Diclofenac teva bv 20 mg/g - gel for joint and muscle pain 60 g

Product Description

Gel for muscle and joint pain.

Indications

Diclofenac Teva Bv 20 Mg/G is a gel used in the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Composition

Active Ingredients: 1 g of gel contains diclofenac in the form of 23.2 mg of diclofenac diethylammonium equivalent to 20 mg of diclofenac sodium.

Excipients:Isopropyl alcohol, Propylene glycol (E1520), Cocoyl caprylocaprate, Liquid paraffin, Carbomer, Macrogol cetostearyl ether, Diethylamine, Oleic acid (E570), Butylhydroxytoluene (E321), Perfume (contains citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, eugenol), Purified water.

How to use and Dosage

Adults and adolescents aged 14 years and over:
Diclofenac Teva BV is used twice a day (preferably in the morning and evening).
Depending on the size of the affected area to be treated, an amount varying in size from a cherry to a walnut is applied, equivalent to 1-4 g of gel (23.2-92.8 mg of diclofenac, diethylammonium salt) corresponding to 20-80 mg of diclofenac sodium.
This dose is sufficient to treat an area of ​​400-800 cm².
The maximum daily dose is 8 g of gel, corresponding to 185.6 mg of diclofenac diethylammonium (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 for one week without consulting your doctor.
If symptoms worsen or do not improve within 3-5 days, you should consult your doctor.
Special patient groups.
Elderly patients: No special dose adjustments are required.
Due to the potential adverse effect profile, elderly people should be carefully monitored.
Patients with impaired renal function: No dose reduction is necessary for patients with impaired renal function.
Patients with impaired hepatic function: No dose reduction is necessary for patients with impaired hepatic function.
Children and adolescents (under 14 years): There are insufficient data on efficacy and safety in children and adolescents under 14 years.

Method of administration:
For cutaneous use.
A thin layer of gel is applied to the affected parts of the body and rubbed gently to penetrate the skin.
Hands should be washed unless they are the area to be treated.
Before applying a bandage, the gel should be allowed to dry on the skin for a few minutes.

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and for a prolonged period (see the summary of product characteristics for systemic forms of diclofenac).
Diclofenac Teva BV should only be applied to intact, healthy, and unwounded skin.
It should not come into contact with the eyes or oral mucosa and should not be ingested.
Topical diclofenac can Diclofenac Teva BV can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass through.
If symptoms worsen or do not improve within 3-5 days, you should consult your doctor.
Patients suffering from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with symptoms similar to allergic rhinitis) and patients with hypersensitivity to painkillers and antirheumatic drugs of any kind are at greater risk of asthma attacks (so-called analgesic intolerance 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 may Diclofenac Teva BV should 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 skin rash develops during treatment with Diclofenac Teva BV, treatment should be discontinued.
Photosensitivity with the appearance of skin reactions following exposure to sunlight may occur during treatment.
Preventive measures should be taken to prevent children from touching skin areas to which the gel has been applied.
Diclofenac Teva BV contains butylhydroxytoluene, which may cause allergic reactions. cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
This medicine contains a perfume with benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.
Additionally, benzyl alcohol may cause mild local irritation.

Interactions

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

Undesirable effects

Adverse reactions are listed below by system organ class and frequency of occurrence.
Frequencies are defined as follows:

• Very common (>1/10);
• Common (>1/100 to <1/10);
• Uncommon (>1/1,000 to <1/100);
• Rare (>1/10,000 to <1/1,000);
• Very rare (<1/10,000);
• Not known (frequency cannot be estimated from the available data). available).

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 may appear after systemic administration of medicinal products containing diclofenac cannot be excluded.

Overdose

The low systemic absorption of diclofenac in limited topical use means that it is not recommended to use the gel in case of systemic administration. that an overdose is unlikely.
If a dose significantly higher than the recommended dose is applied, the gel should be removed from the skin and the area rinsed with water.
Undesirable effects similar to those observed after an overdose of systemic diclofenac can be expected if topical diclofenac is inadvertently ingested (1 100 g tube contains the equivalent of 2320 mg of diclofenac diethylammonium, corresponding to 2000 mg of diclofenac sodium).
In the event of accidental ingestion resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with nonsteroidal anti-inflammatory drugs should be undertaken.
Gastric lavage and the use of activated charcoal should be considered, especially within a short time after ingestion.
There is no antidote. specific.

Contraindications

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

Pregnancy and breastfeeding

The systemic concentration of diclofenac, compared with oral formulations, is higher. low after topical administration.
With reference to the experience of treatment with NSAIDs for systemic administration, the following is recommended:
Pregnancy:
Inhibition of prostaglandin synthesis may may 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 result in increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period.
During the first and second trimesters of pregnancy, diclofenac does not should be administered unless clearly necessary.
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 may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the newborn, at the end of pregnancy, to:

• possible prolongation of bleeding time, an antiaggregant effect which may increase the risk of developing hepatitis C;

the mother and the newborn, at the end of pregnancy, to:

• possible prolongation of bleeding time, an antiaggregant effect which may increase the risk of ... may 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.
Breastfeeding:
Diclofenac is secreted into breast milk in small quantities.
However, at therapeutic doses of Diclofenac Teva BV no effects on the infant are expected.
Due to the lack of controlled studies in breastfeeding 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, nor should it be administered to pregnant women. elsewhere on large areas of skin or for a prolonged period.

Storage

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

Format

60 g tube