Dolomax 40 Mg/Ml Solution for Skin Spray, 1 bottle 30 ml

It is a medicinal product indicated for the local symptomatic relief of mild to moderate pain and inflammation following acute contusion of small and medium-sized joints and periarticular structures.

Adults and children over 14 years of age.

Adults

Spray a sufficient quantity of Dolomax on the affected area. Depending on the size of the area to be treated, apply 4-5 sprays (0.8-1.0 g solution containing 32-40 mg diclofenac sodium) 3 times daily at regular intervals. A maximum single dose of 1.0 g of product should not be exceeded. The maximum daily dose is 15 sprays (3.0 g solution containing 120 mg diclofenac sodium).

Gently massage the skin to promote absorption of Dolomax. Wash hands after application, unless hands are the treatment area. After application, allow to dry for a few minutes before covering or bandaging the treated area.

Discontinue treatment when symptoms (pain and swelling) have subsided. Do not continue treatment for more than 7 days without medical supervision. If after 3 days of application no improvement is observed or if symptoms worsen, consult your doctor.

Special populations

Elderly population

No particular dosage schedule is necessary. Due to the possible side-effect profile, elderly people should be monitored very carefully.

• Hypersensitivity to diclofenac, peanuts, soya or to any of the excipients listed in section 6.1.
• Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients with asthma attacks, urticaria or acute rhinitis after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Use on open wounds, inflamed or infected skin, as well as on eczema or mucous membranes.
• During the third trimester of pregnancy.
• Children and adolescents under 14 years of age.

Due to the very low systemic absorption of diclofenac after topical application of Dolomax, interaction with other medicinal products is unlikely.

• The possibility of systemic adverse events cannot be excluded with the application of Dolomax if the preparation is used over large skin areas and for a prolonged period of time (see Summary of Product Characteristics of systemic forms of diclofenac).
• Dolomax should only be applied to intact, undamaged skin without open wounds or lesions. The medicinal product should not come into contact with the eyes or mucous membranes and should not be swallowed.
• Dolomax can be used with non-occlusive dressings. Do not use with occlusive dressings that do not allow air to pass through.
• Patients should be advised to avoid exposure to sunlight or UV lamp radiation to reduce the incidence of photosensitivity.
• Discontinue treatment in case of skin rash after application of the product.
• Use caution when using Dolomax together with orally ingested NSAIDs as it may increase the incidence of systemic side effects.
• Adverse effects can be reduced by using the lowest effective dose for the shortest possible time.
• Bronchospasm may be aggravated in patients who suffer or have suffered from bronchial asthma or allergic disease.
• Dolomax should be used with caution in patients with a positive history of peptic ulcer, hepatic or renal failure, haemorrhagic diathesis or inflammatory bowel disease, as isolated cases have been reported following topical use of diclofenac.
• Dolomax contains propylene glycol which may cause skin irritation in some people.
• Dolomax contains peppermint essential oil which may cause allergic reactions.
• Dolomax contains 33.3 mg of alcohol (ethanol) per gram, which is equivalent to (3.3% w/w). May cause a burning sensation on damaged skin. Do not use near an open flame, a burning cigarette or some devices (e.g. hair dryers).

Each gram of solution contains 40 mg diclofenac sodium.

Excipients with known effects: 150 mg propylene glycol (E1520)/gram solution, 100 mg soy lecithin/gram solution, 33.3 mg anhydrous ethanol/gram solution.

Excipients:

• Isopropyl alcohol
• Soy lecithin
• Ethanol
• Disodium phosphate dodecahydrate
• Sodium phosphate dihydrate
• Disodium edetate
• Propylene glycol (E1520)
• Peppermint essence
• Ascorbyl palmitate
• Hydrochloric acid 10% (w/w) for pH regulation
• Sodium hydroxide 10% (w/w) for pH regulation
• Purified water

In young people over 14 years of age, if this product is to be used for more than 7 days for pain relief or if symptoms worsen, the patient/parents of the adolescent should/should consult a doctor.

The price of non-prescription medicines is set by law. However, at Farmaciasdirect you can buy Dolomax 40 Mg/Ml Cutaneous Spray Solution, 1 vial 30 ml with a discount of up to 10%, which is the legal maximum allowed.