Cataflam

Cataflam

Cataflam®
NOVARTIS
AntHnflammatory and anti-rheumatic product, non-steroid, acetic actd derivative and ralatad substance
DESCRIPTION AND COMPOSITION
Pharmaceutical form Sugar-coated tablets Active substance
The active subatanca s pesetas im-|o-|(2.ft-dKWoropharryt)-amino(-pnanyt}-ac
•tala (« ckdotenac potassium) In Cataflam the sodium on ol ckctofsnec sodom
(Voltaren*) has bean replaced by t potassium on
One Cataflam sugar-coated tablet contains SO mg of dkflofenac potassium
Certain dosage strengSts may not be evaiabie si a* countnas
Active moiety
Otctotenec
Excipients
Cora: Magnaeom stearate povidone. a*ca coHoOal anhydrous, aodaim starch gtycoSala. maize starch calcium phosphate
Sugar-coat: MgrorrystsSna csSuloaa. potyathytane glycol 8000: rad Son onda (El 72) and Maraum dioxide (El 71) (dispersed Anstead). povidone talc; sue rose Polish: polyethylene glycol 8000; sucrose Imprint with porting n« etvta tar SO mg Pharmaceutical formulations may vary between countries
INDICATIONS
Short-term treatment in the toflowing acuta condMons:
Post-traumatic pain, inflammation and swelling, e g. due to sprains
Post-operative pan. inflammation and swelling, eg toflowing dental or or Ihopedic surgery
Painful anKor inflammatory conditions m gynecology, e g. primary dysmenorrhea or adnexitis.
Migraine attacks
Painful syndromes of the vertebral column
Non-artlcular rheumatism.
As an adjuvant in savers painful Inflammatory infections of the ear, nose or throat, e g. pharyngotonsillitis, otitis
In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
DOSAGE AND ADMINISTRATION
Dosage
As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest affective dose tor the shortest duration necessary to control symptoms (see section WARNINGS AND PRECAUTIONS) General target population
The recomme ided trvtmi deify dose IS too to ISO mg. In mOder cases. 75 to 100 mg daily is usually sufficient The total daily does should generally be divided into 2 or 3 separate doses, as applicable In primary dysmenorrhea, the daily doee should be individually adiusted and la generally 50 to 150 mg An nfliai dose of 60 mgn usually sufficient If necessary, an initial dose of 100 mg can be prescribed with a maximum of 200 mg/day reached over the course of several menstrual cycles Treatment should be started on appearance of the first symptoms and. depending on the symptomatology, continued tor a tow days In migraine, an kttoaf dose of 50 mg should be taken at the first signs of an impending attack In cases whsie pain roflsf withm 2 hours after the »rst doee is not sufficient, a further doee of 50 mg may betoken fl needed, further doses of 50 mg may be taken el sServato of 4 S»6 hours, not exceeding a total dose of 200 mg per day.
Special populations
Cataflam tatters are not 'acommended tor use m chfldron and adotescerSs below 14 years of age For treatment m children and adolescents befow 14 years of age. oral drops or suppositories of tketoienac 12 5 mg and 25 mg could be used For adolescents aged years and over, a daily dote of 75 to 100 mg Is usually
The maximum daOy dose of 150 mg should not be exceeded The total daily dose
should generally be dnnded into 2 to 3 separate doses, as applicable
The use of Cataflam (aN terms I in migraine attacks has not been eslabtshed m
Geriatrics (Patients sged 65 or above)
No adjustment ol the starting dose is required lor elderly patients (tea section WARNINGS ANO PRECAUTIONS)
Established cardiovascular disease or significant cardiovascular risk factors
Treatment with Cataflam it ganarafly not recommended in patients with established cardiovascular disease or uncontrolled hypertension. II needed, patients with established cardiovascular disease uncontrolled hypertension or significant risk factors tor cardiovascular dtoaass should be treated with Cataflam only after careful consideration and only at doass <100 mg dally it Irealed lor more than 4 weeks (see
Rsnal Impairment
Cataflam la contraindicated in patients with renal failure (see section CONTRAINDICATIONS). No specific studies have been carried out in paoenu with renal Impairment, therefore, no specific dose adjustment recommendations can be mad# Caution it advteaO whan administering Cataflam to patients with mild to moderate renal impairment (see section WARNINGS AND PRECAUTIONS) Hspatlc Impairment
