period of more than 7 days for pain relief or if symptoms worsen, it is recommended for the patient/parents of the teenager to consult a doctor. Patients with liver or kidney failure For the use of Diclofenac Mylan Pharma in patients with liver or kidney failure see paragraph 4.4. Method of administration Cut the bag containing the medicated plaster as indicated. Extract a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster on the joint or the sore surface. If necessary, the plaster can be held on the spot by means of an elastic bandage. Carefully lock the envelope with sliding closure. The plaster must be used whole.

Conservation

This medicine does not require any special storage temperature.

Warnings

- The medicated plaster should be applied only on the intact and healthy skin and should not be applied on the skin lesa or on open wounds and should not be applied when bathing or showering. - The medicated patch should not get in touch or be applied on mucosa or eyes. - Don't use an occlusive bandage. - Treatment should be stopped immediately if a rash is developed after the application of the medicated plaster. - Do not administer at the same time, by topical or systemic way, another medicine based on diclofenac or other NSAIDs. - The possibility of systemic adverse events produced by the application of topical diclofenac cannot be excluded if the preparation is used for a prolonged period (see product information on other systemic forms of diclofenac). Although systemic effects may be of a minimum size, the patch should be used with caution in patients with impairment of kidney, heart or liver function, with peptic ulcer anamnesis, intestinal inflammation or hemorrhagic diathesis. Non-steroidal anti-inflammatory drugs must be used with particular caution in elderly patients, since they are more susceptible to the occurrence of unwanted effects. - Patients must be warned not to expose themselves to direct sunlight or sunlight so as to reduce the risk of photosensitivity. - bronchospasm may be precipitated into patients suffering from or with a previous history of bronchial asthma or allergic disease or allergy to acetylicylic acid or other NSAIDs. The medicated patch should be used with caution in patients with or without chronic asthma where asthma attacks, local inflammation of the skin, mucosa (Quincke edema), hives or acute rhinitis are precipitated by acetyl acid or other non-steroidal anti-inflammatory agents (see 4.3 Contraindications). In order to minimize the occurrence of unwanted effects, it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the maximum approved of 14 days (see paragraphs 4.2 and 4.8). - Although systemic absorption is very low, the use of Diclofenac Mylan Pharma, like any drug inhibitor of prostaglandin synthesis and cyclooxygenase, is not recommended in women planning a pregnancy. - The administration of Diclofenac Mylan Pharma must be suspended in women with fertility problems or who are subject to fertility surveys. Excipient This medicine contains 420 mg of propylene glycol for each medicated patch, which can cause skin irritation. Each medicated patch contains methyl parahydroxybenzoate (E218) and propile parahydroxybenzoate (E216) which can cause allergic reactions (also delayed).

Interactions

Since systemic absorption of diclofenac as a result of the use of medicated patches is very low, the risk of developing clinically significant interactions with other medicines is negligible. Clinical studies conducted with Diclofenac Mylan Pharma used in combination with other steroidal and non-steroidal anti-inflammatory drugs (salazopyrin, hydroxychinoline, etc.) have not revealed any interaction. However, the possibility of competition between absorbed diclofenac and other high-binding drugs with plasma proteins should not be excluded. The topical or systemic use of other drugs containing diclofenac or other NSAIDs is not recommended (see paragraph 4.8).

Effects

Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: very common (>1/10); common (≥ 1/100, Infections and infestations Very rare Bustulous exantema Immune system disorders Very rare Hypersensitivity (including hives), angioedema, anaphylactoid reaction Respiratory, chest and mediastinic pathologies Very rare Asthma Pathologies of skin and subcutaneous tissue Town Skin rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching Not common Petecchi Rare Bollous dermatitis (e.g. bollous erythema), dry skin Very rare Photosensitivity reaction Notable Burning sensation in the application Systemic pathologies and conditions for administration Town Reactions in administration Not common Feeling warm Systemic absorption of diclofenac is very low when compared to plasma levels measured after oral diclofenac intake and the probability of systemic side effects (such as gastric, hepatic and kidney disorders) is very low compared to the frequency of unwanted effects associated with oral diclofenac use. However, if Diclofenac Mylan Pharma is used on large skin surfaces and for long periods of time, systemic side effects may appear. The use of the product in combination with other drugs containing diclofenac can give rise to hypersensitivity to light, rash with formation of bladders, eczema, erythema and, in rare cases, severe skin reactions ( Stevens-Johnson syndrome, Lyell syndrome) (see paragraph 4.5). 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported with medical patches of diclofenac. If systemic side effects occur due to incorrect use or accidental overdose (p.es. in children) with the product, we recommend general support measures to be taken in case of intoxication with non-steroidal anti-inflammatory drugs.

Pregnancy

The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, we recommend the following: Inhibition of prostaglandin synthesis can have negative effects on pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. 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 oligoidramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary 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

Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of medicated plaster diclofenac there are no effects on the infant. Due to the lack of controlled studies in nursing women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstance, Diclofenac Mylan Pharma should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati