Voltaren emulgel 2% - pain treatment gel 60 g

Warnings

The possibility of systemic adverse events with the application of Voltaren Emulgel 2% cannot be excluded if the preparation is used on large areas of skin and for a prolonged period.
Voltaren Emulgel 2% should be applied only to intact, non-diseased skin and not to skin wounds or open lesions.
It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested.
Discontinue treatment if a skin rash develops after application of the product.
Voltaren Emulgel 2% may cause systemic adverse events. Voltaren Emulgel 2% gel can be used with non-occlusive dressings, but must not be used with an occlusive dressing that does not allow air to pass through.
Important information about some of the ingredients
Voltaren Emulgel 2% gel contains 200 mg propylene glycol per dose (4 g) equivalent to 50 mg/g which may cause skin irritation.
Voltaren Emulgel 2% gel contains butylhydroxytoluene which may cause skin irritation. cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Voltaren Emulgel 2% gel contains a pungent eucalyptus fragrance, a flavoring containing benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, and linalool, which may cause allergic reactions.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
History of asthma, angioedema, urticaria, or acute rhinitis following the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
During the third trimester of pregnancy.
Use in children and adolescents under 14 years of age is contraindicated.

Interactions

Since Systemic absorption of diclofenac following topical application is very low, interactions are very unlikely.

Undesirable effects

Undesirable effects include mild and transient skin reactions at the application site.
In very rare cases, allergic reactions may occur.
Undesirable effects are listed below by organ class, system organ class and MedDRA frequency.
Frequencies are defined as:

• 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).

Reporting of suspected adverse reactions: Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

The low systemic absorption of topical diclofenac makes overdose very unlikely; However, side effects similar to those observed after an overdose of diclofenac tablets may be expected if Voltaren Emulgel 2% is ingested (1 tube of 60 g contains the equivalent of 1.2 g of diclofenac sodium).
In case of ingestion, resulting in significant systemic side effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be initiated.
Further treatment modalities, within a short time after ingestion, should take into account clinical indications or the recommendation of the poison control center, where available.

Pregnancy and breastfeeding

Pregnancy The systemic concentration of diclofenac compared to oral formulations is higher than that of other oral formulations. low after topical administration.
Based on experience with systemic NSAID treatment, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increases from less than 1% to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors 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 prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary.
If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low 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 lead to:
  • diabetes mellitus (diabetes mellitus), which may lead to:
  the mother and the newborn, at the end of pregnancy, to:
  • possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses;
  • inhibition of uterine contractions resulting in delayed or prolonged labor.
    Diclofenac is contraindicated during the third trimester of pregnancy.

  Breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltaren Emulgel 2%, no effects on the infant are expected.
  Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional.
  In this circumstance, Voltaren Emulgel 2% should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

  Storage

  This medicinal product does not require any special storage conditions.

  Format

  60 g tube

  Product Code:FRCM176176