SULIDOR®
Sulidor 30 mg / g gel

Each gram of gel contains 30 mg of nimesulide.

CNP: 5546494

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018

SULIDOR®
Sulidor is indicated for the symptomatic treatment of pain associated with sprains and acute traumatic tendinitis.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018
SULIDOR®
Adults: Sulidor (usually 3 g, corresponding to a 6-7 cm long line) should be applied in a thin layer on the affected area, 2-3 times a day, and massage until completely absorbed.

The duration of treatment should be from 7 to 15 days.

Children under 12 years old: It should not be used because it has not been studied in this population.

Elderly: No dose adjustment is required according to the pharmacokinetic data. However, it should be considered that these patients are more predisposed to renal and/or hepatic failure.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018
SULIDOR®
Known hypersensitivity to nimesulide or to any of the excipients of the gel.

Use in patients in whom acetylsalicylic acid or other medicinal products that inhibit the synthesis of prostaglandins have induced allergic reactions such as rhinitis, urticaria or bronchospasm.

Use in solutions of continuity of the skin or in the presence of local infection.

Simultaneous use with other topical creams.

Use in children under 12 years old.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018

SULIDOR®
Sulidor should not be applied to skin wounds or open lesions.
Avoid contact with eyes or mucous membranes; in case of accidental contact, wash immediately with water.
This medicine should never be ingested.
Hands should be washed after applying the gel. It should not be used with occlusive dressings.

Sulidor is not recommended for use in children under 12 years old.

Undesirable effects may be reduced by using the lowest effective dose for the shortest possible time.
Patients with gastrointestinal bleeding, active or suspected peptic ulcer, severe hepatic or renal dysfunction, severe coagulation disorders or with severe/uncontrolled cardiac insufficiency should be treated with caution.

Special caution should be used when treating patients with known hypersensitivity to other NSAIDs, since Sulidor has not been studied in individuals with hypersensitivity.
It cannot be excluded the possibility of these patients develop hypersensitivity during treatment. Since a burning sensation and, exceptionally, photodermatitis may occur with other topical NSAIDs, special attention should also be paid during treatment with Sulidor.

Patients should be cautioned against direct exposure to sunlight and sunbeds in order to reduce the risk of photosensitivity.

If symptoms persist or the condition worsens, consult your doctor.

To the extent that there is a possibility of dermal absorption of Sulidor, it is not possible to exclude the occurrence of systemic effects.
The risk of occurrence of these effects depends, among other factors, on the exposed surface, amount applied and period of exposure.

Skin safety of non-steroidal anti-inflammatory drugs (NSAIDs): Severe skin reactions associated with NSAID administration, some of which have been fatal – including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis – have been reported rarely. It appears that the risk of occurrence of these reactions is higher at the beginning of the treatment; in most cases these reactions occur during the first month of treatment.

Treatment with Sulidor should be interrupted at the first signs of rash, mucosal lesions or other manifestations of hypersensitivity.

Sulidor contains methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate, which may cause allergic reactions (possibly delayed). Sulidor contains propylene glycol, which can cause skin irritation.

Fertility, pregnancy and breastfeeding: Sulidor should not be used during pregnancy or breastfeeding, unless clearly necessary, due to the lack of relevant data in these subpopulations.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018

SULIDOR®
Diuretics, Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors), and Angiotensin II Receptor Antagonists/Blockers (ARBs): non-steroidal anti-inflammatory drugs (NSAIDs) may decrease the efficacy of diuretics as well as other antihypertensive drugs.

In some patients with diminished renal function (e.g. dehydrated or elderly patients with impaired renal function), coadministration of an ACE Inhibitor or ARB and cyclooxygenase inhibitors may result in progression of the deterioration of renal function including the possibility of acute renal failure, which is normally reversible.

The occurrence of these interactions should be taken into account in patients using diclofenac sodium, especially if it is being applied in large areas of the skin and for a prolonged time in association with ACE Inhibitors or ARBs. Therefore, this drug association should be used with caution, especially in elderly patients.
Patients should be adequately hydrated and the need to monitor renal function after initiation of concomitant therapy, and periodically thereafter, should be reviewed.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018

SULIDOR®
Skin and subcutaneous tissue disorders – Common: pruritus, erythema. Very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Carefully read this information on the packaging and the package leaflet. In case of doubt or persistence of symptoms you should consult your doctor or pharmacist.

This website is exclusively for residents of Portugal.

Last Review: 24/07/2018