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DICLOFENAC TEVA * GEL 60G 10MG / G

  • Teva B.V.
  • 047883032
Diclofenac Teva BV is a drug based on the active ingredient diclofenac sodium (FU), belonging to the category of NSAID analgesics and specifically non-steroidal anti-inflammatory drugs for topical use. Diclofenac Teva BV can be prescribed with OTC Recipe - self-medication. Adults For the local symptomatic treatment of pain: associated with acute muscle strains, sprains or bruises following impact trauma; soft tissue adjacent to the joint (e.g., bursae, tendons, tendon sheaths, ligaments, muscle inserts, and joint capsules) in osteoarthritis of the knee and finger joints; in epicondylitis; in acute muscle pain, for example in the back Teenagers 14 years of age and older For short-term treatment For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises following impact trauma.
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DICLOFENAC TEVA * GEL 60G 10MG / G

Therapeutic indications

Adults. For the local symptomatic treatment of pain: - associated with acute muscle strains, sprains or bruises resulting from impact trauma; - of the soft tissues adjacent to the joint (for example, bags, tendons, tendon sheaths, ligaments, muscle inserts and joint capsules) in osteoarthritis of the knee and finger joints; - in epicondylitis; - in acute muscle pain, for example in the back.Adolescents aged 14 and over: For short-term treatment. For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises resulting from impact trauma.

Dosage and method of use

Dosage.Adults and adolescents aged 14 years and over: Depending on the extent of the affected part to be treated, an amount of variable size between a cherry and a walnut is applied 3-4 times a day, equivalent to 1-4 g of gel (11.6-46.4 mg of diclofenac diethylammonium corresponding to 10-40 mg of diclofenac sodium). This dose is sufficient to treat an area of 400-800 cm². The maximum daily dose is 16 g of gel, corresponding to 185.6 mg of diclofenac, diethylammonium salt (corresponding to 160 mg of diclofenac sodium). The duration of use depends on the symptoms and the underlying disease. Diclofenac Teva BV cannot be used for more than a week without consulting your doctor. If symptoms worsen or do not improve within 3-5 days, you should see your doctor.Special patient groups.Elderly patients: No special dose adjustments are required. Due to the potential side effect profile, elderly people should be closely monitored.Patients with impaired renal function: No dose reduction is required for patients with impaired renal function.Patients with hepatic impairment:No dose reduction is required for patients with hepatic impairment.Children and adolescents (under the age of 14): There are insufficient data on efficacy and safety in children and adolescents below 14 years (see section 4.3).Method of administration: For cutaneous use. A thin layer of gel is applied to the affected parts of the body and rubbed gently to make it penetrate the skin. Hands should be washed unless they are the area to be treated. Before applying a bandage (see section 4.4), the gel should be allowed to dry on the skin for a few minutes.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients who have developed previous hypersensitivity reactions such as asthma, bronchospasm, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs). - On open wounds, inflammation or infections of the skin, eczema or mucous membranes. - In the last trimester of pregnancy (see section 4.6). - In children and adolescents under the age of 14.

Side effects

Adverse reactions are listed below by system organ class and by frequency of occurrence. Frequencies are defined as follows:Very common(≥1 / 10);Common(≥1 / 100 to Uncommon (≥1 / 1000 to Rare (≥1 / 10,000 to Very rare (Not known (cannot be estimated from the available data).

