COMPOSITION: Each dispersible tablet contains:
Diclofenac (I.N.N.) ..........46.5 mg
Saccharin sodium...........4.5 mg
Microcrystalline cellulose, Corn starch, Carboxymethyl starch, Crospovidone, Orange flavour, Polyethylene glycol, Sodium stearylfulmarate, Microcrystalline silica, q.s
Each tablet contains 46.5 mg of diclofenac under acid form, that correspond to 50 mg of sodic diclofenac.

PROPERTIES: Diclofenac is a non-steroidal substance with an antirheumatic, antiinflammatory, analgesic and antipyretic effect. It is a derivative of phenyl-acetic acid, which reduces the permeability of capillaries in inflamed tissues, inhibits hyaluronidase produced by germs and the synthesis of prostaglandins and platelet aggregation.

INDICATION: Inflammatory and degenerative forms of rheumatism: (rheumatoid, arthritis, ankylopoietic spondylarthritis, arthrosis, spondylarthritis). Extra-articular rheumatism. Acute gout crises. Symptomatic treatment of primary dysmenorrhea. Post-traumatic inflammation and tumefaction.

INTERACTIONS: When diclofenac is administered concurrently with lithium or digoxin compounds, it may increase the plasmatic level of the same, although no sings of overdose have been found in such cases. The simultaneous administration of acetylsalicylic acid reduces the bioavailability of the latter. Non steroidal antiinflammatory drugs may increase the effects of dicumarinic anticoagulants; it is recommended that when under simultaneous treatment with both preparations, the adequate laboratory test be carried out to check that the desired anticoagulant response is maintained. As it happens with other non-steroidal antiinflammatories, it may temporarily inhibit, at high dosages (200 mg), platelet aggregation. Studies with diabetic patients have demonstrated that diclofenac may be administered together with oral antidiabetics without influencing the clinical effects of these. Several non-steroidal antiinflammatories may inhibit the activity of the diuretics. Concomitant treatment with potassium saving diuretics may be associated with an increase in the serum levels of potassium, which makes it necessary to control the serum values of the same. The simultaneous administration of glucocorticoids and non-steroidal antiinflammatories may aggravate the gastrointestinal side effects. The simultaneous treatment with two or more non-steroidal antirheumatic drugs may favour the appearance of side effects. Precaution is imperative when non-steroidal antiinflammatories are employed before (less than 24 hours) or after a treatment with methotrexate, as it may increase the levels in blood of the latter and increase its toxicity. Dolotren may increase the nefrotoxicity of cyclosporine. Convulsion isolated cases may be caused by its simultaneous use with quinolones. Diclofenac may increase the elimination of ceftriaxone. Some studies have related a decrease of the therapeutic efficacy of calcium antagonists like verapamil, isradipine or nifedipine. Therapeutic efficacy of diclofenac can be reduced by ion exchange resine drugs like colestiramine or colestipol. Selective serotonin reuptake inhibitors can increase the risk of intestinal bleeding.

CONTRAINDICATIONS: Gastroduodenal ulcer, stomach or duodenum haemorrhage. Hypersensitivity to diclofenac or to any other component of Dolotren. Hypersensitivity to acetylsalicylic acid or other antiinflammatories. Serious cardiac failure. It is contraindicated in the third quarter of pregnancy. As with other non-steroidal antiinflammatory agents, it is contraindicated in asthmatic patients in which acetylsalicylic acid and other agents which inhibit prostaglandin synthase, trigger attacks of asthma, urticaria or acute rhinitis.

PRECAUTIONS: Patients suffering gastrointestinal disorders, or with a history of peptic ulcer, ulcerative colitis or Crohn's disease, with haematopoietic or coagulation disorders, as well as those suffering from severe hepatic, cardiac or renal lesions, shall be kept under strict medical surveillance. If gastrointestinal haemorrhage or an ulcus takes place, medication must be immediately suspended. In those patients subjected to medication for prolonged periods of time, it is convenient to carry out periodic blood tests, and to control the hepatic and renal function as a precautionary measure. It shall be used with special precaution in patients of an advanced age, in those being treated with diuretics and in those which are convalescent after major surgical operations. Patients that have suffered episodes of hepatic porphyria or with such history in his family must inform their doctor. Patients who experience vertigo or other disorders of the central nervous system, shall not drive automobiles or handle dangerous machinery, and they shall avoid situations which demand a special state of alertness.

Use during pregnancy and lactation: Diclofenac must only be used during pregnancy in very specific and justifiable circumstances, and at the lowest possible dose. As with other inhibitors of prostaglandin synthase, special precautions must be taken during the last three months of pregnancy, due to the possible uterine adynamia and/or premature closure of the ductus arteriosus. The use in the third quarter of pregnancy is contraindicated. Women in the childbearing age must take in account that drugs like Dolotren have been related with a decrease of the capacity to conceive. After a daily dose of 150 mg diclofenac passes to maternal milk, but only in such minute amounts that it is not foreseeable whether any adverse effects will be produced in the child.

