Each film-coated tablet contains Diclofenac potassium 50 mg. betamethasone 0,3mg.
Analgesic and anti-inflammatory.
Symptomatic and short treatment when the patient does not respond to monotherapy of the muscle-skeletal acute inflammatory processes.
Sodium diclofenac is a non-steroidal anti-inflammatory (NSAI) derived from phenylacetic acid. In pharmacological studies, diclofenac has proved to have an anti-inflammatory, analgesic, and antipyretic activity.
As with any other NSAIDs, its method of action is not completely clear; the capacity to inhibit prostaglandin synthesis participates in its pharmacological activity.
Betamethasone is a glucocorticoid suppressing inflammation by multiple mechanisms: It inhibits the production of several immediate methods of inflammatory reactions, among them, vasoactive and chemotactic factors; it lowers the secretion of lipolytic and proteolytic enzymes; it produces less extravasation of leukocytes to the wounded areas and it lowers fibrosis; and finally, it also affects the number and the immune reactions depending on the lymphocytes.
The coated tablets enable diclofenac release in the high pH of the intestine. Food delays the absorption start, by reducing the plasmatic peak. It joins irreversibly to plasmatic albumin in a percentage higher than 99%. Diclofenac is eliminated by hepatic metabolism and it is excreted by urine (65%) and bile (35%) such as metabolites conjugated with sulfate or glucuronic. No variation of pharmacokinetics in the geriatric population or patients with hepatic or renal insufficiency has been detected. After its oral administration, betamethasone is rapidly and completely absorbed, reaching a plasmatic average life of 4 to 6 hours.
One tablet every 8 or 12 hours based on medical criteria. Its administration is recommended after meals.
• Hypersensitivity to the active ingredients, hypersensitivity to aspirin and other NSAIDs, Active gastroduodenal ulcer, severe renal insufficiency, hepatic insufficiency, uncompensated heart failure, severe arterial hypertension, systemic mycosis, active tuberculosis, gout, hepatitis A, B, and non A non B and other viral infections, anticoagulant treatment, pregnancy, and breastfeeding.
May cause a digestive hemorrhage or perforation with or without previous symptoms or pathology at any time of the treatment. This is more probable in old people. Diclofenac can rarely cause severe allergic reactions of anaphylactic or anaphylactoid type.
Betamethasone can cover some infection signs. No immunization procedure must be carried out in patients treated with DIFEN PLUS, due to its possible alteration of an immune response. It must also be administered with great care in patients suspected of suffering from infection by Strongyloides because it may predispose to the spread of the affection, putting lives at risk. People with latent tuberculosis must be controlled carefully since reactivation of the disease is possible.
DIFEN PLUS, since it contains diclofenac, must be used carefully in patients with disorders of renal failure, heart or hepatic failure, and in patients who underwent major surgery or who suffered from the depletion of intravascular volume. Diclofenac may cause acute episodes in patients with hepatic porphyria and may also cause acute exacerbations in patients with bronchial asthma.
Strict medical vigilance in patients with a medical history of duodenal ulcer or Crohn's disease must be observed. Patients with hemostasis disorders or who receive oral anticoagulants must be also strictly controlled.
DIFEN PLUS, due to its content in betamethasone, must be administered, cautiously in patients with diverticulitis, recent intestinal anastomosis, medical history of peptic ulcer, arterial hypertension, osteoporosis, and myasthenia gravis.
In old patients, the minor dose of DIFEN PLUS showing its efficacy must be used.
Simultaneous administration of DIFEN PLUS with other systemic non-steroidal anti-inflammatory drugs may favor the appearance of adverse effects. The strict control of coagulation in patients taking oral anticoagulants is recommended.
DIFEN PLUS may inhibit the pharmacological action of diuretics.
The simultaneous administration of DIFEN PLUS and lithium salts may increase the plasmatic levels of the last one, without producing overdose signs.
Since DIFEN PLUS contains a steroid (betamethasone) in its formula, the following situations are listed:
Not advised associations: erythromycin i.v., astemizole, bepridil, halofantrine, pentamidine, vincamine, upon the risk of appearance of "torsade de pointes"
DIFEN PLUS may cause different adverse reactions in the following systems:
Gastrointestinal tract: Epigastric pain, nausea, vomiting, diarrhea, abdominal distention, digestive hemorrhage, gastric or duodenal ulcer with or without hemorrhage or perforation.
Central nervous system: Convulsions, an increase of endocranial pressure, dizziness, and sleepiness.
Liver: occasionally, increase of transaminases and, rarely, hepatitis with or without jaundice.
Skin: occasionally, skin rash and erythema. Rarely urticaria.
Kidney: Isolated cases of acute renal insufficiency or proteinuria.
Hematological system: Isolated cases of leukopenia, hemolytic anemia, and agranulocytosis.
Cardiovascular system: Arterial hypertension, congestive heart failure, and palpitations.
Endocrine system: Menstrual disorders.
In case of overdose, the gastric emptying-inducing emesis must be carried out or through gastric lavage.
If an overdose occurs, go to the closest hospital.
Packs containing 15 coated tablets.
- Protect from humidity at a temperature under 30°C.
- Keep out of the reach of children.
Laboratories: Laboratorios Casasco S.A.I.C.
Distributor: Droguerie Phenicia