Dicloreum Actigel 1% 100 g gel

Dicloreum Actigel 1% 100 g gel is an anti-inflammatory and analgesic gel based on diclofenac , ideal for the local treatment of joint and muscle pain of rheumatic or traumatic origin. Thanks to its specific formulation, this topical NSAID acts quickly on the affected area, offering targeted relief from inflammation, swelling and pain without passing through the digestive system.

The gel texture of Dicloreum Actigel 1% allows for rapid absorption and easy application, making it particularly suitable for muscle pain, joint inflammation, tendonitis, sprains, bruises and sports injuries . The product is also suitable for the treatment of arthritis and rheumatic pain , helping to reduce swelling and restore mobility to the affected joints and muscles.

Dicloreum Actigel 1% 100 g gel is the ideal pain ointment for those looking for an effective and practical local treatment , to be used in cases of acute or chronic pain affecting muscles, tendons and ligaments . Its targeted action makes it a reference trauma gel for athletes and active people, but also for those suffering from muscle and joint inflammation due to strain or chronic pathologies.

Trust Dicloreum Actigel for rapid pain relief and to promote recovery in the event of post-traumatic swelling or inflammation . The 100 g pack guarantees prolonged and practical use, always at hand for any need for local pain treatment .

ACTIVE INGREDIENTS

Active ingredients contained in Dicloreum Actigel 1% 100 g gel - What is the active ingredient in Dicloreum Actigel 1% 100 g gel?

100 g of gel contain: Active ingredient : diclofenac hydroxyethylpyrrolidine 1.32 g – equivalent to 1.0 g of diclofenac sodium. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Dicloreum Actigel 1% 100 g gel - What does Dicloreum Actigel 1% 100 g gel contain?

macrogols, macrogol stearate, cetyl stearyl–2–ethylhexanoate, carbomers, trolamine, isopropyl alcohol, fragrance, purified water.

DIRECTIONS

Therapeutic indications Dicloreum Actigel 1 % 100 g gel - Why is Dicloreum Actigel 1 % 100 g gel used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Dicloreum Actigel 1% 100 g gel - When should Dicloreum Actigel 1% 100 g gel not be used?

Known individual hypersensitivity to the components of the product. Patients who have experienced attacks of asthma, urticaria or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), as well as isopropanol. Contraindicated in the third trimester of pregnancy (see section 4.6 Fertility, pregnancy and breastfeeding ). Children and adolescents Use in children and adolescents under 14 years of age is contraindicated.

DOSAGE

Quantity and method of taking Dicloreum Actigel 1% 100 g gel - How is Dicloreum Actigel 1% 100 g gel taken?

Adults over 18 years : Apply DICLOREUM ACTIGEL 3 or 4 times a day to the area to be treated, rubbing in lightly. The amount to be applied depends on the size of the affected area. For example, 2–4 g of DICLOREUM ACTIGEL (an amount between the size of a cherry and a walnut) are sufficient to treat an area of ​​400–800 cm². Wash your hands after application, otherwise they will also be treated with the gel. Caution: use only for short periods of treatment. Adolescents aged 14 to 18 years : Apply DICLOREUM ACTIGEL 3 or 4 times a day to the area to be treated, rubbing in lightly. The amount to be applied depends on the size of the affected area. For example, 2–4 g of DICLOREUM ACTIGEL (an amount between the size of 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 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 DICLOREUM ACTIGEL is contraindicated in children under 14 years of age. Elderly : The usual dosage for adults can be used.

CONSERVATION

Storage Dicloreum Actigel 1% 100 g gel - How is Dicloreum Actigel 1% 100 g gel stored?

Do not store above 30°C

WARNINGS

Warnings Dicloreum Actigel 1% 100 g gel - On Dicloreum Actigel 1% 100 g gel 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). DICLOREUM ACTIGEL should not be applied to skin wounds or open lesions, but only to intact skin. Avoid contact of the preparation with eyes and mucous membranes. The gel should not be swallowed. In elderly patients and/or patients with gastric problems, the concomitant use of systemic anti-inflammatory drugs is not recommended. Patients with asthma, chronic obstructive bronchial diseases, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react more often than other patients with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs. The use, especially if prolonged, of other products for topical use may give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an appropriate therapy. Discontinue the treatment if a skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but it must not be used with an occlusive dressing that does not allow air to pass through. Keep the medicine out of the sight and reach of children.

INTERACTIONS

Interactions Dicloreum Actigel 1 % 100 g gel - Which medicines or foods can modify the effect of Dicloreum Actigel 1 % 100 g gel?

Although bioavailability studies suggest that an interaction with other drugs is unlikely, in high-dose and prolonged treatments, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding should be taken into account.

SIDE EFFECTS

Like all medicines, Dicloreum Actigel 1 % 100 g gel can cause side effects - What are the side effects of Dicloreum Actigel 1 % 100 g gel?

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: 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: cannot be estimated from the available data. Table 1

Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic edema.
Infections and infestations
Very rare	Rash 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.

The use of the product in association with other drugs containing diclofenac may give rise to phenomena of hypersensitivity to light, skin rash with the formation of vesicles, eczema, erythema and skin reactions with severe progression (Stevens–Johnson syndrome, Lyell syndrome).

OVERDOSE

Overdose Dicloreum Actigel 1 % 100 g gel - What are the risks of Dicloreum Actigel 1 % 100 g gel 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 tube of 50 g contains the equivalent of 500 mg of 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 of 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 Dicloreum Actigel 1% 100g gel.

Pregnancy The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Based on experience with treatment with systemic 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. Furthermore, 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 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 DICLOREUM ACTIGEL no effects on the infant are anticipated. 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, DICLOREUM ACTIGEL 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

Take Dicloreum Actigel 1 % 100 g gel before driving or using machines - Does Dicloreum Actigel 1 % 100 g gel affect driving or using machines?

It does not interfere with the ability to drive or use machines.