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10-14
brufeN® sachets
Abbott
tion of the above mentioned drug dosage is required
should carefully establish Brufen dose regimen.
NAME OF THE MEDICINAL PRODUCT
Contraindications
Brufen 600 mg Granules for Oral Solution.
Brufen is contraindicated in patients with evidence
COMPOSITION
of individual hypersensitivity toward this product, in
Each Brufen sachet contains 600 mg Ibuprofen.
patients with nasal polyposis, and in subjects with
angioedema. It is also contraindicated in case of
PHARMACEUTICAL FORM
severe liver insufficiency or severe renal failure. As is
Granules for oral solution.
often the case with other nonsteroidal anti-inflammaCLINICAL PARTICULARS
tory drugs, it is not advisable to administer this prodTherapeutic Indications
uct to patients with severe peptic ulcer or to individuBrufen is indicated for its analgesic and anti-inflam- als affected with peptic ulcer in its acute phase.
matory effects in the treatment of: Osteoarthritis Special Warnings and Precautions for Use
including (cervical arthritis, dorsal arthritis, lumbar
Brufen should be prescribed with caution to patients
arthritis; arthritis of shoulder, hip and knee, dissemiwho developed bronchospasm after receiving aspinated arthritis), scapulohumeral periarthritis, backrin or other nonsteroidal anti-inflammatory drugs, as
ache, ischialgia, radiculo-neuritis; fibrositis, tenosywell as in case of subjects with a personal history of
novitis, myositis, sports traumas; rheumatoid arthrigastrointestinal bleeding or ulcer, heart decompentis, Stills disease. It is also indicated in the treatment
sation, hypertension and in individuals with defects
of pain, soreness and tenderness of widely differing
etiology as follows: Traumas caused by accidents in blood clotting mechanisms. Great care should be
and sports traumas, Dentistry: Dental and Post- adopted in treating patients with a history of severe
operative pain, Obstetrics: post-episotomy pain impairment of heart, liver or kidney function. These
and postpartum pain, Gynecology: prevention and individuals should be subject to periodic measuretreatment of dysmenorrhea, Surgery: treatment of ments of clinical and laboratory parameters, espepost-operative pain, Ophtalmology: treatment of cially in case of long-term administration of this
post-operative pain and all forms of pain of differing drug. Eye alterations were observed during studies
etiology, General medicine: treatment of migraine carried out on animals treated with nonsteroidal
anti-inflammatory drugs, in case of long term treatand headache.
ments, as a result, patients should be warned about
Dosage and Method of Administration
the need to undergo periodic eye examinations. The
One sachet 1 - 3 times daily according to physiuse of Brufen as well as of any other drug inhibiting
cian’s recommendation. Brufen maximum daily dose
prostaglandin-synthesis or cycle-oxygenase syntheshould not exceed 1800 mg. In rheumatology, in
sis is not recommended in women who are planning
order to improve muscle and joint morning stiffness,
pregnancy. Brufen administration should be disconBrufen first orally administered dose should be given
tinued in women who are experiencing problems of
to patients upon their awakening; the following drug
doses can be received during meals. In case of renal fertility or are undergoing fertility tests.
Ibuprofen
failure, the elimination of this product may prove to be
reduced and, as a result, dosage adjustment might
be required. In the treatment of geriatric subjects, the
physician who shall evaluate whether or not a reduc-
Interactions with Other Medicinal Products and
Other Forms of Interactions
The extremely widespread use of Ibuprofen worldwide has produced no reports of any interactive
ABBOTT-BRUFEN SACHETS - p.1/2
ABBOTT-BRUFEN SACHETS - p.2/2
effect with other compounds. Nevertheless, patients
on therapy with coumarin anticoagulants should be
preferably subjected to close monitoring and any
combination of Ibuprofen and aspirin or other non
steroidal anti-inflammatory drugs should be carefully
avoided. The concomitant administration of Lithium
and Nonsteroidal Anti-inflammatory Drugs causes
an increase in Lithium plasma levels.
Pregnancy and Lactation
In pregnant women and nursing mothers, this
medicinal product should be administered only in
case of real need, under direct medical supervision.
Effects On Ability To Drive And Use Machines
Brufen does not interfere with the ability to drive
vehicles and to use machines.
Undesirable Effects
The widespread and extensive use of Ibuprofen
has emphasized that the incidence of adverse
reactions resulting from the administration of this
product is very restrained. Patients have more frequently reported skin rash, although these cases
were usually reversed quickly upon discontinuation
of therapy. In addition, some cases of dyspepsia
were reported, and, in some particularly sensitive
patients, some isolated cases of intestinal hemorrhage, gastroduodenal ulcer, even of the perforating
type, and of melena were observed. The following
adverse reactions were eventually reported: bronchospasm and several cases of thrombocytopenia,
neutropenia, aplastic agranulocytosis, hemolytic
anemia, reduction in hemoglobin and hematocrit levels, disorders affecting the Central Nervous System
(like depression, confusion), renal failure in patients
with impaired kidney function, congestive heart failure, hypertension.
Overdosage
In case of drug overdose, gastric lavage and normalization of blood electrolyte balance are strongly recommended. No specific antidote for Ibuprofen is known.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. Its
analgesic activity is of non narcotic type and is 8
to 30 times greater than that of acetylsalicylic acid.
Ibuprofen is a powerful inhibitor of prostaglandin
synthesis and exerts its activity by peripherally inhibiting its synthesis.
Pharmacokinetic Properties
Ibuprofen is well absorbed after oral administration;
when taken on an empty stomach, its peak serum
concentrations in man are reached after 45 minutes
approximately. The administration of equal doses of
drug, soon after food intake, has shown evidence
of a slackened absorption and has resulted in peak
plasma concentrations achieved in a time lag ranging between a minimum of an hour and a half to a
maximum of three hours. Its excretion takes place
rapidly and serum levels do not show evidence
of signs of cumulative effects. 44% of a dose of
Ibuprofen is recovered in the urine in the form of
pharmacologically inactive metabolites and 20%
of its administered dose is found unchanged in the
urine.
PHARMACEUTICAL INFORMATION
Incompatibilities
None.
Special Precautions for Storage
Store below 25°C,
How Supplied
Package containing 20 sachets. Each sachet contains 600 mg Ibuprofen