Cataflam Is contraindicated in patients with hepatic failure (see section CONTRAINDICATIONS) No specific studies have been carried out in patients wflh hepatic impairment, therefore no specific dose adtustment recommendations can be made Caution is advised when admimstenng Cataflam to patients with mild to moderate hepatic impairment Isee section WARNINGS AND PRECAUTIONS) Mode of administration ffluS not be divided or chewed
CONTRAINDICATIONS
Known hypersensitivity to Sis active substance or any of the other exapwnts
Acflve gastoc or totosenaf utoer. b»e*ig or pertoraflon (see secSon WARN PfGS ANO PRECAUTIONS and also secSon ADVERSE DRUG REACTIONS)
- Last trimester of pregnancy (tee section WOMEN OF CHILD-BEARING POTENTIAL, PREGNANCY. BREAST-FEEDING ANO FERTILITY)
WARNINGS AND PRECAUTIONS
Gastrointestinal effects the etderty If
Cataflam, the medicinal product should be withdrawn As with ail NSAIOs. including dictotenac. dose medical particular caution should be exercized when present* symptoms Indicative ol gastrointestinal (Gl) disorders ol gastric or intestinal ulceration, bleeding or perforation DRUG REACTIONS) The risk ol Gl Weeding a higher and in patients with a history of ulcer, particularly if con perforation and In the elderly.
To reduce the risk ol Gl toxicity in patients with a history ol ulcer, particularly it complicated with hemorrhage or perforation, and m the etderty, the treatment should be initiated and maintained at the lowest effective dose.
ComWnatlon therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also tor patients requiring concomitant use of medicinal products containing low-dose aoetytsabcytic acid (ASA) or other medicinal products likely to Increase gastrointestinal risk.
Patients with a Malory ol Gl toxicity, particularly the etderty. should report any
ulceration or Weeding, such as RrttemK corticostoroids. anticoagulants, anti platelet agents or selective serotomn-reuptake inhibitors (sea section INTERACTIONS). Close medical surveillance and caution should also be exercized in patients wiSi ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section ADVERSE DRUG REACTIONS)
significant nsk factors tor cardiovascular di
* i and smoking) should be
id only at doses *100 mg dairy when treatment continues lor more men 4 weeks as the cankovaacutar risks ol dkSofonae may ncrease with dose and duration of exposure, the lowest effective daily doee should be used tor the shortest
should be re-evakialed penockcafly espeaafly whan treatnent continues tor more than 4 weeks Patients should remain alert lor the signs and symptoms of senoui arteriothrombofic events (e g chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings Patients should be instructed to see t physician immediately In case of such an event Hematologic effects
Use of Cataflam It recommended only tor short-term treatment It. however. Cataflam Is used tor a prolonged period, monitoring ol the Wood count is recommended, as with other NSAIDs
Like other NSAIDs. Cataflam may tomporanty inhibit platelet aggregation Patients with detects ol hemostasis should be carefully monitored Respiratory effects (Pre-existing asthma)
In patients with asthma, seasonal allergic rhinitis, swelling ol the nasal mucosa (i.a. nasal DOfvDSi chronic obstructive nulnvmarv diseases or chronic infections of the
Hspafoblllary effects
Close medical surveillance is required when prescribing Cataflam to patients with impaired hepatic function, as Swfr condfiion may be exacerbated As wflh other NSAIDs. including ckdoienac. values of one or more Over enzymes may increase During protongsd treatment with Cataflam. regular monitoring ol hapeSc function is ndicatsd as a precautionary msaaura. It abnormal kvsr function Mats peril or worsen, it ckmcal signs or symptoms oonttotont wflh kver disease develop, or If other manifestations occur (a.g. eosmophike. rash). Cataflam should be discontinued Hepatitis may occur with use W didofenac without prodromal symptoms Caution is cased tor when using Cataflam in pabsnts with hepeke porphyna. since « may trigger an attack

Rsnal effects
As flute retention and edema have Been reported naaoci non wflh NSAIO therapy.

Geriatric patient
Caution Is indicated fit the etderty on basic medical grounds. In particular it M recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight.
