FLEXOMYCIN FORTE

Meloxicam + Paracetamol

PHARMACEUTICAL FORM: Coated Tablets

COMPOSITION: Each coated tablet contains:

Meloxicam 15mg
Paracetamol 500 mg
Excipients: Eudragit L-100 (Acrylic resin – anionic copolymer based on polymethacrylic acid and
methyl acrylate), Polyvinyl Pyrrolidone K-30, Lactose monohydrate, Microcrystalline Cellulose,
Pregelatinized starch, anhydrous lactose, Sodium starch glycolate, Talc, Magnesium stearate ,
Isopropyl alcohol, Purified water, Opadry white ll HP 2 (Polyvinyl alcohol, polyethylene glycol, talc,
titanium dioxide Cl 77891), DC yellow lake dye N° 10 Cl 47005, Blue Lacquer Dye FDC N°2 Cl
73015.

PHARMACOLOGICAL ACTION:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) derived from oxicam, which has
demonstrated anti-inflammatory, analgesic and antipyretic properties.
Meloxicam appears to inhibit prostaglandin biosynthesis in standard inflation models. In vivo
meloxicam inhibits prostaglandin biosynthesis more potently at the site of inflammation than in the
gastric mucosa or kidney.
Meloxicam selectively inhibits COX2 in relation to COX1. Evidence is currently accumulating that
COX2 inhibition provides the therapeutic effects of NSAIDs, while constitutive COX1 inhibition is
responsible for the adverse gastrointestinal, hematological, and renal effects.
Meloxicam is specially coated to promote the protection of the gastric mucosa and its complete
absorption at the intestinal level, guaranteeing optimal bioavailability.
The mechanism of analgesic absorption of paracetamol is not completely established, but it seems
to act by inhibiting the synthesis of prostaglandins in the central nervous system and to a lesser
extent through a peripheral action due to a blockage in the generation of the pain impulse.
Peripheral action may also be due to inhibition of prostaglandin synthesis or by inhibition of the
synthesis or actions of other substances that sensitize pain receptors to chemical or mechanical
stimulation. The antipyretic action occurs because it acts centrally on the hypothalamic regulation
center that produces peripheral vasodilation resulting in increased blood flow through the skin,
sweating and less heat. The central action probably includes inhibition of prostaglandin synthesis in
the hypothalamus.

INDICATIONS AND USES:

Symptomatic treatment of painful crisis in osteoarthritis.
Symptomatic treatment of rheumatoid arthritis.
Symptomatic treatment of ankylosing spondylitis.
Pain and fever of any etiology.

DRUG INTERACTIONS:
With oral anticoagulants such as ticlopidine, systemically administered heparin and thrombolytics,
increasing the risk of bleeding if administered concomitantly.
Its use with aspirin, salicylates or other NSAIDs is not recommended due to the risk of
gastrointestinal toxicity, so it is recommended that prolonged combination therapy should be done
under strict medical supervision. NSAIDs are associated with the potential risk of acute renal failure
in patients who are dehydrated; when using FLEXOMYCIN FORTE and diuretics, they should be
adequately hydrated at the start of treatment.
NSAIDs may potentiate cyclosporine nephrotoxicity via prostaglandin-mediated renal effects. Renal
function should be measured using combination therapy.
FLEXOMYCIN FORTE increases plasma levels of lithium, so this drug should be monitored when used
together.
It increases the hematological toxicity of methotrexate, so blood cell counts must be strictly
monitored. It may decrease the effectiveness of intrauterine devices.
May reduce the antihypertensive effect of beta-blockers, ACE inhibitors, vasodilators, diuretics.
Interactions with oral antidiabetics cannot be excluded.
The risk of hepatotoxicity may be increased in alcoholic patients taking single toxic doses or
prolonged use of high doses of FLEXOMYCIN FORTE.
Chronic use of barbiturates or pidone decreases the therapeutic effects of FLEXOMYCIN FORTE due
to an increase in metabolism due to an increase in the activity of hepatic microsomal enzymes.

FLEXOMYCIN FORTE interferes with the following biochemical tests:

• It may falsely lower blood glucose values when measured by the glucose
oxidase/peroxidase method but not when the hexokinase/glucose 6-phosphate
 dehydrogenase method is used.
• May cause false positives in qualitative analysis tests for 5-hydroxyindoleacetic acid, when
using the reagent nitrosonaphthol; The quantitative test is not affected.
• Pancreatic function tests using bentiromide may be invalid after the administration of
paracetamol since the latter is metabolized into an arylamine, which increases the
concentration of recovered para-aminobenzoic acid (PABA). Paracetamol should be
discontinued three days before administration of bentiromide.
• May cause a false increase in serum uric acid values when using the phosphotungstate
method.
Serum values of bilirubin, lactate dehydrogenase activity, prothrombin time and transaminase
activity may be increased indicating hepatotoxicity, especially in alcoholic patients.

CONTRAINDICATIONS:
Proven hypersensitivity to meloxicam, paracetamol or any of their components.
Active peptic ulcer, severe liver failure, severe non-dialyzed renal failure, children and adolescents
under 15 years of age. Pregnancy and breastfeeding.

