DIFLAC®
Diflac 10 mg / g gel

Each gram of gel contains 10 mg of diclofenac sodium.

CNP: 5668165

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


DIFLAC®
Diflac is indicated on:

- symptomatic treatment (relief of pain, inflammation and swelling) of mild to moderate muscle pain;

- post-traumatic tendonitis;

- muscle, joint and ligament injuries (sprains, strains and bruises);

- localized forms of degenerative rheumatism (osteoarthrosis of the peripheral joints and spine).

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

DIFLAC®
Adults and adolescents over 12 years old: apply on the skin 3 to 4 times a day.

The amount required depends on the extent of the painful area: 2-4 g of Diflac (roughly, the size between a cherry and a walnut) is sufficient to treat an area of approximately 400-800 cm2. Apply by rubbing lightly into the skin. Wash hands after the application, except in the case in which they are the area to treat.

The duration of the treatment depends on the indication and the response obtained.

Diflac should not be used for more than 14 days for soft tissue injuries and/or rheumatism, or 21 days for arthritic pain, unless recommended by your doctor.

When used without a prescription, if the patient does not improve within 7 days or if the symptoms get worse, consult your doctor.

Should not be used 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

DIFLAC®
Patients with hypersensitivity to diclofenac or to any of the excipients in the product.

Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

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

DIFLAC®
Diflac should only be applied on areas of intact and healthy skin and not on wounded or injured skin.

Avoid contact with eyes or mucous membranes and do not swallow.
Contains propylparaben (E216) and methylparaben (E218) which may cause allergic reactions, even if delayed. It also contains propylene glycol that may cause irritation when used topically.

Given the possibility of cutaneous absorption of Diflac, systemic effects cannot be excluded. 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 very 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 Diflac should be discontinued at the first signs of rash, mucosal lesions or other manifestations of hypersensitivity.

Pregnancy and breastfeeding: Diflac should be avoided during pregnancy (especially during the third trimester) or breastfeeding because of limited or non-existent clinical 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

DIFLAC®
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.
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

DIFLAC®
Infections and infestations – Very rare: pustular rash.

Diseases of the immune system – Very rare: hypersensitivity, angioneurotic edema.

Respiratory, thoracic and mediastinal diseases – Very rare: asthma.

Diseases of the skin and subcutaneous tissue – Common: rash, eczema, erythema, dermatitis (including contact dermatitis); Rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare); Very rare: photosensitivity reactions.

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