Dolaut 40 mg/g 25 g gel with dispenser

Dolaut 40 mg/g 25 g gel with dispenser is an anti-inflammatory and pain reliever for topical use, formulated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic nature that affect joints, muscles, tendons and ligaments . Thanks to the presence of diclofenac sodium , an active ingredient known for its effectiveness, Dolaut gel acts quickly to relieve muscle pain, joint pain, inflammation and trauma such as sprains, bruises and rheumatism.

The practical 25 g pack with dispenser allows for precise dosing and hygienic application directly on the affected area, promoting rapid absorption without greasing the skin. Its skin gel formulation allows for targeted penetration of the active ingredient, providing immediate relief from rheumatic and traumatic pain and reducing localized inflammation.

Dolaut gel is indicated for those suffering from rheumatism, joint trauma, tendonitis, muscle pain and inflammation of the ligaments . Regular use helps restore mobility and improve the quality of life in cases of acute or chronic pain related to musculoskeletal pathologies. The presence of propylene glycol and other selected excipients guarantees a light texture and a sensation of freshness thanks to the mint essence.

Choose Dolaut 40 mg/g gel with dispenser for an effective, targeted and practical treatment against inflammation and muscle-joint pain , ideal for daily use in case of trauma, rheumatism and localized pain .

ACTIVE INGREDIENTS

Active ingredients contained in Dolaut 40 mg/g 25 g gel with dispenser - What is the active ingredient of Dolaut 40 mg/g 25 g gel with dispenser?

Each 100 g of gel contains: Active ingredient: Diclofenac sodium 4 g Excipient with known effect: propylene glycol For the complete list of excipients, see section 6.1.

EXCIPIENTS

Composition of Dolaut 40 mg/g 25 g gel with dispenser - What does Dolaut 40 mg/g 25 g gel with dispenser contain?

Propylene glycol, Isopropyl alcohol, Ethyl alcohol, Soy lecithin, Sodium phosphate dihydrate, Disodium phosphate dodecahydrate, Disodium edetate, Ascorbyl palmitate, Peppermint essence, Purified water.

DIRECTIONS

Therapeutic indications Dolaut 40 mg/g 25 g gel with dispenser - Why is Dolaut 40 mg/g 25 g gel with dispenser used? What is it used for?

Local treatment of painful and inflammatory conditions of rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Dolaut 40 mg/g 25 g gel with dispenser - When should Dolaut 40 mg/g 25 g gel with dispenser not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children and adolescents: Use in children and adolescents under 14 years of age is contraindicated. Patients who have experienced attacks of asthma, urticaria or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Third trimester of pregnancy.

DOSAGE

Quantity and method of taking Dolaut 40 mg/g 25 g gel with dispenser - How to take Dolaut 40 mg/g 25 g gel with dispenser?

Adults over 18 years: Apply DOLAUT 3 or 4 times a day to the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected area. For example, 3-5 sprays of DOLAUT are sufficient to treat an area of ​​400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. Caution: use only for short periods of treatment. Adolescents from 14 to 18 years: Apply DOLAUT 3 or 4 times a day to the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected area. For example, 3-5 sprays of DOLAUT 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 your doctor. Children under 14 years: There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see also section 4.3 Contraindications). Therefore, the use of DOLAUT is contraindicated in children under 14 years of age. Elderly: The usual adult dosage may be used.

CONSERVATION

Storage Dolaut 40 mg/g 25 g gel with dispenser - How to store Dolaut 40 mg/g 25 g gel with dispenser?

Keep away from heat sources and open flames

WARNINGS

Warnings Dolaut 40 mg/g 25 g gel with dispenser - About Dolaut 40 mg/g 25 g gel with dispenser it is important to know that:

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 of the systemic forms of diclofenac). Therefore, particularly in patients with previous gastrointestinal diseases, the appearance of systemic side effects such as nausea, dyspepsia, heartburn, excitement, taste disturbance, conjunctivitis cannot be excluded for DOLAUT. Topical Diclofenac 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 the eyes or mucous membranes and should not be ingested. Discontinue treatment if a skin rash develops after application of the product. DOLAUT contains propylene glycol which may cause mild localized skin irritation in some people. Topical diclofenac may be used with non-occlusive dressings, but should not be used with an airtight occlusive dressing. External use. KEEP OUT OF REACH OF CHILDREN.

INTERACTIONS

Interactions Dolaut 40 mg/g 25 g gel with dispenser - Which medicines or foods can modify the effect of Dolaut 40 mg/g 25 g gel with dispenser?

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

SIDE EFFECTS

Like all medicines, Dolaut 40 mg/g 25 g gel with dispenser can cause side effects - What are the side effects of Dolaut 40 mg/g 25 g gel with dispenser?

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); Not known: frequency cannot be estimated from the available data. Table 1

Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic edema.
Infections and infestations
Very rare	Rush with pustules
Respiratory, thoracic and mediastinal pathologies
Very rare	Asthma
Skin and subcutaneous tissue disorders
Common	Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus.
Rare	Bullous dermatitis.
Very rare	Photosensitivity reaction
Not known	Burning sensation at application site, dry skin

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Dolaut 40 mg/g 25 g gel with dispenser - What are the risks of Dolaut 40 mg/g 25 g gel with dispenser in case of overdose?

The low systemic absorption of topical diclofenac makes overdose very unlikely. However, undesirable effects similar to those observed after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 bottle of 25 g contains the equivalent of 1000 mg diclofenac sodium). In the event of accidental ingestion resulting in significant systemic undesirable effects, general therapeutic measures normally adopted to treat poisoning with nonsteroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time after ingestion.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Dolaut 40 mg/g 25 g gel with dispenser.

Pregnancy The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with treatment with systemically administered NSAIDs, the following is recommended. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk was 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. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. 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 and 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 neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and an anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, 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 DOLAUT 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, DOLAUT should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).

DRIVING AND USE OF MACHINERY

Taking Dolaut 40 mg/g 25 g gel with dispenser before driving or using machines - Does Dolaut 40 mg/g 25 g gel with dispenser affect driving or using machines?

The cutaneous application of topical diclofenac does not alter the ability to drive vehicles or use machinery.