Interactions with NSAIDs
The concomitant use ol Cataflam with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential tor additive undesirable effects (see section INTERACTIONS)
Masking signs of infections
Like other NSAIDs. Cataflam may mask the signs and symptoms of infection due to its pharmacodynamic properties
ADVERSE DRUG REACTIONS
Adverse drug reactions from ckmcal triala and/or spontaneous or kterature reports (Table 1) are listed by MedDRA system organ class Wfltun each system organ class, the adverse drug reactions are ranked by frequency, wflh the most trequsnt reactions first Within each frequency grouping, edverse drug reactions are
In addition, the consaponckng frequency category tor each adverse drug reaeflon is based on the toflowing convention (CIOMS III) very oommon (>1/10). common
(*1/100 to <1/10); uncommon (*t/1.000 to <1/100). rare (xt/10.000 to <1/1.000); very rare (<1/10.000) The toflowing undesirable effects nctuds those reported with Cataflam sugar-coated tablets and/or other pharmaceutical forms of diclofenac, wflh either short-term or teng-lerm use
Table 1 Adverse drug reactions
reaction, purpura. Henoch-Schontoxi purpura, prunlus
al and urinary disorders
 General disorders and administration site conditions
Observed interactions to be considered
Potent CYP2C9 'Inhibitor*: Caifllon to recommend* when co-preacrtbmg didoienac with potent CYP2C9 inhibitors (such as voriconazole), which could result sse in peak plasma concentrations and exposure lo didoienac
  Very rare: Hypertension, vasculitis
Respiratory, thoracic and mediastinal disorders
Rare Asthma (including dyspnta)
Vary rare: Pneumonitis
• The frequency reflects data from long-term treatment wflh a high doee (150mgldey)
Description ot selected adverse drug reactions
Mela analysis and pharmacoepidemtological data point towards a small increased risk of artertothrombottc events (for example myocardial infarction) associated with the use of didoienac. particularly at a high dose (1 SO mg daily) and during long-term treatment (see section WARNINGS AND PRECAUTIONS)
INTERACTIONS
The following interactions indude It
converting enzyme (ACE) aifxbflorsl rr effed Therefore the combination should be as especially the etderty should have their blood pressure periodicaty monitored l should be £v*n to
WOMEN OF CHILD-BEARING POTENTIAL, PREGNANCY. BREAST-FEEDING AND FERTILITY
Woman ot child-boaring potential
Breast-feeding
Like other NSAIDs
Therefore. Cataftam should not be administereo during breeaf-feedwig avoid undesirable effects m the infant Fertility
As wflh other NSAIOs. the use of Cataflam may impas tomato fertility and to not recommended m woman attempting to conceive In women who have difficulties conceiving or who are undergoing investigation of IniartilMy. withdrawal of Cataflam should be considered
OVERDOSAGE
Therapeutic measures
Management of acute poisoning with NSAIDs, including rflclotonac, essentially consists of supportive measures and symptomatic treatment Supportive measures and symptoqtafic treatment should be given for complications such as hypotension, renal failure, convulsjjpk gastrointestinal disorder, and respiratory depression Special measures su?Wks forced diuresis, dialysis or hemopertusion are probably of ■0 help m eliminating NSAIDs. including rkdofenac. due lo the high protein binding
in the plasma, and they remain higher tor up to 12 he ad In a low concentration (100 ng/tnL) In ' nursing mother The estimated amount tn| is equivalent to a 0 03 mg/kg/day dose
takes placa partly by ghicuroradaScn ot N intact molecule but manly by single and multiple hydroxytakon and mefhoxylation. resulbng n several pfwnokc metaboMes (3 -hydroxy , 4 -hydroxy-. 5-hydroxy . 4.5-dfliydroxy- and 3'-hydroxy-4’-me«hOjry-actofenec). most of which vs converted
coniugale of the mad molecule are converted to 0ucuro»de ixmjugatoe. Lass than 1% is excreted as unchanged subatanca The rest of tie dose ■ ekmmated as metaboMes through the Me in
Unearlty/non-iinearlty
The amount abeofbed to in Inear proportion to tie siza of the dooe.
Special populations
No relevant age-dependent differences in Via drug’s absorption, metabolism, or axersbon have bean observed
n patients suffsring from rsnal Impairment, no accumulation of tie unchanged
m single-dose kinetics whsn applying the
clearance ol less than to mL/min, the its of the hydroxy metabolites are about 4 limes
highsr than in normal subfeds.