PRECAUTIONS:
It should be used with caution in patients with a history of upper gastrointestinal disease and in
patients receiving treatment with anticoagulants.
Patients with gastrointestinal symptoms should be monitored and FLEXOMYCIN FORTE should be
discontinued if gastrointestinal bleeding or peptic ulcer occur. Bleeding, ulceration or perforation
may occur at any time during treatment with or without premonitory symptoms or previous history
of serious gastrointestinal events and the consequences are more serious in the elderly. If
mucocutaneous adverse effects occur, withdrawal of FLEXOMYCIN FORTE should be considered. In
patients with decreased renal blood flow or blood volume, administration of NSAIDs may precipitate
frank renal decompensation that is followed by recovery to the pretreatment state after
discontinuation of NSAID therapy. Patients at risk for this reaction are dehydrated patients, those
undergoing major surgical procedures that lead to hypovolemia.
In these patients, the volume of urine output and renal function should be carefully monitored at
the beginning of therapy. The dose of meloxicam in patients with renal failure undergoing
hemodialysis should not be greater than 7.5 mg; No dose reduction is required in patients with mild
or moderate renal impairment. Serum transaminases or other liver function parameters may
occasionally be increased.
If the abnormality is significant or persistent, administration of FLEXOMYCIN FORTE should be
discontinued and follow-up testing performed; no dose reduction is required in patients with
clinically stable liver cirrhosis. It should be used with caution in elderly patients who are more likely
to have compromised hepatic or cardiac function. Hypertension or heart failure may be precipitated
or exacerbated in susceptible patients because FLEXOMYCIN FORTE induces sodium and water
retention and interferes with the action of diuretics.

INCOMPATIBILITIES:
They have not been reported.

ADVERSE REACTIONS:
They may occur:
Gastrointestinal: Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea,
altered liver tests, belching, esophagitis, gastroduodenal ulcer, macroscopic gastrointestinal
bleeding, gastrointestinal perforation, colitis, hepatitis.
Hematological: Anemia, agranulocytosis, blood count alterations including differential leukocyte
count, leukopenia and thrombocytopenia and is greater with the use of myelotoxic drugs such as
methotrexate.
Dermatological: Pruritus, dermal erythema, stomatitis, urticaria, photosensitivity, reactions
bullous, erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrosis.
Respiratory: Asthmatic crisis in some patients after the administration of NSAIDs, including aspirin
and meloxicam.
Central Nervous System: Dizziness, headaches, vertigo, tinnitus, drowsiness.
Cardiovascular: Edema, increased blood pressure, palpitations, hot flashes.

Genitourinary: Alteration of renal function tests including creatinine and plasma ulcer, acute renal
failure, renal colic, renal failure, sterile pyuria.
Paracetamol can cause worsening of kidney function up to uremia in patients with pre-existing
kidney failure.
Hypersensitivity: Angioedema, allergic dermatitis and anaphylactic reactions.

Risk of serious adverse skin reactions such as allergic dermatitis, rash, pruritus, urticaria, edema,
Stevens-Johnson, Toxic Epidermal Necrolysis and Acute Generalized Exanthemic Pustulosis.
WARNINGS:
Do not administer to patients with asthmatic manifestations, nasal polyps, angioneurotic edema or
urticaria related to the administration of aspirin or other NSAIDs.
Contains Paracetamol, its use for more than seven days is not recommended. It can cause liver and
kidney damage. In adults, the limit dose of 4 g per day should not be exceeded. It should not be
used for more than three days for the treatment of fever, without consulting a doctor.

DOSAGE AND ROUTE OF ADMINISTRATION:

1 tablet per day in acute osteoarthritis.
1 tablet in rheumatoid arthritis or ankylosing spondylitis.
Do not exceed the dose of one tablet per day.
Administration way: Oral.

TREATMENT IN CASE OF OVERDOSE:

In case of overdose, use standard gastric evacuation measures and general supportive measures
since there is no known antidote. Cholestyramine has been shown to accelerate the elimination of
meloxicam.
Activated charcoal can be used for gastric lavage and is recommended when there is mixed drug
overdose. Acetylcysteine is the antidote used to protect against paracetamol-induced
hepatotoxicity. Hemodialysis or hemoperfusion removes acetaminophen from the circulation and
may be substituted if acetylcysteine cannot be administered within 24 hours of ingestion of a
massive acetaminophen overdose. Supportive care includes electrolyte balance, correction of
hypoglycemia, and administration of vitamin K, fresh frozen plasma, or clotting factor concentrate
(if prothrombin time exceeds ratio 3.0).
Patients in whom the overdose was intentional, known or suspected should be referred for
psychiatric consultation.

FORMS OF PRESENTATION:
Box with 4, 8, 16 coated tablets.
Dispenser boxes with 50, 100, 150, 200, 250, 300, 350, 400 coated tablets

SPECIAL STORAGE CONDITIONS:

Store in a dry environment, preferably between 15ºC and 30ºC and in tightly closed containers.
Keep the medicine out of the reach of children.

USEFUL LIFE TIME: 3 years

ADDRESS AND PHONE OF THE LABORATORY:

For more scientific information about the product, you can direct your correspondence to Av. Nicolás
Ayllón Nº 2931 Int. C-1 El Agustino - Lima 10 or call 439-4595, or write to [email protected]

Manufactured by LABORATORIOS INDUQUÍMICA SA, RUC 20101364152 Calle Santa Lucila Nº 152
Urb. Villa Marina, Chorrillos, Lima 09, telephone 617-6000; for SCOP DEL PERU SA RUC
20501932257, Av. Nicolás Ayllón Nº 2931 Int. C-1 El Agustino - Lima 10.