System and organ classification Adverse reactions and frequency
Infections and infestations Very rare: skin rash with pustules
Disorders of the immune system Very rare: hypersensitivity (including urticaria), angioedema
Respiratory, thoracic and mediastinal disorders Very rare: asthma
Gastrointestinal disorders Very rare:gastrointestinal disorders
Skin and subcutaneous tissue disorders Common: dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus
Uncommon: peeling, dehydration of the skin, edema
Rare: bullous dermatitis
Very rare: photosensitivity reaction
Not known: burning sensation at the site of application, dryness of the skin

When the gel is applied to a large area of skin and for a prolonged period, the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those that can appear after systemic administration of diclofenac-containing medicinal products.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac). Diclofenac Teva BV should only be applied to intact, healthy and wound-free skin. It must not come into contact with the eyes or oral mucous membranes and must not be ingested. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass (see section 5.2). You should consult your doctor if you have acute conditions associated with severe redness, swelling or overheating of the joints, prolonged joint pain or severe back pain that radiates to the legs and / or is associated with neurological deficits (for example, numbness, tingling). If symptoms worsen or do not improve within 3-5 days, you should see your doctor. Patients suffering from asthma, allergic rhinitis, swelling of the nasal mucous membranes (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (associated in particular with symptoms similar to allergic rhinitis) and patients with hypersensitivity to pain relieving medicines and antirheumatics of any kind are exposed to a greater risk of asthma attacks (so-called intolerance to analgesics or analgesic asthma), local swelling of the skin or mucous membranes (so-called Quincke's edema) and urticaria than other patients during treatment with Diclofenac Teva BV. In these patients, Diclofenac Teva BV can only be used with certain precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or hives. If a rash develops during treatment with Diclofenac Teva BV, the treatment should be discontinued. Photosensitivity may occur during treatment with the appearance of skin reactions following exposure to sunlight. Preventive measures should be taken to prevent children from touching the skin areas on which the gel has been applied. This medicine contains a perfume with benzyl alcohol (0.15 mg / g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which can cause allergic reactions. Also, benzyl alcohol can cause mild local irritation.

Pregnancy and breastfeeding

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, the following is recommended:Pregnancy: Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo-fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is taken by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should 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 the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions which causes delay or prolongation of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.Feeding time: Diclofenac is excreted in breast milk in small quantities. However, no effects on the suckling child are anticipated at therapeutic doses of Diclofenac Teva BV. Due to the lack of controlled studies in breastfeeding women, the medicinal product should only be used during breastfeeding under the advice of a physician. In this circumstance, Diclofenac Teva BV should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for a prolonged period (see section 4.4).

Expiration and retention

Store the medicine in the original tube to protect it from light. This medicinal product does not require any special storage temperatures.

Interactions with other drugs

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely in the intended use.

Overdose

The low systemic absorption of diclofenac in limited topical use makes an overdose unlikely. If you apply a significantly higher dose than recommended, you need to remove the gel from the skin and rinse the area with water. Undesirable effects similar to those seen after an overdose of systemic diclofenac may be expected if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1160 mg of diclofenac diethylammonium, corresponding to 1000 mg of diclofenac sodium) . In the event of accidental ingestion resulting in significant systemic adverse effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric lavage and the use of activated charcoal should be considered, especially within a short time of ingestion. There is no specific antidote.

Active principles

1 g of gel contains diclofenac in the form of 11.6 mg of diclofenac diethylammonium equivalent to 10 mg of diclofenac sodium.Excipient (s) with known effect: 1 g of gel contains 50 mg of propylene glycol (E1520) and 1 mg of perfume (contains 0.15 mg / g of benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool). For the full list of excipients, see section 6.1.

Excipients

Carbomer, Cocoyl caprilocaprate, Macrogol cetostearyl ether, Liquid paraffin, Diethylamine, Isopropyl alcohol, Propylene glycol (E1520), Perfume (contains citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Teva B.V.
047883032

Data sheet

Packaging
10 mg / g gel 1 tube of 60 g
Product Type
HUMAN DRUG
ATC code
M02AA15
ATC description
Diclofenac
Therapeutic Group
NSAID analgesics
Active principle
diclofenac sodium (FU)
Class
C.
Pharmaceutical form
gel
Type of Administration
topical
Container
tube
Quantity
1 tube
Capacity
60 grams
Quantity of the Active Ingredient
10MG
Recipe required
OTC - self-medication medicine
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