However, the metabolites are ultimately cleared through the bile
In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and
metabolism ot dldofenac are the same as In patients without Itver disease
section WARNINGS AND PRECAUTIONS)
  respiratory tract (especially If linked to allsrgic rhinitis-like symptoms), reactions on NSAIDs like asthma exacarbalions (so-called intolerance to analgesics/ analgesics asthma). Quincke's edema or urticaria are more frequent than m other pettents. Therefore, special precaution is recommended in such patients (readiness lor emergency) This Is applicable as well for patients who are allergic to other substances eg with skin reactions, pruritus or urticaria
or renal tunebon. history of hypertension. Sw elderly, patients receiving concomitant treatment wflh dwreScs or merkcinal products that can significantly snpect renal function, and in those patients with substantial extracefiular volume depletion from any cause, e g. before or after major surgery (see taction CONTRAINDICATIONS) Monitoring of rsnal function is recommended as a precautionary measure when using Cataflam in such cases Discontinuation of taerapy is usually toflowed by recovery to the pre-treatment state.
Blood and lymphatic system disorders
Very rare Thrombocytopenia, leukopenia, anemia (nctuckng hemolytic and aplastic anemia), agranutocytosis Immune system disorders
Rare Hypersensitivity anaphylactic and anaphylactoid reactions
Including hypotension and shock)
Very rare; Angioedema (including lace edema)
Psychiatric disorders
Very rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder Nervous system disorders
Common: Headache, dizziness
Very rare: Paresthesia, memory impairment, convulsion, anxiety, tremor, meningitis aseptic, dysgeusia. cerebrovascular accident
Eye disorders
Very rare; Visual impairment, vision blurred diplopia Ear and labyrinth disorders Common: Vertigo
Vary rare: Tinnitus, hearing impaired
CLINICAL STUDIES
Cataflam to a wet established produd.
CLINICAL PHARMACOLOGY
Cataflam labials have a rapid one si of ackon which makes them parkcutorty suflabto
• - SrAS and t
 necessitating changes in the dosage of the antidiabetic agents during tra ‘ ‘ Forth
re during concomitant therapy
Sn plasma conce
re to phenytotn.
on I
hi 24 hours b<
in NSAIDs. including didoienac a
dose of equal siza.
accumulation occurs provided the recommended dosage intervals are observed
Distribution
99.7% of didoienac binds lo serum proteins, mainly to atoumin (99.4%). The apparent volume of distribution calculated is 0.12 to 0.17 LAg Diclofenac enters the synovial fluid, where maximum oc
NON-CLINICAL SAFETY DATA
 Jt suppress proteoglycan biosynthesis in cartilage
headache and m improving the accompanying symptoms na

serum potassium levels, which should therefore be monitored frequently (see section WARNINGS ANO PRECAUTIONS) rtfbectertato: Thera have bean n due lo ooncomrtant use of qumolones and NSAIDs Anticipated interactions to be considered
— d corffcooM - "
: NSAIDs o
increased risk of hemorrhage In patients receiving di concomitantly close monltonng of such patients is therefore recommended. Se/ecr/ve serolonln rauplake Inhibitor* (SSHIa): Concomitant administration ot systemic NSAIDs. including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section WARNINGS AND PRECAUTIONS) AnttdlMbollct: Clinical studies have shown that diclofenac can be given together
Pharmacokinetics (PK)
Absorption
The absorption sets in immediately after administration and the same amount is absorbed as from an squivatont dose of diclofenac sodium gsatro-resistant tablets Mean peak plasma concentrations of 3.8 micro mol/L are attained after 20 to 60 minutes after ingestion of one tablet of 50 mg Ingestion together with food has no influence on the amount of diclofenac absorbed although onset and rate of absorption may be slightly delayed.
Since about half of diclofenac to metabolized during its first pessage through the liver (first pass" effect), the area under the concentration curve (AUC) Is about
INCOMPATIBILITIES
STORAGE
See tokkng box.
Cataflam tablets should not be used after the date marked "EXP" on the pack Cataflam tablets must be kept out of the reach and sight of children.
INSTRUCTIONS FOR USE AND HANDLING
No special requirements
Manufacturer: * - registered trademark
Novartis Pharma AG. Basel, Switzerland