Voltaren Emulgel is a gel based on diclofenac diethylammonium .
Therapeutic indications
Voltaren Emulgel is used in the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
Dosage and Posology
Voltaren Emulgel should be used in the following doses:
- Adults over 18 years: apply Voltaren Emulgel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel. Attention use only for short periods of treatment
The gel should not be used for more than 14 days without medical advice. Consult your doctor if symptoms persist or worsen after 7 days of treatment.
- Teenagers from 14 to 18 years: apply Voltaren Emulgel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.
- Children below 14 years: There are insufficient data on efficacy and safety in children and adolescents below 14 years. Therefore, the use of the medicine is contraindicated in children under 14 years of age.
- Elderly (over 65 years): the usual dosage for adults can be used.
Overdose
In case of accidental ingestion or use of an excessive dose of Voltaren Emulgel, notify your doctor immediately or go to the nearest hospital. After application to the skin, the amount of diclofenac reaching the blood is very low so it is unlikely that you will experience any effects from using an overdose. If you accidentally ingest the contents of a tube of Voltaren Emulgel you may experience side effects similar to those seen after ingesting an overdose of diclofenac tablets.
If you forget to take Voltaren emulgel?
Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients;
- History of asthma attacks, hives or acute rhinitis following the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- During the third trimester of pregnancy;
- Use in children and adolescents under the age of 14 is contraindicated.
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people): various reactions on the skin characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema). Rare side effects (may affect up to 1 in 1,000 people): inflammation of the skin with blistering (bullous dermatitis). Very rare side effects (may affect up to 1 in 10,000 people): allergic reactions including hives; swelling of the skin, tissues and mucous membranes (angioedema); rash on the skin with the appearance of pustules; asthma; appearance of spots or redness on the skin following exposure to sunlight or sunlamps.
Pregnancy and breastfeeding
- Pregnancy
The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Inhibition of prostaglandin synthesis can negatively 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 risk is believed to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors 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, has been reported in animals administered prostaglandin synthesis inhibitors 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 used 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, and antiplatelet effect which can 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.
- Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, no effects on the infant are expected at therapeutic doses of the drug.
Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, the medicine should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for an extended period of time.
Special warnings
The possibility of systemic adverse events with the application of the drug cannot be excluded if the preparation is used on large skin areas and for a prolonged period. The drug should only be applied 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 skin rash develops after application of the product. The product can be used with non-occlusive bandages, but must not be used with an occlusive bandage that does not allow air to pass. The medicine contains propylene glycol.
It can cause skin irritation. The drug contains butylhydroxytoluene. It can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.
Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.
Warning : do not use the medicine after the expiry date indicated on the package.
Composition
Active principle
1.16 g of diclofenac diethylammonium, equivalent to 1 g of diclofenac sodium.
Excipients
Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water.