DICLOFENAC TE 5CER MED 140 MG OR MORE

DICLOFENAC TEVA MEDICAL CEROTTS

active ingredients

Each medicated patch contains 140 mg of sodium diclofenac. Excipients with known effects: 2.8 mg of butylhydroxytoluene (E321) and 1400 mg of propylene glycol (E1520) for patch. For the full list of excipients, see paragraph 6.1.

Excellent

glycol propylene glycol (E1520) diisopropyl adipato liquid sorbitol (crystallizing) (E420) carmellosa sodium polyacrylic acid salt sodium copolymer butylate basic methacrylate edetate sodium sulphite (E221) butylhydroxytoluene (E321) aluminium-potassium bis(sulphate)

Therapeutic indications

For short-term treatments. Local symptomatic relief of pain associated with acute muscle strains, distortions or contusions of the limbs resulting in non-pervasive trauma.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 (e.g. propylene glycol, butylhydroxytoluene). - Last trimester of pregnancy (see paragraph 4.6). - Hypersensitivity to other analgesic and anti-rheumatic drugs (non-steroidal anti-inflammatory drugs [FANS], including acetylsalicylic acid). - Patients who have previously had asthma, urticaria or acute rhinitis attacks after the use of acetylsalicylic acid or other NSAIDs. - Active peptic ulcer. - Applications on damaged skin, regardless of the type of injury: exudatory dermatitis, open wounds, burns, skin infections or eczema. - Use in children and teenagers under the age of 16 is contraindicated.

Population

Population In adults, apply one medicated plaster twice a day, in the morning and in the evening, to the painful area.The maximum daily dose is 2 medicated plasters, even if more than one area is to be treated.Only one painful area should be treated at a time.The diclofenac medicated plaster should be used for the shortest possible time in relation to the indication for use. Pediatric population Children and adolescents under 16 years of age The use of this medicated patch is not recommended in children and adolescents under the age of 16 because sufficient data is not available to assess the safety and effectiveness of the medicinal product (see paragraph 4.3). Seniors This medicinal product must be used with caution in elderly patients as they are more prepared for unwanted effects (see paragraph 4.4). Patients with liver or kidney failure For the use of diclofenac medicated plasters in patients with hepatic or renal insufficiency, see the section 4.4. Method of administration For cutaneous use only.The product should only be applied to intact, healthy skin and should not be kept in while bathing or showering.Cut the pouch containing the medicated plaster as directed.Remove a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster to the painful joint or area.If necessary, the medicated plaster can be held in place using an elastic band.Carefully reseal the pouch with a sliding seal.The plaster should be used whole. Duration of use Based on the limited data available, short-term treatments are recommended.The therapeutic benefit of administrations lasting more than 7 days has not been established.If no improvement is seen following the recommended treatment period, a doctor should be consulted (see section 4.4).In adults and adolescents over 16 years of age, if use of the product for more than 7 days is necessary to relieve pain or if symptoms worsen, patients or parents of the adolescent are advised to consult their doctor.

Conservation

Do not store above 25°C.Store in the original package to protect from drying and light.Keep the bag tightly closed to protect from drying.

Warnings

If diclofenac medicated plasters are used on large areas of skin and for a prolonged period of time, the possibility of systemic adverse events cannot be excluded (see the Summary of Product Characteristics of systemic diclofenac formulations).Although systemic effects are expected to be minimal, Diclofenac Teva should be used with caution in patients with impaired renal, cardiac or hepatic function, or with a history of peptic ulcer or inflammatory bowel disease or haemorrhagic diathesis.Nonsteroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more susceptible to the development of undesirable effects.The medicated plaster should only be applied to intact, healthy skin and should not be applied to broken skin or open wounds.Diclofenac Teva should not come into contact with or be applied to the eyes or mucous membranes.The medicated plaster should not be used in conjunction with an occlusive dressing that does not allow air to pass through.Do not administer together with other medicinal products containing diclofenac or other NSAIDs, either topically or systemically.Patients should be advised to avoid direct exposure to sunlight or sun lamps of the treated areas for approximately one day after removal of the medicated plaster in order to reduce the risk of photosensitivity.If symptoms persist for more than 3 days, or worsen, it is necessary to contact the doctor.Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.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 Diclofenac Teva, treatment should be stopped immediately.Diclofenac Teva contains propylene glycol and butylhydroxytoluene.Propylene glycol may cause skin irritation.Butylhydroxytoluene may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.The use of diclofenac may impair female fertility and is not recommended in women attempting to conceive.Administration of diclofenac should be discontinued in women who have difficulties conceiving or who are undergoing investigation of fertility (see section 4.6).

Interactions

If Diclofenac Teva is used correctly, the rate of systemic exposure is low, and therefore the interactions reported following the use of oral diclofenac are unlikely to occur.

Effects

Very common (≥1/10)

Common (≥1/100;

Uncommon (≥1/1,000;

Rare (≥1/10,000;

Very rare (

Not known (frequency cannot be estimated from the available data)

Infections and infestations Very rare: pustolose exantema Immune system disorders Uncommon: generalized skin rash, hypersensitivity reactions (including urticaria), angioneurotic oedema, anaphylactic-type reaction. Respiratory, chest and mediastinic pathologies Very rare: asthma attack. Pathologies of skin and subcutaneous tissue Town: localized skin reaction, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), skin swelling, itching and burning sensation. Rare: bollous dermatitis, dry skin. Very rare: severe eczema, ulcerative rash, photosensitivity reaction (patients must be warned to avoid excessive exposure to sunlight to reduce the incidence of photosensitivity). Notable: hematoma on the application site. Systemic pathologies and conditions for administration Town: Systemic absorption as a result of the topical use of diclofenac is very low and the corresponding plasma levels of diclofenac are therefore very low when compared to the plasma levels measured after oral intake of diclofenac. Thus, the probability of systemic side effects (such as gastrointestinal, hepatic or kidney disorders, bronchospasm) is very low after topical application compared to the frequency of unwanted effects associated with oral use of diclofenac. 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 via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported. In the event of undesirable serious systemic effects due to the incorrect use of the drug or accidental overdose (e.g. in children), the appropriate therapeutic measures used for intoxication by non-steroidal anti-inflammatory drugs must be applied.

Fertility

The use of diclofenac can alter female fertility and is not recommended in women who intend to start a pregnancy. The administration of diclofenac should be suspended in women who have difficulty in conceiving or who are undergoing fertility investigations.

Pregnancy

The clinical data available regarding the skin use of diclofenac during pregnancy are insufficient. Animal studies showed reproductive toxicity after systemic application (see paragraph 5.3). 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 may adversely affect 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%. Risk is believed to increase 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, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals in which inhibitors of prostaglandin synthesis were administered 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. The maximum daily dose is two medicated patches (see paragraph 4.2). 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 that can progress in kidney failure with oligoidramnios; the mother and the newborn at the end of pregnancy to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low dosages; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, the use of diclofenac is contraindicated during the third trimester of pregnancy.

Food

Minimum amounts of diclofenac and its metabolites are excreted in breast milk. However, at therapeutic doses of diclofenac medicated patches 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, medicated diclofenac patches 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