INCOMPATIBILITIES: None have been described.

SIDE EFFECTS: Gastrointestinal: occasionally: epigastric pain and other disorders (e.g. nausea, vomits, diarrhoea). Rarely: haemorrhage, peptic ulcer. In isolated cases: peptic ulcer with perforation, hypogastric disorders (e.g. non-specific haemorrhagic colitis and exacerbation of ulcerative colitis). Cardiovascular: rarely: edema, palpitations, thoracic pain, hypertension, cardiac insufficiency. High dosage of diclofenac during a long period may increase the risk of heart attack or stroke. On the CNS: occasionally: headaches, dizziness or vertigo. Rarely: somnolence and, insomnia, irritability, convulsions. Ear and eye: rarely: in isolated cases alterations of sensitivity or of the sight (blurred vision, diplopia), tinnitus. Dermal: occasionally: skin rash or eruption. Rarely: urticaria. In isolated cases: vesicular eruptions, eczema, multiform erythema Stevens-Johnson syndrome, Lyell syndrome, hair loss, photosensitivity reactions. Renal: in isolated cases: acute renal insufficiency, urinary anomalies (e.g. haematuria), interstitial nephritis, nephrotic syndrome. Hepatic: rarely: disorders of the hepatic function, including hepatitis with or without jaundice, being in isolated cases, fulminating. Treatment must be suspended immediately if skin or eyes get a yellowish colour, and the doctor must be informed. Haematological: in isolated cases: thrombocytopenia, leukopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia. In other organs: Rarely: oedema, hypersensitivity reactions (e.g. bronchospasms, anaphylactic / anaphylactoid systemic reactions, including hypotension).

POSOLOGY: DOLOTREN 46.5 mg Dispersible tablets is presented in tablets, which must be taken orally once dispersed in half a glass of water. Chewing the tablet or swallowing it whole is not convenient.

Adults: The treatment shall be initiated with a dose of 100-150 mg per day (of 2 to 3 tablets). Administered in 2 - 3 intakes. The most effective and best tolerated maintenance dose is that of 100 mg per day. In primary dysmenorrhea, the daily dose, which has to be adjusted for each individual, is of 50 - 200 mg (from 1 to 4 tablets). A single dose of 50-100 mg (from 1 to 2 tablets) will be administered, and if necessary, it shall be increased in the following menstrual cycles. The treatment must be commenced when the first symptoms appear. Depending on their intensity, it shall be continued for a few days.

Children: The dosage for children over 1 year of age is of 0.5 - 3 mg/Kg of weight, per day.

Elderly: The treatment shall be initiated with the lower possible dose. The posology must be established by the doctor.

INTOXICATION AND ITS TREATMENT: In the event of overdose, the following symptoms can be observed: headaches, motor agitation, muscular cramps, irritability, ataxia, vertigo, convulsions, especially in children. Equally, the following may appear: epigastric pains, nausea, vomits, haematemesis, diarrhoea, gastroduodenal ulcer, disorders of the hepatic function and oliguria. Urgent measures: the treatment of diclofenac intoxication is mainly symptomatic and supportive. A stomach wash and the administration of 50-100 g of activated carbon are of use, especially during the first hours post-ingestion. Specific treatments (forced diuresis, dialysis or haemoperfusion) for the elimination of non-steroidal antiinflammatories are probably of no use due to their high rate of fixation to protein and their extensive metabolism. In the event of overdose or accidental ingestion, consult the Toxicology Information Unit.

INFORMATION FOR THE PATIENT: It combats inflammation and alleviates the pain. Adhere strictly to the instructions of your doctor in relation to the dosage and administration. Do not drive automobiles or operate machinery if dizziness or other disorders of the central nervous system appear. Immediately consult with your practitioner if more severe symptoms appear, such as stomach discomfort and/or black coloured faeces, or hypersensitivity reactions (e.g.: skin eruption or asthma attacks). Inform your doctor if you are or get pregnant, or if you are breast-feeding. Also inform your doctor of any other medicines that you may be taking. Patients with a history of severe gastrointestinal problems, hypertension and/or cardiac insufficiency, coagulation disorders, hepatic or renal lesions, as well as those above a certain age, require careful medical monitoring.

PRESENTATION: Dolotren 46.5 mg Dispersible tablets, 40 tablets.

Dolotren 75 mg Intra-muscular, 6 ampoules of 3 ml.
Dolotren 50 mg Gastro-resistant tablets, box of 20 tablets.
Dolotren Gel 60 grams.
Dolotren Retard Capsules 100 mg, box of 20 capsules.
Dolotren 100 mg Suppositories, box of 12 suppositories.

Under medical prescription. Medicines must be kept out of the reach of children. Do not store above 30°C.

Manufactured by FAES FARMA, S.A.

Máximo Aguirre, 14 – 48940 Leioa (SPAIN)