DICLOFENAC TEVA GEL120G 10MG/G

DICLOFENAC TEVA BV 10 MG GEL

active ingredients

1 g gel contains diclofenac in the form of 11,6 mg diethylene diethylene diethylene equivalent to 10 mg of sodium diclofenac. Excipient(s) with known effects: 1 g gel contains 50 mg of propylene glycol (E1520) and 1 mg of perfume (contains 0.15 mg/g of benzilic alcohol, citral, citronellol, cumarin, eugenol, foliage, geranium, d-limonene and linalol). For the full list of excipients, see paragraph 6.1.

Excellent

Carbomer, Cocoile caprilocaprate, Macrogol cetostearile ether, Paraffin liquid, Dietilamine, Alcohol isopropyl, propylene glycol (E1520), Perfume (contains citronellol, geranium, benzilic alcohol, linalol, lemon, citral, foliage, cumarin, eugenol), Purified water.

Therapeutic indications

Adults. For local symptomatic treatment of pain: - associated with acute muscle strains, distortions or contusions resulting from impact traumas; - soft tissues adjoining to joints (e.g. bags, tendons, tendon sheaths, ligaments, muscle inserts and joint capsules) in osteoarthritis of knee and fingers joints; - in the epichonditis; - in acute muscle pain, like back. Teenagers aged 14 or over: For short-term treatment. For local symptomatic treatment of pain associated with acute muscle strains, sprains or contusions resulting from impact trauma.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Patients who have developed previous reactions of hypersensitivity, such as asthma, bronchospasm, hive rhinitis or angioedema in response to acetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAID). - On open wounds, inflammations or skin infections, eczemas or mucosa. - In the last trimester of pregnancy (see paragraph 4.6). - In children and adolescents under 14.

Population

Population. . Adults and teenagers aged 14 or over: Depending on the extent of the part concerned to be treated, 3-4 times a day a quantity of variable dimensions between a cherry and a walnut, equivalent to 1-4 g gel (11.6-46.4 mg of diethylene diethylene diethylene corresponding to 10-40 mg of sodium dichlofenac). This dose is sufficient to treat an area of 400-800 cm2. The maximum daily dose is 16 g gel, corresponding to 185.6 mg diclofenac, diethylene salt (corresponding to 160 mg diclofenac sodium). The duration of use depends on the symptoms and basic 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, consult your doctor. Special patient groups. . Senior Patients: No special dose adjustments are required. Due to the potential profile of side effects, older people must be subject to careful monitoring. Patients with impairment of kidney function: No dose reduction is required for patients with impairment of kidney function. Patients with impairment of liver function: No dose reduction is required for patients with impairment of liver function. Children and teenagers (under 14 years): There is no sufficient information on effectiveness and safety in children and adolescents under 14 years (see paragraph 4.3). Method of administration: For skin use. It applies a thin layer of gel on the affected body parts and fry gently to make it penetrate into the skin. Hands must be washed unless they are the area to be treated. Before applying a bandage (see paragraph 4.4), let the gel dry on the skin for a few minutes.

Conservation

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

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). Diclofenac Teva BV must be applied only on the intact, healthy and wound-free skin. You should not get in touch with the eyes or oral mucosa and should not be ingested. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass (see paragraph 5.2). You should consult your doctor in the presence of acute conditions associated with severe redness, swelling or overheating of joints, prolonged joint pain or severe back pain that radiates to your legs and/or is associated with neurological deficits (for example, numbness, tingling). If symptoms worsen or do not improve within 3-5 days, consult your doctor. Patients suffering from asthma, allergic rhinitis, swelling of nasal mucous membranes (the so-called nasal polyps) or chronic obstructive bronchopathy, chronic infections of the respiratory tract (associated in particular to symptoms similar to allergic rhinitis) and patients with hypersensitivity to painkillers and anti-reumatic drugs of any type are exposed to a greater risk of asthmagic attacks (. In these patients, Diclofenac Teva BV can only be used with certain precautions (preparation to emergencies) and under direct medical control. The same applies to patients who are allergic to other substances and manifest, for example, skin, itching or hives. If during treatment with Diclofenac Teva BV develops a skin rash, the treatment must be suspended. During treatment, photosensitivity may occur with the appearance of skin reactions following exposure to sunlight. Preventive measures must be taken to prevent children from touching the skin areas on which the gel was applied. This medicine contains a perfume with benzyl alcohol (0.15 mg/g), cytral, cytronellol, cumarin, eugenol, foliage, geranium, d-limonene and linalol that can cause allergic reactions. In addition, benzyl alcohol can cause mild local irritation.

Interactions

Since systemic absorption of diclofenac as a result of the topical application is very low, these interactions are very unlikely in the intended use.

Effects

Adverse reactions are listed below according to a classification for systems and organs and according to the frequency of appearance. The frequencies are defined as follows: Very common (≥1/10); Town (from ≥1/100 to Non-common (from ≥1/1000 to Raro (from ≥1/10,000 to Very rare (Note (frequency cannot be defined on the basis of available data).

Classification for systems and organs	Adverse reactions and frequency
Infections and infestations	Very rare: rash with pustula
Immune system disorders	Very rare: hypersensitivity (including hives), angioedema
Respiratory, chest and mediastinic pathologies	Very rare: asthma
Gastrointestinal diseases	Very rare: gastrointestinal disorders
Pathologies of skin and subcutaneous tissue	Town: dermatitis (including contact dermatitis), rash, erythema, eczema, itching
	Not common: dequamation, skin dehydration, edema
	Rare: bollous dermatitis
	Very rare: photosensitivity reaction
	Notable: burning sensation in the seat of application, skin dryness

When the gel is applied on an extended skin area and for a prolonged period, the possibility of systemic undesirable effects cannot be excluded (e.g., kidney, hepatic or gastrointestinal effects, systemic hypersensitivity reactions) similar to those that may appear after systemic administration of diclofenac drugs. 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Low systemic absorption of diclofenac in limited topical use causes an overdose to be unlikely. If you apply a dose significantly higher than the recommended one, you must remove the gel from the skin and rinse the area with water. Undesirable effects similar to those observed after a overdose of systemic diclofenac may be expected in case the topical diclofenac was inadvertently ingested (1 100 g tube contains the equivalent of 1160 mg diethylene diclofenac, corresponding to 1000 mg diclofenac sodium). In case of accidental ingestion, which results in significant systemic adverse effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. They must be taken into account, especially within a short time of ingestion, gastric lavender and the use of activated carbon. There is no specific antidote.

The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the treatment experience with NSAIDs for systemic administration, we recommend the following:

Pregnancy

: Inhibition of prostaglandin synthesis can negatively 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 cardiovascular malformations increased from less than 1%, up to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals the administration of an inhibitor of the synthesis of prostaglandins has shown to cause an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals to which an inhibitor of prostaglandin synthesis was given, during the organogenetic period. During the first and second quarter of pregnancy, diclofenac should not be administered if not in strictly necessary cases. If diclofenac is taken 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 • fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions that determines delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Food

: Diclofenac is secreted in breast milk in small quantities. However, the therapeutic doses of Diclofenac Teva BV are not expected to affect the infant. Due to the lack of controlled studies in nursing women, the medicinal product should be used during breastfeeding only under the advice of a doctor. In this circumstance, Diclofenac Teva BV should not be applied to the breasts of nursing mothers, or elsewhere on large skin areas or for a prolonged period (see paragraph 4.4).

Source: Farmadati